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Famotidine (Monograph)

Brand name: Pepcid
Drug class: Histamine H2-Antagonists

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Histamine H2 receptor antagonist.1 3 4 6 23 46 48 114

Uses for Famotidine

Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).1 4 5 6 7 12 16 18 19 22 91 92 93 94 114 123 124 128 129 130 135

Maintenance of healing and reduction in recurrence of duodenal ulcer.1 4 8 88 91 93 114

Pathologic GI Hypersecretory Conditions

Treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas.1 4 5 10 51 93 114 122 132

Gastric Ulcer

Short-term treatment of active benign gastric ulcer.1 4 5 9 12 14 20 22 75 89 93 94 124 131 136 140

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD.1 139 167 168 169 170 171 172 173 174 175

Short-term treatment of esophagitis, including erosions or ulcers (endoscopically diagnosed) in patients with GERD.1 167 168 171

Self-medication as initial therapy for less severe symptomatic GERD [off-label].261

Short-term self-medication for relief of heartburn symptoms in adults and adolescents ≥12 years of age.238 260

Short-term self-medication for prevention of heartburn symptoms associated with acid indigestion and sour stomach brought on by ingestion of certain foods and beverages in adults and children ≥12 years of age.238 260

Famotidine Dosage and Administration

Administration

Administered orally,1 or by slow IV injection or intermittent IV infusion in hospitalized patients with pathological GI hypersecretory conditions or intractable duodenal ulcer, or when oral therapy is not feasible.240

Oral Administration

Administer with or without food; administration with food may slightly enhance bioavailabilty.1 3 47 114

Antacids may be used as necessary for pain relief.1 4 6 7 16 18 19 49 94

Tablet for self-medication should be administered with a glass of water.c d

Chewable tablets (Pepcid AC Chewable, Pepcid Complete) for self-medication should be chewed thoroughly before swallowing.238 260

For duodenal ulcer treatment, the advantage of administration once daily at bedtime (when convenience is important for compliance) over twice-daily administration has not been determined.4 7 16 18 93 130

For gastric ulcer treatment in adults, administer once daily at bedtime.1 9 22 93 131 136

For gastroesophageal reflux, once daily dosage not considered appropriate.261

Oral Suspension

Add 46 mL of water to bottle containing 400 mg of famotidine for 40 mg/5mL suspension.1 3 14

Shake oral suspension vigorously for 5–10 seconds after reconstitution and before each use.1

Intermittent Direct IV Injection

Dilution

Dilute 20 mg to 5–10 mL with 0.9% sodium chloride injection or other compatible IV solution before direct IV injection.240

Rate of Administration

Inject over not less than 2 minutes (no faster than 10 mg/minute).240

Intermittent IV infusion

Dilution

Dilute 20 mg in at least 100 mL of 5% dextrose injection or other compatible IV solution.240

No additional dilution required for commercially available infusion solution (20 mg famotidine in 50 mL of 0.9% sodium chloride injection).240

Rate of Administration

Over 15–30 minutes.240

Dosage

Pediatric Patients

General Parenteral Dosage

May administer IV in hospitalized pediatric patients with pathologic hypersecretory conditions, intractable ulcer, or for short-term use when oral therapy is not feasible.b

Safety and efficacy have not been established in children <1 year of age.b

Treatment of Children 1–16 Years of Age

Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.1 240

Intermittent Direct IV Injection

Initially, 0.25 mg/kg (15-minute infusion) every 12 hours (maximum 40 mg daily).240 Up to 0.5 mg/kg every 12 hours has provided gastric acid suppression.b

Intermittent IV Infusion

Initially, 0.25 mg/kg (over not less than 2 minutes) every 12 hours (maximum 40 mg daily).240 Up to 0.5 mg/kg every 12 hours has provided gastric acid suppressionb

Gastroesophageal Reflux
Treatment of GERD in Infants <3 Months of Age
Oral

0.5 mg/kg once daily for up to 4 weeks.a

Infants should also be receiving conservative measures (e.g., thickened feedings).a

IV

Safety and efficacy not established.b

Treatment of GERD in Infants 3 Months to <1 Year of Age
Oral

0.5 mg/kg twice daily for up to 4 weeks.a

Infants should also be receiving conservative measures (e.g., thickened feedings).a

IV

Safety and efficacy not established.b

Treatment of GERD in Children 1–16 Years of Age
Oral

1 mg/kg daily in 2 divided doses (maximum 40 mg twice daily); up to 2 mg/kg daily has been used.a

Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.1 240 b

IV

Dosage not established.b

Treatment of Esophagitis in Children 1- 16 Years of Age
Oral

1 mg/kg daily in 2 divided doses (maximum 40 mg twice daily); up to 2 mg/kg daily has been used.a

Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.1 240 b

IV

Dosage not established.b

Self-medication for Heartburn in Adolescents ≥12 Years of Age
Oral

10-mg tablets: 10 mg once or twice daily (maximum 20 mg in 24 hours continuously for 2 weeks) or as directed by clinician.238 239 260 267 268 269

Chewable tablets: 10 mg once or twice daily (maximum 20 mg in 24 hours continuously for 2 weeks) or as directed by clinician.238 260 Do not swallow whole; chew completely before swallowing.238 260

20-mg tablets: 20 mg once or twice daily (maximum 40 mg in 24 hours continuously for 2 weeks) or as directed by clinician.238 239 260 267 268 269

Fixed combination of famotidine, calcium carbonate, and magnesium hydroxide (Pepcid Complete): 1 tablet (10 mg of famotidine) once or twice daily (maximum 2 tablets in 24 hours continuously for 2 weeks).e Do not swallow whole; chew completely before swallowing.e

Self-medication for Prevention of Heartburn In Adolescents ≥12 Years of Age
Oral

10-mg tablets: 10 mg once or twice daily (15–60 minutes before ingestion of causative food or beverage); maximum 20 mg in 24 hours continuously for 2 weeks or as directed by clinician.238 239 260 267 268 269

10-mg chewable tablets: 10 mg once or twice daily (15–60 minutes before ingestion of causative food or beverage); maximum 20 mg in 24 hours continuously for 2 weeks or as directed by clinician.238 260 Do not swallow whole; chew completely before swallowing.238 260

20-mg tablets: 20 mg once or twice daily (10–60 minutes before ingestion of causative food or beverage); maximum 40 mg in 24 hours continuously for 2 weeks or as directed by clinician.d

Duodenal Ulcer
Treatment of Duodenal Ulcer in Children 1–16 Years of Age
Oral

0.5 mg/kg once daily at bedtime or in 2 divided doses daily (maximum 40 mg daily);1 up to 1 mg/kg daily has been used.1 240

Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.1 240

Gastric Ulcer
Treatment of Gastric Ulcer in Children 1–16 Years of Age
Oral

0.5 mg/kg once daily at bedtime or in 2 divided doses daily (maximum 40 mg daily);1 up to 1 mg/kg daily has been used.1 240

Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.1

Adults

General Parenteral Dosage

May administer IV in hospitalized adults with pathologic hypersecretory conditions, intractable ulcer, or for short-term use when oral therapy is not feasible.b

Dosage for parenteral administration in patients with GERD has not been established.b

Intermittent Direct IV Injection

20 mg every 12 hours (maximum 40 mg daily).2 114 240

Intermittent IV Infusion

20 mg every 12 hours (maximum 40 mg daily).2 114 240

Gastroesophageal Reflux
Treatment of GERD
Oral

20 mg twice daily for up to 6 weeks.1 167 173 174

40 mg once daily at bedtime also has been used, but is less effective1 139 167 168 and not considered appropriate therapy.261

Treatment of Esophagitis
Oral

20 or 40 mg twice daily for up to 12 weeks.1 167 168 171

Self-medication for Heartburn
Oral

10-mg tablets: 10 mg once or twice daily (maximum 20 mg in 24 hours continuously for 2 weeks) or as directed by clinician.238 239 260 267 268 269

Chewable tablets: 10 mg once or twice daily (maximum 20 mg in 24 hours continuously for 2 weeks) or as directed by clinician.238 260 Do not swallow whole; chew completely before swallowing.238 260

Fixed combination of famotidine, calcium carbonate, and magnesium hydroxide (Pepcid Complete): 1 tablet (10 mg of famotidine) once or twice daily (maximum 2 tablets in 24 hours continuously for 2 weeks).e Do not swallow whole; chew completely before swallowing.e

20-mg tablets: 20 mg once or twice daily (maximum 40 mg in 24 hours continuously for 2 weeks) or as directed by clinician.238 239 260 267 268 269

Self-medication for Prevention of Heartburn
Oral

10-mg tablets: 10 mg once or twice daily (15–60 minutes before ingestion of causative food or beverage); maximum 20 mg in 24 hours continuously for 2 weeks or as directed by clinician.238 239 260 267 268 269

Chewable tablets: 10 mg once or twice daily (15–60 minutes before ingestion of causative food or beverage); maximum 20 mg in 24 hours continuously for 2 weeks or as directed by clinician.238 260 Do not swallow whole; chew completely before swallowing.238 260

20-mg tablets: 20 mg once or twice daily (10–60 minutes before ingestion of causative food or beverage); maximum 40 mg in 24 hours continuously for 2 weeks or as directed by clinician .d

Duodenal Ulcer
Treatment of Active Duodenal Ulcer
Oral

40 mg once daily at bedtime, or 20 mg twice daily.1 2 4 7 16 18 19 22 92 114 129 130

Healing may occur within 2 weeks in some, 1 4 6 16 18 19 22 and within 4 weeks in most patients;1 4 6 7 16 18 19 22 93 114 129 some patients may benefit from an additional 4 weeks of therapy.1 4 7 16 18 19 22 129

Occasionally may be necessary to continue full-dose therapy for >6–8 weeks.1 114 116

Safety and efficacy of continuing full-dose therapy for >8 weeks have not been established.1 4

Maintenance of Healing of Duodenal Ulcer
Oral

20 mg once daily at bedtime.1 4 8 114

Gastric Ulcer
Oral

40 mg daily at bedtime for up to 8 weeks.1 9 22 93 131 136

Complete healing of gastric ulcers usually occurs within 8 weeks.9 22 131 136

Safety and efficacy of therapy for >8 weeks have not been established.1

Pathologic GI Hypersecretory Conditions
Zollinger-Ellison Syndrome
Oral

20 mg every 6 hours.1 4 114 Higher doses administered more frequently may be necessary; adjust dosage according to response and tolerance and continue as long as necessary.1 4 10 114 122 141

20–160 mg every 6 hours generally has been necessary to maintain basal gastric acid secretion at <10 mEq/hour.1 10 51 114 123 141

Up to 160 mg every 6 hours,1 or 800 mg daily in divided doses, 2 3 4 10 122 has been used in severe disease.

Intermittent IV Infusion

20 mg every 12 hours.b Higher initial dosage may be required;10 114 115 116 240 adjust to individual needs and continue as long as necessary.115 116 240 b

Prescribing Limits

Pediatric Patients

General Parenteral Dosage
Treatment of children 1–16 Years of Age
Intermittent Direct IV Injection

Maximum 40 mg daily.240

Intermittent IV Infusion

Maximum 40 mg daily.240

Gastroesophageal Reflux
Treatment of GERD in Infants <1 Year of Age
Oral

Safety and efficacy for >4 weeks not established.a

Treatment of GERD without Esophagitis in Children 1–16 Years of Age
Oral

Maximum 40 mg twice daily.a

Treatment of Esophagitis (including Erosions, Ulcerations) in Children 1- 16 Years of Age
Oral

Maximum 40 mg twice daily.a

Self-Medication For Heartburn in Adolescents ≥12 Years of Age
Oral

Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.238 260 267 268 269

Self-medication for Prevention of Heartburn in Adolescents ≥12 Years of Age
Oral

Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.238 260 267 268 269

Duodenal Ulcer
Treatment of Active Duodenal Ulcer in Children 1–16 Years of Age
Oral

Maximum 40 mg daily.1

Gastric Ulcer
Treatment of Gastric Ulcer in Children 1–16 Years of Age
Oral

Maximum 40 mg daily.1

Adults

General Parenteral Dosage
Intermittent Direct IV Injection

Maximum 40 mg daily.240

Intermittent IV Infusion

Maximum 40 mg daily.240

Gastroesophageal Reflux
Treatment of Symptomatic GERD
Oral

Safety and efficacy for >6 weeks not established.1 167 173 174

Treatment of Esophagitis
Oral

Safety and efficacy for >12 weeks not established.1 167 168 171

Self-medication for Heartburn
Oral

Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.238 260 238 260 267 268 269

Self-medication for Prevention of Heartburn

Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.238 260 267 268 269

Duodenal Ulcer
Treatment of Active Duodenal Ulcer
Oral

Safety for >8 weeks not established.1 4

Gastric Ulcer
Short-term Treatment of Active Benign Gastric Ulcer
Oral

Safety and efficacy for >8 weeks not established.1

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
Oral

Up to 160 mg every 6 hours,1 or 800 mg daily in divided doses.2 3 4 10 122

Special Populations

Renal Impairment

Pediatric Patients

Consider dosage adjustment in children with moderate or severe renal impairment.1 240

Adults

In adults, modify dose and/or frequency of administration to the degree of renal impairment; adverse CNS effects have been reported.1 4 86 114

Moderate (Clcr<50 mL/minute) or Severe (Clcr< 10 mL/minute)
Oral

Decrease to 50% of usual dosage.1 114 115

Alternatively, increase dosing interval to 36–48 hours according to response.1 114 115

IV

Decrease to 50% of usual dosage.b

Alternatively, increase dosing interval to 36–48 hours according to response.b

Clcr of 30–60 mL/minute per 1.48 m2

50% of usual adult dosage has been recommended.4 86

Clcr < 30 mL/minute per 1.48 m2

25% of usual adult dosage has been recommended.4 86

Cautions for Famotidine

Contraindications

Warnings/Precautions

General Precautions

Gastric Malignancy

Response to famotidine does not preclude presence of gastric malignancy.1

Phenylketonuria

Pepcid AC chewable tablets contain aspartame (Nutrasweet), which is metabolized in the GI tract to provide 1.4 mg of phenylalanine per tablet.c

Respiratory Effects

Administration of H2-receptor antagonists has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).270 271

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category B.1 3

Self-medication in pregnant women: consult clinician before using.238

Lactation

Distributed into milk.1 Discontinue nursing or the drug.1

Self-medication in nursing women: consult clinician before using.238

Pediatric Use

Infants <1 year of age: Consider for GERD treatment only if other conservative measures (e.g., thickened feedings) are used concurrently and potential benefits outweigh risks.a b

Safety and efficacy for self-medication not established in children <12 years of age; do not use unless directed by clinician.238 239 260

Renal Impairment

Use with caution.1 3 114 240 Dosage adjustments necessary in patients with severe renal impairment.1 3 114 240

Common Adverse Effects

Headache, dizziness, constipation, diarrhea.1 4 5 7 9 13 22 123 130

Drug Interactions

Does not appear to inhibit hepatic metabolism of drugs by hepatic CYP isoenzymes.1 3 4 21 39 40 41 42 45 46 93 114 118 125 127

Antacids appear to cause slight but clinically unimportant decrease in bioavailability.1 3 47 114 May concomitantly administer with antacids.1 4 6 7 16 18 19 47 49 94

Famotidine Pharmacokinetics

Absorption

Bioavailability

Oral: about 40–50%.1 3 4 11 46 85 114 118 Similar (50%) in children 11–15 years of age.1

Tablets and oral suspension reportedly are bioequivalent.1 2 3 114

Onset

Gastric acid inhibition within 1 hour after IV or oral administration.1 2 11 118 Peak inhibition within 0.5–3 hours following IV,1 11 114 118 1–4 hours following oral1 10 11 46 51 114 administration.

Duration

Dose-dependent inhibition of gastric acid secretion.1 4 11 46 48 60 61 62 63 65 81 118

Inhibition of basal and nocturnal secretion for 10–12 hours after single oral 20-1 2 11 61 62 63 81 or 40-mg1 2 46 61 62 dose.1 2 11 46 61 62 63 81 93 114 118

Inhibition of food-stimulated secretion generally persists for 8–10 hours after morning administration, but may dissipate within 6–8 hours after a 20-mg oral dose in some patients.1 4 81

Inhibition of nocturnal gastric acid secretion is 10–15 hours after single 10- or 20-mg IV dose.1 2 11

Food

May slightly enhance bioavailability.1 3 47 114

Distribution

Extent

Widely distributed, highest concentrations in the kidney, liver, pancreas, and submandibular gland.4 84

Distributed into human milk.a b

Does not cross the placenta in animal studies;2 not known if famotidine crosses the placenta in humans.2

Plasma Protein Binding

15–20%.1 3 4 114 118

Elimination

Metabolism

Metabolized in the liver115 to inactive famotidine S-oxide (S-famotidine).1 2 3 82 84 114

Minimal first-pass metabolism.1 3 114 118

Elimination Route

Excreted principally in urine;1 2 3 4 53 86 114 118 25–30% excreted unchanged within 24 hours after oral administration,1 2 3 4 65 81 83 114 65–80%1 2 3 4 85 86 114 after IV administration.1 2 3 4 83 85 86 Small fraction of orally administered dose is excreted in urine as famotidine S-oxide.4 83 Remainder of orally administered dose eliminated in feces.4

Interindividual variation in metabolism and excretion.4 83 118

Half-life

2.5–4 hours (adults).1 2 4 11 65 81 83 85 86 93 118

Special Populations

In patients with renal impairment, close correlation between Clcr and elimination half-life;a b >20 hours when Clcr <10 mL/minute,1 3 4 86 114 24 hours in anuric patients.1

Does not appear to be removed by hemodialysis.4

Stability

Storage

Oral

Tablets

20 and 40 mg film-coated tablets: 25°C (may be exposed to 15–30°C) in tight, light-resistant containers.1 2 3 152

Tablets for Self-medication

10 mg tablets, chewable tablets, film-coated tablets: 25–30°C.238 267 268

10 mg chewable tablets in combination with calcium carbonate and magnesium hydroxide: 25–30°C.e

20 mg film-coated tablets: 20–30°C.d

Protect from moisture.238 267 268 d e

For Suspension

Reconstituted suspension or dry powder: 25°C (may be exposed to 15–30°C) in tight containers.a

Suspension may be refrigerated;115 protect from freezing.1 2 3

Discard unused suspension after 30 days.1 2 3

Parenteral

Injection

2–8°C;1 2 expiration date of 24 months following the date of manufacture when stored at this temperature.2 3 If freezing occurs, thaw at room temperature,1 3 or in warm water bath, or under running hot tap water;115 allow sufficient time for dissolution of all ingredients.1 3 Do not thaw by microwave because of potential hazard of rapidly increased temperature and vapor pressure in a closed system. Diluted solutions of famotidine not used immediately after preparation should be refrigerated and used within 48 hours.b 115

Injection for IV infusion only

25°C.241 Protect from excessive heat; brief exposure up to 35°C will not adversely affect the stability of the solution.240 Stable for 15 months when stored as recommended.241

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Famotidine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

40 mg/5 mL

Pepcid (with parabens)

Merck

Tablets

10 mg

Pepcid AC Gelcaps

J&J-Merck

Tablets, chewable

10 mg

Pepcid AC (with aspartame)

J&J-Merck

Tablets, film-coated

10 mg

Pepcid AC

J&J-Merck

20 mg*

Pepcid

Merck

Pepcid AC Maximum Strength

J&J-Merck

40 mg

Pepcid

Merck

Parenteral

For injection, concentrate

10 mg/mL (pharmacy bulk package)

Famotidine for Injection

Bedford

For injection concentrate, for IV use

10 mg/mL

Famotidine for Injection

American Pharmaceutical Partners

Pepcid I.V. (preservative-free; in single-dose vials or with benzyl alcohol 0.9% in multiple-dose vials)

Merck

Famotidine in Sodium Chloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use only

0.4 mg/mL (20 mg) in 0.9% Sodium Chloride

Pepcid Premixed in Iso-osmotic Sodium Chloride Injection (Galaxy [Baxter])

Merck

Famotidine Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, chewable

10 mg with calcium carbonate 800 mg and magnesium hydroxide 165 mg

Pepcid Complete

J&J-Merck

AHFS DI Essentials™. © Copyright 2025, Selected Revisions October 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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