BACTRIM DS sulfamethoxazole and trimethoprim tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Sulfamethoxazole (UNII: JE42381TNV) (Sulfamethoxazole - UNII:JE42381TNV)

Tillgänglig från:

AR Scientific, Inc.

INN (International namn):

Sulfamethoxazole

Sammansättning:

Sulfamethoxazole 800 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

New Drug Application

Produktens egenskaper

BACTRIM DS- SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET
BACTRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET
AR SCIENTIFIC, INC.
----------
BACTRIM™
SULFAMETHOXAZOLE AND TRIMETHOPRIM DS
(DOUBLE STRENGTH) TABLETS AND TABLETS USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Bactrim
(sulfamethoxazole and trimethoprim) tablets and other antibacterial
drugs, Bactrim (sulfamethoxazole
and trimethoprim) tablets should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
BACTRIM (sulfamethoxazole and trimethoprim) is a synthetic
antibacterial combination product
available in DS (double strength) tablets, each containing 800 mg
sulfamethoxazole and 160 mg
trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and
80 mg trimethoprim for oral
administration.
Sulfamethoxazole is _N_ -(5-methyl-3-isoxazolyl)sulfanilamide; the
molecular formula is C
H N O S.
It is an almost white, odorless, tasteless compound with a molecular
weight of 253.28 and the following
structural formula:
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the
molecular formula is
C
H N O . It is a white to light yellow, odorless, bitter compound with
a molecular weight of 290.3
and the following structural formula:
INACTIVE INGREDIENTS: Docusate sodium 85%, sodium benzoate 15%, sodium
starch glycolate,
magnesium stearate and pregelatinized starch.
CLINICAL PHARMACOLOGY
1
10
11
3
3
14
18
4
3
BACTRIM is rapidly absorbed following oral administration. Both
sulfamethoxazole and trimethoprim
exist in the blood as unbound, protein-bound and metabolized forms;
sulfamethoxazole also exists as the
conjugated form. Sulfamethoxazole is metabolized in humans to at least
5 metabolites: the N -acetyl-,
N -hydroxy-, 5-methylhydroxy-, N -acetyl-5-methylhydroxy-
sulfamethoxazole metabolites, and an N-
glucuronide conjugate. The formulation of N -hydroxy metabolite is
mediated_ via _CYP2C9.
Trimethoprim is metabolized_ in vitro _to 1