País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Sulfamethoxazole (UNII: JE42381TNV) (Sulfamethoxazole - UNII:JE42381TNV), Trimethoprim (UNII: AN164J8Y0X) (Trimethoprim - UNII:AN164J8Y0X)
Central Texas Community Health Centers
ORAL
PRESCRIPTION DRUG
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 Media
Sulfamethoxazole and trimethoprim tablets, USP are supplied as follows: Sulfamethoxazole 400 mg and trimethoprim 80 mg tablets, white, round, scored, debossed MP 81 Sulfamethoxazole 800 mg and trimethoprim 160 mg tablets, double strength, white, oval shaped, scored, debossed MP 85 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET CENTRAL TEXAS COMMUNITY HEALTH CENTERS ---------- 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 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 290.3 and the following structural formula: INACTIVE INGREDIENTS: Docusate sodium 85%, sodium benzoate 15%, sodium starch glycolate, magnesium stearate and pregelatinized starch. 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 metabolites, of which, five are glutathione Leer el documento completo