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 2020; Hagberg 2019; O'Reardon 2011; Rabheru 2001):

IV: 20 mg as a single dose ~40 to 90 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 (Abir 2019; ASA 2016; ASA 2017; Berkow 2020; 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 2020).

Note: If symptoms persist after 2 weeks of 20 mg twice daily, discontinue and consider PPI therapy (Kahrilas 2020).

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, H1 antihistamine 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)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function (Echizen 1991; Takabatake 1985; manufacturer’s labeling):

IV:

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

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

Oral:

Famotidine Oral Dosage Adjustments in Altered Kidney Function

CrCl (mL/minute)

If usual dose is 10 mg twice daily

If usual dose is 20 mg once daily

If usual dose is 20 mg twice daily

CrCl ≥60

No dosage adjustment necessary.

No dosage adjustment necessary.

No dosage adjustment necessary.

CrCl 30 to <60

10 mg once daily or 20 mg every other day

10 mg once daily or 20 mg every other day

20 mg once daily or 40 mg every other day

CrCl <30

10 mg every other day

10 mg every other day

10 mg once daily or 20 mg every other day

Hemodialysis, intermittent (thrice weekly): Dialyzable (6% to 16%) (Gladziwa 1988):

IV, Oral: Dose as for CrCl <30 mL/minute; administer after hemodialysis on dialysis days. No supplemental dose necessary (Gladziwa 1988; expert opinion).

Peritoneal dialysis: Minimally dialyzed (5%) (Gladziwa 1988):

IV, Oral: Dose as for CrCl <30 mL/minute (expert opinion).

CRRT: Limited data utilizing hemofiltration rates of ≤1,800 mL/hour did not demonstrate a dose reduction is necessary (Saima 1990); however, no data regarding famotidine disposition utilizing contemporary flow rates of up to ~3,000 mL/hour are available:

IV, Oral: Dose as for CrCl <30 mL/minute (expert opinion).

PIRRT (eg, sustained, low-efficiency diafiltration):

IV, Oral: Dose as for CrCl <30 mL/minute; administer post-PIRRT session (expert opinion).

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)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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.

Calculations

• Creatinine Clearance by Cockcroft-Gault
• Creatinine Clearance by Cockcroft-Gault (SI units)
• Creatinine Clearance by Cockcroft-Gault with IBW
• Creatinine Clearance by Cockcroft-Gault with IBW (SI units)

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.

* See Uses in AHFS Essentials for additional information.

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 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, 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).

Class and Related Monographs

Histamine H2 Antagonists

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

Open Trissel's IV Compatibility

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

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.

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

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:

• Dizziness

• Passing out

• Fast heartbeat

• Abnormal heartbeat

• 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.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

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.

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.

* See Cautions in AHFS Essentials for additional information.

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. The American Geriatrics Society Beers Criteria recommends against the use of H2 blockers in those with delirium (Beers Criteria [AGS 2019]).

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

• Famotidine

Briggs' Drugs in Pregnancy & Lactation

• Famotidine

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 QT interval on ECG, pruritus, psychiatric disturbance, rhabdomyolysis, seizure, skin rash, Stevens-Johnson syndrome, taste disorder, thrombocytopenia, tinnitus, toxic epidermal necrolysis, urticaria, vomiting, xeroderma, xerostomia

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Histamine H2 Antagonist Allergy

Toxicology

• Histamine H2 Antagonists

Metabolism/Transport Effects

Substrate of OCT2

Drug Interactions Open 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. 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

Dichlorphenamide: May increase the serum concentration of Famotidine. Risk X: Avoid combination

Enoxacin: Histamine H2 Receptor Antagonists may decrease the absorption of Enoxacin. Risk C: Monitor therapy

Erdafitinib: May increase the serum concentration of OCT2 Substrates. 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 6 hours 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 Preparations: Histamine H2 Receptor Antagonists may decrease the absorption of Iron Preparations. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Derisomaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk C: Monitor therapy

Itraconazole: Histamine H2 Receptor Antagonists may decrease the serum concentration of Itraconazole. Histamine H2 Receptor Antagonists may increase 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. Management: Administer H2 receptor antagonist doses less than or comparable to famotidine 40 mg twice daily simultaneously or 12 hours prior to ledipasvir. The effect of administering H2 receptor antagonists at other time intervals is unknown and not recommended. 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 serum concentrations of the active metabolite(s) of 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 D: Consider therapy modification

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

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

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

Pexidartinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Pexidartinib. Management: Administer pexidartinib 2 hours before or 10 hours after histamine H2 receptor antagonists. Risk D: Consider therapy modification

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

Selpercatinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Selpercatinib. Management: Coadministration of selpercatinib and H2 receptor antagonists should be avoided. If coadministration cannot be avoided, selpercatinib should be administered 2 hours before or 10 hours after H2 receptor antagonists. 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); 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: 10 mg [contains corn starch]

Acid Reducer Maximum Strength: 20 mg

Famotidine 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.

Solution, Intravenous:

Generic: 10 mg/mL (2 mL, 4 mL, 5 mL, 20 mL)

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 - $0.68

200 mg/20 mL (per mL): $0.48 - $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): $1.73 - $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): $13.63

40 mg (per each): $26.34

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 function 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

Key adverse event(s) related to dental treatment: Rare occurrence of Stevens-Johnson syndrome, taste disorder, and xerostomia (normal salivary flow resumes upon discontinuation) have been reported.

Effects on Bleeding

No information available to require special precautions

Related Information

• Beers Criteria 2019: Potentially Inappropriate Medication Use in Older Adults ≥65 Years of Age
• Relative Infant Dose

Index Terms

Pepcid

FDA Approval Date

November 04, 1986

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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, PA, SV); Facid (ID, IN); Facidex (MX); Fadin (TW, VN); Fadine (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Famagen (KR); Famatel (UA); Famo (BD); 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); Famopsin (BH, CY, TR); Famosan (CZ, EE, HR); Famosia (TH); Famosin (AT); Famotaz (LK); Famotec (AE, QA); Famotid (BR); Famotin (SG); Famowal (IN); Famox (BR, 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); 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); Nulcerin (ES); Nulcex (ES); Pamacid (AU); Pepcid (BB, BM, BS, BZ, ES, FI, GY, IE, JM, SE, SR, TT); Pepcid AC (CH); Pepcidin (DK, JO, QA); Pepcidina (PT); Pepcidine (BE, CH, LU, MX, NZ, PE, VN); Pepdine (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); Pepfamin (TH); Peptan (GR); Peptifam (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Peptoci (TH); Pepzan (AU, MY, NZ); Pharmotidine (PH); Quamatel (HU, LV); Quamtel (BM, BS, BZ, GY, JM, SR, TT); Rogasti (IL); Sedanium-R (GR); Snow (BD); Stadin (KR); Stomax (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Sunpepcin (HK); 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); Ulcusan (AT); Ulfadin (CO); Ulfagel (EC); Ulfamid (HR, HU, PL); Ulmo (ID); Ultra Hearttburn Relief (GB); Vesmo-20 (TH); Voker (MY); Weimok (TW); Winiful (TW); Yamadin (BD)

Last Updated 10/21/20