SULFAMETHOXAZOLE AND TRIMETHOPRIM DS- sulfamethoxazole and trimethoprim tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Advanced Rx Pharmacy of Tennessee, LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

INDICATIONS AND USAGE 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. Urinary Tract Infections: 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. A

उत्पाद समीक्षा:

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. Bottles of 14 Tablets NDC 80425-0003-01 Bottles of 20 Tablets NDC 80425-0003-02 Bottles of 30 Tablets NDC 80425-0003-03 Bottles of 10 Tablets NDC 80425-0003-04 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

SULFAMETHOXAZOLE AND TRIMETHOPRIM DS- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG/160MG TABLETS
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 N1-(5-methyl-3-isoxazolyl) sulfanilamide; the
molecular formula is
C10H11N3O3S. 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 C14H18N4O3. It is a white or cream-colored crystals or
crystalline powder
with a molecular weight of 290.3 and the following structural formula:
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 N4-acetyl-, N4-
hydroxy-, 5-methylhydroxy-, N4-acetyl-5-methylhydroxy-
sulfamethoxazole metabolites,
and an N-glucuronide conjugate. The formulation of N4-hydroxy
metabolite is mediated
via CYP2C9.
Trimethoprim is metabolized in vitro to 11 different metabolites, of
which, five are
glutathione adducts and six are oxidative metabolites, including the
major metabolites, 1-
and 3-oxides and the 3- and 4-hydroxy derivatives.
The free forms of sulfamethoxazole and trimethoprim are considered to
be the
therapeutically active forms.
In vitro studies suggest that trimethoprim is a substrat