Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
PD-Rx Pharmaceuticals, Inc.
FAMOTIDINE
FAMOTIDINE 40 mg
ORAL
PRESCRIPTION DRUG
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (DU). - active gastric ulcer (GU). - symptomatic nonerosive gastroesophageal reflux disease (GERD). - erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were ob
Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 30 (NDC 43063-533-30) tablets. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid storage of famotidine tablets at temperatures above 40°C (104°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FAMOTIDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FAMOTIDINE TABLETS. FAMOTIDINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1986 INDICATIONS AND USAGE Famotidine tablets are a histamine-2 (H ) receptor antagonist indicated (1): In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence. DOSAGE AND ADMINISTRATION INDICATION RECOMMENDED DOSAGE (2.1) _Adult and Pediatric Patients 40 kg and greater_ Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily _Adults_ Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Reocurrence 20 mg once daily See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration. ( 2.1, 2.2) Administration ( 2.3): Take once daily before bedtime or twice daily in the morning and before bedtime with or without food. DOSAGE FORMS AND STRENGTHS Tablets: 20 mg, 40 mg ( 3) CONTRAINDICATIONS History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H receptor antagonists. ( 4) WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.2, 5.1, 8.5, 8.6) GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric Læs hele dokumentet