البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Carlsbad Technology, Inc
Famotidine
Famotidine 20 mg
ORAL
PRESCRIPTION DRUG
Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: • active duodenal ulcer. • active gastric ulcer. • symptomatic non-erosive 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 is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. 8.1 Pregnancy 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
Famotidine 20 mg tablets are white, round, film-coated tablets engraved with CTI 121 on one side, supplied as follows: • NDC 61442-121-01 unit of use bottles of 100 • NDC 61442-121-10 unit of use bottles of 1000 Famotidine 40 mg tablets are white, round, film-coated tablets engraved with CTI 122 on one side, supplied as follows: • NDC 61442-122-01 unit of use bottles of 100 • NDC 61442-122-10 unit of use bottles of 1000 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET CARLSBAD TECHNOLOGY, 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. INITIAL U.S. APPROVAL: 1986 FAMOTIDINE TABLETS INDICATIONS AND USAGE Famotidine is a histamine-2 (H2) receptor antagonist indicated (1): (1) In adult and pediatric patients 40 kg and greater for the treatment of: (1) 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: (1) treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). (1) 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 Recurrence 20 mg once daily (2) See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration. (2.1, 2.2) (2) Administration (2.3): (2) Take once daily before bedtime or twice daily in the morning and before bedtime with or without food. (2) DOSAGE FORMS AND STRENGTHS Tablets: 20 mg, 40 mg (3) (3) CONTRAINDICATIONS History of serious hypersensitivity reactions (e.g., anaphylaxis) to Famotidine or other H receptor antagonists. (4) (4) WARNINGS AND PRECAUTIONS (5) Central Nervous System (CNS) Adverse Reactions: Elderly patients and 2 patients with renal impairment at increased risk; reduce the dosage. (2.2, 5.1, 8.5, 8.6) (5) GI Malignancy: Absence of GI symptoms does not preclude the presence of gastri اقرأ الوثيقة كاملة