País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)
State of Florida DOH Central Pharmacy
ORAL
PRESCRIPTION DRUG
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 empiric selection of therapy. 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. For the treatment of acute otitis m
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) (white to off-white, oval shaped, uncoated tablets with ‘G340’ debossed on one side and breakline on the other side) containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP. Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg (white to off-white, round, standard biconvex, uncoated tablets with ‘G339’ debossed on one side and breakline on the other side) containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP. They are supplied by State of Florida DOH Central Pharmacy as follows:
Abbreviated New Drug Application
SULFAMETHOXAZOLE AND TRIMETHOPRIM - SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- 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 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 bacteria. DESCRIPTION Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) 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 _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 USP 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: colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc. 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. The metabolism of sulfamethoxazole occurs predominately by N -acetylation, although the glucuronide conjugate has been identified. The principal metabolites of trimethoprim are the 1- and 3-oxides and the 3'- and 4'-hydroxy derivatives. The free forms of sulfamethoxazole Leer el documento completo