SULFAMETHOXAZOLE AND TRIMETHOPRIM- sulfamethoxazole and trimethoprim tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

SULFAMETHOXAZOLE

Composition:

SULFAMETHOXAZOLE 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Acute Otitis Med

Product summary:

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim (DS) Tablets, USP 800 mg/160 mg are white to off white, oval, scored tablets, debossed "5898" on one side and debossed "V" on the reverse side, supplied in bottles of 6 (NDC 63187-285-06), 10(NDC 63187-285-10), 14(NDC 63187-285-14), 20 (NDC 63187-285-20) and 40 (NDC 63187-285-40). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
PROFICIENT RX LP
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP,
800 MG/160 MG (DOUBLE STRENGTH) AND 400 MG/80 MG
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 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
290.32 and the following structural formula:
INACTIVE INGREDIENTS: Docusate sodium 85%, magnesium stearate,
povidone, pregelatinized starch,
sodium benzoate 15%, and sodium starch glycolate.
1
10
11
3
3
14
18
4
3
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 meta