BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

BISMUTH SUBCITRATE POTASSIUM (UNII: R3O80H60KX) (BISMUTH CATION - UNII:ZS9CD1I8YE), METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E), TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)

Disponibbli minn:

Ingenus Pharmaceuticals, LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE
HYDROCHLORIDE- BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE,
TETRACYCLINE
HYDROCHLORIDE CAPSULE
INGENUS PHARMACEUTICALS, LLC
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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