Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
BluePoint Laboratories
ORAL
PRESCRIPTION DRUG
Famotidine tablets are indicated in adult and pediatric patients 40 kg and above 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 famotine, 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 observ
Famotidine Tablets, USP, 20 mg, are yellow colored, circular, biconvex film-coated tablets embossed with ‘L113’on one side and ‘20’ on the other side. NDC 68001-240-00 bottles of 100 NDC 68001-240-08 bottles of 1000 Famotidine Tablets USP, 40 mg, are brown colored, circular, biconvex film-coated tablets embossed with ‘L114’on one side and ‘40’ on the other side. NDC 68001-241-00 bottles of 100 NDC 68001-241-03 bottles of 500 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET BLUEPOINT LABORATORIES ---------- 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 tablet is a histamine-2 (H ) receptor antagonist indicated (1): (1) In adult and pediatric patients 40 kg and above 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). reduction of the risk of DU recurrence. DOSAGE AND ADMINISTRATION Indication (2) Recommended Dosage (2.1) (2) _Adults and Pediatric Patients 40 kg and greater_ (2) Active DU (2) 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer (2) 40 mg once daily GERD (2) 20 mg twice daily (2) Erosive Esophagitis (2) 20 mg twice daily; or 40 mg twice daily (2) _Adults_ (2) Pathological Hypersecretory Conditions (2) 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours (2) Risk Reduction of DU Recurrence (2) 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) Administration (2.3): (2) 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) (3) CONTRAINDICATIONS History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H receptor antagonists. (4) (4) 2 2 antagonists. (4) (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) G Прочитајте комплетан документ