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Famotidine

Famotidine is a histamine H₂-receptor antagonist that inhibits stomach acid production, and is commonly used in the treatment of peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). more...

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Clinical use

Certain preparations of famotidine are available over the counter (OTC) in various countries. In the United States, preparations of 10 mg and 20mg tablets, sometimes in combination with a more traditional antacid (brand name Pepcid Complete), are available OTC. Larger doses still require a prescription.

History and development

Famotidine was developed by Merck & Co.. The imidazole-ring of cimetidine was replaced with a 2-guanidinothiazole ring. Famotidine proved to be 30 times more active than cimetidine.

It was first marketed (as Pepcidine® and Pepcid®) in 1985. Pepcid RPD® (orally disintegrating tablets that are not swallowed) was released in 1999. Generic forms (e.g. Fluxid®, Schwarz Pharma) became available in 2001.

In the United States, a product called Pepcid Complete is available that combines famotidine with an antacid in a chewable tablet to ameliorate the relatively slow onset of effects.

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Efficacy of famotidine in the prevention of ulcers - adapted from the New England Journal of Medicine 1996;334:1435-9 - Tips from Other Journals
From American Family Physician, 9/15/96

A common side effect of nonsteroidal anti-inflammatory drug (NSAID) therapy is gastroduodenal injury. Studies have demonstrated that famotidine, a histamine [H.sub.2]-receptor antagonist, inhibits acid secretion and provides protection against mucosal injury in persons taking short courses of aspirin or naproxen. Taha and colleagues conducted a double-blind clinical trial to evaluate the long-term efficacy of famotidine in preventing ulcers in patients receiving NSAIDs.

The study included 285 patients without ulcers who were receiving long-term NSAID therapy for rheumatoid arthritis (82 percent of patients) or for osteoarthritis (18 percent). The patients were randomized to receive placebo (93 patients), or either 20 mg (95 patients) or 40 mg (97 patients) of famotidine orally twice daily. Co-magal-drox tablets were provided for relief of dyspepsia. The patients were evaluated clinically and endoscopically at baseline and after four, 12 and 24 weeks of treatment. Abdominal symptoms and antacid use were recorded daily by the patients.

The cumulative incidence of gastric ulcers in the high-dose famotidine group was 8 percent, compared with 13 percent in the low-dose famotidine group and 20 percent in the placebo group. The cumulative incidence of duodenal ulcers in the high-dose famotidine group was 2 percent, compared with 4 percent in the low-dose famotidine group and 13 percent in the placebo group. Adverse effects of low-and high-dose famotidine were minimal and included abdominal pain, rash and diarrhea. Many of the patients did not have abdominal pain or dyspepsia. In those who did, there was a trend toward a reduction in dyspepsia in the patients receiving famotidine.

The study results suggest that treatment with a high-dose regimen of famotidine is safe and effective in preventing gastric and duodenal ulcers in patients receiving long-term NSAID therapy. (Taha AS, et al. Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med 1996;334:1435-9.)

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