BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE- bismuth subsalicylate chewable tablets/metronidazole tablets/tet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Beszerezhető a:

Ailex Pharmaceuticals, LLC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptib

Termék összefoglaló:

Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules is supplied in a carton containing patient instructions, patient reminders, and 14 blister cards, each card containing the following daily dosage: 8 bismuth subsalicylate 262.4-mg chewable tablets, each pink round tablet debossed “W10”. 4 metronidazole 250-mg tablets are round, white, debossed with “WPI” on one side and “3969” on the other. 4 tetracycline hydrochloride 500-mg capsules, each black/yellow capsule imprinted with “WPI” on cap and “2235” on the body. NDC 70556-103-14 carton containing 14 days of therapy Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.].

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE-
BISMUTH SUBSALICYLATE CHEWABLE TABLETS/METRONIDAZOLE
TABLETS/TETRACYCLINE HYDROCHLORIDE CAPSULES
AILEX PHARMACEUTICALS, LLC
----------
BISMUTH SUBSALICYLATE CHEWABLE TABLETS/METRONIDAZOLE
TABLETS/TETRACYCLINE HYDROCHLORIDE
CAPS ULES
PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. The individual
products contained
in this package should not be used alone or in combination for other
purposes. The information
described in this labeling concerns only the use of these products as
indicated in this combination
package. For information on use of the individual components when
dispensed as individual medications
outside this combined use for treating _Helicobacter pylori_, please
see the package inserts for each
individual product.
WARNING: POTENTIAL FOR CARCINOGENICITY
METRONIDAZOLE HAS BEEN SHOWN TO BE CARCINOGENIC IN MICE AND RATS. IT
IS UNKNOWN WHETHER
METRONIDAZOLE IS ASSOCIATED WITH CARCINOGENICITY IN HUMANS (SEE
WARNINGS).
DESCRIPTION:
Bismuth Subsalicylate Chewable Tablets/Metronidazole
Tablets/Tetracycline Hydrochloride Capsules
consists of 112 bismuth subsalicylate 262.4-mg chewable tablets, 56
metronidazole 250-mg tablets,
USP, and 56 tetracycline hydrochloride 500-mg capsules, USP, for oral
administration.
Bismuth subsalicylate chewable tablets: Each pink round tablet
contains 262.4 mg bismuth subsalicylate
(102 mg salicylate) for oral administration.
Bismuth subsalicylate is a fine, white, odorless, and tasteless powder
that is stable and non-
hygroscopic. It is a highly insoluble salt of trivalent bismuth and
salicylic acid.
Bismuth subsalicylate is 2-Hydroxybenzoic acid bismuth (3+) salt with
the following structural formula:
Molecular weight: 362.11
INACTIVE INGREDIENTS: Each bismuth subsalicylate chewable tablet
contains calcium carbonate, D&C
Red No. 27 aluminum lake, magnesium stearate, mannitol, povidone,
saccharin sodium, talc, and
wintergreen flavor.
Metronidazole tablets, USP: Each round, white tablet contains 250 mg
metronidazole. Me