País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)
PD-Rx Pharmaceuticals, Inc.
SULFAMETHOXAZOLE
SULFAMETHOXAZOLE 800 mg
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
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 6: NDC 43063-616-06 Bottles of 20: NDC 43063-616-20 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 PD-RX PHARMACEUTICALS, INC. ---------- SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH 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, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP 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: 1 10 11 3 3 14 18 4 3 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 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 gluta Llegiu el document complet