BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Par Pharmaceutical, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules, 140 mg/125 mg/125 mg are supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, USP, and 125 mg tetracycline hydrochloride, USP, with the "440" printed on the body and "PAR" 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 capsules for a total of 120 capsules.   Blister pack of 12 Capsules        NDC 49884-151-24 Carton of 120 Capsules              NDC 49884-151-54 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE
HYDROCHLORIDE- BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND
TETRACYCLINE HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL, INC.
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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 capsules are 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