No

Histamine H₂ Antagonist

Pepcid®: Therapy and treatment of duodenal ulcer, gastric ulcer, control gastric pH in critically ill patients, symptomatic relief in gastritis, gastroesophageal reflux, active benign ulcer, and pathological hypersecretory conditions

Pepcid® AC Acid Controller: Relieves heartburn, acid indigestion and sour stomach

B

Clinical effects on the fetus: Crosses the placenta. No data on effects on the fetus (insufficient data).

Breast-feeding/lactation: Crosses into breast milk. American Academy of Pediatrics has NO RECOMMENDATIONS.

Hypersensitivity to famotidine or other H₂-antagonists

Modify dose in patients with renal impairment

1% to 10%:

Central nervous system: Dizziness, headache

Gastrointestinal: Constipation, diarrhea

<1%: Bradycardia, tachycardia, palpitations, hypertension, fever, fatigue, seizures, insomnia, drowsiness, acne, pruritus, urticaria, dry skin, abdominal discomfort, flatulence, belching, anorexia, agranulocytosis, neutropenia, thrombocytopenia, increased AST/ALT, paresthesia, weakness, increased BUN/creatinine, proteinuria, bronchospasm, allergic reaction

Symptoms of overdose include hypotension, tachycardia, vomiting, drowsiness

Treatment is primarily symptomatic and supportive

Decreased effect of ketoconazole, itraconazole

Reconstituted I.V. solution is stable for 48 hours at room temperature; I.V. infusion in NS or D₅W solution is stable for 48 hours at room temperature; reconstituted oral solution is stable for 30 days at room temperature

Competitive inhibition of histamine at H₂ receptors of the gastric parietal cells, which inhibits gastric acid secretion

Onset of GI effect: Oral: Within 1 hour

Duration: 10-12 hours

Protein binding: 15% to 20%

Bioavailability: Oral: 40% to 50%

Half-life: 2.5-3.5 hours; increases with renal impairment, oliguric patients: 20 hours

Time to peak serum concentration: Oral: Within 1-3 hours

Elimination: In urine as unchanged drug

Children: Oral, I.V.: Doses of 1-2 mg/kg/day have been used; maximum dose: 40 mg

Adults:

Oral:

Duodenal ulcer, gastric ulcer: 40 mg/day at bedtime for 4-8 weeks

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

GERD: 20 mg twice daily for 6 weeks

I.V.: 20 mg every 12 hours

Dosing adjustment in renal impairment:

Cl_cr <10 mL/minute: Administer every 24 hours or 50% of dose

May cause dizziness or drowsiness; may rarely cause insomnia

May cause agranulocytosis; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed, for full dose as prescribed, even if feeling better. Avoid alcohol and smoking (smoking decreases effectiveness of medication). You may experience some drowsiness or dizziness; use caution when driving or engaging in tasks that require alertness until response to drug is known. Increased exercise, increased dietary fluids, fruits, or fiber may reduce constipation; yogurt or buttermilk may help relieve diarrhea. Report acute headache, unresolved constipation or diarrhea, palpitations, black tarry stools, abdominal pain, rash, worsening of condition being treated, or recurrence of symptoms after therapy is completed.

Administer over 15-30 minutes; may be administered undiluted I.V. push

Gelcap (Pepcid® AC): 10 mg

Infusion, premixed in NS: 20 mg (50 mL)

Injection: 10 mg/mL (2 mL, 4 mL)

Powder for oral suspension (cherry-banana-mint flavor): 40 mg/5 mL (50 mL)

Tablet (Mylanta AR®): 10 mg

Tablet, chewable (Pepcid® AC): 10 mg

Tablet, film coated: 20 mg, 40 mg

Tablet, orally disintegrating (Pepcid RPD™): 20 mg, 40 mg

Pepcid® AC Acid Controller: 10 mg

Ahmad S, "Famotidine and Cardiac Arrhythmia," DICP, 1991, 25(3):315.

Fish DN, "Safety and Cost of Rapid I.V. Injection of Famotidine in Critically Ill Patients," Am J Health Syst Pharm, 1995, 52(17):1889-94.

Inotsume N, Mishimura M, Nakano M, et al, "Removal of Famotidine by Haemodialysis in Elderly Anuric Patients," Eur J Clin Pharmacol, 1990, 38(3):313-4.

James LP and Kearns GL, "Pharmacokinetics and Pharmacodynamics of Famotidine in Paediatric Patients," Clin Pharmacokinet, 1996, 31(2):103-10.

Treem WR, Davis PM, and Hyams JS, "Suppression of Gastric Acid Secretion by Intravenous Administration of Famotidine in Children," J Pediatr, 1991, 118(5):812-6.