Ciprofloxacin (Systemic) (Lexi-Drugs)

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Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(sip roe FLOKS a sin)

Brand Names: US

Cipro; Cipro in D5W; Cipro XR

Brand Names: Canada

ACT Ciprofloxacin; APO-Ciproflox; Auro-Ciprofloxacin; BIO-Ciprofloxacin; Cipro; Cipro XL; DOM-Ciprofloxacin; GEN-Ciprofloxacin; GMD-Ciprofloxacin; JAMP-Ciprofloxacin; Mar-Ciprofloxacin; MINT-Ciproflox; MINT-Ciprofloxacin [DSC]; MYLAN-Ciprofloxacin [DSC]; NU-Ciprofloxacin [DSC]; PHL-Ciprofloxacin [DSC]; PMS-Ciprofloxacin; PMS-Ciprofloxacin XL; Priva-Ciprofloxacin; PRO-Ciprofloxacin; RAN-Ciproflox; RATIO-Ciprofloxacin; RIVA-Ciprofloxacin; SANDOZ Ciprofloxacin; Septa-Ciprofloxacin; TARO-Ciprofloxacin; TEVA-Ciprofloxacin [DSC]; VAN-Ciprofloxacin

Pharmacologic Category

Antibiotic, Fluoroquinolone

Dosing: Adult

Note: Extended-release tablets and immediate-release formulations are not interchangeable. Unless otherwise specified, oral dosing reflects the use of immediate-release formulations.

Anthrax: Note: Consult public health officials for event-specific recommendations.

Inhalational exposure (postexposure prophylaxis):

Oral: 500 mg every 12 hours for 60 days

IV: 400 mg every 12 hours for 60 days

Note: Anthrax vaccine should also be administered to exposed individuals (CDC [Hendricks 2014]).

Cutaneous (without systemic involvement), treatment (off-label use): Oral: 500 mg every 12 hours for 7 to 10 days after naturally acquired infection; 60 days following biological weapon-related event. Note: Patients with cutaneous lesions of the head or neck or extensive edema should be treated for systemic involvement (CDC [Hendricks 2014]).

Systemic (meningitis excluded), treatment (off-label use): IV: 400 mg every 8 hours, in combination with other appropriate agents for 2 weeks or until clinically stable, whichever is longer (CDC [Hendricks 2014])

Meningitis, treatment (off-label use): IV: 400 mg every 8 hours, in combination with other appropriate agents for 2 to 3 weeks or until clinically stable, whichever is longer (CDC [Hendricks 2014])

Note: Following the course of IV combination therapy for systemic anthrax infection (including meningitis), patients exposed to aerosolized spores require oral monotherapy to complete a total antimicrobial course of 60 days (CDC [Hendricks 2014]).

Bite wound infection, prophylaxis or treatment (animal and human bites) (alternative agent) (off-label use): Note: Use in combination with an appropriate agent for anaerobes.

Oral: 500 to 750 mg twice daily

IV: 400 mg every 12 hours

Duration of therapy: 3 to 5 days for prophylaxis; duration of treatment for established infection varies based on clinical response and patient-specific factors (Baddour 2019a; Baddour 2019b; IDSA [Stevens 2014]).

Cat scratch disease, lymphadenitis (nondisseminated) (alternative agent) (off-label use): Oral: 500 mg twice daily (Holley 1991). Additional data may be necessary to further define the role of ciprofloxacin in this condition.

Chancroid (alternative agent) (off-label use): Oral: 500 mg twice daily for 3 days (CDC [Workowski 2015])

Cholera (Vibrio cholerae) (alternative agent) (off-label use): Oral: 1 g as a single dose (IDSA [Guerrant 2001]; Khan 1996)

Chronic obstructive pulmonary disease, acute exacerbation (off-label use): Oral: 500 to 750 mg twice daily (Nouira 2010; Umut 1999) for 5 to 7 days (GOLD 2018). Note: Some experts reserve ciprofloxacin for patients with complicated COPD (eg, age ≥65 years, FEV1 <50% predicted, frequent exacerbations, major comorbidities) at risk of Pseudomonasinfection (Bartlett 2019; Sethi 2008).

Crohn disease, treatment of simple perianal fistulas (off-label use): Oral: 500 mg twice daily; treat for 4 to 8 weeks with or without metronidazole (ACG [Lichtenstein 2018]).

Diabetic foot infections (off-label use) (IDSA [Lipsky 2012]; Weintrob 2017): Note: When used as empiric therapy, ciprofloxacin should be used in combination with other appropriate agents.

Moderate: Oral: 500 mg every 12 hours (750 mg every 12 hours if Pseudomonas aeruginosa is suspected)

Moderate to severe: IV: 400 mg every 12 hours (400 mg every 8 hours if P. aeruginosa is suspected)

Endocarditis due to HACEK organisms (alternative agent) (off-label use) (AHA [Baddour 2015]):

Oral: 500 mg every 12 hours for 4 weeks (native valve) or 6 weeks (prosthetic valve)

IV: 400 mg every 12 hours for 4 weeks (native valve) or 6 weeks (prosthetic valve)

Granuloma inguinale (donovanosis) (alternative agent) (off-label use): Oral: 750 mg twice daily for at least 3 weeks (and until lesions have healed) (CDC [Workowski 2015]). Note:If symptoms do not improve within the first few days of therapy, another agent (eg, aminoglycoside) can be added (CDC [Workowski 2015]).

Intraabdominal infection (including perforated appendix, appendiceal abscess, acute diverticulitis, acute cholecystitis), community-acquired: Note: For empiric therapy, usually administered in combination with metronidazole. The addition of metronidazole may not be necessary for uncomplicated biliary infection of mild to moderate severity (IDSA [Solomkin 2010]; Vollmer 2019).

Oral: 500 mg every 12 hours

IV: 400 mg every 12 hours

Duration of therapy: Duration depends on whether source of infection has been controlled. Guidelines recommend treatment duration of 4 to 7 days (provided source controlled) (IDSA [Solomkin 2010]).

Meningitis, bacterial (community-acquired or health care-associated) (alternative agent) (off-label use): IV: 400 mg every 8 to 12 hours; for empiric therapy, must be used in combination with other appropriate agents (IDSA [Tunkel 2004]; IDSA [Tunkel 2017])

Meningococcal meningitis prophylaxis (off-label use): Oral: 500 mg as a single dose (CDC 2005)

Neutropenia (chemotherapy-induced), antibacterial prophylaxis in high-risk patients anticipated to have an ANC ≤100 cells/mm3 for >7 days (off-label use): Oral: 500 to 750 mg twice daily (IDSA [Freifeld 2011]; Wingard 2019); some clinicians will provide antibacterial prophylaxis if ANC is anticipated to be <500 cells/mm3 for >7 days (Wingard 2019). For hematopoietic cell transplant recipients, begin at the time of stem cell infusion and continue until recovery of neutropenia or until initiation of empiric antibiotic therapy for neutropenic fever (Tomblyn 2009).

Neutropenic fever, low-risk cancer patients (empiric therapy) (off-label use): Oral: 750 mg every 12 hours (Kern 1999; Kern 2013) in combination with amoxicillin and clavulanate; continue until fever and neutropenia have resolved. Note: Avoid in patients who have received fluoroquinolone prophylaxis. Administer first dose in the health care setting (after blood cultures are drawn); observe patient for ≥4 hours before discharge (ASCO/IDSA [Taplitz 2018]; IDSA [Freifeld 2011]).

Osteomyelitis:

Oral:

Treatment: 500 to 750 mg every 12 hours; when treating P. aeruginosa, 750 mg every 12 hours (Calhoun 2005; IDSA [Berbari 2015])

Chronic suppression in presence of retained infected orthopedic hardware: 250 to 500 mg every 12 hours (IDSA [Osmon 2013])

IV: 400 mg every 12 hours; when treating P. aeruginosa, 400 mg every 8 hours (Calhoun 2005; IDSA [Berbari 2015])

Peritoneal dialysis catheter, exit-site or tunnel infection (off-label use): Oral: 250 mg twice daily. When used for empiric therapy, must be used in combination with other appropriate agents (ISPD [Szeto 2017]).

Peritonitis, spontaneous bacterial (prevention), high-risk patients (eg, hospitalized patients with Child-Pugh class B or C cirrhosis and active GI bleeding) (alternative agent) (off-label use) (Runyon 2017):

Oral: 500 mg every 12 hours; total duration of therapy is 7 days (parenteral and oral)

IV (alternative for nonfunctional GI tract): 400 mg every 12 hours; total duration of therapy is 7 days (parenteral and oral)

Long-term secondary SBP prophylaxis: Oral: 500 mg once daily

Plague (Yersinia pestis) infection (alternative agent) (CDC [plague] 2015): Note: Consult public health officials for event-specific recommendations:

Postexposure prophylaxis: Oral: 500 mg twice daily for 7 days

Treatment: Note: Duration of therapy is 10 to 14 days

Oral: 500 to 750 mg every 12 hours

IV: 400 mg every 8 to 12 hours

Pneumonia, community-acquired, as a component of empiric therapy for P. aeruginosa coverage (hospitalized patient) (off-label use) (File 2017; IDSA/ATS [Mandell 2007]): Note: For empiric therapy, must be used in combination with other appropriate agents.

Oral: 750 mg every 12 hours

IV: 400 mg every 8 hours

Duration of therapy: Minimum of 5 days and varies based on disease severity and response to therapy. Patients should be afebrile for ≥48 hours and clinically stable prior to discontinuation.

Pneumonia, hospital-acquired (nosocomial) (including ventilator-associated), as a component of empiric therapy for P. aeruginosa coverage (IDSA [Kalil 2016]; Klompas 2019): Note: For empiric therapy, must be used in combination with other appropriate agents.

Oral: 750 mg every 12 hours

IV: 400 mg every 8 hours

Duration of therapy: 7 days; may be individualized based on patient-specific factors and response to therapy.

Prostatitis (acute bacterial) (off-label use):

Oral: 500 mg every 12 hours (Meyrier 2017a)

IV: 400 mg every 12 hours (Meyrier 2017a)

Duration of therapy: 6 weeks (Meyrier 2017a; Yoon 2013)

Prostatitis (chronic bacterial): Oral: 500 mg every 12 hours for ≥6 weeks (Meyrier 2017b)

Prosthetic joint infection (off-label use): Note: Alternative agent for certain pathogens.

Treatment:

Gram-negative bacilli:

Oral: 750 mg twice daily (IDSA [Osmon 2013])

IV: 400 mg every 12 hours (IDSA [Osmon 2013]); some experts prefer 400 mg every 8 hours for infections caused by P. aeruginosa (Berbari 2019).

Staphylococci: Oral: 500 to 750 mg twice daily (Berdal 2005; Zimmerli 1998). Note: For use in combination with rifampin, following pathogen-specific IV therapy in patients undergoing 1-stage exchanges or debridement with retention of prosthesis (IDSA [Osmon 2013]).

Chronic suppressive therapy for P. aeruginosa: Oral: 250 to 500 mg twice daily (IDSA [Osmon 2013])

Salmonella species, GI infection:

Nontyphoidal, severe (nonbacteremic) illness or any severity in patients at high risk for invasive disease: Oral: 500 mg twice daily for 3 to 7 days. Note: Immunosuppressed patients require longer duration of treatment (eg, weeks to months) (Hohmann 2017; IDSA [Guerrant 2001]).

Typhoid fever (Salmonella typhi and paratyphi): Severe disease or mild to moderate infection in patients at high risk of developing invasive disease (Ryan 2017)

Oral: 500 mg every 12 hours for 7 to 10 days

IV: 400 mg every 12 hours for 7 to 10 days

Septic arthritis (without prosthetic material) (alternative agent): Note: Use in combination with an aminoglycoside for initial treatment if P. aeruginosa suspected (Goldenberg 2019).

Oral: 500 to 750 mg twice daily

IV: 400 mg every 12 hours

Duration of therapy: 3 to 4 weeks (in the absence of osteomyelitis), including oral step-down therapy (Goldenberg 2019).

Shigella GI infection (off-label dose): Oral: 500 mg twice daily or 750 mg once daily for 3 days; the duration should be extended to 5 to 7 days for those with S. dysenteriae type 1 infection or HIV coinfection (Agha 2017; IDSA [Guerrant 2001]).

Surgical (preoperative) prophylaxis (alternative agent) (off-label use): Note: Use in combination with other appropriate agents may be warranted (procedure-dependent). IV: 400 mg within 120 minutes prior to surgical incision (Bratzler 2013)

Surgical site infection (intestinal or GU tract, perineum, or axilla) (off-label use) (IDSA [Stevens 2014]):

Oral: 750 mg every 12 hours, in combination with metronidazole

IV: 400 mg every 12 hours, in combination with metronidazole

Traveler’s diarrhea, uncomplicated (empiric therapy) (off-label dose): Oral: 500 mg twice daily for 3 days or 750 mg as a single dose (ACG [Riddle 2016]; Riddle 2017). If symptoms not resolved after 24 hours following single-dose therapy, continue with 500 mg twice daily for 2 more days. The 3-day therapy course is recommended in patients with fever or dysentery; enteric infection due to Shigella dysenteriae is an exception as a 5-day treatment duration appears to be superior to single-dose or 3-day regimens (ACG [Riddle 2016]). Note: Fluoroquinolone resistance is increasing; azithromycin may be preferred, particularly in regions such as Southeast Asia or India with a high prevalence of Campylobacter (ACG [Riddle 2016]).

Tularemia (Francisella tularensis) (off-label use): Note: Consult public health officials for event-specific recommendations.

Mild disease: Oral: 500 or 750 mg twice daily for 10 to 14 days (Bossi 2004; Dennis 2001)

Postexposure prophylaxis: Oral: 500 or 750 mg twice daily for 14 days (Bossi 2004; Dennis 2001)

Urinary tract infection:

Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder and no systemic signs/symptoms of upper tract or systemic infection): Note: Use for uncomplicated urinary tract infections is discouraged due to significant E. coli resistance and safety issues; reserve for clinical situations where other appropriate treatment options cannot be used (Bidell 2016; IDSA [Gupta 2011]). Females:

Oral, immediate release: 250 mg every 12 hours for 3 days

Oral, extended release: 500 mg every 24 hours for 3 days

UTI, complicated (including pyelonephritis): Note: If the prevalence of fluoroquinolone resistance is >10%, an initial dose of a long-acting parenteral antimicrobial, such as ceftriaxone, or a consolidated 24-hour dose of an aminoglycoside is recommended for outpatients (Hooton 2018; IDSA [Gupta 2011]).

Oral, immediate release: 500 mg every 12 hours for 5 to 7 days

Oral, extended release: 1,000 mg every 24 hours for 5 to 7 days

IV (inpatient): 400 mg every 12 hours for a total of 5 to 7 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Manufacturer’s labeling:

Oral, immediate release:

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 50 mL/minute: 250 to 500 mg every 12 hours

CrCl 5 to 29 mL/minute: 250 to 500 mg every 18 hours

ESRD on intermittent hemodialysis (IHD)/peritoneal dialysis (PD) (administer after dialysis on dialysis days): 250 to 500 mg every 24 hours

Oral, extended release:

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl ≤30 mL/minute:

Cystitis, acute uncomplicated: No dosage adjustment necessary.

UTI, complicated (including pyelonephritis): 500 mg every 24 hours

ESRD on intermittent hemodialysis (IHD)/peritoneal dialysis (PD) (administer after dialysis on dialysis days): 500 mg every 24 hours

IV:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 5 to 29 mL/minute: 200 to 400 mg every 18 to 24 hours

Alternative recommendations: Oral (immediate release), IV:

CrCl >50 mL/minute: No dosage adjustment necessary (Aronoff 2007).

CrCl 10 to 50 mL/minute: Administer 50% to 75% of usual dose every 12 hours (Aronoff 2007).

CrCl <10 mL/minute: Administer 50% of usual dose every 12 hours (Aronoff 2007).

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Minimally dialyzable (<10%): Oral: 250 to 500 mg every 24 hours or IV: 200 to 400 mg every 24 hours (Heintz 2009). Note: Dosing dependent on the assumption of 3 times weekly, complete IHD sessions.

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH/CVVHD/CVVHDF: IV: 200 to 400 mg every 12 to 24 hours

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling. Use with caution in severe impairment.

Dosing: Pediatric

Note: In pediatric patients, ciprofloxacin is not routinely first-line therapy, but after assessment of risks and benefits, can be considered a reasonable alternative for some situations [eg, anthrax, resistance (cystic fibrosis)] or in situations where the only alternative is parenteral therapy and ciprofloxacin offers an oral therapy option (Bradley 2011b). Oral liquid products are available in two concentrations (ie, 50 mg/mL and 100 mg/mL); precautions should be taken to verify product selection and avoid confusion between the different concentrations. Extended release tablets and immediate release formulations are not interchangeable.

General dosing, susceptible infection (Red Book [AAP 2015]): Infants, Children, and Adolescents:

Mild to moderate infections: Oral, immediate release: 10 mg/kg/dose twice daily; maximum dose: 500 mg/dose

Severe infections:

Oral, immediate release: 15 to 20 mg/kg/dose twice daily; maximum dose: 750 mg/dose

IV: 10 mg/kg/dose every 8 to 12 hours; maximum dose: 400 mg/dose

Anthrax: Infants, Children, and Adolescents:

Cutaneous, without systemic involvement: AAP recommendations: Oral, immediate release: 15 mg/kg/dose every 12 hours; maximum dose: 500 mg/dose. Duration: 7 to 10 days for naturally acquired infection, up to 60 days for biological weapon-related event (AAP [Bradley 2014])

Inhalational (postexposure prophylaxis):

Oral, immediate release: 15 mg/kg/dose every 12 hours for 60 days; maximum dose: 500 mg/dose

IV: 10 mg/kg/dose every 12 hours for 60 days; maximum dose: 400 mg/dose; may substitute oral antibiotics for IV antibiotics as soon as clinical condition improves

Systemic (including meningitis): AAP recommendations (Bradley 2014):

Initial treatment as part of combination therapy: IV: 10 mg/kg/dose every 8 hours; maximum dose: 400 mg/dose; continue until clinical criteria for stability are met

Oral step-down to complete a 60 day total course: Oral, immediate release: 15 mg/kg/dose twice daily

Campylobacteriosis, HIV-exposed/-infected (HHS [adult] 2015): Duration of therapy: 7 to 10 days for gastroenteritis, at least 14 days for bacteremia, 2 to 6 weeks for recurrent bacteremic disease

Oral, immediate release: Adolescents: 500 to 750 mg every 12 hours

IV: Adolescents: 400 mg every 12 hours

Catheter (peritoneal dialysis); exit-site or tunnel infection: Infant, Children, and Adolescents: Oral, immediate release: 10 to 15 mg/kg/dose once daily; maximum dose: 500 mg/dose (Warady [ISPD 2012])

Chancroid: Adolescents: Oral, immediate release: 500 mg twice daily for 3 days (Red Book [AAP 2015])

Cystic fibrosis: Limited data available: Children and Adolescents:

Oral, immediate release: 20 mg/kg/dose every 12 hours; maximum dose: 1,000 mg/dose (Stockmann 2012)

IV: 10 mg/kg/dose every 8 hours; maximum dose: 400 mg/dose (Stockmann 2012)

Endocarditis, culture negative, empiric therapy: AHA guidelines (Baltimore 2015): Administer in combination with other antibiotics: Children and Adolescents:

Oral, immediate release: 10 to 15 mg/kg/dose twice daily for 4 to 6 weeks; maximum dose: 750 mg/dose

IV: 10 to 15 mg/kg/dose twice daily for 4 to 6 weeks; maximum dose: 400 mg/dose

Infectious diarrhea: Limited data available:

Cholera: Infants, Children, and Adolescents: Oral, immediate release: 15 mg/kg/dose twice daily for 3 days; maximum dose: 500 mg/dose (Red Book [AAP 2015]; WHO 2012). Alternately, 20 mg/kg/dose as a single dose has been used (Red Book [AAP 2015]).

Shigellosis dysentery:

Non-HIV-exposed/-infected: Infants, Children, and Adolescents: Oral, immediate release: 15 mg/kg/dose twice daily for 3 days; maximum dose: 500 mg/dose (WHO 2005)

HIV-exposed-infected (HHS [adult] 2015): Adolescents: Duration of therapy: 7 to 10 days for gastroenteritis, at least 14 days for bacteremia, up to 6 weeks for recurrent infection

Oral, immediate release: Adolescents: 500 to 750 mg every 12 hours

IV: Adolescents: 400 mg every 12 hours

Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 10 to 15 mg/kg/dose every 12 hours; maximum dose: 400 mg/dose (IDSA [Solomkin 2010])

Meningococcal invasive disease prophylaxis, high-risk contacts: Infants, Children, and Adolescents: Oral: Immediate release: 20 mg/kg as a single dose, maximum dose 500 mg/dose (Red Book [AAP 2015])

Mycobacterium avium Complex, severe or disseminated disease, HIV-exposed/-infected (HHS [pediatric] 2013): Infants and Children: Oral, immediate release: 10 to 15 mg/kg/dose twice daily in addition to other antibiotics; maximum dose: 750 mg/dose

Plague:

Manufacturer’s labeling: Infants, Children, and Adolescents:

Oral, immediate release: 15 mg/kg/dose every 8 to 12 hours for 10 to 21 days; maximum dose: 500 mg/dose

IV: 10 mg/kg/dose every 8 to 12 hours for 10 to 21 days; maximum dose: 400 mg/dose

Alternate dosing (CDC [plague] 2015): Children and Adolescents:

Treatment:

Initial treatment: IV: 15 mg/kg/dose every 12 hours; maximum dose: 400 mg/dose; continue until 2 days after fever subsides, then may change to oral therapy

Oral step-down to complete a 10 to 14 day course: Oral, immediate release: 20 mg/kg/dose twice daily; maximum dose: 500 mg/dose

Postexposure prophylaxis: Oral, immediate release: 20 mg/kg twice daily for 7 days; maximum dose: 500 mg/dose.

Pneumonia, community acquired (Haemophilus influenza): Infants >3 months and Children: IV: 15 mg/kg/dose every 12 hours (IDSA/PIDS [Bradley 2011a])

Salmonellosis, HIV-exposed/-infected (HHS [adult] 2015): Duration of therapy: At least 7 to 14 days if CD4 > 200 cells/mm2, 2 to 6 weeks if CD4 <200 cells/mm2

Oral, immediate release: Adolescents: 500 to 750 mg every 12 hours

IV: Adolescents: 400 mg every 12 hours

Surgical prophylaxis: Children and Adolescents: IV: 10 mg/kg within 120 minutes prior to surgical incision; maximum dose: 400 mg/dose (ASHP [Bratzler 2013])

Tularemia, mild disease: Limited data available: Infants, Children, and Adolescents:

Treatment or contained casualty situation: IV: 15 mg/kg/dose twice daily for at least 10 days; maximum dose: 400 mg/dose (Dennis 2001; WHO 2007)

Prophylaxis, mass casualty situation: Oral, immediate release: 15 mg/kg/dose twice daily for 14 days; maximum dose: 500 mg/dose (Dennis 2001)

Urinary tract infection:

Cystitis, acute uncomplicated: Adolescents ≥ 18 years: Oral, extended release: 500 mg every 24 hours for 3 days

Complicated (including pyelonephritis):

Oral, immediate release: Children and Adolescents: 10 to 20 mg/kg/dose every 12 hours for 10 to 21 days; maximum dose: 750 mg/dose

Oral, extended release: Adolescents ≥18 years: 1,000 mg every 24 hours for 7 to 14 days

IV: Children and Adolescents: 6 to 10 mg/kg/dose every 8 hours for 10 to 21 days; maximum dose: 400 mg/dose

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents:

IV and Oral, immediate release: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following guidelines have been used by some clinicians (Aronoff 2007):

GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary

GFR 10 to 29 mL/minute/1.73m2: 10 to 15 mg/kg/dose every 18 hours

GFR <10 mL/minute/1.73m2: 10 to 15 mg/kg/dose every 24 hours

Hemodialysis/peritoneal dialysis (PD) (after dialysis on dialysis days): Minimally dialyzable (<10%): 10 to 15 mg/kg/dose every 24 hours

CRRT: 10 to 15 mg/kg/dose every 12 hours

Oral, extended release: Adolescents ≥18 years:

CrCl ≥30 mL/minute: No dosage adjustment necessary

CrCl <30 mL/minute: 500 mg every 24 hours

Hemodialysis/peritoneal dialysis (PD) (administer after dialysis on dialysis days): 500 mg every 24 hours

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; use with caution in severe impairment.

Use: Labeled Indications

Children and Adolescents: Treatment of complicated urinary tract infections and pyelonephritis due to E. coliNote: Although effective, ciprofloxacin is not the drug of first choice in children.

Infants, Children, Adolescents, and Adults: Prophylaxis to reduce incidence or progression of disease following inhalation exposure to Bacillus anthracis; prophylaxis and treatment of plague (Yersinia pestis).

Adults: Treatment of the following infections when caused by susceptible bacteria: Urinary tract infections; acute uncomplicated cystitis in females, chronic bacterial prostatitis, bone and joint infections, complicated intra-abdominal infections (in combination with metronidazole), infectious diarrhea, typhoid fever (Salmonella typhi), hospital-acquired (nosocomial) pneumonia.

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve ciprofloxacin for use in patients who have no alternative treatment options for acute uncomplicated cystitis.

Use: Off-Label: Adult

  AnthraxLevel of Evidence [G]

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax, ciprofloxacin is an effective and recommended agent for treatment of cutaneous or systemic anthrax.

  Bite wound infection (animal and human bites)Level of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), ciprofloxacin, in combination with an appropriate agent for anaerobes, is an effective and recommended alternative option for prophylaxis and treatment of human or animal bite wounds, particularly in patients who are hypersensitive to beta-lactams.

  Cat scratch disease, lymphadenitis (nondisseminated)Level of Evidence [C]

Data from a limited number of patients suggest that ciprofloxacin may be beneficial for the treatment of cat scratch disease Ref.

Clinical experience suggests the utility of ciprofloxacin as an alternative agent in the treatment of cat scratch disease Ref.

  ChancroidLevel of Evidence [G]

Based on the CDC sexually transmitted diseases treatment guidelines, ciprofloxacin is an effective and recommended alternative agent in the treatment of chancroid due to H. ducreyi. However, intermediate resistance to ciprofloxacin has been reported in several isolates. Potential resistance issues should be considered when initiating therapy for the treatment of chancroid.

  Cholera (Vibrio cholerae)Level of Evidence [G]

Based on the CDC guidelines for cholera treatment with antibiotics, ciprofloxacin is an effective and recommended alternative agent for the treatment of moderate to severe cholera, in combination with aggressive hydration. Potential resistance issues should be considered when initiating therapy Ref.

  Chronic obstructive pulmonary disease, acute exacerbationLevel of Evidence [A]

Data from a randomized, double-blind study support the use of ciprofloxacin for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD) Ref. In addition, data from a smaller randomized study support the use of ciprofloxacin for treatment of acute exacerbations of COPD Ref.

  Crohn disease, treatment of simple perianal fistulasLevel of Evidence [G]

Based on the American College of Gastroenterology guidelines for the management of Crohn disease in adults, ciprofloxacin (with or without metronidazole) is an effective and recommended treatment for patients with simple perianal fistulas.

  Diabetic foot infectionsLevel of Evidence [G]

Based on the IDSA guidelines for diagnosis and treatment of diabetic foot infections, ciprofloxacin, in combination with other appropriate agents, is an effective and recommended treatment option for diabetic foot infections.

  Endocarditis, treatmentLevel of Evidence [G]

Based on the American Heart Association (AHA) scientific statement on infective endocarditis in adults, ciprofloxacin is an effective and recommended alternative treatment option for infective endocarditis (native or prosthetic valve) due to HACEK organisms (Haemophilus spp., Aggregatibacter spp., Cardiobacterium hominisEikenella corrodens, and Kingella spp.) in patients unable to tolerate beta-lactam therapy.

  Granuloma inguinale (donovanosis)Level of Evidence [G]

Based on the CDC sexually transmitted diseases treatment guidelines, ciprofloxacin is an effective and recommended alternative agent in the treatment of granuloma inguinale (donovanosis) when azithromycin is not appropriate.

  Meningitis, bacterialLevel of Evidence [G]

Based on the IDSA guidelines for the management of bacterial meningitis and health care-associated ventriculitis and meningitis, ciprofloxacin is an effective and recommended alternative therapy for susceptible Pseudomonas aeruginosa meningitis; meningitis caused by susceptible multidrug-resistant gram-negative bacilli (in patients who have not responded to or cannot receive standard antimicrobial therapy); and health care-associated meningitis or ventriculitis requiring empiric therapy for gram-negative pathogens in patients with anaphylaxis to beta-lactams (in combination with other appropriate agents).

  Meningococcal disease (prevention and control)Level of Evidence [G]

Based on the CDC guidelines for the prevention and control of meningococcal disease (Neisseria meningitidis), ciprofloxacin is an effective and recommended agent for management of this disease.

  Neutropenia (chemotherapy-induced), antibacterial prophylaxisLevel of Evidence [G]

Based on IDSA guidelines for the use of antimicrobial agents in neutropenic patients with cancer, oral ciprofloxacin is effective and recommended for antibiotic prophylaxis in high-risk patients with expected durations of prolonged and profound neutropenia (ANC ≤100 cells/mm3 for >7 days). Based on the Center for International Blood and Marrow Transplant Research, the National Marrow Donor Program, the European Blood and Marrow Transplant Group, and multiple other organizations guidelines for preventing infectious complications among hematopoietic cell transplant (HCT) recipients, oral ciprofloxacin may be used in adult HCT recipients to prevent bacterial infections in the first 100 days after transplant when the anticipated period of neutropenia is ≥7 days.

  Neutropenic fever, low-risk cancer patients (empiric therapy)Level of Evidence [A, G]

Data from 3 randomized trials (blinding varied) support the use of oral ciprofloxacin (in combination with amoxicillin and clavulanate) for the outpatient empiric management of low-risk neutropenic fever Ref. The American Society of Clinical Oncology (ASCO) and IDSA guidelines for outpatient management of fever and neutropenia in adults treated for malignancy and the IDSA guidelines for use of antimicrobial agents in neutropenic patients with cancer also support oral ciprofloxacin use (in combination with amoxicillin and clavulanate) in this patient population. Use should be avoided in patients who have received fluoroquinolone prophylaxis.

  Peritoneal dialysis catheter-related infectionsLevel of Evidence [G]

Based on the International Society for Peritoneal Dialysis (ISPD) catheter-related infection recommendations, ciprofloxacin is an effective and recommended agent for the management of peritoneal dialysis catheter exit-site or tunnel infection.

  Peritonitis, spontaneous bacterial (prevention)Level of Evidence [B, G]

Limited data from controlled trials support use of ciprofloxacin as an alternative to norfloxacin for primary long-term prophylaxis in cirrhotic patients with low protein ascites, or as secondary long-term prophylaxis in patients who have experienced a prior spontaneous bacterial peritonitis (SBP) episode. Additional trials may be necessary to further define the role of ciprofloxacin in the prevention of SBP.

According to AASLD and EASL guidelines, ciprofloxacin is suggested as an alternative to norfloxacin; however, recommendations regarding the use of daily or weekly dosing vary. The AASLD prefers daily dosing, given the risk of increasing quinolone bacterial resistance rates with weekly dosing. Increasing bacterial resistance rates to antibiotics used in the treatment and prevention of SBP have been documented; therefore, local epidemiological patterns should be considered, and use of antibiotic prophylaxis should be restricted to patients at high risk of SBP. Access Full Off-Label Monograph

  Pneumonia, community-acquiredLevel of Evidence [G]

Based on the IDSA/American Thoracic Society (ATS) consensus guidelines on the management of community-acquired pneumonia, ciprofloxacin, in combination with an antipneumococcal, antipseudomonal beta-lactam, is effective and recommended as empiric therapy in hospitalized patients with community-acquired pneumonia who require coverage for P. aeruginosa.

  Prostatitis, acute bacterialLevel of Evidence [C]

Data from a limited number of patients studied suggest that ciprofloxacin may be beneficial for the treatment of acute bacterial prostatitis Ref.

Clinical experience also suggests the utility of ciprofloxacin in the treatment of acute bacterial prostatitis Ref.

  Prosthetic joint infectionLevel of Evidence [G]

Based on the IDSA guidelines for the management of prosthetic joint infection, ciprofloxacin is an effective and recommended agent for treatment of prosthetic joint infection with either Pseudomonas aeruginosaEnterobacter spp, or Enterobacteriaceae. Ciprofloxacin is also an effective and recommended agent for indefinite oral antimicrobial suppression of Pseudomonas aeruginosa. Ciprofloxacin, in combination with rifampin, is also an effective and recommended agent for oral phase treatment of prosthetic joint infection with staphylococci after completion of parenteral therapy.

  Surgical prophylaxisLevel of Evidence [G]

Based on the American Society of Health-System Pharmacists (ASHP), the IDSA, the Surgical Infection Society (SIS), and the Society for Healthcare Epidemiology of America (SHEA) guidelines for antimicrobial prophylaxis in surgery, ciprofloxacin is an effective and recommended agent for prophylaxis of certain surgical procedures (eg, gastroduodenal, biliary tract, appendectomy, hysterectomy, and some urologic procedures) when allergy to beta-lactams exist and is a recommended agent for lower urologic tract instrumentation in patients with risk factors for infection (including transrectal prostate biopsy).

  Surgical site infectionLevel of Evidence [G]

Based on the IDSA guidelines for the diagnosis and management of SSTIs, ciprofloxacin, in combination with metronidazole, is an effective and recommended option for treatment of surgical site infections occurring after surgery of the intestinal or genitourinary tract, perineum, or axilla. Systemic antibacterials are not routinely indicated for surgical site infections, but may be beneficial (in conjunction with suture removal plus incision and drainage) in patients with significant systemic response (eg, temperature >38.5°C, heart rate >110 beats per minute, erythema/induration extending >5 cm from incision, WBC >12,000/mm3).

  TularemiaLevel of Evidence [C, G]

Data from retrospective studies and case reports/series demonstrate varied results with the use of ciprofloxacin in the management of tularemia. Guidelines created by the Infectious Diseases Society of America, Working Group on Civilian Biodefense, and the European Commission’s Task Force on Biological and Chemical Agent Threats (BICHAT) recommend ciprofloxacin as an alternative in the management of mild tularemia infection. In scenarios of mass casualty management and postexposure prophylaxis, the Working Group on Civilian Biodefense considers oral ciprofloxacin and doxycycline as drugs of choice. Access Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Use: Unsupported: Adult
Gonorrhea

Although included as an FDA-approved use in the manufacturer’s prescribing information for the treatment of uncomplicated cervical and urethral gonorrhea, clinical practice guidelines do not recommend ciprofloxacin for the treatment of gonorrhea because of widespread resistance (CDC [Workowski 2015]).

Lower respiratory tract infections (acute bronchitis)

Although included as an FDA-approved use in the manufacturer’s prescribing information, ciprofloxacin is not recommended empirically for healthy adults (without chronic lung disease or immunosuppression) for the treatment of lower respiratory tract infections (acute bronchitis) (ACP/CDC [Harris 2016]). Additionally, the FDA recommends that ciprofloxacin be reserved for patients who have no alternative treatment options in the treatment of bronchitis (FDA 2016).

Sinusitis (acute)

Although included as an FDA-approved use in the manufacturer’s prescribing information, ciprofloxacin is not recommended empirically for the treatment of sinusitis (Rosenfeld 2015). Additionally, the FDA recommends that ciprofloxacin be reserved for patients who have no alternative treatment options in the treatment of sinusitis (FDA 2016).

Skin and soft tissue infections

Although included as an FDA-approved use in the manufacturer’s prescribing information, ciprofloxacin is not recommended for empiric treatment of uncomplicated skin and soft tissue infections since the majority are due to gram-positive bacteria (IDSA [Stevens 2014]).

Clinical Practice Guidelines

Ascites:

AASLD Practice Guidelines: “Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012,” 2012

Crohn Disease:

ACG, “Management of Crohn’s Disease in Adults,” 2018

Diabetic Foot Infection:

IDSA, “The Diagnosis and Treatment of Diabetic Foot Infections,” 2012

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Infective Endocarditis:

AHA, “Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications,” October 2015

British Society for Antimicrobial Chemotherapy (BSAC), “Guidelines for the Diagnosis and Antibiotic Treatment of Endocarditis in Adults,” 2012

Intra-abdominal Infection:

Infectious Diseases Society of America (IDSA), “Diagnosis and Management of Complicated Intra-Abdominal Infections in Adults and Children,” January 2010

Meningitis, bacterial:

IDSA, Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis, February 2017

IDSA, Practice Guidelines for the Management of Bacterial Meningitis, October 2004

Neutropenic Fever:

ASCO/IDSA, “Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America Clinical Practice Guideline Update,” February 2018.

IDSA, “Use of Antimicrobial Agents in Neutropenic Patients with Cancer,” February 2011

Oncology:

ASBMT, IDSA, SHEA, “Guidelines for Preventing Infectious Complications Among Hematopoietic Cell Transplant Recipients,” October 2009

Opportunistic Infections:

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children, November 2013Note: Information contained within this monograph is pending revision based on these more recent guidelines.

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, April September 2015.

Osteomyelitis:

IDSA, “Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults,” 2015

Pneumonia, Community-Acquired:

IDSA/ATS, “Consensus Guideline on Management of Community-Acquired Pneumonia in Adults,” 2007

IDSA/PIDS, “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age,” 2011

Pneumonia, Hospital-Acquired and Ventilator-Associated

IDSA/ATS, “Management of Adults with Hospital-Acquired and Ventilator-Associated Pneumonia,” July 2016.

Prosthetic Joint Infection:

IDSA, “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline,” January 2013

Sexually-Transmitted Disease:

CDC, “Sexually Transmitted Diseases Treatment Guidelines,” June 2015.

Public Health Agency of Canada, “Canadian Guidelines on Sexually Transmitted Infections,” January 2010

Shigellosis:

World Health Organization, “Guidelines for the Control of Shigellosis, Including Epidemics Due to Shigella dysenteriae type 1”, 2005

Skin and Soft-tissue Infection:

IDSA, “Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections,” June 2014.

Surgical Prophylaxis:

ASHP, “Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery,” February 2013

Traveler’s Diarrhea:

American College of Gastroenterology (ACG), “ACG Clinical Guideline: Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults,” May 2016

CDC, “The Yellowbook: Travelers’ Diarrhea,” 2018

IDSA, “2017 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Management of Infectious Diarrhea,” 2017

Urinary Tract Infections:

IDSA, “International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women,” March 2011

Urinary Tract Infections, Catheter-Related:

IDSA, “Diagnosis, Prevention, and Treatment of Catheter- Associated Urinary Tract Infection in Adults,” February 2010

Administration: IV

Administer by slow IV infusion over 60 minutes into a large vein (reduces risk of venous irritation).

Administration: Injectable Detail

pH: 3.3 to 3.9 (vials); 3.5 to 4.6 (PVC bags)

Administration: Oral

May administer with most foods to minimize GI upset; avoid antacid use; maintain proper hydration and urine output. Avoid concomitant administration with dairy products (eg, milk, yogurt) or calcium-fortified juices alone, however, may be taken with meals that contain these products; separate administration of Cipro XR and calcium >800 mg by at least 2 hours. Administer immediate release ciprofloxacin and Cipro XR at least 2 hours before or 6 hours after antacids or other products containing calcium, iron, or zinc. Separate oral administration from drugs which may impair absorption (see Drug Interactions).

Oral suspension: Should not be administered through feeding tubes (suspension is oil-based and adheres to the feeding tube). Shake vigorously before use for ~15 seconds; administer using the co-packaged graduated teaspoon. Do not chew the microcapsules in the suspension; swallow whole.

Nasogastric/orogastric tube: Crush immediate-release tablet and mix with water. Flush feeding tube before and after administration. Hold tube feedings at least 1 hour before and 2 hours after administration.

Tablet, extended release: Do not crush, split, or chew.

Administration: Pediatric

Oral: May administer with food to minimize GI upset; divalent and trivalent cations [dairy foods (milk, yogurt) and mineral supplements (eg, iron, zinc, calcium) or calcium-fortified juices] decrease ciprofloxacin absorption; usual dietary calcium intake (including meals which include dairy products) has not been shown to interfere with ciprofloxacin absorption (per manufacturer). Administer immediate release ciprofloxacin and Cipro XR at least 2 hours before or 6 hours after any of these products.

Oral suspension: Shake vigorously prior to each dose. Should not be administered through feeding tubes (suspension is oil-based and adheres to the feeding tube). Patients should avoid chewing on the microcapsules.

Tablets:

Immediate release: Administering 2 hours after meals is preferable.

Extended release: Do not crush, split, or chew. May be administered with meals containing dairy products (calcium content <800 mg), but not with dairy products alone.

Nasogastric/orogastric tube: Crush immediate release tablet and mix with water. Flush feeding tube before and after administration. Hold tube feedings at least 1 hour before and 2 hours after administration.

Parenteral: Administer by slow IV infusion over 60 minutes to reduce the risk of venous irritation (burning, pain, erythema, and swelling)

Dietary Considerations

Food: May be taken with meals that contain dairy products (eg, milk, yogurt) or calcium-fortified juices, but not with these products alone; separate administration of Cipro XR and calcium >800 mg by at least 2 hours.

Caffeine: Patients consuming regular large quantities of caffeinated beverages may need to restrict caffeine intake if excessive cardiac or CNS stimulation occurs.

Storage/Stability

Injection:

Premixed infusion: Store between 5°C to 25°C (41°F to 77°F); avoid freezing. Protect from light.

Vial: Store between 5°C to 30°C (41°F to 86°F); avoid freezing. Protect from light. Diluted solutions of 0.5 to 2 mg/mL in D51/4NS, D51/2NS, D5W, D10W, LR, NS are stable for up to 14 days refrigerated or at room temperature.

Microcapsules for oral suspension: Prior to reconstitution, store below 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from freezing. Following reconstitution, store at 25°C (77°F) for 14 days; excursions permitted to 15°C to 30°C (59°F to 86°F) for up to 14 days. Protect from freezing.

Tablet:

Immediate release: Store between 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Extended release: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Preparation for Administration: Adult

Injection, vial: May be diluted with NS, D5W, SWFI, D10W, D51/4NS, D51/2NS, LR to a final concentration not to exceed 2 mg/mL.

Preparation for Administration: Pediatric

Oral: Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.

Parenteral: May be diluted with NS, D5W, SWFI, D10W, D51/4NS, D51/2NS, LR to a final concentration not to exceed 2 mg/mL

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

A 50 mg/mL oral suspension may be made using 2 different vehicles (a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Methylcellulose 1% and Simple Syrup, NF). Crush twenty 500 mg tablets and reduce to a fine powder. Add a small amount of vehicle and mix to a uniform paste; mix while adding the vehicle in geometric proportions to almost 200 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 200 mL. Label “shake well” and “refrigerate”. Stable 91 days refrigerated and 70 days at room temperature. Note: Microcapsules for oral suspension available (50 mg/mL; 100 mg/mL); not for use in feeding tubes.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, vomiting, or nausea. Have patient report immediately to prescriber signs of tendon inflammation or rupture (pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of nerve problems (sensitivity to heat or cold; decreased sense of touch; burning, numbness, or tingling; pain, or weakness in the arms, hands, legs, or feet), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), abnormal heartbeat, passing out, angina, thrush, severe loss of strength and energy, vision changes, hallucinations, seizures, severe headache, anxiety, insomnia, nightmares, dizziness, confusion, agitation, restlessness, behavioral changes, mood changes, shortness of breath, bruising, bleeding, tremors, abnormal gait, sunburn, chills, pharyngitis, vaginitis, muscle pain, muscle weakness, difficulty focusing, memory impairment, injection site irritation, severe or persistent pain in abdomen, severe or persistent chest pain, severe or persistent back pain, signs of Clostridioides (formerly Clostridiumdifficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Cipro: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf#page=41

Contraindications

Hypersensitivity to ciprofloxacin, any component of the formulation, or other quinolones; concurrent administration of tizanidine

Canadian labeling: Additional contraindications (not in the US labeling): Concurrent administration of agomelatine

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with a history of or at risk for QTc prolongation, torsades de pointes, uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), cardiac disease (heart failure, myocardial infarction, bradycardia) or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).

• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic aneurysm ruptures or dissection and should not be used in patients with a known history of aortic aneurysm or those at increased risk unless no other treatment options are available.

• Crystalluria: Rarely, crystalluria has occurred; urine alkalinity may increase the risk. Ensure adequate hydration during therapy.

• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose regulation, including hyperglycemia and hypoglycemia. These events have occurred most often in patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases of hypoglycemia, including coma and death, have been reported. Diabetic patients should be monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if a hypoglycemic reaction occurs and immediately initiate appropriate therapy.

• Hepatotoxicity: Hepatocellular, cholestatic, or mixed liver injury has been reported, including hepatic necrosis, life-threatening hepatic events, and fatalities. Acute liver injury can be rapid onset (range: 1 to 39 days) and is often associated with hypersensitivity. The pattern of injury can be hepatocellular, cholestatic, or mixed. Most fatalities occurred in patients >55 years of age. Discontinue immediately if signs/symptoms of hepatitis (abdominal tenderness, dark urine, jaundice, pruritus) occur. Additionally, temporary increases in transaminases or alkaline phosphatase, or cholestatic jaundice may occur (highest risk in patients with previous liver damage).

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with fluoroquinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatitis, jaundice, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Photosensitivity/phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe phototoxicity reactions which may appear as exaggerated sunburn reactions. Discontinue use if phototoxicity occurs.

• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue ciprofloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without preexisting risk factors have experienced these reactions; may occur within hours to weeks after initiation.

– CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects, including seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors. Status epilepticus cases have been reported. Use with caution in patients with a history of seizures, with known or suspected CNS disorder (severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or with other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction). Discontinue if seizures occur and institute appropriate therapy.

– Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue immediately if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy.

– Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of psychiatric reactions, including toxic psychosis, hallucinations, or paranoia; may also cause nervousness, agitation, delirium, attention disturbances, insomnia, anxiety, nightmares, memory impairment, confusion, depression, and suicidal thoughts or actions. Use with caution in patients with a history of or risk factor for mental illness. Reactions may appear following the first dose; discontinue if reaction occurs and institute appropriate therapy.

– Tendinitis/tendon rupture: Fluoroquinolones have been associated with an increased risk of tendonitis and tendon rupture in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant recipients, and in patients >60 years of age, but has also occurred in patients without these risk factors. Rupture of the Achilles tendon has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Inflammation and rupture may occur bilaterally. Cases have been reported within hours or days of initiation, and up to several months after discontinuation of therapy. Strenuous physical activity, renal failure, and previous tendon disorders may be independent risk factor for tendon rupture. Discontinue at first sign of tendon pain, swelling, inflammation or rupture. Avoid use in patients with a history of tendon disorders or who have experienced tendinitis or tendon rupture.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with a known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support and deaths have been reported.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required. May increase risk of tendon rupture.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.

• Syphilis: Since ciprofloxacin is ineffective in the treatment of syphilis and may mask symptoms, all patients should be tested for syphilis at the time of gonorrheal diagnosis and 3 months later.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in elderly patients.

• Pediatric: Adverse effects, including those related to joints and/or surrounding tissues, are increased in pediatric patients and therefore, ciprofloxacin should not be considered as drug of choice in children (exception is anthrax treatment).

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Reserve use of ciprofloxacin for treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or acute uncomplicated cystitis for patients who have no alternative treatment options because of the risk of disabling and potentially serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects).

Geriatric Considerations

Ciprofloxacin should not be used as first-line therapy unless the culture and sensitivity findings show resistance to usual therapy. The interactions with caffeine and theophylline can result in serious toxicity in the elderly. Adjust dose for renal function. The risk of torsade de pointes and tendon inflammation and/or rupture associated with the concomitant use of corticosteroids and quinolones is increased in the elderly population. See Warnings/Precautions regarding tendon rupture in patients >60 years of age.

Warnings: Additional Pediatric Considerations

Increased osteochondrosis in immature rats and dogs was observed with ciprofloxacin and fluoroquinolones have caused arthropathy with erosions of the cartilage in weight-bearing joints of immature animals. In an international safety data analysis of ciprofloxacin in approximately 700 pediatric patients (1 to 17 years), the follow-up arthropathy rate at 6 weeks and cumulative arthropathy rate at 1 year were higher in ciprofloxacin treatment group than comparative controls (6 weeks: 9.3% vs 6%; 1 year: 13.7% to 9.5%). In pediatric patients, fluoroquinolones are not routinely first-line therapy, but after assessment of risks and benefits, can be considered a reasonable alternative for situations where no safe and effective substitute is available (eg, resistance [anthrax, common CF pathogens, multidrug resistant tuberculosis]) or in situations where the only alternative is parenteral therapy and ciprofloxacin offers an oral therapy option (Bradley 2011b).

Pregnancy Risk Factor

C

Pregnancy Considerations

Ciprofloxacin crosses the placenta and produces measurable concentrations in the amniotic fluid and cord serum (Ludlam 1997). Based on available data, an increased risk of teratogenic effects has not been observed following ciprofloxacin use during pregnancy (Bar-Oz 2009; Padberg 2014). Ciprofloxacin is recommended for prophylaxis and treatment of pregnant women exposed to anthrax (Meaney-Delman 2014). Serum concentrations of ciprofloxacin may be lower during pregnancy than in nonpregnant patients (Giamarellou 1989).

Breast-Feeding Considerations

Ciprofloxacin is present in breast milk.

The relative infant dose (RID) of ciprofloxacin is 2.8% when calculated using the highest average breast milk concentration located and compared to an infant therapeutic dose of 20 mg/kg/day.

In general, breastfeeding is considered acceptable when the relative infant dose is <10% (Anderson 2016; Ito 2000).

Using the highest average milk concentration (3.79 mcg/mL), the estimated daily infant dose via breast milk is 0.569 mg/kg/day. This milk concentration was obtained following a maternal dose of ciprofloxacin 750 mg every 12 hours for 3 doses (n=10) (Giamarellou 1989).

There is a case report of perforated pseudomembranous colitis in a breastfeeding infant whose mother was taking ciprofloxacin (Harmon 1992). In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).

Ciprofloxacin is recommended for the prophylaxis and treatment of Bacillus anthracis in breastfeeding women (Meaney-Delman 2014). Alternative agents are recommended in nursing women for the treatment of chancroid (CDC [Workowski 2015]). The manufacturer does not recommend use of ciprofloxacin in breastfeeding women due to concerns of potential articular damage; however, this risk is considered low even in children receiving high therapeutic doses. Therefore, some sources do not consider maternal use of ciprofloxacin to be a reason to discontinue nursing as long as the infant is monitored for gastrointestinal symptoms (eg, diarrhea) which could occur following antibiotic exposure (Kaplan 2015). Other sources recommend avoiding quinolone antibiotics if alternative agents are available (WHO 2002).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Central nervous system: Neurological signs and symptoms (children 2%; includes dizziness, insomnia, nervousness, somnolence), headache (IV administration), restlessness (IV administration)

Dermatologic: Skin rash (children 2%, adults 1%)

Gastrointestinal: Diarrhea (children 5%; adults 2%), vomiting (children 5%; adults 1%), abdominal pain (children 3%; adults <1%), dyspepsia (children 3%; adults <1%), nausea (3%)

Hepatic: Increased serum AST (adults 1%), increased serum ALT

Local: Injection site reactions (IV administration)

Respiratory: Rhinitis (children 3%)

Miscellaneous: Fever (children 2%; adults <1%)

<1%, postmarketing, and/or case reports: Abnormal gait, acute generalized exanthematous pustulosis, acute gout attack, acute renal failure, ageusia, agitation, agranulocytosis, albuminuria, anaphylactic shock, anaphylaxis, anemia, angina pectoris, angioedema, anorexia, anosmia, anxiety, arthralgia, ataxia, atrial flutter, bone marrow depression (life-threatening), bronchospasm, candidiasis, candiduria, cardiorespiratory arrest, casts in urine, cerebral thrombosis, chills, cholestatic jaundice, chromatopsia, Clostridioides (formerly Clostridiumdifficile-associated diarrhea, confusion, constipation, crystalluria (particularly in alkaline urine), decreased hematocrit, decreased hemoglobin, decreased prothrombin time, delirium, depersonalization, depression (including self-injurious behavior), dizziness, drowsiness, dyspepsia (adults), dysphagia, dysphasia, dyspnea, edema, eosinophilia, erythema multiforme, erythema nodosum, exacerbation of myasthenia gravis, exfoliative dermatitis, fixed drug eruption, flatulence, gastrointestinal hemorrhage, hallucination, headache (oral), hematuria, hemolytic anemia, hepatic failure, hepatic necrosis, hepatotoxicity (idiosyncratic) (Chalasani 2014), hyperesthesia, hyperglycemia, hyperpigmentation, hypersensitivity reaction, hypertension, hypertonia, hypoglycemia, hypotension, increased blood urea nitrogen, increased creatine phosphokinase, increased INR (in patients treated with vitamin K antagonists), increased intracranial pressure, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum bilirubin, increased serum cholesterol, increased serum creatinine, increased serum glucose, increased serum lipase, increased serum triglycerides, increased uric acid, insomnia, interstitial nephritis, intestinal perforation, irritability, jaundice, laryngeal edema, lethargy, lymphadenopathy, malaise, manic behavior, mastalgia, methemoglobinemia, migraine, myalgia, myocardial infarction, myoclonus, nephritis, nephrolithiasis, nightmares, nystagmus, orthostatic hypotension, palpitations, pancreatitis, pancytopenia (life-threatening), paranoia, paresthesia, peripheral neuropathy, petechia, phobia, phototoxicity, pneumonitis, polyneuropathy, prolonged prothrombin time (in patients treated with vitamin K antagonists), pseudotumor cerebri, pulmonary edema, rupture of tendon, seizure (including grand mal), serum sickness-like reaction, skin photosensitivity, status epilepticus, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, syncope, tachycardia, tendonitis, thrombocythemia, thrombocytopenia, thrombophlebitis, tinnitus, torsades de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, twitching, unresponsive to stimuli, urethral bleeding, vaginitis, vasculitis, ventricular arrhythmia, ventricular ectopy, visual disturbance, vulvovaginal candidiasis, weakness

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of OAT3, P-glycoprotein/ABCB1; Inhibits CYP1A2 (moderate), CYP3A4 (weak)

Drug Interactions 

Agomelatine: Ciprofloxacin (Systemic) may increase the serum concentration of Agomelatine. Risk X: Avoid combination

Alosetron: CYP1A2 Inhibitors (Moderate) may increase the serum concentration of Alosetron. Risk X: Avoid combination

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Antacids: May decrease the absorption of Quinolones. Of concern only with oral administration of quinolones. Management: Avoid concurrent administration of quinolones and antacids to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. Exceptions: Sodium Bicarbonate. Risk D: Consider therapy modification

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Risk C: Monitor therapy

Ataluren: May increase the serum concentration of Ciprofloxacin (Systemic). Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Bendamustine: Ciprofloxacin (Systemic) may increase the serum concentration of Bendamustine. Concentrations of the active metabolites of bendamustine may be decreased. Risk C: Monitor therapy

Blood Glucose Lowering Agents: Quinolones may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Caffeine: Ciprofloxacin (Systemic) may increase the serum concentration of Caffeine. Risk C: Monitor therapy

Calcium Salts: May decrease the absorption of Quinolones. Of concern only with oral administration of both agents. Exceptions: Calcium Chloride. Risk D: Consider therapy modification

CarBAMazepine: Ciprofloxacin (Systemic) may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

CloZAPine: Ciprofloxacin (Systemic) may enhance the QTc-prolonging effect of CloZAPine. Ciprofloxacin (Systemic) may increase the serum concentration of CloZAPine. Management: Reduce the clozapine dose to one-third of the original dose when adding ciprofloxacin and monitor closely for evidence of excessive QTc prolongation and clozapine toxicity. Resume the previous clozapine dose following ciprofloxacin discontinuation. Risk D: Consider therapy modification

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy

CYP1A2 Substrates (High risk with Inhibitors): CYP1A2 Inhibitors (Moderate) may decrease the metabolism of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Delamanid: Quinolones may enhance the QTc-prolonging effect of Delamanid. Management: Avoid concomitant use if possible. If coadministration is unavoidable, frequent monitoring of electrocardiograms (ECGs) throughout the full delamanid treatment period should occur. Exceptions are discussed in separate monographs. Risk D: Consider therapy modification

Didanosine: Quinolones may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Risk D: Consider therapy modification

Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Risk C: Monitor therapy

Erlotinib: Ciprofloxacin (Systemic) may increase the serum concentration of Erlotinib. Management: Avoid use of this combination when possible. When the combination must be used, monitor the patient closely for the development of severe adverse reactions, and if such severe reactions occur, reduce the erlotinib dose (in 50 mg decrements). Risk D: Consider therapy modification

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Risk C: Monitor therapy

Fosphenytoin: May enhance the QTc-prolonging effect of Ciprofloxacin (Systemic). Ciprofloxacin (Systemic) may diminish the therapeutic effect of Fosphenytoin. Ciprofloxacin (Systemic) may decrease the serum concentration of Fosphenytoin. Risk C: Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk – Avoid) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Heroin: Quinolones may enhance the adverse/toxic effect of Heroin. Risk C: Monitor therapy

Iron Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, oflox-, pefloxacin, or nalidixic acid) oral iron salts Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Risk D: Consider therapy modification

Kola Nut: Ciprofloxacin (Systemic) may increase the serum concentration of Kola Nut. Specifically, ciprofloxacin may increase serum concentrations of caffeine, a major component of kola nut. Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Lanthanum: May decrease the serum concentration of Quinolones. Management: Administer oral quinolone antibiotics at least one hour before or four hours after lanthanum. Risk D: Consider therapy modification

Lomitapide: Ciprofloxacin (Systemic) may increase the serum concentration of Lomitapide. Risk X: Avoid combination

Magnesium Salts: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Risk D: Consider therapy modification

Meptazinol: May decrease the serum concentration of Ciprofloxacin (Systemic). Risk X: Avoid combination

Methotrexate: Ciprofloxacin (Systemic) may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolones. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolones. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Risk D: Consider therapy modification

Mycophenolate: Quinolones may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate.Risk C: Monitor therapy

Nadifloxacin: May enhance the adverse/toxic effect of Quinolones. Risk X: Avoid combination

Neratinib: Ciprofloxacin (Systemic) may increase the serum concentration of Neratinib. Management: Avoid concomitant use of neratinib and ciprofloxacin if possible. If combined, monitor for increased neratinib effects/toxicities. Risk D: Consider therapy modification

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy

Olaparib: Ciprofloxacin (Systemic) may increase the serum concentration of Olaparib. Risk C: Monitor therapy

Patiromer: May decrease the serum concentration of Ciprofloxacin (Systemic). Management: Administer oral ciprofloxacin at least 3 hours before or 3 hours after patiromer. Risk D: Consider therapy modification

Pentoxifylline: Ciprofloxacin (Systemic) may increase the serum concentration of Pentoxifylline. Risk C: Monitor therapy

Phenytoin: Ciprofloxacin (Systemic) may diminish the therapeutic effect of Phenytoin. Ciprofloxacin (Systemic) may decrease the serum concentration of Phenytoin. Risk C: Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination

Pirfenidone: Ciprofloxacin (Systemic) may increase the serum concentration of Pirfenidone. Management: With ciprofloxacin doses of 1,500 mg/day, the pirfenidone dose should be reduced to 1,602 mg daily (ie, 534 mg three times a day). With lower daily doses of ciprofloxacin, use pirfenidone with caution. Risk D: Consider therapy modification

Pomalidomide: Ciprofloxacin (Systemic) may increase the serum concentration of Pomalidomide. Management: Avoid concomitant use of pomalidomide and ciprofloxacin when possible. If coadministration is considered necessary, consider reducing the pomalidomide dose 50% and monitoring patients for increased pomalidomide effects/toxicities. Risk D: Consider therapy modification

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Probenecid: May decrease the excretion of Quinolones. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Probenecid may increase the serum concentration of Quinolones. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk – Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Quinapril: May decrease the serum concentration of Quinolones. Management: Separate doses of quinapril and oral quinolones by at least 2 hours in order to reduce the risk of interaction. Monitor for reduced efficacy of the quinolone if these products are used concomitantly. Risk D: Consider therapy modification

Rasagiline: CYP1A2 Inhibitors (Moderate) may increase the serum concentration of Rasagiline. Management: Limit rasagiline dose to 0.5 mg once daily in patients taking moderate CYP1A2 inhibitors. Risk D: Consider therapy modification

Roflumilast: Ciprofloxacin (Systemic) may increase the serum concentration of Roflumilast. Risk C: Monitor therapy

ROPINIRole: Ciprofloxacin (Systemic) may increase the serum concentration of ROPINIRole. Risk C: Monitor therapy

Ropivacaine: Ciprofloxacin (Systemic) may increase the serum concentration of Ropivacaine. Risk C: Monitor therapy

Sevelamer: May decrease the absorption of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Risk D: Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Spironolactone: May enhance the arrhythmogenic effect of Ciprofloxacin (Systemic). Risk C: Monitor therapy

Strontium Ranelate: May decrease the serum concentration of Quinolones. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Risk X: Avoid combination

Sucralfate: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after the sucralfate dose. Greater separation of doses may further lessen the risk for a significant interaction. Risk D: Consider therapy modification

Teriflunomide: May increase the serum concentration of OAT3 Substrates. Risk C: Monitor therapy

Theophylline Derivatives: Quinolones may decrease the metabolism of Theophylline Derivatives. Ciprofloxacin and enoxacin are of greatest concern. Theophylline/quinolone therapy might augment the seizure-producing potential of each of the individual agents. Exceptions: Dyphylline. Risk D: Consider therapy modification

Thyroid Products: Ciprofloxacin (Systemic) may decrease the serum concentration of Thyroid Products. Risk C: Monitor therapy

TiZANidine: Ciprofloxacin (Systemic) may increase the serum concentration of TiZANidine. Risk X: Avoid combination

Tolvaptan: May increase the serum concentration of OAT3 Substrates. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Risk D: Consider therapy modification

Varenicline: Quinolones may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concurrent use of levofloxacin or other quinolone antibiotics, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Quinolones may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Zinc Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Exceptions: Zinc Chloride. Risk D: Consider therapy modification

Zolpidem: Ciprofloxacin (Systemic) may increase the serum concentration of Zolpidem. Management: Consider avoiding the combination of ciprofloxacin and zolpidem if possible. If combined, monitor for signs of zolpidem toxicity (eg, somnolence, dizziness, lethargy). Risk D: Consider therapy modification

Food Interactions

Food decreases rate, but not extent, of absorption. Ciprofloxacin may increase serum caffeine levels if taken concurrently. Rarely, crystalluria may occur. Enteral feedings may decrease plasma concentrations of ciprofloxacin probably by >30% inhibition of absorption. Management: May administer with most foods to minimize GI upset. If unable to avoid the following foods, administer ciprofloxacin at least 2 hours before or 6 hours after dairy products or calcium-fortified juices alone or in a meal containing >800 mg calcium. Restrict caffeine intake if excessive cardiac or CNS stimulation occurs. Ensure adequate hydration during therapy. Ciprofloxacin should not be administered with enteral feedings. The feeding would need to be discontinued for 1 to 2 hours prior to and after ciprofloxacin administration. Nasogastric administration produces a greater loss of ciprofloxacin bioavailability than does nasoduodenal administration.

Test Interactions

Some quinolones may produce a false-positive urine screening result for opioids using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opioid screens by more specific methods should be considered.

Monitoring Parameters

CBC, renal and hepatic function during prolonged therapy, altered mental status, signs and symptoms of tendonitis; signs and symptoms of disordered glucose regulation

Advanced Practitioners Physical Assessment/Monitoring

Assess results of culture and sensitivity tests prior to beginning therapy. Monitor for hypersensitivity reactions (severe reactions, including anaphylaxis, have occurred with quinolone therapy). Obtain CBC, renal function tests, and liver function tests periodically with prolonged therapy. Assess for signs of tendonitis or altered mental status. Assess for effectiveness of treatment. Test for C. difficile if patient develops diarrhea.

Nursing Physical Assessment/Monitoring

Check lab results and report abnormalities. Monitor for hypersensitivity reactions (severe reactions, including anaphylaxis, have occurred with quinolone therapy). Educate patient to report signs of tendonitis (unable to bear weight on a joint or feeling a snap or pop) or any signs of altered mental status (anxiety, nightmares, agitation, hallucinations, suicidal ideation, behavioral changes). Monitor for severe or bloody diarrhea and send a specimen to the lab for C. difficile. Monitor for improvement with infection.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Generic: 200 mg/100 mL (100 mL); 400 mg/200 mL (200 mL); 200 mg/20 mL (20 mL [DSC]); 400 mg/40 mL (40 mL [DSC])

Solution, Intravenous [preservative free]:

Cipro in D5W: 400 mg/200 mL (200 mL) [latex free]

Generic: 200 mg/100 mL (100 mL [DSC]); 400 mg/200 mL (200 mL); 200 mg/20 mL (20 mL [DSC]); 400 mg/40 mL (40 mL [DSC])

Suspension Reconstituted, Oral:

Cipro: 250 mg/5 mL (100 mL); 500 mg/5 mL (100 mL) [strawberry flavor]

Generic: 250 mg/5 mL (100 mL [DSC]); 500 mg/5 mL (100 mL)

Tablet, Oral, as hydrochloride [strength expressed as base]:

Cipro: 250 mg, 500 mg

Generic: 100 mg, 250 mg, 500 mg, 750 mg

Tablet Extended Release 24 Hour, Oral, as base and hydrochloride [strength expressed as base]:

Cipro XR: 500 mg, 1000 mg

Generic: 500 mg, 1000 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Generic: 10 mg/mL (20ml, 40ml); 2 mg/mL in D5W (100ml, 200ml)

Suspension Reconstituted, Oral:

Cipro: 500 mg/5 mL (100ml) [contains SOYBEAN LECITHIN]

Tablet, Oral, as hydrochloride [strength expressed as base]:

Cipro: 250 mg [DSC], 500 mg, 750 mg [DSC] [contains CORN STARCH]

Generic: 100 mg, 250 mg, 500 mg, 750 mg

Tablet Extended Release 24 Hour, Oral, as base and hydrochloride [strength expressed as base]:

Cipro XL: 500 mg, 1000 mg

Generic: 500 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • J01MA02
Generic Available (US)

Yes

Pricing: US

Solution (Cipro in D5W Intravenous)

400 mg/200 mL (per mL): $0.15

Solution (Ciprofloxacin in D5W Intravenous)

200 mg/100 mL (per mL): $0.02 – $0.15

400 mg/200 mL (per mL): $0.02 – $0.14

Suspension (reconstituted) (Cipro Oral)

250 MG/5ML (5%) (per mL): $1.56

500 MG/5ML (10%) (per mL): $1.83

Suspension (reconstituted) (Ciprofloxacin Oral)

500 MG/5ML (10%) (per mL): $1.43

Tablet, 24-hour (Ciprofloxacin-Ciproflox HCl ER Oral)

500 mg (per each): $9.80

1000 mg (per each): $11.16

Tablets (Cipro Oral)

250 mg (per each): $5.88

500 mg (per each): $6.88

Tablets (Ciprofloxacin HCl Oral)

100 mg (per each): $15.22

250 mg (per each): $0.24 – $4.59

500 mg (per each): $0.22 – $5.59

750 mg (per each): $5.17 – $5.65

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA

Pharmacodynamics/Kinetics

Absorption: Oral: Well-absorbed; 500 mg orally every 12 hours produces an equivalent AUC to that produced by 400 mg IV over 60 minutes every 12 hours

Distribution: Vd: 2.1 to 2.7 L/kg; tissue concentrations often exceed serum concentrations especially in kidneys, gallbladder, liver, lungs, gynecological tissue, and prostatic tissue; CSF concentrations: 10% of serum concentrations (noninflamed meninges), 14% to 37% (inflamed meninges)

Protein binding: 20% to 40%

Metabolism: Partially hepatic; forms 4 metabolites (limited activity)

Bioavailability: Oral: 50% to 85%; younger CF patients have a lower bioavailability of 68% vs CF patients >13 years of age with bioavailability of 95%

Half-life elimination: Children: 4 to 5 hours; Adults: Normal renal function: 4 to 6 hours

Time to peak: Oral:

Immediate release tablet: 0.5 to 2 hours

Extended release tablet: Cipro XR: 1 to 2.5 hours

Excretion: Urine (35% to 70% as unchanged drug); feces (15% to 35%; <1% as unchanged drug)

Clearance: After IV: CF children: 0.84 L/hour/kg; Adults: 0.5 to 0.6 L/hour/kg

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: The half-life is prolonged.

Geriatric: Cmax increased 16% to 40%, AUC increased approximately 20% to 30%, and half-life increased approximately 20%.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Ciprofloxacin HCl; Ciprofloxacin Hydrochloride; Proquin XR

FDA Approval Date
October 22, 1987
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Brand Names: International

AC Ear Drops (IN); Acipro (PH); Aciren (KR); Adiflox (IN); Alcon Cilox (CO, ID); Antox (CR, DO, GT, HN, NI, PA, SV); Apoflox (MX); Aprocin (HK); Asflox (ET); Bacquinor (ID); Bactiflox (BF, BJ, CI, EG, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SG, SL, SN, TN, TZ, UG, ZM, ZW); Baflox (CO); Baquinor (ID); Baycip (CL, ES); Bearcin (KR); Bernoflox (ID); C-Flox (AU, UY); Cefaxin (KR); Ceflox (IN); Cetraxal (CR, DO, ES, GT, HN, NI, PA, SV); Ciclodin (PH); Cifex (PH); Cifloc (ZA); Ciflodal (PH); Ciflomed (PH); Cifloptic (PE); Ciflox (AE, FR, HR, KW, QA, VE); Cifloxager (IE); Cifloxin (HK, PH); Cifox (IE); Cifran (AU, BF, BJ, CI, CN, ET, GH, GM, GN, IN, KE, LK, LR, LV, MA, ML, MR, MU, MW, NE, NG, RO, SC, SD, SL, SN, TN, TZ, UA, UG, VN, ZM, ZW); Cilobact (CO); Cilox (NO); Cimoxin (PE); Cinaflox (PE); Cinolone (MY); Cipflox (NZ); Ciploc (PK); Ciplox (BF, BJ, CI, ET, GH, GM, GN, HK, IE, KE, LR, LV, MA, ML, MR, MU, MW, NE, NG, SC, SD, SK, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Ciplus (KR); Cipquin (MY); Ciprecu (EC); Ciprinol (BG, EE, LV, RO, SI); Cipro (AR, BR, CO, JO, PY); Cipro A (BD); Cipro XR (BB, BM); Cipro-Denk (TZ); Ciprobac (MX); Ciprobay (AE, BG, BH, CY, CZ, EG, IQ, IR, JO, KR, KW, LB, LY, MY, OM, PH, PL, QA, SA, SI, SY, TH, UA, VN, YE, ZA, ZW); Ciprobay Uro (DE); Ciprobeta (DE); Ciprobid (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TH, TN, TZ, UG, YE, ZM, ZW); Ciprobiotic (GT, HN, ID, NI); Ciprocan (KR); Ciprocep (TH); Ciprocin (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Ciprodac (ZW); Ciprodar (AE, CY, HK, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ciprodex (IL); Ciproflox (CY, PE, SA); Ciproglen (MY); Ciprol (AU); Ciprolak (PE); Ciprolet (SG); Ciprolin (PE); Ciprolon (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Cipromed (PE); Cipromycin (GR); Cipropharm (AE, CY, ET, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Ciprophil (PH); Ciproquin (QA); Ciprotal (PH); Ciprouro SR (KR); Ciproval (CL); Ciprovar (ZW); Ciprovita (PH); Ciprox (AE, CY, IQ, IR, JO, KW, LB, LY, MY, OM, SA, SY, YE); Ciproxan (JP); Ciproxin (AT, AU, CH, DK, FI, GB, GR, HK, ID, IT, KR, MT, NO, NZ, SE, TR, TW, ZW); Ciproxina (BB, BM, BS, BZ, CR, CU, DO, EC, GT, HN, JM, MX, NI, NL, PA, PR, PT, SR, SV, TT); Ciproxine (BE, LU); Ciproxyl (HK, TH); Cipzy (LK); Ciriax (PE); Cirok (PH, SG); Ciroxin (TW); Cirpobay (CN); Citopcin (KR); Cixa (TW); Cobay (TH); Cobay-500 (PH); Cosflox (IN); Cycin (KR, SG); Cyplox (HK); Cypral (VE); Cypro (KR); Dibactil (PY); Eni (CR, DO, GT, HN, NI, PA, SV); Enoxin (SG, TH); Eprocin (KR); Estecina (ES); Fexin (PH); Flaprox (UA); Floroxin (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Floxabid (BD); Floxager (MX); Floxine (ET); Floxsid (ID); Giroflox (IL); Glocip (VN); Glojaya (ID); Hexiquin (ID); Hiflox (BD); Hippro (TH); Hippro Forte (TH); Ifloxin (PH); Interflox (ID); Iprolan (PH); Iprubac (PH); Jayacin (ID); Karmaflox (EG); Ladinin (ET); Licoprox (ID); Lofucin (KR); Loxan (CO); Maxpro (PH); Medcoflox (ID); Novaflox (SG); Novidat (AR); Oftacilox (PT); Optal-Pro (TH); Orlin (AE); Orpic (PH); Otosec (CO, PE); Procip (NZ, ZW); Proflox (EC, TH); Profloxin (IE); Proxacin (BD, BR); Pycip (MY); Qilaflox (ID); Qinosyn (PH); Quilox (PH); Quinobiotic (ID, PE); Quinocip (LK); Quinos (KR); Quintor (BH, ET); Qupron (KR); Rancif (EG); Sepcen (MT); Serviflox (MY, SG); Sifloks (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Siflox (ID); Sophixin Ofteno (CR, DO, GT, HN, NI, PA, SV, VE); Superocin (TW); Supraflox (ET); Tequinol (ID); Topistin (SG); Truoxin (IE); Tyflox (ZW); Unex (EC); Uniflox (FR); Uroxin (HK, SG); Vexcipro (PH); Viflox (ID); Viprolox (SG); Vistaflox (PH); Xenoflox (PH); Zindolin (TR); Zumaflox (ID)

Ciprofloxacin (Systemic) (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(sip roe FLOKS a sin)

Brand Names: US

Cipro; Cipro in D5W; Cipro XR

Brand Names: Canada

Cipro; Cipro XL; Ciprofloxacin Injection; Ciprofloxacin Injection USP; Ciprofloxacin Intravenous Infusion

Warning
  • This drug may cause very bad side effects. These include irritated or torn tendons; nerve problems in the arms, hands, legs, or feet; and nervous system problems. These side effects can happen alone or at the same time. They can happen within hours to weeks after starting this drug. Some of these side effects may not go away, and may lead to disability or death. Talk with the doctor.
  • The chance of irritated or torn tendons is greater in people over the age of 60; heart, kidney, or lung transplant patients; or people taking steroid drugs. Tendon problems can happen as long as several months after treatment. Call your doctor right away if you have pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints. Call you doctor right away if you are not able to move or bear weight on a joint or if you hear or feel a snap or pop.
  • Call your doctor right away if you have signs of nerve problems. These may include not being able to handle heat or cold; change in sense of touch; or burning, numbness, tingling, pain, or weakness in the arms, hands, legs, or feet.
  • Call your doctor right away if you have signs of nervous system problems. These may include anxiety, bad dreams, trouble sleeping, change in eyesight, dizziness, feeling confused, feeling nervous or agitated, feeling restless, hallucinations (seeing or hearing things that are not there), new or worse behavior or mood changes like depression or thoughts of killing yourself, seizures, or very bad headaches.
  • Do not take if you have myasthenia gravis. Very bad and sometimes deadly breathing problems have happened with this drug in people who have myasthenia gravis.
  • For some health problems, this drug is only for use when other drugs cannot be used or have not worked. Talk with the doctor to be sure that the benefits of this drug are more than the risks.
What is this drug used for?
  • It is used to treat or prevent bacterial infections.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ciprofloxacin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Long QTc on ECG or other heartbeat that is not normal, slow heartbeat, or low potassium or magnesium levels.
  • If you have kidney problems.
  • If you have heart failure (weak heart).
  • If you have had a recent heart attack.
  • If you have ever had any of these health problems: Nerve problems or tendon problems.
  • If you have had tendons get irritated or torn when taking this drug or an alike drug in the past.
  • If you have an aortic aneurysm (ballooning or bulging of the aorta, the main blood vessel that comes out of the heart) or you are at risk for this health problem. This includes if you have other blood vessel problems, high blood pressure, or certain health problems like Marfan syndrome or Ehlers-Danlos syndrome.
  • If you have been taking any drugs to treat a heartbeat that is not normal.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are taking any of these drugs: Duloxetine, theophylline, tizanidine, or zolpidem.
  • If you are breast-feeding or plan to breast-feed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • High and low blood sugar has happened with drugs like this one. Most of the time, low blood sugar happened in people with diabetes who were taking drugs that lower blood sugar like insulin. Very low blood sugar has led to coma and sometimes death. Check blood sugar as you have been told by the doctor.
  • Tell your doctor if you have signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Do not use longer than you have been told. A second infection may happen.
  • Tell your doctor if you take a drug that has caffeine, or you eat or drink products that have caffeine, like tea, coffee, cola, or chocolate.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
  • Rarely, very bad and sometimes deadly effects have happened with this drug. These include muscle or joint, kidney, liver, blood, and other problems. Talk with the doctor if you have questions.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
  • Very bad and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If you are over the age of 60, use this drug with care. You could have more side effects.
  • Use care in children younger than 18 years of age. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All dose forms:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Chest pain or pressure.
  • Feeling very tired or weak.
  • Shortness of breath.
  • Any unexplained bruising or bleeding.
  • Shakiness.
  • Trouble walking.
  • Vaginal itching or discharge.
  • White patches in mouth.
  • Sunburn.
  • Fever or chills.
  • Sore throat.
  • Muscle pain or weakness.
  • Not able to focus.
  • Memory problems or loss.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • It is common to have diarrhea when taking antibiotics. Rarely, a severe form of diarrhea called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking an antibiotic or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
  • Drugs like this one may raise the chance of a rare but severe problem with the main blood vessel that comes out of the heart (aorta). This includes tears or bursting of the aorta. This can lead to severe bleeding and even death. Call your doctor right away if you have sudden pain in the stomach, chest, or back that is severe and does not go away.
  • Injection:
  • Irritation where the shot is given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Upset stomach or throwing up.
  • Diarrhea.
  • Headache.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take this drug at the same time of day.
  • Take with or without food.
  • Take with a full glass of water.
  • Do not take this drug along with dairy products, like milk or yogurt, or calcium-rich juices. This drug may be taken with a full meal if the meal has these products.
  • Take this drug 2 hours before or 6 hours after antacids, didanosine, lanthanum, sucralfate, quinapril, bismuth, sevelamer, multivitamins, or other products that contain magnesium, calcium, aluminum, iron, or zinc.
  • To gain the most benefit, do not miss doses.
  • Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Liquid (suspension):
  • Shake well for about 15 seconds before each use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • Do not chew the mixture.
  • Keep lid tightly closed.
  • Do not put liquid suspension down a feeding tube.
  • After using the measuring spoon, clean with soap and water and be sure it is completely dry before using it again.
  • Throw away any part not used after treatment is done.
  • Tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Injection:
  • It is given as an infusion into a vein over a period of time.
What do I do if I miss a dose?
  • All oral products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Extended-release tablets:
  • Do not take more than 1 dose of this drug in the same day.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablet:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Liquid (suspension):
  • Store liquid (suspension) at room temperature or in a refrigerator. Do not freeze. Throw away any part not used after 2 weeks.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All dose forms:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Ciprofloxacin (Systemic) (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(sip roe FLOKS a sin)

Brand Names: US

Cipro; Cipro in D5W; Cipro XR

Brand Names: Canada

Cipro; Cipro XL; Ciprofloxacin Injection; Ciprofloxacin Injection USP; Ciprofloxacin Intravenous Infusion

Warning
  • This drug may cause very bad side effects. These include irritated or torn tendons; nerve problems in the arms, hands, legs, or feet; and nervous system problems. These side effects can happen alone or at the same time. They can happen within hours to weeks after starting this drug. Some of these side effects may not go away, and may lead to disability or death. Talk with the doctor.
  • The chance of irritated or torn tendons is greater in heart, kidney, or lung transplant patients and in people taking steroid drugs. Tendon problems can happen as long as several months after treatment. Call your child’s doctor right away if your child has pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints. Call your child’s doctor right away if your child is not able to move or bear weight on a joint or if your child hears or feels a snap or pop.
  • Call your child’s doctor right away if your child has signs of nerve problems. These may include not able to handle heat or cold; change in sense of touch; or burning, numbness, tingling, pain, or weakness in the arms, hands, legs, or feet.
  • Call your child’s doctor right away if your child has signs of nervous system problems. These may include anxiety, bad dreams, trouble sleeping, change in eyesight, dizziness, feeling confused, feeling nervous or agitated, feeling restless, hallucinations (seeing or hearing things that are not there), new or worse behavior or mood changes like depression or thoughts of killing him/herself, seizures, or very bad headaches.
  • Do not give this drug if your child has myasthenia gravis. Very bad and sometimes deadly breathing problems have happened with this drug in people who have myasthenia gravis.
  • For some health problems, this drug is only for use when other drugs cannot be used or have not worked. Talk with the doctor to be sure that the benefits of this drug are more than the risks.
What is this drug used for?
  • It is used to treat or prevent bacterial infections.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Long QT on ECG, low magnesium levels, low potassium levels, or slow heartbeat.
  • If your child has kidney disease.
  • If your child has heart failure, talk with the doctor.
  • If your child has had a recent heart attack.
  • If your child has ever had any of these health problems: Nerve problems or tendon problems.
  • If your child has had tendons get irritated or torn when taking this drug or an alike drug in the past.
  • If your child has an aortic aneurysm (ballooning or bulging of the aorta, the main blood vessel that comes out of the heart) or is at risk for this health problem. This includes if your child has other blood vessel problems, high blood pressure, or certain health problems like Marfan syndrome or Ehlers-Danlos syndrome.
  • If your child is taking any drugs used for a heartbeat that is not normal.
  • If your child is taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
  • If your child is taking any of these drugs: Duloxetine, theophylline, tizanidine, or zolpidem.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • High and low blood sugar has happened with drugs like this one. Most of the time, low blood sugar happened in people with diabetes who were taking drugs that lower blood sugar like insulin. Very low blood sugar has led to coma and sometimes death. Check blood sugar as you have been told by the doctor.
  • Tell your child’s doctor if your child has signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Do not give to your child longer than you have been told. A second infection may happen.
  • Tell the doctor if your child takes a drug that has caffeine or eats or drinks products that have caffeine, like tea, coffee, cola, or chocolate.
  • Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
  • Have your child drink lots of noncaffeine liquids unless told to drink less liquid by your child’s doctor.
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your child’s doctor.
  • Rarely, very bad and sometimes deadly effects have happened with this drug. These include muscle or joint, kidney, liver, blood, and other problems. Talk with the doctor if you have questions.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call the doctor right away if your child has a fast heartbeat, a heartbeat that does not feel normal, or if your child passes out.
  • Use care in children younger than 18 years of age. Talk with the doctor.
  • If your child is or may be pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Chest pain or pressure.
  • Feeling very tired or weak.
  • Shortness of breath.
  • Any unexplained bruising or bleeding.
  • Shakiness.
  • Trouble walking.
  • Vaginal itching or discharge.
  • White patches in mouth.
  • Sunburn.
  • Fever or chills.
  • Sore throat.
  • Muscle pain or weakness.
  • Not able to focus.
  • Memory problems or loss.
  • Very bad and sometimes deadly liver problems have happened with this drug. Call your child’s doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • It is common to have diarrhea when taking antibiotics. Rarely, a severe form of diarrhea called C diff-associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while your child is taking an antibiotic or within a few months after he/she stops taking it. Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with the doctor.
  • Drugs like this one may raise the chance of a rare but severe problem with the main blood vessel that comes out of the heart (aorta). This includes tears or bursting of the aorta. This can lead to severe bleeding and even death. Call your child’s doctor right away if your child has sudden pain in the stomach, chest, or back that is severe and does not go away.
  • Injection:
  • Irritation where the shot is given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Upset stomach or throwing up.
  • Diarrhea.
  • Headache.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug at the same time of day.
  • Give this drug with or without food.
  • Give this drug with a full glass of water.
  • Do not take this drug along with dairy products, like milk or yogurt, or calcium-rich juices. This drug may be taken with a full meal if the meal has these products.
  • Give this drug 2 hours before or 6 hours after antacids, didanosine, lanthanum, sucralfate, quinapril, bismuth, sevelamer, multivitamins, or other products that contain magnesium, calcium, aluminum, iron, or zinc.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Throw away any part not used after treatment is done.
  • Liquid (suspension):
  • Shake well for about 15 seconds before each use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • Do not let your child chew this drug.
  • Keep lid tightly closed.
  • Do not put liquid suspension down a feeding tube.
  • After using the measuring spoon, clean with soap and water and be sure it is completely dry before using it again.
  • Tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Injection:
  • It is given as an infusion into a vein over a period of time.
What do I do if my child misses a dose?
  • All oral products:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Extended-release tablets:
  • Do not give more than 1 dose of this drug in the same day.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablet:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Liquid (suspension):
  • Store liquid (suspension) at room temperature or in a refrigerator. Do not freeze. Throw away any part not used after 2 weeks.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.