البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
FAMOTIDINE
MERCK CANADA INC
A02BA03
FAMOTIDINE
20MG
TABLET
FAMOTIDINE 20MG
ORAL
28
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0118722001; AHFS:
CANCELLED POST MARKET
2013-07-15
PRODUCT MONOGRAPH PEPCID ® Tablets (famotidine tablets, USP) 20, 40 mg Histamine H 2 Receptor Antagonist MERCK CANADA INC. 16750 route Transcanadienne Kirkland QC H9H 4M7 Canada http//www.merck.ca Date of Revision: April 27, 2011 SUBMISSION CONTROL NUMBER. 145448 ® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Used under license. _© 2011, Merck Canada Inc., a subsidiary OF MERCK & CO., INC. All rights reserved. _ _ _ 1 PRODUCT MONOGRAPH NAME OF DRUG PEPCID ® Tablets (famotidine tablets, USP) 20, 40 mg 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); 6. Maintenance of remission of patients with GERD. 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 2 H 2 -receptor antagonists. PRECAUTIONS PATIENTS WITH MODERATE OR SEVERE RENAL INSUFFICIENCY Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, longer intervals between doses or lower doses may need to be used in patients with moderate (creatinine clearance 30 - 50 mL/min) or severe (creatinine cleara اقرأ الوثيقة كاملة