Famotidine (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

Pronunciation

(fa MOE ti deen)

Brand Names: US

Acid Controller Max St [OTC]; Acid Controller Original Str [OTC]; Acid Reducer Maximum Strength [OTC]; Acid Reducer [OTC]; Heartburn Relief Max St [OTC]; Heartburn Relief [OTC]; Pepcid; Pepcid AC Maximum Strength [OTC]

Brand Names: Canada

ALTI-Famotidine; APO-Famotidine; BCI-Famotidine [DSC]; CO Famotidine; Famotidine Omega W-O Preserv; Famotidine Omega W-Preserv; GMD-Famotidine; MYLAN-Famotidine [DSC]; NTP-Famotidine [DSC]; TEVA-Famotidine

Pharmacologic Category

Histamine H2 Antagonist

Dosing: Adult

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: 20 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: 20 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: 10 mg twice daily as needed; if symptoms persist after 2 to 4 weeks, increase to 20 mg twice daily for 2 weeks; if symptoms improve, may continue therapy as needed (Kahrilas 2019).

Note: If symptoms persist after 2 weeks of 20 mg twice daily, discontinue and consider PPI therapy (Kahrilas 2019).

Residual acid reflux symptoms despite maximal PPI therapy (adjunct): Oral: 20 mg once daily given at bedtime in addition to PPI therapy (ACG [Katz 2013]; Wang 2009); may also administer famotidine intermittently or on demand with scheduled PPI (Fass 2019).

OTC labeling (patient-guided therapy): Heartburn, mild intermittent symptoms: Oral: 10 to 20 mg up to twice daily when needed (maximum: 40 mg/day); may also be taken 10 to 60 minutes before meals or beverages that cause heartburn (maximum: 40 mg/day).

Infusion reaction, premedication (adjunct) (off-label use): IV, Oral: 20 mg 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 glucocorticoid (refer to institutional protocols) (Castells 2019b).

Mastocytosis (adjunct) (off-label use): Oral: 10 to 20 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 2019a).

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): 20 mg twice daily (ASHP 1999; Weinhouse 2019)

IV: 20 mg twice daily (ASHP 1999; Weinhouse 2019)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Injection:

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

CrCl <50 mL/minute: Administer 50% of dose or increase the dosing interval to every 36 to 48 hours.

Oral:

Duodenal ulcer, active:

CrCl 30 to 60 mL/minute: Maximum dose: 20 mg once daily or 40 mg every other day

CrCl <30 mL/minute: Maximum dose: 20 mg every other day or 10 mg once daily

Duodenal ulcer, maintenance:

CrCl 30 to 60 mL/minute: Maximum dose: 20 mg every other day or 10 mg once daily

CrCl <30 mL/minute: Maximum dose: 10 mg every other day

Gastric ulcer:

CrCl 30 to 60 mL/minute: Maximum dose: 20 mg once daily or 40 mg every other day

CrCl <30 mL/minute: Maximum dose: 20 mg every other day or 10 mg once daily

GERD:

Esophagitis and accompanying symptoms due to GERD:

CrCl 30 to 60 mL/minute:

Maximum dose for the 20 mg twice-daily regimen: 20 mg once daily or 40 mg every other day

Maximum dose for the 40 mg twice-daily regimen: 40 mg once daily

CrCl <30 mL/minute:

Maximum dose for the 20 mg twice-daily regimen: 20 mg every other day or 10 mg once daily

Maximum dose for the 40 mg twice-daily regimen: 20 mg once daily

Treatment of GERD (short-term):

CrCl 30 to 60 mL/minute: Maximum dose: 20 mg once daily

CrCl <30 mL/minute: Maximum dose: 20 mg every other day or 10 mg once daily

Pathological hypersecretory conditions: Avoid use

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

GERD:

Oral:

Suspension:

Infants <3 months: 0.5 mg/kg/dose once daily for up to 8 weeks; if not effective after 2 weeks, increasing to 1 mg/kg/dose once daily has been suggested (Orenstein 2003)

Infants ≥3 months, Children, and Adolescents ≤16 years: Initial: 0.5 mg/kg/dose twice daily; maximum dose: 40 mg/dose; doses up to 1 mg/kg/dose twice daily have been reported (Orenstein 2003)

Tablets: Children and Adolescents ≥40 kg: 20 mg twice daily for up to 6 weeks; for esophagitis and accompanying symptoms due to GERD, may use 20 to 40 mg twice daily for up to 12 weeks

IV:

Infants <3 months: Limited data available: 0.25 mg/kg/dose once daily; dosing based on a pharmacokinetic study which included 7 patients <3 months who received IV famotidine (Wenning 2005)

Infants ≥3 months: Limited data available: Initial: 0.25 mg/kg/dose every 12 hours; maximum dose: 20 mg/dose; dosing based on a pharmacokinetic study which included 11 patients >3 to 12 months who received IV famotidine (Wenning 2005)

Children and Adolescents: Initial: 0.25 mg/kg/dose every 12 hours; maximum dose: 20 mg/dose; doses up to 0.5 mg/kg/dose every 12 hours have been reported

Heartburn, acid indigestion, or sour stomach (OTC labeling): Children ≥12 years and Adolescents: Oral: 10 to 20 mg every 12 hours; dose may be taken 15 to 60 minutes before eating foods known to cause heartburn; maximum daily dose: 2 tablets/day (20 to 40 mg dependent upon OTC product)

Pathological hypersecretory conditions (eg, Zollinger-Ellison): Adolescents ≥17 years:

Oral: Initial: 20 mg every 6 hours, may increase up to 160 mg every 6 hours

IV: 20 mg every 12 hours

Peptic ulcer disease:

Oral:

Suspension: Children and Adolescents ≤16 years: 0.5 mg/kg/day at bedtime or divided twice daily; maximum daily dose: 40 mg/day; doses up to 1 mg/kg/day at bedtime or divided twice daily have been used

Tablets: Children and Adolescents >40 kg:

Duodenal ulcer: Acute therapy: 40 mg once daily at bedtime or 20 mg twice daily for 4 to 8 weeks

Gastric ulcer: Acute therapy: 40 mg once daily at bedtime for up to 8 weeks

IV: Children and Adolescents: Initial: 0.25 mg/kg/dose every 12 hours; maximum dose: 20 mg/dose; doses up to 0.5 mg/kg/dose every 12 hours have been reported

Stress ulcer prophylaxis, gastric acid suppression: Limited data available: Infants, Children, and Adolescents: IV: 1 to 2 mg/kg/day in divided doses every 8 to 12 hours; maximum daily dose: 40 mg/day (Aanpreung 1998; ASHP 1999; Behrens 1994; Kraus 1990; Treem 1991)

Dosing: Renal Impairment: Pediatric

Weight-based dosing: Infants, Children, and Adolescents: There are no specific dosage adjustments provided in the manufacturer’s labeling; however, decreased doses or extended dosing intervals are recommended in patients with moderate to severe renal impairment; some have suggested the following (Aronoff 2007): Note: Renally adjusted dose recommendations are based on doses of 0.5 to 1 mg/kg/day divided every 12 hours.

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

GFR 30 to 50 mL/minute/1.73 m2: 0.5 mg/kg/dose every 24 hours

GFR 10 to 29 mL/minute/1.73 m2: 0.25 mg/kg/dose every 24 hours

GFR <10 mL/minute/1.73 m2: 0.125 mg/kg/dose every 24 hours

Intermittent hemodialysis: 0.125 mg/kg/dose every 24 hours

Peritoneal dialysis (PD): 0.125 mg/kg/dose every 24 hours

Continuous renal replacement therapy (CRRT): 0.5 mg/kg/dose every 24 hours

Fixed dosing: Children and Adolescents ≥40 kg: Tablets:

GERD:

Treatment (short-term):

CrCl >60 mL/minute: No dosage adjustment necessary

CrCl 30 to 60 mL/minute: Maximum dose: 20 mg once daily

CrCl <30 mL/minute: Maximum dose: 20 mg every other day or 10 mg once daily

Esophagitis and accompanying symptoms due to GERD:

CrCl >60 mL/minute: No dosage adjustment necessary

CrCl 30 to 60 mL/minute:

Maximum dose for the 20 mg twice daily regimen: 20 mg once daily or 40 mg every other day

Maximum dose for the 40 mg twice daily regimen: 40 mg once daily

CrCl <30 mL/minute:

Maximum dose for the 20 mg twice daily regimen: 20 mg every other day or 10 mg once daily

Maximum dose for the 40 mg twice daily regimen: 20 mg once daily

Duodenal ulcer, active or gastric ulcer:

CrCl >60 mL/minute: No dosage adjustment necessary

CrCl 30 to 60 mL/minute: Maximum dose: 20 mg once daily or 40 mg every other day

CrCl <30 mL/minute: Maximum dose: 20 mg every other day or 10 mg once daily

Dosing: Hepatic Impairment: Pediatric

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

Use: Labeled Indications

Oral:

Gastroesophageal reflux disease: Treatment of gastroesophageal reflux disease (GERD) and esophagitis due to GERD.

Heartburn (OTC only): Relief of heartburn, 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, famotidine) (Lanas 2017; Vakil 2019).

Injection:

Patients not able to take oral medication: As an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.

Use: Off-Label: Adult

  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, famotidine 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 American Academy of Allergy, Asthma, and Immunology (AAAAI), American College of Allergy, Asthma, and Immunology (ACAAI), and the Joint Council of Allergy, Asthma, & Immunology, the addition of an H2-receptor antagonist (eg, famotidine) may be considered as adjunctive therapy to an H1antihistamine 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, famotidine) 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, famotidine) 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 GI 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 GI 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, famotidine) 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, famotidine) 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

Gastroesophageal Reflux Disease:

ACG, “Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease,” March 2013

Critical Care:

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

Administration: IV

Administer IV push over at least 2 minutes. Administer IV infusion over 15 to 30 minutes.

Administration: Injectable Detail

pH: 5.7 to 6.4 (premixed solution); 5 to 5.6 (injection)

Administration: Oral

Administer without regard to meals. May administer with antacids.

Suspension: Shake vigorously before use.

Tablet (OTC): Do not chew; dose may be taken 10 to 60 minutes before eating food or drinking beverages known to cause heartburn.

Administration: Pediatric

Oral: May administer with antacids. May be taken without regard to meals.

Suspension: Shake vigorously for 10 to 15 seconds prior to each use

Tablet (OTC): Do not chew; dose may be taken 10 to 60 minutes before eating food or drinking beverages known to cause heartburn

Parenteral:

IV push: May be administered at a rate of ≤10 mg/minute over at least 2 minutes

IV infusion: Infuse over 15 to 30 minutes

Storage/Stability

Oral:

Powder for oral suspension: Prior to reconstitution, store at 25°C (77°F). Reconstituted oral suspension is stable for 30 days at room temperature; do not freeze.

Tablet: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

IV:

Solution for injection: Prior to use, store at 2°C to 8°C (36°F to 46°F). If solution freezes, allow to solubilize at room temperature. Protect from light.

IV push: Following preparation, solutions for IV push should be used immediately, or may be stored in refrigerator and used within 48 hours.

Infusion: Following dilution in D5W, D10W, NS or LR, may be stored for up to 48 hours under refrigeration; however, solutions for infusion have been found to be physically and chemically stable for 7 days at room temperature (maintains at least 90% of initial potency).

Solution for injection, premixed bags: Store at 25°C (77°F); avoid excessive heat.

Preparation for Administration: Adult

Solution for injection:

IV push: Dilute 2 mL (20 mg) with NS (or another compatible solution) to a total of 5 to 10 mL. May also administer undiluted (Lipsy 1995).

Infusion: Dilute 2 mL (20 mg) with 100 mL of D5W or another compatible solution.

Preparation for Administration: Pediatric

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

Parenteral:

IV push: Dilute famotidine with NS or another compatible solution (eg, D5W, D10W, LR) to a maximum concentration of 4 mg/mL; in adults may also administer undiluted (Lipsy 1995)

IV Infusion: Dilute to 0.2 mg/mL in an appropriate diluent; in adolescents or adults typically prepared with 100 mL D5W or another compatible solution (eg, NS, D10W, LR)

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

Note: A famotidine suspension (8 mg/mL) is commercially available.

8 mg/mL Oral Suspension

An 8 mg/mL oral suspension may be made with tablets. Crush seventy 40 mg tablets in a mortar and reduce to a fine powder. Add small portions of sterile water and mix to a uniform paste. Mix while adding a 1:1 mixture of Ora-Plus and Ora-Sweet in incremental proportions to almost 350 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 350 mL. Label “shake well.” Stable for 95 days at room temperature.

Dentinger PJ, Swenson CF, Anaizi NH. Stability of famotidine in an extemporaneously compounded oral liquid. Am J Health Syst Pharm. 2000;57(14):1340-1342.[PubMed 10918924]

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. Have patient report immediately to prescriber dizziness, passing out, tachycardia, or abnormal heartbeat (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

Serious hypersensitivity (eg, anaphylaxis) to famotidine, other H2 antagonists, 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 other acid reducers; renal impairment; coadministration with other acid reducers.

Warnings/Precautions

Concerns related to adverse effects.

• ECG changes: Prolonged QT interval has been reported in patients with moderate to severe renal impairment. The FDA has received reports of torsades de pointes occurring with famotidine (Poluzzi 2009).

• 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.

• Renal impairment: Use with caution; increased risk of CNS adverse reactions and QT prolongation; dosage adjustment recommended in moderate and severe renal impairment (CrCl ≤60 mL/minute).

Concurrent drug therapy issues:

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

Special populations:

• Elderly: Use with caution; CNS adverse reactions (eg, confusion, delirium, hallucinations, disorientation, agitation, seizures, lethargy) have been reported in elderly patients.

• Pediatric: 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:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

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 >3 months; heartburn with light-headedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath; sweating; pain that spreads to arms, neck, or shoulders; light-headedness. Discontinue use and notify health care provider if heartburn continues or worsens, or if use is required >14 days.

Geriatric Considerations

H2 blockers are the preferred drugs for treating PUD in the elderly due to cost and ease of administration. They are no less or more effective than any other therapy. Famotidine is one of the preferred agents (due to side effects, drug interaction profile, and pharmacokinetics). Treatment for PUD in the elderly is recommended for 12 weeks since their lesions are typically 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 4 to 36 months of age (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 famotidine has not been demonstrated. A cohort analysis including over 11,000 neonates reported an association of H2 blocker use and an increased incidence of necrotizing enterocolitis (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 2012). Routine use in preterm infants is not recommended (AAP [Eichenwald 2018]).

Pregnancy Considerations

Famotidine crosses the placenta (Wang 2013).

Due to pregnancy-induced physiologic changes, renal clearance of famotidine may be increased (Wang 2011).

Histamine H2 antagonists have been evaluated for the treatment of gastroesophageal reflux disease (GERD) during pregnancy. Agents other than famotidine may be preferred for initial therapy (Richter 2005; van der Woude 2014). Histamine H2 antagonists may be used for aspiration prophylaxis prior to cesarean delivery (ASA 2016).

Breast-Feeding Considerations

Famotidine is present in breast milk.

The relative infant dose (RID) of famotidine is 2.2% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 0.5 mg/kg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

The RID of famotidine was calculated using a milk concentration of 0.072 mcg/mL, providing an estimated daily infant dose via breast milk of 0.011 mg/kg/day. This milk concentration was obtained following maternal administration of a single dose of famotidine 40 mg orally (Courtney 1988).

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. When treatment with a histamine H2 antagonist is needed, famotidine is one of the preferred agents due to its lower concentrations in breast milk (Richter 2005).

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

All reported ADRs are for the oral formulations unless otherwise noted.

>10%: Central nervous system: Agitation (infants: ≤14%; adults: <1%)

1% to 10%:

Central nervous system: Headache (5%), dizziness (1%)

Gastrointestinal: Diarrhea (2%), constipation (1%), necrotizing enterocolitis (very low birth weight neonates; Guillet 2006)

Frequency not defined: Local: Irritation at injection site (IV)

<1%, postmarketing, and/or case reports: Abdominal distress, acne vulgaris, agranulocytosis, alopecia, anaphylaxis, angioedema, anorexia, anxiety, arthralgia, asthenia, atrioventricular block, bronchospasm, cardiac arrhythmia, cholestatic jaundice, confusion, conjunctival injection, decreased libido, depression, drowsiness, facial edema, fatigue, fever, flushing, hallucination, hepatitis, hypersensitivity reaction, impotence, increased liver enzymes, insomnia, interstitial pneumonitis, leukopenia, muscle cramps, musculoskeletal pain, nausea, palpitations, pancytopenia, paresthesia, periorbital edema, prolonged Q-T interval on ECG, pruritus, psychiatric disturbance, rhabdomyolysis, seizure, skin rash, Stevens-Johnson syndrome, taste disorder, thrombocytopenia, tinnitus, toxic epidermal necrolysis, urticaria, vomiting, xeroderma, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of OCT2

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

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

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

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

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

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

Food Interactions

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

Monitoring Parameters

CBC, gastric pH, occult blood with GI bleeding

Advanced Practitioners Physical Assessment/Monitoring

Teach patient proper timing of administration.

Nursing Physical Assessment/Monitoring

Teach patient proper timing of administration.

Dosage Forms: US

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

Solution, Intravenous:

Generic: 20 mg (50 mL); 20 mg/2 mL (2 mL); 40 mg/4 mL (4 mL); 200 mg/20 mL (20 mL)

Solution, Intravenous [preservative free]:

Generic: 20 mg/2 mL (2 mL)

Suspension Reconstituted, Oral:

Pepcid: 40 mg/5 mL (50 mL [DSC]) [contains methylparaben sodium, propylparaben sodium, sodium benzoate; cherry banana mint flavor]

Generic: 40 mg/5 mL (50 mL)

Tablet, Oral:

Acid Controller Max St: 20 mg

Acid Controller Original Str: 10 mg

Acid Reducer: 10 mg

Acid Reducer Maximum Strength: 20 mg

Heartburn Relief: 10 mg

Heartburn Relief Max St: 20 mg

Pepcid: 20 mg, 40 mg [contains corn starch]

Pepcid AC Maximum Strength: 20 mg

Generic: 10 mg, 20 mg, 40 mg

Dosage Forms: Canada

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

Solution, Intravenous:

Generic: 10 mg/mL (1ml[DSC], 2ml, 4ml, 5ml, 20ml)

Tablet, Oral:

Generic: 20 mg, 40 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A02BA03
Generic Available (US)

Yes

Pricing: US

Solution (Famotidine Intravenous)

20 mg/2 mL (per mL): $0.44 – $0.54

40 mg/4 mL (per mL): $0.53 – $0.62

200 mg/20 mL (per mL): $0.44 – $0.54

Suspension (reconstituted) (Famotidine Oral)

40 mg/5 mL (per mL): $3.54

Tablets (Famotidine Oral)

10 mg (per each): $0.31

20 mg (per each): $0.10 – $2.42

40 mg (per each): $3.35 – $4.68

Tablets (Pepcid AC Maximum Strength Oral)

20 mg (per each): $0.25

Tablets (Pepcid Oral)

20 mg (per each): $12.86

40 mg (per each): $24.85

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

Pharmacodynamics/Kinetics

Onset of action: Antisecretory effect: Oral: Within 1 hour

Peak effect: Antisecretory effect: Oral: Within 1 to 3 hours (dose-dependent); IV: Within 30 minutes

Duration: Antisecretory effect: IV, Oral: 10 to 12 hours

Absorption: Oral: Incompletely absorbed

Distribution: Vd: IV:

Infants: ≤3 months: 1.4 ± 0.4 L/kg to 1.8 ± 0.3 L/kg; >3 to 12 months: 2.3 ± 0.7 L/kg

Children <11 years: 2.07 ± 1.49 L/kg

Children ≥11 years and Adolescents ≤15 years: 1.5 ± 0.4 L/kg

Adults: 1.3 ± 0.2 L/kg

Protein binding: 15% to 20%

Metabolism: 30% to 35%; minimal first-pass metabolism; forms one metabolite (S-oxide)

Bioavailability: Oral: 40% to 45%

Half-life elimination: IV:

Infants: ≤3 months: 8.1 ± 3.5 hours to 10.5 ± 5.4 hours; >3 to 12 months: 4.5 ± 1.1 hours

Children <11 years: 3.38 ± 2.6 hours

Children ≥11 years and Adolescents ≤15 years: 2.3 ± 0.4 hours

Adults: 2.5 to 3.5 hours; prolonged with renal impairment; Oliguria: >20 hours; Anuria: 24 hours

Time to peak, serum: Oral: ~1 to 3 hours

Excretion: Urine (25% to 30% [oral], 65% to 70% [IV] as unchanged drug)

Clearance: IV:

Infants: ≤3 months: 0.13 ± 0.06 to 0.21 ± 0.06 L/hour/kg; >3 to 12 months: 0.49 ± 0.17 L/hour/kg

Children <11 years: 0.54 ± 0.34 L/hour/kg

Children ≥11 years and Adolescents ≤15 years: 0.48 ± 0.14 L/hour/kg

Adults: 0.39 ± 0.14 L/hour/kg

Pharmacodynamics/Kinetics: Additional Considerations

Renal impairment: AUC increased at least 5-fold and at least 2-fold in adults with CrCl < 30 mL/minute and CrCl 30 to 60 mL/minute, respectively.

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

Pepcid

FDA Approval Date
November 04, 1986
References

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Akin C, Gotlib J. Systemic mastocytosis: Management and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi: 10.1002/ppul.23319[PubMed 26446832]

American Society of Anesthesiologists (ASA). Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016;124(2):270-300.[PubMed 26580836]

American Society of Anesthesiologists (ASA). Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017;126(3):376-393. doi: 10.1097/ALN.0000000000001452.[PubMed 28045707]

American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998. Am J Health Syst Pharm. 1999;56(4):347-379.[PubMed 10690219]

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, eds. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007.

Barbateskovic M, Marker S, Granholm A, et al. Stress ulcer prophylaxis with proton pump inhibitors or histamine-2 receptor antagonists in adult intensive care patients: a systematic review with meta-analysis and trial sequential analysis. Intensive Care Med. 2019;45(2):143-158. doi: 10.1007/s00134-019-05526-z.[PubMed 30680444]

Berkow L. Rapid sequence induction and intubation (RSII) for anesthesia. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133(5):1270-1277. doi: 10.1016/j.jaci.2014.02.036.[PubMed 24766875]

Canani RB, Cirillo P, Roggero P, et al; Working Group on Intestinal Infections of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP). Therapy with gastric acidity inhibitors increases the risk of acute gastroenteritis and community-acquired pneumonia in children. Pediatrics. 2006;117(5):e817-e820. doi: 10.1542/peds.2005-1655[PubMed 16651285]

Castells MC, Akin C. Treatment and prognosis of cutaneous mastocytosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019a.

Castells MC, Matulonis UA, Horton TM. Infusion reactions to systemic chemotherapy. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019b.

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Courtney, TP, Shaw RW, Cedar E, et al, “Excretion of Famotidine in Breast Milk,” Proceedings of the British Pharmacological Society, Clinical Pharmacology Section. Ireland, 6-8 July, 1988. Abstracts. Br J Clin Pharmacol, 1988;26(5):639P.[PubMed 3207568]

Famotidine injection [prescribing information]. New York NY: Pfizer Labs; January 2011.

Fass R. Approach to refractory gastroesophageal reflux disease in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

Guarnotta V, Martini C, Davì MV, Pizza G, Colao A, Faggiano A; NIKE Group. The Zollinger-Ellison syndrome: is there a role for somatostatin analogues in the treatment of the gastrinoma? Endocrine. 2018;60(1):15-27. doi: 10.1007/s12020-017-1420-4.[PubMed 29019150]

Guillet R, Stoll BJ, Cotten CM, et al. Association of H2-Blocker Therapy and Higher Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants. Pediatrics. 2006;117(2):137-142.[PubMed 16390920]

Hagberg CA, Artime C. Flexible scope intubation for anesthesia. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

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

Ito T, Igarashi H, Uehara H, Jensen RT. Pharmacotherapy of Zollinger-Ellison syndrome. Expert Opin Pharmacother. 2013;14(3):307-321. doi: 10.1517/14656566.2013.767332.[PubMed 23363383]

Kahn DA. Chronic spontaneous urticaria: Standard management and patient education. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

Kahrilas PJ. Medical management of gastroesophageal reflux disease in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease [published correction appears in Am J Gastroenterol. 2013;108(10):1672]. Am J Gastroenterol. 2013;108(3):308-328. doi: 10.1038/ajg.2012.444.[PubMed 23419381]

Kellner C. Technique for performing electroconvulsive therapy (ECT) in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 6, 2019.

Kulthanan K, Tuchinda P, Chularojanamontri L, et al. Clinical practice guideline for diagnosis and management of urticaria. Asian Pac J Allergy Immunol. 2016;34(3):190-200.[PubMed 27690471]

Lam JR, Schneider JL, Zhao W, Corley DA. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA. 2013;310(22):2435-2422.[PubMed 24327038]

Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7.[PubMed 28242110]

Lipsy R, Freeman CD. Hemodynamic Effects of Intravenous Famotidine in Critically Ill Patients. Pharmacotherapy. 1995;15(1):48-51.[PubMed 7739945]

Manchikanti L, Marrero TC, Roush JR. Preanesthetic cimetidine and metoclopramide for acid aspiration prophylaxis in elective surgery. Anesthesiology. 1984;61(1):48-54.[PubMed 6377973]

McCammon RL. Prophylaxis for aspiration pneumonitis. Can Anaesth Soc J. 1986;33(3, pt 2):s47-s53.[PubMed 2872952]

Nixon H, Leffert L. Anesthesia for cesarean delivery. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

Olsson GL, Hallén B. Pharmacological evacuation of the stomach with metoclopramide. Acta Anaesthesiol Scand. 1982;26(5):417-420.[PubMed 7148360]

O’Reardon JP, Cristancho MA, von Andreae CV, Cristancho P, Weiss D. Acute and maintenance electroconvulsive therapy for treatment of severe major depression during the second and third trimesters of pregnancy with infant follow-up to 18 months: case report and review of the literature. J ECT. 2011;27(1):e23-e26. doi: 10.1097/YCT.0b013e3181e63160.[PubMed 20562638]

Orenstein SR, Shalaby TM, Devandry SN, et al. Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial. Aliment Pharmacol Ther. 2003;17(9):1097-1107.[PubMed 12752346]

Pepcid AC (famotidine) [prescribing information]. Fort Washington, PA: McNeil Consumer; June 2013.

Pepcid AC Maximum Strength (famotidine) [prescribing information]. Fort Washington, PA: McNeil Consumer; May 2013.

Pepcid (famotidine) oral suspension [prescribing information]. Minneapolis, MN: Perrigo; October 2011.

Pepcid (famotidine) tablets [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; November 2018.

Poluzzi E, Raschi E, Moretti U, et al. Drug-Induced Torsades de Pointes: Data Mining of the Public Version of the FDA Adverse Event Reporting System (AERS). Pharmacoepidemiol Drug Saf. 2009;18(6):512-518.[PubMed 19358226]

Rabheru K. The use of electroconvulsive therapy in special patient populations. Can J Psychiatry. 2001;46(8):710-719.[PubMed 11692973]

Reynolds PM, MacLaren R. Re-evaluating the utility of stress ulcer prophylaxis in the critically ill patient: a clinical scenario-based meta-analysis [published online ahead of print August 13, 2018]. Pharmacotherapy. doi: 10.1002/phar.2172.[PubMed 30101529]

Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43(3):304-377.[PubMed 28101605]

Richter JE. Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther. 2005;22(9):749-757. doi: 10.1111/j.1365-2036.2005.02654.x[PubMed 16225482]

Stuart JC, Kan AF, Rowbottom SJ, Yau G, Gin T. Acid aspiration prophylaxis for emergency Caesarean section. Anaesthesia. 1996;51(5):415-421.[PubMed 8694150]

Treem WR, Davis PM, Hyams JS. Suppression of Gastric Acid Secretion by Intravenous Administration of Famotidine in Children. J Pediatr. 1991;118(5):812-816.[PubMed 2019939]

Vakil NB. Peptic ulcer disease: Management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 18, 2019.

van der Woude CJ, Metselaar HJ, Danese S. Management of gastrointestinal and liver diseases during pregnancy. Gut. 2014;63(6):1014-1023.[PubMed 24429582]

Wang Y, Pan T, Wang Q, Guo Z. Additional bedtime H2-receptor antagonist for the control of nocturnal gastric acid breakthrough. Cochrane Database Syst Rev. 2009;(4):CD004275. doi: 10.1002/14651858.CD004275.pub3.[PubMed 19821323]

Wang X, Zhan Y, Hankins GD et al. Pharmacokinetics of famotidine in pregnant women. Am J Obstet Gynecol. 2011;204:S72-S73.

Wang X, Rytting E, Abdelrahman DR, Nanovskaya TN, Hankins GD, Ahmed MS. Quantitative determination of famotidine in human maternal plasma, umbilical cord plasma and urine using high-performance liquid chromatography-mass spectrometry. Biomed Chromatogr. 2013;27(7):866-873.[PubMed 23401067]

Weinhouse GL. Stress ulcer prophylaxis in the intensive care unit. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 15, 2019.

Brand Names: International

Acifam (JO); Androtin (MX); Antiflam (UY); Antodine (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Aulzadin (HK); Ausfam (AU); Bestidine (KR); Corocyd (ID); Denufam (ID); Durater (CR, DO, GT, HN, MX, NI, PA, SV); Facid (ID, IN); Facidex (CR, DO, GT, HN, MX, NI, PA, SV); Fadin (TW, VN); Fadine (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Fadul (DE); Famagen (KR); Famatel (UA); Famo (BD, IL); Famoc (SG); Famocid (AE, BF, BH, BJ, CI, ET, GH, GM, GN, IN, KE, KW, LR, MA, ML, MR, MU, MW, NE, NG, QA, SA, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Famodar (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Famodil (IT); Famodin (RO); Famodine (AE, CY, EG, IQ, IR, JO, KW, LB, LY, MY, OM, PK, QA, SA, SY, YE); Famogal (CO); Famogard (RU); Famonerton (DE); Famopsin (BH, CY, TR); Famosan (CZ, EE, HR); Famosia (TH); Famotaz (LK); Famotec (AE, QA); Famotid (BR); Famotin (SG); Famowal (IN); Famox (BR, NZ, TW); Famozol (UA); Faradin (HK); Farotin (KR); Ferotine (KR); Fibonel (CL); Fudone (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); Fuweidin (TW); Gasafe (TW); Gasmodin (VN); Gaster (CN, JP, KR, TW); Gastren (PY); Gastridin (IT); Gastril (CR, DO, GT, HN, NI, PA, SV); Gastrium (PY); Gastro (IL); Gastrodomina (BF, BJ, CI, ET, GH, GM, GN, HU, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Gastrum (CO); H2 Bloc (PH); Hista-Bloc (PH); Interfam (HK); Keamotin (HK); Kimodin (TW); Logos (ZA); Ludex (MX); Modin (PH); Motiax (IT); Motidin (HU); Navatac (BD); Nenvofam (VN); Nulcerin (ES); Nulcex (ES); Pamacid (AU); Pepcid (BB, BM, BS, BZ, ES, GB, GY, IE, JM, SE, SR, TT); Pepcid AC (CH); Pepcidac (FR); Pepcidin (DK, FI, JO, NL, QA, SE); Pepcidina (PT); Pepcidine (AT, BE, CH, LU, MX, NZ, PE, VN); Pepdif (TR); Pepdine (BF, BJ, CI, ET, FR, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Pepfamin (TH); Peptifam (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Peptoci (TH); Pepzan (MY, NZ); Pharmotidine (PH); Quamatel (HU, LV); Quamtel (BM, BS, BZ, GY, JM, SR, TT); Sedanium-R (GR); Snow (BD); Stadin (KR); Stomax (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Supertidine (TW); Tarpan (PY); Tismafam (ID); Topcid (IN); Ulcatif (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ulcelac (AR); Ulcenol (VE); Ulceran (AE, BG, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SG, SY, TR, YE); Ulfadin (CO); Ulfagel (EC); Ulfamid (HR, HU, PL); Ulmo (ID); Vesmo-20 (TH); Voker (MY); Weimok (TW); Winiful (TW); Yamadin (BD)

Famotidine (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

(fa MOE ti deen)

Brand Names: US

Acid Controller Max St [OTC]; Acid Controller Original Str [OTC]; Acid Reducer Maximum Strength [OTC]; Acid Reducer [OTC]; Heartburn Relief Max St [OTC]; Heartburn Relief [OTC]; Pepcid; Pepcid AC Maximum Strength [OTC]

Brand Names: Canada

Acid Control; Apo-Famotidine; Famotidine Omega; Maximum Strength Pepcid AC; Mylan-Famotidine; Pepcid AC; Pepcid Complete; Peptic guard; Teva-Famotidine; Ulcidine

What is this drug used for?
  • It is used to treat or prevent GI (gastrointestinal) ulcers.
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • 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 famotidine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Black or bloody stools; heartburn with light-headedness, sweating, or dizziness; chest pain; shoulder pain with shortness of breath; pain that spreads to the arms, neck, or shoulders; light-headedness; sweating a lot; throwing up blood; or trouble or pain swallowing food.
  • If you are taking any of these drugs: Cefditoren, dasatinib, delavirdine, or fosamprenavir.
  • 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?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have kidney problems or are elderly, talk with your doctor. Hallucinations (seeing or hearing things that are not there); seizures; and feeling agitated, confused, sluggish, or out of sorts have happened in people with kidney problems and in older people.
  • This drug may prevent other drugs taken by mouth from getting into the body. If you take other drugs by mouth, you may need to take them at some other time than this drug. Talk with your 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.
  • Tablets and chewable tablets:
  • If you need Pepcid® AC for more than 14 days in a row, talk with your doctor.
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.
  • Dizziness or passing out.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
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:
  • Headache.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take with or without food.
  • Ask your doctor before you take antacids with this drug.
  • Chewable tablet:
  • Chew or crush well. Do not swallow it whole.
  • 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.
  • Injection:
  • It is given as a shot into a vein.
What do I do if I miss a dose?
  • All oral products:
  • If you take this drug on a regular basis, 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.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Liquid (suspension):
  • Throw away any part not used after 1 month.
  • 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.
Famotidine (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

(fa MOE ti deen)

Brand Names: US

Acid Controller Max St [OTC]; Acid Controller Original Str [OTC]; Acid Reducer Maximum Strength [OTC]; Acid Reducer [OTC]; Heartburn Relief Max St [OTC]; Heartburn Relief [OTC]; Pepcid; Pepcid AC Maximum Strength [OTC]

Brand Names: Canada

Acid Control; Apo-Famotidine; Famotidine Omega; Maximum Strength Pepcid AC; Mylan-Famotidine; Pepcid AC; Pepcid Complete; Peptic guard; Teva-Famotidine; Ulcidine

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 any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Black or bloody stools; heartburn with lightheadedness, sweating, or dizziness; chest pain; shoulder pain with shortness of breath; pain that spreads to the arms, neck, or shoulders; lightheadedness; sweating a lot; throwing up blood; or trouble or pain swallowing food.
  • If your child is taking any of these drugs: Cefditoren, dasatinib, delavirdine, or fosamprenavir.
  • 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?
  • All products:
  • 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.
  • If your child has kidney problems, talk with your child’s doctor. Hallucinations (seeing or hearing things that are not there); seizures; and feeling agitated, confused, sluggish, or out of sorts have happened in people with kidney problems.
  • This drug may prevent other drugs taken by mouth from getting into the body. If your child takes other drugs by mouth, you may need to give them at some other time than this drug. 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.
  • Tablets and chewable tablets:
  • If your child needs Pepcid® AC for more than 14 days in a row, talk with healthcare provider.
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.
  • Dizziness or passing out.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
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:
  • Headache.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug with or without food.
  • Ask the doctor before you give your child antacids with this drug.
  • Chewable tablet:
  • Have your child chew or crush well. Do not let your child swallow it whole.
  • 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.
  • Injection:
  • It is given as a shot into a vein.
What do I do if my child misses a dose?
  • All oral products:
  • If your child takes this drug on a regular basis, 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.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Liquid (suspension):
  • Throw away any part not used after 1 month.
  • 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.