Short-term treatment of active benign gastric ulcer.
Gastroesophageal Reflux (GERD)
Short-term treatment of symptomatic GERD.
Short-term treatment of esophagitis, including erosions or ulcers (endoscopically diagnosed) in patients with GERD.
Self-medication as initial therapy for less severe symptomatic GERD†.
Short-term self-medication for relief of heartburn symptoms in adults and adolescents ≥12 years of age.
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.
Dosage and Administration
Administration
Administered orally, 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.
Oral Administration
Administer with or without food; administration with food may slightly enhance bioavailabilty.
Antacids may be used as necessary for pain relief.
Tablet for self-medication should be administered with a glass of water.
Chewable tablets (Pepcid® AC Chewable, Pepcid® Complete) for self-medication should be chewed thoroughly before swallowing.
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.
For gastric ulcer treatment in adults, administer once daily at bedtime.
Add 46 mL of water to bottle containing 400 mg of famotidine for 40 mg/5mL suspension.
Shake oral suspension vigorously for 5–10 seconds after reconstitution and before each use.
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.
Rate of Administration
Inject over not less than 2 minutes (no faster than 10 mg/minute).
Intermittent IV infusion
Dilution
Dilute 20 mg in at least 100 mL of 5% dextrose injection or other compatible IV solution.
No additional dilution required for commercially available infusion solution (20 mg famotidine in 50 mL of 0.9% sodium chloride injection).
Rate of Administration
Over 15–30 minutes.
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.
Safety and efficacy have not been established in children <1 year of age.
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.
Intermittent Direct IV Injection
Initially, 0.25 mg/kg (15-minute infusion) every 12 hours (maximum 40 mg daily). Up to 0.5 mg/kg every 12 hours has provided gastric acid suppression.
Intermittent IV Infusion
Initially, 0.25 mg/kg (over not less than 2 minutes) every 12 hours (maximum 40 mg daily). Up to 0.5 mg/kg every 12 hours has provided gastric acid suppression
Gastroesophageal Reflux
Treatment of GERD in Infants <3 Months of Age
Oral
0.5 mg/kg once daily for up to 4 weeks.
Infants should also be receiving conservative measures (e.g., thickened feedings).
IV
Safety and efficacy not established.
Treatment of GERD in Infants 3 Months to <1 Year of Age
Oral
0.5 mg/kg twice daily for up to 4 weeks.
Infants should also be receiving conservative measures (e.g., thickened feedings).
IV
Safety and efficacy not established.
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.
Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.
IV
Dosage not established.
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.
Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.
IV
Dosage not established.
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.
Chewable tablets: 10 mg once or twice daily (maximum 20 mg in 24 hours continuously for 2 weeks) or as directed by clinician. Do not swallow whole; chew completely before swallowing.
20-mg tablets: 20 mg once or twice daily (maximum 40 mg in 24 hours continuously for 2 weeks) or as directed by clinician.
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). Do not swallow whole; chew completely before swallowing.
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.
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. Do not swallow whole; chew completely before swallowing.
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.
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); up to 1 mg/kg daily has been used.
Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.
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); up to 1 mg/kg daily has been used.
Individualize duration and dosage based on clinical response and/or gastric or esophageal pH determination and endoscopy.
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.
Dosage for parenteral administration in patients with GERD has not been established.
Intermittent Direct IV Injection
20 mg every 12 hours (maximum 40 mg daily).
Intermittent IV Infusion
20 mg every 12 hours (maximum 40 mg daily).
Gastroesophageal Reflux
Treatment of GERD
Oral
20 mg twice daily for up to 6 weeks.
40 mg once daily at bedtime also has been used, but is less effective and not considered appropriate therapy.
Treatment of Esophagitis
Oral
20 or 40 mg twice daily for up to 12 weeks.
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.
Chewable tablets: 10 mg once or twice daily (maximum 20 mg in 24 hours continuously for 2 weeks) or as directed by clinician. Do not swallow whole; chew completely before swallowing.
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). Do not swallow whole; chew completely before swallowing.
20-mg tablets: 20 mg once or twice daily (maximum 40 mg in 24 hours continuously for 2 weeks) or as directed by clinician.
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.
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. Do not swallow whole; chew completely before swallowing.
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 .
Duodenal Ulcer
Treatment of Active Duodenal Ulcer
Oral
40 mg once daily at bedtime, or 20 mg twice daily.
Healing may occur within 2 weeks in some, and within 4 weeks in most patients; some patients may benefit from an additional 4 weeks of therapy.
Occasionally may be necessary to continue full-dose therapy for >6–8 weeks.
Safety and efficacy of continuing full-dose therapy for >8 weeks have not been established.
Maintenance of Healing of Duodenal Ulcer
Oral
20 mg once daily at bedtime.
Gastric Ulcer
Oral
40 mg daily at bedtime for up to 8 weeks.
Complete healing of gastric ulcers usually occurs within 8 weeks.
Safety and efficacy of therapy for >8 weeks have not been established.
Pathologic GI Hypersecretory Conditions
Zollinger-Ellison Syndrome
Oral
20 mg every 6 hours. Higher doses administered more frequently may be necessary; adjust dosage according to response and tolerance and continue as long as necessary.
20–160 mg every 6 hours generally has been necessary to maintain basal gastric acid secretion at <10 mEq/hour.
Up to 160 mg every 6 hours, or 800 mg daily in divided doses, has been used in severe disease.
Intermittent IV Infusion
20 mg every 12 hours. Higher initial dosage may be required; adjust to individual needs and continue as long as necessary.
Prescribing Limits
Pediatric Patients
General Parenteral Dosage
Treatment of children 1–16 Years of Age
Intermittent Direct IV Injection
Maximum 40 mg daily.
Intermittent IV Infusion
Maximum 40 mg daily.
Gastroesophageal Reflux
Treatment of GERD in Infants <1 Year of Age
Oral
Safety and efficacy for >4 weeks not established.
Treatment of GERD without Esophagitis in Children 1–16 Years of Age
Oral
Maximum 40 mg twice daily.
Treatment of Esophagitis (including Erosions, Ulcerations) in Children 1- 16 Years of Age
Oral
Maximum 40 mg twice daily.
Self-Medication For Heartburn in Adolescents ≥12 Years of Age
Oral
Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.
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.
Duodenal Ulcer
Treatment of Active Duodenal Ulcer in Children 1–16 Years of Age
Oral
Maximum 40 mg daily.
Gastric Ulcer
Treatment of Gastric Ulcer in Children 1–16 Years of Age
Oral
Maximum 40 mg daily.
Adults
General Parenteral Dosage
Intermittent Direct IV Injection
Maximum 40 mg daily.
Intermittent IV Infusion
Maximum 40 mg daily.
Gastroesophageal Reflux
Treatment of Symptomatic GERD
Oral
Safety and efficacy for >6 weeks not established.
Treatment of Esophagitis
Oral
Safety and efficacy for >12 weeks not established.
Self-medication for Heartburn
Oral
Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.
Self-medication for Prevention of Heartburn
Maximum 20 or 40 mg in 24 hours continuously for 2 weeks.
Duodenal Ulcer
Treatment of Active Duodenal Ulcer
Oral
Safety for >8 weeks not established.
Gastric Ulcer
Short-term Treatment of Active Benign Gastric Ulcer
Oral
Safety and efficacy for >8 weeks not established.
Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
Oral
Up to 160 mg every 6 hours, or 800 mg daily in divided doses.
Special Populations
Renal Impairment
Pediatric Patients
Consider dosage adjustment in children with moderate or severe renal impairment.
Adults
In adults, modify dose and/or frequency of administration to the degree of renal impairment; adverse CNS effects have been reported.
Moderate (Clcr<50 mL/minute) or Severe (Clcr< 10 mL/minute)
Oral
Decrease to 50% of usual dosage.
Alternatively, increase dosing interval to 36–48 hours according to response.
IV
Decrease to 50% of usual dosage.
Alternatively, increase dosing interval to 36–48 hours according to response.
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