RaNITIdine (Lexi-Drugs)

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

FDA: http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Ranitidine Injection, USP&st=c&tab=tabs-1

Pronunciation

(ra NI ti deen)

Brand Names: US

Acid Reducer [OTC]; GoodSense Acid Reducer [OTC]; raNITIdine 150 Max Strength [OTC]; raNITIdine Acid Reducer [OTC]; Zantac; Zantac 150 Maximum Strength [OTC]; Zantac 75 [OTC]

Brand Names: Canada

ACT Ranitidine; APO-Ranitidine; BCI Ranitidine [DSC]; DOM-Ranitidine; JAMP-Ranitidine; MAR-Ranitidine; MED Ranitidine; MYL-Ranitidine [DSC]; MYLAN-Ranitidine [DSC]; PHL-Ranitidine [DSC]; PMS-Ranitidine; RAN-Ranitidine; Ranitidine-150; Ranitidine-300; RIVA-Ranitidine; SANDOZ Ranitidine; TEVA-Ranitidine; TRIA-Ranitidine [DSC]; Zantac C; Zantac [DSC]

Pharmacologic Category

Histamine H2 Antagonist

Dosing: Adult

Anaphylaxis or severe infusion reaction (adjunct to epinephrine) (off-label use): Note: Do not use for initial or sole treatment of anaphylaxis because H2-receptor antagonists do not treat airway obstruction or shock. Although an added benefit in anaphylaxis is not well established, some experts give ranitidine after epinephrine for additional relief of hives based upon clinical experience (Campbell 2019).

IV: 50 mg as a single dose (WAO [Simons 2011])

Aspiration prophylaxis in patients undergoing anesthesia (off-label use): Note: May be considered in patients at high risk for aspiration (ASA 2016; Berkow 2019; Hagberg 2019; O’Reardon 2011; Rabheru 2001):

IV: 50 mg as a single dose ~40 to 60 minutes prior to induction of anesthesia; may be given with a rapid-acting nonparticulate antacid (eg, oral sodium citrate and citric acid) and/or metoclopramide (ASA 2016; ASA 2017; Berkow 2019; McCammon 1986).

Chronic spontaneous urticaria (alternative agent) (adjunct) (off-label use): Note: Use as additional therapy if insufficient response to full-dose H1 antihistamine.

Oral: 150 mg twice daily given in combination with H1 antihistamine; a trial of 2 to 4 weeks is suggested to assess response (Bernstein 2014; Kahn 2019; Kulthanan 2016).

Gastroesophageal reflux disease, treatment:

Initial therapy:

Mild and intermittent symptoms (<2 episodes/week), and no evidence of erosive esophagitis: Note: For more severe or frequent initial symptoms, with or without evidence of erosive esophagitis, a proton pump inhibitor (PPI) as initial therapy is recommended.

Oral: 75 mg twice daily as needed; if symptoms persist after 2 to 4 weeks, increase to 150 mg twice daily for 2 weeks; if symptoms improve, may continue therapy as needed (Kahrilas 2019).

Note: If symptoms persist after 2 weeks of 150 mg twice daily, discontinue and consider PPI therapy (Kahrilas 2019).

Residual acid reflux symptoms despite maximal PPI therapy (adjunct): Oral: 150 mg once daily given at bedtime in addition to PPI therapy (ACG [Katz 2013]; Iwakiri 2016); may also administer ranitidine intermittently or on-demand with scheduled PPI (Fass 2019).

OTC labeling (patient-guided therapy): Heartburn, mild intermittent symptoms: Oral: 75 to 150 mg up to twice daily when needed (maximum: 300 mg/day); may also be taken 30 to 60 minutes before meals or beverages that cause heartburn.

Infusion reaction, premedication (adjunct) (off-label use): Typically administered 30 to 60 minutes prior to infusion of certain chemotherapy agents or biologics; usually given in conjunction with an H1 antihistamine (eg, diphenhydramine) and glucocorticoids (refer to institutional protocols) (Castells 2019a; Lee 2009)

Oral: 150 to 300 mg

IV: 50 mg

Mastocytosis (adjunct) (off-label use): Oral: 150 mg every 12 hours adjusted to achieve GI symptom relief. Typically used in combination with other appropriate agent(s) (eg, H1antihistamine and/or leukotriene inhibitor) (Akin 2019; Castells 2019b; Worobec 2000).

Stress ulcer prophylaxis in select critically ill patients (off-label use): Note: For ICU patients with associated risk factors for GI bleeding (including coagulopathy, mechanical ventilation for >48 hours, traumatic brain injury, history of GI ulceration or bleeding within past year, extensive burns); discontinue prophylaxis once risk factors have resolved (Rhodes 2017; Weinhouse 2019).

Oral or via nasogastric (NG) tube (alternative to enteral PPI): 150 mg twice daily (ASHP 1999; Weinhouse 2019)

IV: 50 mg every 6 to 8 hours (ASHP 1999; Weinhouse 2019)

Dosing: Geriatric

Refer to adult dosing (use caution with dose selection).

Dosing: Renal Impairment: Adult

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

CrCl <50 mL/minute:

Oral: 150 mg every 24 hours; adjust dose cautiously if needed (frequency of dosing may be increased to every 12 hours or further with caution).

IV: 50 mg every 18 to 24 hours; adjust dose cautiously if needed

Hemodialysis: Adjust dosing schedule so that dose is scheduled to coincide with the end of hemodialysis.

Stress ulcer prophylaxis (ASHP 1999): CrCl <50 mL/minute:

Oral, nasogastric (NG) tube: 150 mg 1 to 2 times daily

IV: Intermittent bolus: 50 mg every 12 to 24 hours

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

Duodenal or gastric ulcer:

Oral:

Treatment:

Infants, Children, and Adolescents ≤16 years: 4 to 8 mg/kg/day divided twice daily; maximum daily dose: 300 mg/day

Adolescents >16 years:

Duodenal ulcer: 150 mg twice daily or 300 mg once daily after the evening meal or at bedtime

Gastric ulcer: 150 mg twice daily

Maintenance:

Infants, Children, and Adolescents ≤16 years: 2 to 4 mg/kg/day once daily; maximum daily dose: 150 mg/day

Adolescents >16 years: 150 mg once daily at bedtime

IM: Adolescents >16 years: 50 mg every 6 to 8 hours

IV:

Infants, Children, and Adolescents ≤16 years: 2 to 4 mg/kg/day divided every 6 to 8 hours; maximum dose: 50 mg/dose

Adolescents >16 years: 50 mg every 6 to 8 hours

Erosive esophagitis:

Infants, Children, and Adolescents ≤16 years: Oral: 5 to 10 mg/kg/day divided twice daily; maximum dose: 150 mg/dose

Adolescents >16 years: Oral

Treatment: 150 mg 4 times daily

Maintenance: 150 mg twice daily

GI bleed or stress ulcer; prophylaxis: Limited data available; dosing regimens variable: IV:

Intermittent infusion:

Infants: 2 to 6 mg/kg/day divided every 8 hours (ASHP, 1999; Crill, 1999)

Children and Adolescents: 3 to 6 mg/kg/day divided every 6 hours; maximum daily dose: 300 mg/day (ASHP, 1999; Crill, 1999)

Continuous infusion: Infants, Children, and Adolescents: Initial: 0.15 to 0.5 mg/kg/dose for 1 dose, followed by infusion of 0.08 to 0.2 mg/kg/hour (2 to 5 mg/kg/day) (Kleigman, 2007; Lugo, 2001; Osteyee, 1994)

GERD: Oral:

Infants, Children, and Adolescents ≤16 years: 5 to 10 mg/kg/day divided twice daily; maximum daily dose: 300 mg/day

Adolescents >16 years: 150 mg twice daily

Heartburn: OTC labeling: Note: Do not use for more than 14 days.

Prevention: Children ≥12 years and Adolescents: Oral: 75 to 150 mg 30 to 60 minutes before eating food or drinking beverages which cause heartburn; maximum daily dose: 2 doses/day

Relief of symptoms: Children ≥12 years and Adolescents: Oral: 75 to 150 mg twice daily; maximum daily dose: 2 doses/day

Patients not able to take oral medication:

Infants, Children, and Adolescents <16 years: IV: 2 to 4 mg/kg/day divided every 6 to 8 hours; maximum dose: 50 mg/dose

Adolescents ≥ 16 years:

I.M, IV: 50 mg every 6 to 8 hours

Continuous IV infusion: 6.25 mg/hour

Pathological hypersecretory conditions (eg, Zollinger-Ellison): Adolescents >16 years:

Oral: 150 mg twice daily; adjust dose or frequency as clinically indicated; doses of up to 6 g/day have been used

Continuous IV infusion: Initial: 1 mg/kg/hour; measure gastric acid output at 4 hours, if >10 mEq/hour or if patient is symptomatic, increase dose in increments of 0.5 mg/kg/hour; doses of up to 2.5 mg/kg/hour (or 220 mg/hour) have been used

Anaphylaxis, adjunct therapy: Infants, Children, and Adolescents: IV: 1 mg/kg/dose; maximum dose: 50 mg/dose; Note: Should not be used as monotherapy or as first line therapy (AAAAI/ACAAI [Lieberman, 2010]; Canadian Paediatric Society [Cheng, 2011])

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents (Aronoff 2007):

Oral: Based on a usual dose of 2 to 6 mg/kg/day divided every 8 to 12 hours

GFR >50 mL/minute/1.73 m2: No adjustment required

GFR 30 to 50 mL/minute/1.73 m2: 2 mg/kg/dose every 12 hours

GFR 10 to 29 mL/minute/1.73 m2: 1 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m2: 1 mg/kg/dose every 24 hours

Hemodialysis: 1 mg/kg/dose every 24 hours

Peritoneal dialysis: 1 mg/kg/dose every 24 hours

Continuous renal replacement therapy: 2 mg/kg/dose every 12 hours

Parenteral (IV): Based on a usual dose of 2 to 4 mg/kg/day divided every 6 to 24 hours

GFR >50 mL/minute/1.73 m2: No adjustment required

GFR 30 to 50 mL/minute/1.73 m2: 1 mg/kg/dose every 12 hours

GFR 10 to 29 mL/minute/1.73 m2: 0.5 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m2: 0.5 mg/kg/dose every 24 hours

Hemodialysis: 0.5 mg/kg/dose every 24 hours

Peritoneal dialysis: 0.5 mg/kg/dose every 24 hours

Continuous renal replacement therapy: 1 mg/kg/dose every 12 hours

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however dosage adjustment unlikely necessary due to minimal hepatic metabolism.

Use: Labeled Indications

Oral:

Gastroesophageal reflux disease: Treatment of gastroesophageal reflux disease (GERD).

Heartburn (OTC only): Relief and prevention of heartburn associated with acid indigestion and sour stomach.

Peptic ulcer disease: Treatment of active duodenal or gastric ulcers. Note: Although a labeled indication, proton pump inhibitors (PPIs) are considered the standard of care for treatment of peptic ulcer disease (PUD) rather than H2-receptor antagonists (eg, ranitidine) (Lanas 2017; Vakil 2019).

Injection:

Patients not able to take oral medication: As an alternative to the oral ranitidine dosage form for short-term (eg, GERD, peptic ulcer disease) use in patients who are unable to take oral medication.

Use: Off-Label: Adult

  Anaphylaxis or severe infusion reaction (adjunct to epinephrine)Level of Evidence [G]

Based on joint guidelines from the American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) for the diagnosis and management of anaphylaxis and guidelines from the World Allergy Organization on anaphylaxis, ranitidine may be used as adjunctive treatment, but should not be used as monotherapy or as first-line therapy for anaphylaxis.

  Aspiration prophylaxis in patients undergoing anesthesiaLevel of Evidence [B, G]

Data from multiple studies of varying methodologies support the use of H2-receptor antagonists for the prevention of aspiration in patients undergoing anesthesia Ref. Studies have encompassed a wide variety of patient populations and surgical and procedural settings, including (but not limited to) elective and emergency surgeries, rapid sequence intubation, and scheduled or emergent cesarean deliveries. Clinical experience and case reports also suggest use may be especially beneficial in patients at high risk for aspiration (eg, patients with a full stomach, severe GERD, gastroparesis and/or pregnant patients undergoing anesthesia for electroconvulsive therapy [ECT]) Ref.

Based on the American Society of Anesthesiologists (ASA) practice guidelines for obstetric anesthesia, ranitidine is an effective and recommended prophylactic agent for the prevention of aspiration during surgical procedures (eg, cesarean delivery, postpartum tubal ligation) in pregnant patients.

  Chronic spontaneous urticariaLevel of Evidence [G]

Based on a joint guideline published by the AAAAI, ACAAI, and the Joint Council of Allergy, Asthma, & Immunology, the addition of an H2-receptor antagonist (eg, ranitidine) may be considered as adjunctive therapy to an H1 antihistamine in patients with insufficient response to a full-dose H1 antihistamine alone.

  Infusion reaction, premedicationLevel of Evidence [C]

Clinical experience suggests the utility of H2-receptor antagonists (eg, ranitidine) as adjunctive therapy for premedication prior to the infusion of certain chemotherapy agents (eg, certain taxanes) or biologics to prevent infusion reactions Ref.

  MastocytosisLevel of Evidence [C]

Clinical experience suggests the utility of H2-receptor antagonists (eg, ranitidine) as adjunctive therapy for cutaneous or systemic mastocytosis Ref.

  Stress ulcer prophylaxis in select critically ill patientsLevel of Evidence [B, G]

A meta-analysis found no difference between PPIs and H2-receptor antagonists in terms of stress-related upper gastrointestinal bleeding prophylaxis, pneumonia, and mortality in intensive care units Ref.

Based on the American Society of Health-System Pharmacists (ASHP) therapeutic guidelines on stress ulcer prophylaxis, H2-receptor antagonists are recommended for stress ulcer prophylaxis in critically ill patients, although there was limited data on the use of PPIs for stress ulcer prophylaxis at the time of publication.

Based on the Surviving Sepsis Campaign international guidelines for the management of sepsis and septic shock, stress ulcer prophylaxis using an H2-receptor antagonist or a PPI is recommended in sepsis or septic shock patients who have gastrointestinal bleeding risk factors.

Level of Evidence Definitions
  Level of Evidence Scale
Use: Unsupported: Adult
Erosive esophagitis due to GERD

Although a labeled indication, the American College of Gastroenterology clinical practice guidelines do not recommend H2-receptor antagonists (eg, ranitidine) for the treatment of erosive esophagitis caused by GERD due to the availability of proton pump inhibitors (PPIs) (ACG [Katz 2013]).

Pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome [gastrinoma])

Although a labeled indication, clinical experience suggests there is currently no role for H2-receptor antagonists (eg, ranitidine) for controlling acid hypersecretion in pathological hypersecretory conditions such as Zollinger-Ellison syndrome due to the availability of PPIs (Guarnotta 2018; Ito 2013).

Clinical Practice Guidelines

Anaphylaxis

AAAAI/ACAAI, Diagnosis and Management of Anaphylaxis, September 2010

AAAAI/ACAAI/JCAAI, “Anaphylaxis – a Practice Parameter Update 2015,” November 2015

Critical Care:

“Surviving Sepsis Campaign: International Guidelines for the Management of Severe Sepsis and Septic Shock: 2016,” March 2017

Gastroesophageal Reflux Disease:

“AGA Medical Position Statement on the Management of Gastroesophageal Reflux Disease,” October 2008

Helicobacter pylori Infection:

“ACG Guideline on the Management of Helicobacter pylori Infection,” August 2007

Usual Infusion Concentrations: Pediatric

IV infusion: 0.5 mg/mL

Usual Infusion Concentrations: Adult

IV infusion: 50 mg in 50 mL (concentration: 1 mg/mL) or 500 mg in 250 mL (concentration: 2 mg/mL) of D5W or NS

Administration: IM

No dilution is needed.

Administration: IV

IV must be diluted; may be administered intermittent bolus or intermittent IV infusion

Intermittent bolus: Manufacturer recommends a maximum rate of administration of 10 mg/minute (infuse over at least 5 minutes); however, in adults may also be administered at a maximum rate of 25 mg/minute (or over 2 minutes) if necessary (Coursin 1988; Goelzer 1988; Smith 1987).

Intermittent IV infusion: Administer over a maximum rate of 2.5 to 3.5 mg/minute (infuse over at least 15 to 20 minutes)

Administration: Injectable Detail

pH: 6.7 to 7.3 (25 mg/mL solution in vial)

Administration: Pediatric

Oral: Administer with meals and/or at bedtime

Parenteral:

IV: Must be diluted prior to administration; may be administered IV push, intermittent IV infusion, or continuous IV infusion

Intermittent IV infusion: Preferred over IV push to decrease risk of bradycardia; infuse over 15 to 20 minutes

IV push: Manufacturer recommends administering over a period of at least 5 minutes, not to exceed 10 mg/minute (4 mL/minute)

Continuous IV infusion: Administer at ordered rate; titration may be necessary for some conditions.

IM: Administer undiluted

Dietary Considerations

Some products may contain phenylalanine and/or sodium. Oral dosage forms may be taken with or without food.

Storage/Stability

Capsules, tablets: Store between 20°C and 25°C (68°F and 77°F). Protect from light. Protect from moisture.

Injection: Store intact vials between 4°C and 25°C (39°F to 77°F); excursion permitted to 30°C (86°F). Protect from light; do not freeze. Avoid excessive heat (brief exposure up to 40°C does not affect the product). Undiluted solution is a clear, colorless to yellow color; slight darkening does not affect potency. Stable for 48 hours at room temperature when diluted for infusion in commonly used IV solutions (eg, NS, D5W, D10W, Ringer’s lactate injection, sodium bicarbonate 5% injection).

Syrup: Store between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze. Protect from light.

Preparation for Administration: Adult

Intermittent bolus injection: Dilute in NS or other compatible IV solution to a maximum concentration of 2.5 mg/mL (20 mL).

Intermittent infusion: Dilute in D5W or other compatible IV solution to a maximum concentration of 0.5 mg/mL (100 mL).

IM: No dilution necessary.

Preparation for Administration: Pediatric

Parenteral: Solution may be further diluted with NS or D5W.

Intermittent IV infusion: Dilute to maximum concentration of 0.5 mg/mL

IV push: Dilute to maximum concentration of 2.5 mg/mL

Continuous IV infusion: Dilute to a concentration of ≤0.6 mg/mL; concentrations up to 2.5 mg/mL have been used when treating Zollinger-Ellison syndrome

Compatibility

See Trissel’s IV Compatibility Database

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 headache, nausea, vomiting, constipation, diarrhea, abdominal pain, or injection site irritation. 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) (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 ranitidine or any component of the formulation

OTC labeling: When used for self-medication (OTC), do not use if trouble or pain when swallowing food, vomiting with blood, or bloody or black stools, allergic to ranitidine or other acid reducers. Do not use with other acid reducers. Do not use 150 mg tablet with kidney disease without medical advice.

Documentation of allergenic cross-reactivity for histamine H2 antagonists is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Confusion: Rare cases of reversible confusion have been associated with ranitidine; usually elderly or severely ill patients, or in patients with renal or hepatic impairment.

• Hepatic effects: Elevation in ALT levels has occurred with higher doses (≥100 mg) or prolonged IV therapy (≥5 days); monitor ALT levels daily for the remainder of treatment.

• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

• Hepatic impairment: Use with caution in patients with hepatic impairment (ranitidine undergoes hepatic metabolism).

• Porphyria: Avoid use in patients with a history of acute porphyria; may precipitate attacks.

• Renal impairment: Ranitidine is primarily excreted renally; dosage adjustment is recommended in patients with renal 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.

Special populations:

• Children: Use of gastric acid inhibitors, including proton pump inhibitors and H2 blockers, has been associated with an increased risk for development of acute gastroenteritis and community-acquired pneumonia in pediatric patients (Canani 2006).

Dosage form specific issues:

• Injection: Rapid administration has been associated with bradycardia (rare), usually in patients with predisposing risk factors for cardiac rhythm disorders. Do not exceed the recommended IV administration rate(s).

• Syrup: May contain up to 7.5% alcohol.

Other warnings/precautions:

• OTC labeling: When used for self-medication (OTC), notify health care provider before use if any of the following are present: Frequent chest pain; frequent wheezing particularly with heartburn; nausea/vomiting; unexplained weight loss; stomach pain; heartburn longer than 3 months; heartburn with light-headedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath; sweating or pain that spreads to arms, neck, or shoulders; light-headedness. Stop use and notify health care provider if heartburn continues, worsens, or lasts longer than 14 days.

Geriatric Considerations

Ulcer healing rates and incidence of adverse effects are similar in the elderly, when compared to younger patients; dosing adjustments not necessary based on age alone. Always adjust dose based upon creatinine clearance. Serum half-life is increased to 3 to 4 hours in elderly patients. H2 blockers are the preferred drugs for treating PUD in the elderly due to cost and ease of administration. These agents are no less or more effective than any other therapy. The preferred agents, due to side effects and drug interaction profile and pharmacokinetics are ranitidine, famotidine, and nizatidine. Treatment for PUD in the elderly is recommended for 12 weeks since their lesions are larger; therefore, take longer to heal. Always adjust dose based upon creatinine clearance, since accumulation may result in CNS side effects, mainly confusion and potential delirium. For these reasons, the American Geriatrics Society Beers Criteria recommends against the use of H2 blockers in those with dementia, cognitive impairment, or delirium (Beers Criteria [AGS 2015]).

Warnings: Additional Pediatric Considerations

Use of gastric acid inhibitors, including proton pump inhibitors and H2 blockers, has been associated with an increased risk for development of acute gastroenteritis and community-acquired pneumonia in pediatric patients (Canani, 2006). A large epidemiological study has suggested an increased risk for developing pneumonia in patients receiving H2 receptor antagonists; however, a causal relationship with ranitidine has not been demonstrated. A cohort analysis including over 11,000 neonates reported an association of H2 blocker use and an increased incidence of NEC in VLBW neonates (Guillet, 2006). An approximate sixfold increase in mortality, NEC, and infection (ie, sepsis, pneumonia, UTI) was reported in patients receiving ranitidine in a cohort analysis of 274 VLBW neonates (Terrin, 2011).

Pregnancy Considerations

Ranitidine crosses the placenta (Armentano 1989). Histamine H2 antagonists have been evaluated for the treatment of gastroesophageal reflux disease (GERD) as well as gastric and duodenal ulcers during pregnancy. If needed, ranitidine is the agent of choice (Cappell 2003; Richter 2003). Histamine H2 antagonists may be used for aspiration prophylaxis prior to cesarean delivery (ASA 2016).

Breast-Feeding Considerations

Ranitidine is excreted into breast milk. Notable interpatient variability has been observed with regards to the extent of excretion (Riley 1982); information is limited.

The relative infant dose (RID) of ranitidine is 3.9% to 19.6% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 2 to 10 mg/kg/day. In general, breastfeeding is considered unacceptable when the RID is >10% (Anderson 2016; Ito 2000). Using the highest milk concentration (2.61 mcg/mL), the estimated daily infant dose via breast milk is 0.392 mg/kg/day. This milk concentration was obtained following maternal administration of oral ranitidine 150 mg twice daily for five doses. In this case report, the highest milk concentration was reported at 5.5 hours after the administration of the maternal dose; the half-life in breast milk was 2.91 hours (Kearns 1985).

No adverse effects were noted in one infant exposed to ranitidine following maternal administration of oral ranitidine 150 mg twice daily for 5 doses (Kearns 1985). The manufacturer recommends that caution be exercised when administering ranitidine to breastfeeding women.

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

Frequency not defined.

Cardiovascular: Asystole, atrioventricular block, bradycardia (with rapid IV administration), tachycardia, vasculitis, ventricular premature contractions

Central nervous system: Agitation, confusion, dizziness, depression, drowsiness, hallucination, headache, insomnia, involuntary motor activity, malaise, vertigo

Dermatologic: Alopecia, erythema multiforme, injection site pruritus (transient), skin rash

Endocrine & metabolic: Acute porphyria, increased serum prolactin

Gastrointestinal: Abdominal distress, abdominal pain, constipation, diarrhea, nausea, necrotizing enterocolitis (very low weight neonates; Guillet 2006), pancreatitis, vomiting

Hematologic & oncologic: Agranulocytosis, aplastic anemia, granulocytopenia, hemolytic anemia (immune; acquired), leukopenia, pancytopenia, thrombocytopenia

Hepatic: Cholestatic hepatitis, hepatic failure, hepatitis, jaundice

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (eg, bronchospasm, eosinophilia, fever)

Local: Burning sensation at injection site (transient), pain at injection site (transient)

Neuromuscular & skeletal: Arthralgia, myalgia

Ophthalmic: Blurred vision

Renal: Acute interstitial nephritis, increased serum creatinine

Respiratory: Pneumonia (causal relationship not established)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2C19 (minor), CYP2D6 (minor), OCT2, P-glycoprotein/ABCB1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Acalabrutinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Acalabrutinib. Management: To minimize the potential for a significant interaction, separate administration of these agents by giving acalabrutinib 2 hours before ingestion of a histamine-2 receptor antagonist. Risk D: Consider therapy modification

Atazanavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Atazanavir. Management: Specific dose limitations and administration guidelines exist; consult full interaction monograph or atazanavir prescribing information. Risk D: Consider therapy modification

Bosutinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Bosutinib. Management: Administer histamine H2 receptor antagonists more than 2 hours before or after bosutinib. Risk D: Consider therapy modification

Cefditoren: Histamine H2 Receptor Antagonists may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with H2-antagonists and antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of H2-antagonists can not be avoided. Risk D: Consider therapy modification

Cefpodoxime: Histamine H2 Receptor Antagonists may decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy

Cefuroxime: Histamine H2 Receptor Antagonists may decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Risk X: Avoid combination

Cysteamine (Systemic): Histamine H2 Receptor Antagonists may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy

Dacomitinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Dacomitinib. Management: Administer dacomitinib at least 6 hours before or 10 hours after an histamine H2-receptor antagonist (H2RA). Risk D: Consider therapy modification

Dasatinib: Histamine H2 Receptor Antagonists may decrease the absorption of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of H2-antagonists if some acid-reducing therapy is needed. Risk X: Avoid combination

Delavirdine: Histamine H2 Receptor Antagonists may decrease the serum concentration of Delavirdine. Management: Chronic therapy with H2-antagonists should be avoided in patients who are being treated with delavirdine. The clinical significance of short-term H2-antagonist therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination

Dexmethylphenidate: Histamine H2 Receptor Antagonists may increase the absorption of Dexmethylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Doxofylline: RaNITIdine may increase the serum concentration of Doxofylline. Risk C: Monitor therapy

Erlotinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Erlotinib. Management: Avoid H2-antagonists in patients receiving erlotinib when possible. If concomitant treatment cannot be avoided, erlotinib should be dosed once daily, 10 hours after and at least 2 hours before H2-antagonist dosing. Risk D: Consider therapy modification

Fosamprenavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Fosamprenavir. Cimetidine may also inhibit the metabolism of the active metabolite amprenavir, making its effects on fosamprenavir/amprenavir concentrations difficult to predict. Risk C: Monitor therapy

Gefitinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Gefitinib. Management: Administer gefitinib at least 6 hours before or after administration of a histamine H2-antagonist, and closely monitor clinical response to gefitinib. Risk D: Consider therapy modification

Indinavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Indinavir. Risk C: Monitor therapy

Iron Salts: Histamine H2 Receptor Antagonists may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Risk C: Monitor therapy

Itraconazole: Histamine H2 Receptor Antagonists may increase the serum concentration of Itraconazole. Histamine H2 Receptor Antagonists may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any histamine H2 receptor antagonists (H2RAs). Exposure to Tolsura brand itraconazole may be increased by (H2RAs); consider itraconazole dose reduction. Risk D: Consider therapy modification

Ketoconazole (Systemic): Histamine H2 Receptor Antagonists may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any H2-receptor antagonist. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Risk D: Consider therapy modification

Ledipasvir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Ledipasvir. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

Mesalamine: Histamine H2 Receptor Antagonists may diminish the therapeutic effect of Mesalamine. Histamine H2-Antagonist-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose histamine H2-receptor antagonists with sustained-release mesalamine products. Risk D: Consider therapy modification

Methylphenidate: Histamine H2 Receptor Antagonists may increase the absorption of Methylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Histamine H2 Receptor Antagonists may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be impaired by H2-antagonists. Risk C: Monitor therapy

Nelfinavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Nelfinavir. Concentrations of the active M8 metabolite may also be reduced. Risk C: Monitor therapy

Neratinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Neratinib. Specifically, histamine H2 receptor antagonists may reduce neratinib absorption. Management: Administer neratinib at least 2 hours before or 10 hours after administration of a histamine H2 receptor antagonist to minimize the impact of this interaction. Risk X: Avoid combination

Nilotinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Nilotinib. Management: The nilotinib dose should be given 10 hours after or 2 hours before the H2 receptor antagonist in order to minimize the risk of a significant interaction. Risk D: Consider therapy modification

PAZOPanib: Histamine H2 Receptor Antagonists may decrease the serum concentration of PAZOPanib. Management: Avoid the use of histamine H2-antagonists in combination with pazopanib. Strategies to minimize the expected interaction between these agents (eg, dose separation) have not been investigated. Risk X: Avoid combination

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

Posaconazole: Histamine H2 Receptor Antagonists may decrease the serum concentration of Posaconazole. Management: Avoid concurrent use of oral suspension with H2-antagonists whenever possible. Monitor patients closely for decreased antifungal effects if this combination is used. Delayed-release posaconazole tablets may be less likely to interact. Risk D: Consider therapy modification

Prasugrel: RaNITIdine may decrease serum concentrations of the active metabolite(s) of Prasugrel. Risk C: Monitor therapy

Procainamide: RaNITIdine may increase the serum concentration of Procainamide. Ranitidine may also increase the concentration of the active N-acetyl-procainamide (NAPA) metabolite. Risk C: Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

Rilpivirine: Histamine H2 Receptor Antagonists may decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists at least 12 hours before or 4 hours after rilpivirine. Risk D: Consider therapy modification

Risedronate: Histamine H2 Receptor Antagonists may increase the serum concentration of Risedronate. This applies specifically to delayed-release risedronate. Risk X: Avoid combination

Saquinavir: Histamine H2 Receptor Antagonists may increase the serum concentration of Saquinavir. Risk C: Monitor therapy

Secretin: Histamine H2 Receptor Antagonists may diminish the diagnostic effect of Secretin. Specifically, use of H2-Antagonists may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of histamine H2-antagonists (H2RAs) and secretin. Discontinue H2RAs at least 2 days prior to secretin administration. Risk D: Consider therapy modification

Sulfonylureas: RaNITIdine may increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Tafenoquine: May increase the serum concentration of OCT2 Substrates. Management: Avoid use of OCT2 substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the OCT2 substrate and consider a reduced dose of the OCT2 substrate according to that substrate’s labeling. Risk D: Consider therapy modification

Varenicline: Histamine H2 Receptor Antagonists may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of cimetidine or other H2-antagonists, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling.Risk C: Monitor therapy

Velpatasvir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Velpatasvir. Risk C: Monitor therapy

Warfarin: RaNITIdine may increase the serum concentration of Warfarin. Risk C: Monitor therapy

Food Interactions

Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam 2013).

Test Interactions

False-positive urine protein using Multistix.

Monitoring Parameters

AST, ALT, serum creatinine; occult blood with GI bleeding, signs/symptoms of peptic ulcer disease; when used to prevent stress-related GI bleeding, measure the intragastric pH and try to maintain pH >4; when used for Zollinger-Ellison syndrome, monitor gastric acid secretion (goal: <10 mEq/hour); signs of confusion

Advanced Practitioners Physical Assessment/Monitoring

Use caution in presence of renal impairment; dosage adjustment may be necessary. Monitor for CNS changes (depression, hallucinations, confusion, malaise), rash, and GI disturbance.

Nursing Physical Assessment/Monitoring

Monitor for CNS changes (depression, hallucinations, confusion, malaise), rash, and GI disturbance.

Dosage Forms: US

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

Capsule, Oral:

Generic: 150 mg, 300 mg

Solution, Injection:

Zantac: 50 mg/2 mL (2 mL); 150 mg/6 mL (6 mL); 1000 mg/40 mL (40 mL) [contains phenol]

Generic: 50 mg/2 mL (2 mL); 150 mg/6 mL (6 mL)

Syrup, Oral:

Generic: 15 mg/mL (10 mL [DSC], 473 mL, 474 mL, 480 mL); 75 mg/5 mL (473 mL); 150 mg/10 mL (10 mL)

Tablet, Oral:

Acid Reducer: 75 mg

Acid Reducer: 75 mg, 150 mg [contains fd&c red #40 aluminum lake]

Acid Reducer: 150 mg [sodium free, sugar free]

GoodSense Acid Reducer: 75 mg [gluten free]

raNITIdine 150 Max Strength: 150 mg [contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake, fd&c yellow #10 aluminum lake]

raNITIdine Acid Reducer: 75 mg

Zantac 75: 75 mg

Zantac: 150 mg [DSC], 300 mg [DSC]

Zantac 150 Maximum Strength: 150 mg

Zantac 150 Maximum Strength: 150 mg [sodium free, sugar free; contains brilliant blue fcf (fd&c blue #1); mint flavor]

Generic: 75 mg, 150 mg, 300 mg

Dosage Forms: Canada

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

Capsule, Oral:

Zantac C: 150 mg, 300 mg [contains SOYBEAN LECITHIN]

Solution, Injection:

Zantac: 25 mg/mL (2ml[DSC], 40ml[DSC]) [contains PHENOL]

Generic: 25 mg/mL (2ml, 50ml, 100ml)

Solution, Oral:

Generic: 15 mg/mL (300ml)

Tablet, Oral:

Zantac: 150 mg [DSC], 300 mg [DSC]

Generic: 150 mg, 300 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A02BA02
Generic Available (US)

Yes

Pricing: US

Capsules (raNITIdine HCl Oral)

150 mg (per each): $0.91 – $1.52

300 mg (per each): $1.64 – $2.74

Solution (raNITIdine HCl Injection)

50 mg/2 mL (per mL): $7.73

150 mg/6 mL (per mL): $7.74

Solution (Zantac Injection)

50 mg/2 mL (per mL): $9.90

150 mg/6 mL (per mL): $9.90

1000 mg/40 mL (per mL): $7.95

Syrup (raNITIdine HCl Oral)

15 mg/mL (per mL): $0.74

Tablets (raNITIdine HCl Oral)

75 mg (per each): $0.07 – $0.08

150 mg (per each): $1.48 – $1.75

300 mg (per each): $2.69 – $3.22

Tablets (Zantac 150 Maximum Strength Oral)

150 mg (per each): $0.34

Tablets (Zantac 75 Oral)

75 mg (per each): $0.30

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

Competitive inhibition of histamine at H2-receptors of the gastric parietal cells, which inhibits gastric acid secretion, gastric volume, and hydrogen ion concentration are reduced. Does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin.

Pharmacodynamics/Kinetics

Absorption: Oral: 50%; IM: Rapid

Distribution: Vd: Minimally penetrates the blood-brain barrier

Infants, Children, and Adolescents: IV, Oral: 1 to 2.3 L/kg

Adults: Normal renal function: ~1.4 L/kg; CrCl 25 to 35 mL/minute: 1.76 L/kg

Protein binding: ~15%

Metabolism: Hepatic (minor) to N-oxide, S-oxide, and N-desmethyl metabolites

Bioavailability: Oral tablets: ~50%; IM: 90% to 100%

Half-life elimination:

Neonates (receiving ECMO): IV: 6.6 hours

Infants, Children, and Adolescents: IV: 1.7 to 2.4 hours

Adults:

Oral: Normal renal function: 2.5 to 3 hours; Elderly: 3 to 4 hours

IV: Normal renal function: 2 to 2.5 hours; CrCl 25 to 35 mL/minute: 4.8 hours; Elderly: 3.1 hours

Time to peak, serum: Oral: 2 to 3 hours; IM: ≤15 minutes

Excretion: Urine (as unchanged drug): Oral: 30%, IV: 70%; feces (as metabolites)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Plasma half-life, clearance, and volume of distribution are all altered in proportion to creatinine clearance.

Hepatic function impairment: Plasma half-life, clearance, and volume of distribution are all altered in proportion to creatinine clearance.

Geriatric: Total clearance is lowered.

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

Ranitidine HCl; Ranitidine Hydrochloride

FDA Approval Date
June 09, 1983
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Zantac injection (ranitidine) [prescribing information]. Buena, NJ: Teligent Pharma Inc.; September 2016.

Brand Names: International

Acicard (TW); Acidex (AR); Acidine (BE); Aciflux (CL); Aciloc (BF, BJ, CI, CZ, EG, ET, GH, GM, GN, IN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TW, TZ, UG, VN, ZM, ZW); Acloral (MX); Acran (ID); Aldin (IN); Alquen (ES); Anistal (DO, GT, HN, NI, SV); Antac (BD); Antagonin (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); Antak (BR); Apo-Ranitidine (NZ); Ardoral (ES); Arnetin (MY); Artonil (SE); Atural (PE); Ausran (AU); Azantac (FR, MX); Bindazac (MT); Bloxer (ID); Consec (IN); Contracid (PH); Curan (KR); Danitin (PH); Diciran (LK); Eltidine (KR); Epiran (EG); Ezopta (GR); Galidrin (MX); Gastrial (AR); Gastridin (ID); Gastril (MY); Gastrone (PH); Gastrosedol (AR); Gertac (IE); Haratac (VN); Hazitac (VN); Hexal Ranitic (AU); Hexer (ID); Histac (BF, BH, BJ, CI, ET, GH, GM, GN, HU, IN, JO, KE, KW, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TH, TN, TZ, UG, ZM, ZW); Histak (ZA); Huma-Ranidine (HU); Hyzan (HK, MY); Iqfadina (MX); Junizac (DE); Locid (KR); Lumeran (HK); Lydin (IN); Nadine (AE, CY, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Neoceptin-R (SG); Nipodur (MT); Nitidin (PY); Pepiture (LK); Peptoran (HR); Ponaltin (KR); Ptinolin (GR); Pylorid (HR, HU, LU, PH); R-Loc (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); Radinat (EC); Ranacid (BH, JO, KW, LB, SA); Randin (AE, CY, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Rani (BD); Rani 2 (AU); Ranial (IN); Raniben (IT); Raniberl (CZ, LV); Ranicux (DE); Ranidil (IT); Ranidin (BD, ES); Ranidine (TH); Ranigast (LV); Ranihasan (VN); Ranimex (FI); Ranin (ID, TH); Ranione (KR); Ranipin (VN); Raniplex (FR); Ranisan (AE, CY, CZ, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ranisen (MX); Ranitab (EC); Ranital (CZ, HR); Ranitic (IE, LU); Ranitidin-B (HU); Ranitin-150 (ET, ZW); Ranix (HR); Ranopine (IE); Ranpex (BD); Rantac (AE, CY, IN, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Rantacid (FI); Rantag (AE, BH, QA, SA); Rantin (ID); Ratic (HK, TH); Ratinal (ID); Raxide (PH); Ribotine (KR); RND (TW); Rolan (AE, CY, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Sostril (DE); Tanidina (ES); Taural (AR, CR, DO, EG, GT, HN, NI, PA, SV); Tyran (ID); Ulcaid (AU, ZA); Ulceran (HU, PE, ZW); Ulceranin (ID); Ulcex (IT); Ulcin (PH); Ulcinorm (VN); Ulciran (PY); Ulcodin (HR); Ulcosan (CZ); Ulsal (AT); Ulticer (HK); Ultran (PH); Umaren (HU); Verlost (GR); Vesyca (SG); Vizerul (AR); Weichilin (TW); Weidos (TW); Wontac (ET); X’Tac (MY); Xanidine (SG); Xanomel (HU); Xantid (BD); Xeradin (ID); Zantac (AE, AU, BB, BE, BF, BG, BH, BJ, BM, BS, BZ, CI, CN, CO, CR, CY, CZ, DK, DO, EC, EE, EG, ES, ET, FI, GB, GH, GM, GN, GR, GT, GY, HK, HN, HU, ID, IE, IL, IQ, IR, IS, IT, JM, JO, KE, KR, KW, LB, LK, LR, LT, LU, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PR, PT, PY, QA, RO, RU, SA, SC, SD, SE, SI, SL, SN, SR, SV, SY, TN, TR, TT, TW, TZ, UG, UY, VE, VN, YE, ZA, ZM, ZW); Zantadin (ID); Zantic (CH, DE); Zaridex (IL); Zendhin (MY); Zerdin (PH); Zinetac (IN); Zydac (AE, QA); Zylium (BR); Zynol (ZW)

Ranitidine (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

(ra NI ti deen)

Brand Names: US

Acid Reducer [OTC]; GoodSense Acid Reducer [OTC]; raNITIdine 150 Max Strength [OTC]; raNITIdine Acid Reducer [OTC]; Zantac; Zantac 150 Maximum Strength [OTC]; Zantac 75 [OTC]

Brand Names: Canada

Acid Reducer; ACT Ranitidine; Apo-Ranitidine; Dom-Ranitidine; Myl-Ranitidine; Mylan-Ranitidine; PHL-Ranitidine; PMS-Ranitidine; RAN-Ranitidine; Ranitidine Injection, USP; Riva-Ranitidine; Sandoz-Ranitidine; Teva-Ranitidine; Zantac; Zantac 75; Zantac Maximum Strength Non-Prescription

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat or prevent GI (gastrointestinal) ulcers.
  • It is used to treat heartburn and sour stomach.
  • It is used to treat syndromes caused by lots of stomach acid.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ranitidine hydrochloride 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 ever had porphyria.
  • 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.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Tell your doctor if you have black, tarry, or bloody stools; you throw up blood; or your throw up looks like coffee grounds.
  • 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.
  • This drug prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than this drug.
  • Liver problems have happened with this drug. Most of the time, liver problems went back to normal after this drug was stopped. Rarely, liver problems have led to death. If you have questions, talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • 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.
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:
  • All products:
  • Headache.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Belly pain.
  • Injection:
  • Irritation where this drug is given.
  • 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 with or without food. Take with food if it causes an upset stomach.
  • Take at bedtime if you are taking once a day.
  • All liquid products:
  • 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.
  • Liquid (suspension):
  • Shake well before use.
  • Injection:
  • It is given as a shot into a muscle or vein.
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.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • Liquid (suspension):
  • Store in a refrigerator. Do not freeze.
  • Throw away any part not used after 8 weeks.
  • All other oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Injection:
  • If you need to store this drug at home, talk with your 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 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.
Ranitidine (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

(ra NI ti deen)

Brand Names: US

Acid Reducer [OTC]; GoodSense Acid Reducer [OTC]; raNITIdine 150 Max Strength [OTC]; raNITIdine Acid Reducer [OTC]; Zantac; Zantac 150 Maximum Strength [OTC]; Zantac 75 [OTC]

Brand Names: Canada

Acid Reducer; ACT Ranitidine; Apo-Ranitidine; Dom-Ranitidine; Myl-Ranitidine; Mylan-Ranitidine; PHL-Ranitidine; PMS-Ranitidine; RAN-Ranitidine; Ranitidine Injection, USP; Riva-Ranitidine; Sandoz-Ranitidine; Teva-Ranitidine; Zantac; Zantac 75; Zantac Maximum Strength Non-Prescription

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat or prevent GI (gastrointestinal) ulcers.
  • It is used to treat heartburn and sour stomach.
  • It is used to treat syndromes caused by lots of stomach acid.
  • It may be given to your child for other reasons. Talk with the doctor.
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 ever had porphyria.
  • 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.
  • 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.
  • Tell the doctor if your child has black, tarry, or bloody stools; your child throws up blood; or your child’s throw up looks like coffee grounds.
  • 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.
  • This drug prevents many other drugs from getting into the body. If your child takes other drugs, check with the doctor or pharmacist to see if your child needs to take them at some other time than this drug.
  • Liver problems have happened with this drug. Most of the time, liver problems went back to normal after this drug was stopped. Rarely, liver problems have led to death. If you have questions, talk with the doctor.
  • 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.
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:
  • All products:
  • Headache.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Belly pain.
  • Injection:
  • Irritation where this drug is given.
  • 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 with or without food. Give with food if it causes an upset stomach.
  • Give at bedtime if your child is taking it once a day.
  • All liquid products:
  • 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.
  • Liquid (suspension):
  • Shake well before use.
  • Injection:
  • It is given as a shot into a muscle or vein.
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 give 2 doses at the same time or extra doses.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • Liquid (suspension):
  • Store in a refrigerator. Do not freeze.
  • Throw away any part not used after 8 weeks.
  • All other oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • 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.