Land: Bandaríkin
Tungumál: enska
Heimild: 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)
H2-Pharma, 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 white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALIS™ logo printed on the body and "BMT" printed on the cap. Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules are supplied 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: 61269-385-12, Blister pack of 120. Storage Store at controlled room temperature [68° to 77°F or 20° to 25°C].
New Drug Application
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE- BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE CAPSULE H2-PHARMA, 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 Capsules 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 Capsules 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 (after mea Lestu allt skjalið