Country: Canada
Language: English
Source: Health Canada
FAMOTIDINE
MERCK CANADA INC
A02BA03
FAMOTIDINE
10MG
SOLUTION
FAMOTIDINE 10MG
INTRAVENOUS
2ML
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0118722003; AHFS:
CANCELLED POST MARKET
2006-11-10
PRODUCT MONOGRAPH PEPCID ® Tablets (famotidine tablets, USP) 20, 40 mg PEPCID ® for Oral Suspension (famotidine for oral suspension) 8 mg/mL PEPCID ® I.V. (famotidine injection) 10 mg/mL Histamine H 2 Receptor Antagonist Date of Revision: August 17, 2007 MERCK FROSST CANADA LTD. 16711 Trans Canada Highway Kirkland QC H9H 3L1 Canada www.merckfrosst.com Control No. 114477 PEPCID ® is a Registered Trademark of Merck & Co., Inc. Used under license. 1 PRODUCT MONOGRAPH NAME OF DRUG PEPCID ® Tablets (famotidine tablets, USP) 20, 40 mg PEPCID ® for Oral Suspension (famotidine for oral suspension) 8 mg/mL PEPCID ® I.V. (famotidine injection) 10 mg/mL THERAPEUTIC CLASSIFICATION Histamine H 2 Receptor Antagonist CLINICAL PHARMACOLOGY PEPCID ® (famotidine) is a competitive inhibitor of histamine H 2 -receptors. The primary clinically important pharmacologic activity of PEPCID ® is inhibition of gastric juice secretion. PEPCID ® reduces the acid and pepsin content, as well as the volume, of basal, nocturnal, and stimulated gastric secretion. INDICATIONS AND CLINICAL USE PEPCID ® (famotidine) is indicated in the treatment of the following conditions where a controlled reduction of gastric secretion is required: 1. Treatment of acute duodenal ulcer; 2. Prophylactic use in duodenal ulcer; 3. Treatment of acute benign gastric ulcer; 4. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome); 5. Treatment of gastroesophageal reflux disease (GERD); 2 6. Maintenance of remission of patients with GERD. PEPCID ® I.V. is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication. CONTRAINDICATIONS Hypersensitivity to any component of this medication. Cross sensitivity in this class of compounds has been observed. Therefore, PEPCID ® (famotidine) should not be administered to patients with a history of hypersensitivity to other H 2 Read the complete document