SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

NuCare Pharmaceuticals, Inc.

INN (Kansainvälinen yleisnimi):

SULFAMETHOXAZOLE

Koostumus:

SULFAMETHOXAZOLE 800 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP 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 rath

Tuoteyhteenveto:

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg are white to off-white oval, beveled edge uncoated tablets, debossed with “H 49” on one side and deep break line on other side. NDC 66267-816-02 NDC 66267-816-04 NDC 66267-816-06 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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