البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
BISMUTH SUBCITRATE POTASSIUM (UNII: R3O80H60KX) (BISMUTH CATION - UNII:ZS9CD1I8YE), METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E), TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)
Ingenus Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori . The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. To reduce the development of drug-resistant bacteria and maintain the effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules and other antibacterial drugs, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may
Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules are supplied as a hard gelatin capsule with a white opaque body and a white opaque cap, imprinted with “ING283” in black on both body and cap, filled with white to off-white powder and a smaller hard gelatin capsule. Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules for a total of 120 capsules. NDC Number: 50742-283-12, Bottles of 120. NDC Number: 50742-283-13, Blister pack of 120. Storage Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE- BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE CAPSULE INGENUS PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULES. BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2006 WARNING: POTENTIAL FOR CARCINOGENICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ METRONIDAZOLE HAS BEEN SHOWN TO BE CARCINOGENIC IN MICE AND RATS. IT IS UNKNOWN WHETHER METRONIDAZOLE IS ASSOCIATED WITH CARCINOGENICITY IN HUMANS (5.1). RECENT MAJOR CHANGES Warnings and Precautions, Drugs Interactions (5.14) 3/2021 Contraindications (4) 12/2021 INDICATIONS AND USAGE Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline, - a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (1.1) To reduce the development of drug-resistant bacteria and maintain the effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules and other antibacterial drugs, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2) DOSAGE AND ADMINISTRATION Administer three bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules 4 times a day (afte اقرأ الوثيقة كاملة