SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Tillgänglig från:

A-S Medication Solutions

INN (International namn):

SULFAMETHOXAZOLE

Sammansättning:

SULFAMETHOXAZOLE 800 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent 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 contribute to empiric selection of therapy. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. For the treatment of acute otitis media in pe

Produktsammanfattning:

Product: 50090-2198 NDC: 50090-2198-0 10 TABLET in a BOTTLE NDC: 50090-2198-1 14 TABLET in a BOTTLE NDC: 50090-2198-2 20 TABLET in a BOTTLE NDC: 50090-2198-3 28 TABLET in a BOTTLE NDC: 50090-2198-5 100 TABLET in a BOTTLE NDC: 50090-2198-7 6 TABLET in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

SULFAMETHOXAZOLE AND TRIMETHOPRIM - SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
A-S MEDICATION SOLUTIONS
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
sulfamethoxazole and trimethoprim tablets and other antibacterial
drugs,
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
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 a white to off-white, practically odorless, crystalline
powder, 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 or cream-colored crystals or crystalline powder
with
a molecular weight of 290.3 and the following structural formula:
1
10
11
3
3
14
18
4
3
INACTIVE INGREDIENTS: Docusate sodium, magnesium stearate,
pregelatinized starch
(maize), sodium benzoate, and sodium starch glycolate.
CLINICAL PHARMACOLOGY
Sulfamethoxazole and trimethoprim 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 11 different metabolites