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Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:2186.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has changed the labeling for prescription famotidine (Pepcid tablets; Pepcid for oral suspension; Pepcid RPD orally disintegrating tablets; and Pepcid injection and Pepcid injection premixed; Merck & Co Inc, Whitehouse Station, NJ), indicated for short-term treatment and maintenance therapy for duodenal ulcer; short-term treatment of active benign gastric ulcer, gastroesophageal reflux disease (GERD), and esophagitis due to GERD; and treatment of pathological hypersecretory conditions.

The new labeling calls for an adjustment of dosage for patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency. Previous labeling recommended adjustments for severe insufficiency only.

Based on reported central nervous system adverse effects in famotidine users with moderate as well as severe renal insufficiency, the new labeling recommends that the dosage of the drug for such patients be reduced by half, or the dosing interval prolonged to 36 to 48 hours, as . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration

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