Cephalexin (Lexi-Drugs)

Special Alerts
  Beta-Lactam Antibiotics Safety AlertSeptember 2018
Pronunciation

(sef a LEKS in)

Brand Names: US

Daxbia [DSC]; Keflex

Brand Names: Canada

APO-Cephalex; AURO-Cephalexin; DOM-Cephalexin; Keflex; LUPIN-Cephalexin; PMS-Cephalexin; TEVA-Cephalexin; TEVA-Cephalexin 125; TEVA-Cephalexin 250

Dosing: Adult

Usual dosage range: Oral: 250 to 1,000 mg every 6 hours or 500 mg every 12 hours (maximum: 4 g/day)

Indication-specific dosing:

Cellulitis (nonpurulent)/erysipelas, mild (alternative agent): Oral: 500 mg 4 times daily for at least 5 days (duration should be extended if not resolved/slow response) (IDSA [Stevens 2014])

Cystitis, uncomplicated (alternative agent): Oral: 500 mg every 12 hours for 5 to 7 days (Hooton 2018)

Endocarditis, prophylaxis (dental or invasive respiratory tract procedures) (alternative agent) (off-label use): Oral: 2 g 30 to 60 minutes prior to procedure. Note: AHA guidelines recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur (AHA [Wilson 2007]).

Impetigo or ecthyma: Oral: 250 to 500 mg 4 times daily for 7 days. Note: Not an appropriate agent if MRSA is suspected or confirmed (Baddour 2018; IDSA [Stevens 2014]).

Prosthetic joint infection (off-label use): Oral: Treatment (following pathogen-specific IV therapy in patients undergoing 1-stage exchange or debridement with retention of prosthesis). Note: Duration ranges from a minimum of 3 months to indefinitely, depending on patient-specific factors (Berbari 2018):

Staphylococci (methicillin-susceptible): 500 mg every 6 to 8 hours. For the first 3 to 6 months of therapy, combine with rifampin (Berbari 2018; IDSA [Osmon 2013]).

Streptococci, beta-hemolytic (alternative agent): 500 mg every 6 to 8 hours (Berbari 2018; IDSA [Osmon 2013])

Cutibacterium spp (alternative agent): 500 mg every 6 to 8 hours (IDSA [Osmon 2013]; Kanafani 2018)

Streptococcal pharyngitis (group A) (alternative agent for mild [non-anaphylactic] penicillin allergy): Oral: 500 mg every 12 hours for 10 days (IDSA [Shulman 2012]; Pichichero 2018; manufacturer’s labeling)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl 30 to 59 mL/minute: There are no specific dosage adjustments provided in the manufacturer’s labeling; maximum recommended daily dose: 1,000 mg/day.

CrCl 15 to 29 mL/minute: 250 mg every 8 to 12 hours

CrCl 5 to 14 mL/minute (not yet on dialysis): 250 every 24 hours

CrCl 1 to 4 mL/minute (not yet on dialysis): 250 mg every 48 to 60 hours

End-stage renal disease (ESRD) on intermittent hemodialysis: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following guidelines have been used by some clinicians (Aronoff 2007): Oral: 250 to 500 mg every 12 to 24 hours; moderately dialyzable (20% to 50%); give dose after dialysis session.

Peritoneal dialysis: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following guidelines have been used by some clinicians (Aronoff 2007): Oral: 250 to 500 mg every 12 to 24 hours.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

General dosing, susceptible infection: Infants, Children, and Adolescents:

Mild to moderate infection: Oral: 25 to 50 mg/kg/day divided every 6 or 12 hours; maximum daily dose: 2,000 mg/day (Red Book [AAP 2015])

Severe infection: Oral: 75 to 100 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 4,000 mg/day (Bradley 2015; Red Book [AAP 2015])

Catheter (peritoneal dialysis); exit-site or tunnel infection: Limited data available: Infants, Children, and Adolescents: Oral: 10 to 20 mg/kg/day once daily or divided into 2 doses; maximum dose: 1,000 mg/dose (Warady [ISPD] 2012)

Pharyngitis/tonsillitis (group A streptococcal):

Manufacturer’s labeling: Note: Experts recommend dosing on the higher end of the presented range (IDSA [Shulman 2012])

Children and Adolescents <15 years: Oral: 25 to 50 mg/kg/day divided every 12 hours; maximum dose: 500 mg/dose

Adolescents ≥15 years: Oral: 500 mg every 12 hours

Alternate dosing: IDSA recommendation: Infants, Children, and Adolescents: Oral: 20 mg/kg/dose twice daily for 10 days, maximum dose: 500 mg/dose (IDSA [Shulman 2012])

Impetigo (staphylococcus or streptococcus): Infants, Children, and Adolescents: Oral: 25 to 50 mg/kg/day divided every 6 or 8 hours; maximum dose: 250 mg/dose; continue for at least 7 days, full duration dependent upon clinical response (IDSA [Stevens 2014])

Otitis media, acute (AOM): Infants and Children: Oral: 75 to 100 mg/kg/day divided every 6 hours; maximum dose not established for AOM; usual maximum adult dose for mild to moderate infections: 500 mg/dose and for severe infections: 1,000 mg/dose. Note: Cephalexin is not routinely recommended as an empiric treatment option (AAP [Lieberthal 2013]).

Skin and skin structure infections (eg, cellulitis, erysipelas):

Manufacturer’s labeling:

Infants, Children, and Adolescents ≤15 years: Oral: 25 to 50 mg/kg/day divided every 12 hours, maximum dose: 500 mg/dose; for β-hemolytic streptococcal infections, a duration of 10 days is suggested

Adolescents >15 years: 500 mg every 12 hours

Alternate dosing: IDSA recommendations: Infants, Children, and Adolescents: Oral: 25 to 50 mg/kg/day divided every 6 hours; maximum dose: 500 mg/dose; continue for at least 5 days or longer depending upon clinical response (IDSA [Stevens 2014])

Endocarditis; prophylaxis (dental, oral, or respiratory tract procedures): Infants, Children, and Adolescents: Oral: 50 mg/kg administered 30 to 60 minutes prior to procedure; maximum dose: 2,000 mg/dose (AHA [Wilson 2007]). Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur (AHA [Wilson 2007]).

Pneumonia, community-acquired: S. aureus (methicillin-susceptible), mild infection or step-down therapy: Infants >3 months, Children, and Adolescents: Oral: 75 to 100 mg/kg/day in 3 to 4 divided doses; maximum daily dose: 4,000 mg/day (IDSA/PIDS [Bradley 2011])

Urinary tract infection:

Empiric therapy in febrile patients: Infants ≥2 months and Children <24 months: Oral: 50 to 100 mg/kg/day divided every 6 hours for 7 to 14 days (AAP 2011)

Treatment:

Children and Adolescents <15 years: Oral: 25 to 50 mg/kg/day divided every 6 to 12 hours for 7 to 14 days, maximum dose: 500 mg/dose; for severe infections, 50 to 100 mg/kg/day divided every 6 to 12 hours may be necessary; maximum daily dose: 4,000 mg/day

Adolescents ≥15 years: Oral: 250 mg every 6 hours or 500 mg every 12 hours for 7 to 14 days; higher doses may be necessary for severe infections; maximum daily dose: 4,000 mg/day.

Osteoarticular infection (eg, septic arthritis, osteomyelitis); step-down therapy: Infants, Children, and Adolescents: Oral: 100 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 4,000 mg/day; duration of therapy variable, dependent upon clinical response and typically extensive (weeks of therapy); compliance should be monitored (Bradley 2015; Red Book [AAP 2015]); a small (n=11) prospective, open-label pharmacokinetic study reported a median dose of 40 mg/kg/dose every 8 hours (mean age: 7 years; range: 1 to 16 years; dose range: 19 to 51 mg/kg/dose every 8 hours) maintained serum concentrations long enough to meet the pharmacokinetic/pharmacodynamic target for efficacy (T>MIC ≥ 40%) (Autmizguine 2013)

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: There are no recommendations in the manufacturer’s labeling; the following adjustments have been recommended (Aronoff 2007). Note:Renally adjusted dose recommendations are based on doses of 25 to 50 mg/kg/day divided every 6 hours: Oral:

CrCl >50 mL/minute/1.73 m2: No adjustment necessary

CrCl 30 to 50 mL/minute/1.73 m2: 5 to 10 mg/kg/dose every 8 hours (maximum dose: 500 mg/dose)

CrCl 10 to 29 mL/minute/1.73 m2: 5 to 10 mg/kg/dose every 12 hours (maximum dose: 500 mg/dose)

CrCl <10 mL/minute/1.73 m2: 5 to 10 mg/kg/dose every 24 hours (maximum dose: 500 mg/dose)

Intermittent hemodialysis: 5 to 10 mg/kg/dose every 24 hours after dialysis (maximum dose: 500 mg/dose)

Peritoneal dialysis: 5 to 10 mg/kg/dose every 24 hours (maximum dose: 500 mg/dose)

Dosing: Hepatic Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Bone infections: Treatment of bone infections caused by Staphylococcus aureus and/or Proteus mirabilis.

Genitourinary tract infections: Treatment of genitourinary tract infections, including acute prostatitis, caused by Escherichia coliP. mirabilis, and Klebsiella pneumoniae.

Otitis media: Treatment of otitis media caused by Streptococcus pneumoniaeHaemophilus influenzaeS. aureusStreptococcus pyogenes, and Moraxella catarrhalis.

Respiratory tract infections: Treatment of respiratory tract infections (including pharyngitis) caused by S. pneumoniae and S. pyogenes.

Skin and skin structure infections: Treatment of skin and skin structure infections caused by S. aureus and/or S. pyogenes.

Use: Off-Label: Adult

  Endocarditis, prophylaxisLevel of Evidence [G]

Based on the American Heart Association (AHA) guidelines for the prevention of infective endocarditis, cephalexin is an effective and recommended alternative agent for prophylaxis against infective endocarditis in patients with certain cardiac conditions who are undergoing dental or respiratory tract procedures and are allergic to penicillins or ampicillin. Note: Cephalexin should not be used in patients with a history of anaphylaxis, angioedema, or urticaria with penicillins or ampicillin.

  Prosthetic joint infectionLevel of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of prosthetic joint infection, cephalexin is an effective and recommended agent for treatment (following pathogen-specific IV therapy in patients undergoing 1-stage exchange or debridement with retention of prosthesis) and long-term oral antimicrobial suppression of prosthetic joint infection caused by staphylococci (methicillin-susceptible) (for the first 3 to 6 months of therapy, in combination with rifampin), and an effective and recommended alternative agent when this condition is caused by beta-hemolytic streptococci or Cutibacterium species.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Acne:

American Academy of Dermatology, “Guidelines of care for the management of acne vulgaris,” May 2016

Diabetic Foot Infection:

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

Infective Endocarditis:

“AHA 2007 Guidelines for the Prevention of Infective Endocarditis,” April 2007

Pharyngitis, Group A Streptococci:

IDSA, “Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis,” September 2012

Pneumonia, Community-Acquired:

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

Prosthetic Joint Infection:

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

Skin and Soft-tissue Infection:

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

Urinary Tract Infections:

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

Administration: Oral

Administer without regard to food. If GI distress, take with food. Give around-the-clock to promote less variation in peak and trough serum levels.

Administration: Pediatric

Oral: Shake suspension well before use. Take without regard to food. If GI distress, may take with food. Give around-the-clock to promote less variation in peak and trough serum levels.

Storage/Stability

Capsule: Store at 25°C (77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).

Powder for oral suspension: Store at 20°C to 25°C (68°F to 77°F). Refrigerate after reconstitution; discard after 14 days.

Tablet: Store at 20°C to 25°C (68°F to 77°F).

Preparation for Administration: Pediatric

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

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 nausea, vomiting, abdominal pain, or diarrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), bruising, bleeding, chills, pharyngitis, severe loss of strength and energy, confusion, hallucinations, urinary retention, change in amount of urine passed, seizures, vaginitis, 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), or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (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:
Contraindications

Hypersensitivity to cephalexin, other cephalosporins, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Allergic reactions (eg, rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [TEN]) have been reported. If an allergic reaction occurs, discontinue immediately and institute appropriate treatment.

• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• Seizure disorder: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.

• 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:

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

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.

Other warnings/precautions:

• Direct Coombs tests: Positive direct Coombs tests and acute intravascular hemolysis has been reported. If anemia develops during or after therapy, discontinue use and work up for drug-induced hemolytic anemia.

Geriatric Considerations

Adjust dose for renal function.

Pregnancy Considerations

Cephalexin crosses the placenta and produces therapeutic concentrations in the fetal circulation and amniotic fluid (Creatsas 1980).

An increased risk of major birth defects or other adverse fetal or maternal outcomes has generally not been observed following use of cephalosporin antibiotics, including cephalexin, during pregnancy

Peak concentrations in pregnant patients are similar to those in nonpregnant patients. Prolonged labor may decrease oral absorption (Griffith 1983; Paterson 1972).

Breast-Feeding Considerations

Cephalexin is present in breast milk.

The relative infant dose (RID) of cephalexin is 0.13% to 0.52% when compared to an infant therapeutic dose of 25 to 100 mg/kg/day.

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

The RID of cephalexin was calculated using a milk concentration of 0.85 mcg/mL, providing an estimated daily infant dose via breast milk of 0.13 mg/kg/day. This milk concentration was obtained following a single maternal dose of cephalexin 1 g orally on the third postpartum day. The mean peak milk concentration occurred 4 to 5 hours after the dose (Kafetzis 1981). Slightly higher concentrations of cephalexin were detected in the breast milk of a lactating woman also administered probenecid and cephalexin for ≥16 days (Ilett 2006).

Diarrhea has been reported in breastfeeding infants (Ilett 2006; Ito 1993). In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).

When an antibiotic is needed, cephalexin may be used to treat mastitis in breastfeeding women allergic to preferred agents (Amir 2014; Berens 2015). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother

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

Frequency not defined.

Central nervous system: Agitation, confusion, dizziness, fatigue, hallucination, headache

Dermatologic: Erythema multiforme (rare), genital pruritus, skin rash, Stevens-Johnson syndrome (rare), toxic epidermal necrolysis (rare), urticaria

Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, gastritis, nausea (rare), pseudomembranous colitis, vomiting (rare)

Genitourinary: Genital candidiasis, vaginal discharge, vaginitis

Hematologic & oncologic: Eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia

Hepatic: Cholestatic jaundice (rare), hepatitis (transient, rare), increased serum ALT, increased serum AST

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Neuromuscular & skeletal: Arthralgia, arthritis, arthropathy

Renal: Interstitial nephritis (rare)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

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

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

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

MetFORMIN: Cephalexin may increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Cephalexin. Specifically, the zinc contained in many multivitamins may decrease cephalexin absorption. Management: Consider administering multivitamins at least 3 hours after cephalexin. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Cephalexin. Specifically, the zinc contained in many multivitamins may decrease cephalexin absorption. Management: Consider administering multivitamins at least 3 hours after cephalexin. Risk D: Consider therapy modification

Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy

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

Sucroferric Oxyhydroxide: May decrease the serum concentration of Cephalexin. Management: Administer cephalexin at least 1 hour before administration of sucroferric oxyhydroxide.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

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

Zinc Salts: May decrease the absorption of Cephalexin. Management: Consider administering oral zinc salts at least 3 hours after cephalexin. Exceptions: Zinc Chloride. Risk D: Consider therapy modification

Food Interactions

Peak antibiotic serum concentration is lowered and delayed, but total drug absorbed is not affected. Cephalexin serum levels may be decreased if taken with food. Management: Administer without regard to food.

Test Interactions

Positive direct Coombs’, false-positive urinary glucose test using cupric sulfate (Benedict’s solution, Clinitest®, Fehling’s solution), false-positive serum or urine creatinine with Jaffé reaction, false-positive urinary proteins and steroids

Monitoring Parameters

With prolonged therapy monitor renal, hepatic, and hematologic function periodically; monitor for signs of anaphylaxis during first dose

Advanced Practitioners Physical Assessment/Monitoring

Assess results of culture/sensitivity tests and patient’s allergy history prior to therapy. Obtain CBC, renal function tests, liver function tests periodically with prolonged therapy. Monitor for signs of anaphylaxis during first dose. Advise patients with diabetes about use of Clinitest (may cause false-positive test). Assess for effectiveness of treatment. Test for C.difficile if patient develops diarrhea.

Nursing Physical Assessment/Monitoring

Check labs results and report abnormalities. Monitor closely for signs of hypersensitivity (shortness-of-breath, dyspnea, chest pain, complaints of difficulty swallowing or throat tightness, or change in vital signs). Monitor for severe or bloody diarrhea and send a specimen to the lab for C.difficile. Monitor for improvement with infection. Advise patients with diabetes about use of Clinitest (may cause false-positive test). Teach patient to report opportunistic infection and hypersensitivity reaction.

Dosage Forms: US

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

Capsule, Oral:

Daxbia: 333 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Keflex: 250 mg, 500 mg, 750 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Generic: 250 mg, 500 mg, 750 mg

Suspension Reconstituted, Oral:

Generic: 125 mg/5 mL (100 mL, 200 mL); 250 mg/5 mL (100 mL, 200 mL)

Tablet, Oral:

Generic: 250 mg, 500 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 250 mg, 500 mg

Suspension Reconstituted, Oral:

Keflex: 125 mg/5 mL (100ml, 150ml, 200ml); 250 mg/5 mL (100ml, 150ml, 200ml)

Generic: 125 mg/5 mL (100ml, 150ml, 200ml); 250 mg/5 mL (100ml, 150ml, 200ml)

Tablet, Oral:

Keflex: 250 mg, 500 mg

Generic: 250 mg, 500 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • J01DB01
Generic Available (US)

Yes

Pricing: US

Capsules (Cephalexin Oral)

250 mg (per each): $0.19 – $0.87

500 mg (per each): $0.34 – $1.97

750 mg (per each): $7.38 – $7.69

Capsules (Keflex Oral)

250 mg (per each): $10.43

500 mg (per each): $10.43

750 mg (per each): $10.43

Suspension (reconstituted) (Cephalexin Oral)

125 mg/5 mL (per mL): $0.09 – $0.24

250 mg/5 mL (per mL): $0.19 – $0.29

Tablets (Cephalexin Oral)

250 mg (per each): $4.18

500 mg (per each): $8.22

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 bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Pharmacodynamics/Kinetics

Absorption: Rapid (90%); delayed in young children and may be decreased up to 50% in neonates

Distribution: Widely into most body tissues and fluids, including gallbladder, liver, kidneys, bone, sputum, bile, and pleural and synovial fluids; CSF penetration is poor

Protein binding: 6% to 15%

Half-life elimination: Neonates: 5 hours; Children 3-12 months: 2.5 hours; Adults: 0.5 to 1.2 hours (prolonged with renal impairment)

Time to peak, serum: ~1 hour

Excretion: Urine (80% to 100% as unchanged drug) within 8 hours

Dental Use

Prophylaxis in total joint replacement patients undergoing dental procedures; alternative oral antibiotic for prevention of infective endocarditis in individuals allergic to penicillins or ampicillin

Note: Individuals allergic to amoxicillin (penicillins) may receive cephalexin provided they have not had an immediate, local, or systemic IgE-mediated anaphylactic allergic reaction to penicillin.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

Cephalexin is effective against anaerobic bacteria, but the sensitivity of alpha-hemolytic Streptococcus vary; approximately 10% of strains are resistant. Nearly 70% are intermediately sensitive. Patients allergic to penicillins can use a cephalosporin; the incidence of cross-reactivity between penicillins and cephalosporins is 1% to 5% when the allergic reaction to penicillin is delayed. If the patient has a history of anaphylaxis to penicillin, cephalosporins are contraindicated in these patients.

Effects on Dental Treatment

No significant effects or complications reported (see Dental Health Professional Considerations)

Effects on Bleeding

No information available to require special precautions

Dental Usual Dosing

Prophylaxis against infective endocarditis (dental, oral, or respiratory tract procedures): Oral:

Children >1 year: 50 mg/kg 30 to 60 minutes prior to procedure; maximum: 2 g

Children >15 years and Adults: 2 g 30 to 60 minutes prior to procedure

Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur.

Prophylaxis in total joint replacement patients undergoing dental procedures which produce bacteremia: Oral: Adults: 2 g 1 hour prior to procedure

Note: In general, patients with prosthetic joint implants do not require prophylactic antibiotics prior to dental procedures. In planning an invasive oral procedure, dental consultation with the patient’s orthopedic surgeon may be advised to review the risks of infection.

Index Terms

Cephalexin Monohydrate

FDA Approval Date
January 04, 1971
References

Amir LH, Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #4: Mastitis, revised March 2014. Breastfeed Med. 2014;9(5):239-243.[PubMed 24911394]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007.

Baddour LM. Impetigo. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 22, 2018.

Berbari E, Baddour LM. Prosthetic joint infection. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 22, 2018.

Berens PD. Breast pain: engorgement, nipple pain, and mastitis. Clin Obstet Gynecol. 2015;58(4):902-914.[PubMed 26512442]

Bradley JS, Byington CL, Shah SS, et al; Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. Clin Infect Dis.2011;53(7):e25-e76.[PubMed 21880587]

Creatsas G, Pavlatos M, Lolis D, Kaskarelis D. A study of the kinetics of cephapirin and cephalexin in pregnancy. Curr Med Res Opin. 1980;7(1):43-46.[PubMed 7428412]

Dajani AS, Taubert KA, Wilson W, et al, “Prevention of Bacterial Endocarditis Recommendations by the American Heart Association,” JAMA, 1997, 277(22):1794-801.[PubMed 9178793]

Griffith RS. The pharmacology of cephalexin. Postgrad Med J. 1983;59(Suppl 5):16-27.[PubMed 6364086]

Hooton TM, Gupta K. Acute uncomplicated cystitis in women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 22, 2018.

Ilett KF, Hackett LP, Ingle B, Bretz PJ. Transfer of probenecid and cephalexin into breast milk. Ann Pharmacother. 2006;40(5):986-989.[PubMed 16551765]

Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168(5):1393-1399.[PubMed 8498418]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Kafetzis DA, Siafas CA, Georgakopoulos PA, Papadatos CJ. Passage of cephalosporins and amoxicillin into the breast milk. Acta Paediatr Scand. 1981;70(3):285-288.[PubMed 7246123]

Kanafani ZA. Invasive Cutibacterium (formerly Propionibacterium) infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 22, 2018.

Keflex (cephalexin) capsules [prescribing information]. Locust Valley, NY: Pragma Pharmaceuticals, LLC; December 2018.

Keflex (cephalexin) suspension [prescribing information]. Locust Valley, NY: Pragma Pharmaceuticals, LLC; December 2018.

Osmon DR, Berbari EF, Berendt AR, et al; Infectious Diseases Society of America. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013;56(1):e1-e25.[PubMed 23223583]

Paterson ML, Henderson A, Lunan CB, et al, “Transplacental Transfer of Cephalexin,” Clinical Medicine, 1972, 22-4.

Pichichero ME. Treatment and prevention of streptococcal pharyngitis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 18, 2018.

Shulman ST, Bisno AL, Clegg HW, et al; Infectious Diseases Society of America. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2014;58(10):1496].Clin Infect Dis. 2012;55(10):e86-e102.[PubMed 22965026]

Sollecito TP, Abt E, Lockhart PB, et al. The use of prophylactic antibiotics prior to dental procedures in patients with prosthetic joints: Evidence-based clinical practice guideline for dental practitioners–a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2015; 146(1):11-16.[PubMed 25569493]

Stevens DL, Bisno AL, Chambers HF, et al; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2015;60(9):1448]. Clin Infect Dis. 2014;59(2):e10-e52.[PubMed 24973422]

Wilson W, Taubert KA, Gewitz M, et al; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Surgery and Anesthesia; Quality of Care and Outcomes Research Interdisciplinary Working Group. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group [published correction appears in Circulation. 2007;116(15):e376-e377]. Circulation. 2007;115(15):1736-1754.[PubMed 17446442]

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/

Wynn RL, Bergman SA, Meiller TF, et al, “Antibiotics in Treating Oral-Facial Infections of Odontogenic Origin: An Update,” Gen Dent, 2001, 49(3):238-40, 242, 244 passim.[PubMed 12004720 ]

Brand Names: International

Acelex (BD); Airex (PH); Alexin (IN); Arlexin (CR, DO, GT, HN, NI, PA, SV); Asef (BD); Avloxin (BD); Axcel (LK); Bloflex (PH); Capxin (CR, DO, GT, HN, NI, PA, SV); Cecan (PY); Cefabiotic (ID); Cefacet (FR); Cefacin-M (HK); Cefadal (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Cefadin (EC); Cefadyl (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Cefalin (ID, PH); Cefalver (MX); Cefamor (ET, ZW); Cefastad (HK); Ceff (ET); Cefovit (IL); Cefrax (TR); Celexin (ET); Cephadar Forte (LB); Cephalen (SG); Cephalex (BH, DE); Cephalexyl (TH); Cephanmycin (MY, SG); Cephast (ET); Cephoxin (EG); Ceporex (BB, BM, BS, BZ, CR, CY, EG, GB, GT, GY, HN, IQ, IR, IT, JM, JO, KW, LB, LY, MX, NI, NZ, OM, PA, PH, PT, SA, SR, SV, SY, TT, VN, YE, ZA); Ceporex Forte (PT); Ceporexin (AR); Ceprax (CO); Ceproex (DO); Ceralin (HR); Cerexin (ZA); Erocetin (PY, UY); Falexin (KR); Farmalex (TH); Felexin (ET, LK, MY, TR); Fexin (ZA); Glexil (VN); Glopixin (VN); Ibilex (AU, NZ, TH); Inphalex (ID); Italcefal (EC); Kefacin (CY, IQ, IR, JO, KR, KW, LY, OM, SA, SY, YE); Kefalex (FI); Kefalospes (GR); Kefaxin (GR); Keflex (AE, AT, AU, BB, BF, BJ, BM, BR, BS, BZ, CI, CO, CY, DK, EE, EG, ET, GB, GH, GM, GN, GR, GY, IE, IL, JM, JO, KE, KW, LB, LI, LR, MA, ML, MR, MU, MW, MX, NE, NG, NO, PE, PH, PK, PL, PT, QA, RO, SA, SC, SD, SE, SL, SN, SR, TH, TN, TT, TZ, UG, ZM, ZW); Kefloridina (ES); Keforal (AR, BE, FR, IT, NL, VE); Kidolex (TW); Larixin (JP); LC-Lexin (PH); Lecef (LK); Lenocef (ZA); Lexin (AE, BD, JO, PE, QA); Lexipron (ID); Madlexin (ID); Meceta (VN); Medolexin (MY); Midaflex (QA); Monocef (LI); Nafacil-S (MX); Neokef (MY); Nufex (IN); Oracef (CZ); Oriphex (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Ospeksyn (UA); Ospexin (AT, BG, CY, CZ, EG, IQ, IR, JO, KW, LY, MY, OM, QA, SA, SY, YE); Ospexina (CO); Paferxin (MX); Palitrex (ID); Pectril (PH); Pharmexin (CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Plecef (LK); Proxicef (HR); Ramoxin (JO); Rancef (AU); Relaxin (PH); Sanaxin (AT); Sef (LI); SEF (TR); Sepexin (IN); Septilisin (AR); Servicef (MX); Servispor (TW); Sialexin (TH); Sofilex (HK, MY, SG); Solulexin (MY); Sorlex (PH); Sporicef (TH); Sporidex (AE, IN, PH); Sporidin (TH); Sporidin AF (TH); Theoflex (LK); Torlasporin (LB); Uphalexin (MY, SG); Winlex (TW); Zecef (LK); Zelexin (PH)

Cephalexin (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

(sef a LEKS in)

Brand Names: US

Daxbia [DSC]; Keflex

Brand Names: Canada

Keflex

What is this drug used for?
  • It is used to treat bacterial infections.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to cephalexin 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 are taking probenecid.
  • 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.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • If you have high blood sugar (diabetes), do not use Clinitest®. Use some other urine glucose testing like Clinistix® or Tes-Tape®.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Do not use longer than you have been told. A second infection may happen.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • 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.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
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:
  • 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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Any unexplained bruising or bleeding.
  • Fever or chills.
  • Sore throat.
  • Feeling very tired or weak.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Not able to pass urine or change in how much urine is passed.
  • Seizures.
  • Vaginal itching or discharge.
  • 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.
  • 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.
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.
  • Belly pain.
  • 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 products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Take with or without food. Take with food if it causes an upset stomach.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • 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.
How do I store and/or throw out this drug?
  • Tablets and capsules:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Liquid (suspension):
  • Store in a refrigerator. Throw away any part not used after 2 weeks.
  • Do not freeze.
  • Keep lid tightly closed.
  • 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 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.
Cephalexin (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

(sef a LEKS in)

Brand Names: US

Daxbia [DSC]; Keflex

Brand Names: Canada

Keflex

What is this drug used for?
  • It is used to treat 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 is taking probenecid.
  • 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’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • If your child has high blood sugar (diabetes), do not use Clinitest®. Use some other urine glucose testing like Clinistix® or Tes-Tape®.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Do not give to your child longer than you have been told. A second infection may happen.
  • If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
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:
  • 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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Any unexplained bruising or bleeding.
  • Fever or chills.
  • Sore throat.
  • Feeling very tired or weak.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Not able to pass urine or change in how much urine is passed.
  • Seizures.
  • Vaginal itching or discharge.
  • 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.
  • 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.
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:
  • Belly pain.
  • Upset stomach or throwing up.
  • Diarrhea.
  • 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 products:
  • 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.
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • 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 give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Tablets and capsules:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Liquid (suspension):
  • Store in a refrigerator. Throw away any part not used after 2 weeks.
  • Do not freeze.
  • Keep lid tightly closed.
  • 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.