SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

RedPharm Drug, Inc.

INN (International namn):

TRIMETHOPRIM

Sammansättning:

TRIMETHOPRIM 160 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, 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 the 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. Acute Oti

Produktsammanfattning:

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim DS (double strength) Tablets, USP, 800 mg/160 mg, are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. They are available as follows: Bottles of 10: NDC 53746-272-11 Bottles of 24: NDC 53746-272-24 Bottles of 100: NDC 53746-272-01 Bottles of 250: NDC 53746-272-02 Bottles of 500: NDC 53746-272-05 Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, are supplied as white, round, bisected tablets debossed “IP” over “271” on one side. They are available as follows: Bottles of 50: NDC 53746-271-50 Bottles of 100: NDC 53746-271-01 Bottles of 500: NDC 53746-271-05 Bottles of 1000: NDC 53746-271-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
REDPHARM DRUG, INC.
----------
DESCRIPTION
Sulfamethoxazole and trimethoprim is a synthetic antibacterial
combination product
available in DS (double strength) tablets, each containing 800 mg
sulfamethoxazole, USP
and 160 mg trimethoprim, USP; in tablets, each containing 400 mg
sulfamethoxazole,
USP and 80 mg trimethoprim, USP for oral administration.
Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the
molecular formula
is C10H11N3O3S. It is almost white, odorless, tasteless compound with
a molecular
weight of 253.28 and the following structural formula:
[fad6060f-figure-01]
Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)
pyrimidine; the molecular
formula is C14H18N4O3. It is a white to light yellow, odorless, bitter
compound with a
molecular weight of 290.3. It has the following structural formula:
[fad6060f-figure-02]
Inactive Ingredients: Magnesium stearate, povidone, pregelatinized
starch 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 substrate of
P-glycoprotein, OCT1 and
OCT2, and that sulfamethoxazole is not a substrat