国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)
Aidarex Pharmaceuticals LLC
SULFAMETHOXAZOLE
SULFAMETHOXAZOLE 400 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 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 Otitis M
Sulfamethoxazole and Trimethoprim Tablets 400 mg/80 mg are available as: White, round, bisected tablets debossed “IP” over “271” on one side. Bottles of 6 – NDC 33261-396-06 Bottles of 10 – NDC 33261-396-10 Bottles of 14 – NDC 33261-396-14 Bottles of 20 – NDC 33261-396-20 Bottles of 28 – NDC 33261-396-28 Bottles of 30 – NDC 33261-396-30 Bottles of 40 – NDC 33261-396-40 Bottles of 60 – NDC 33261-396-60 Bottles of 90 – NDC 33261-396-90 Bottles of 100 – NDC 33261-396-00 Bottles of 120 – NDC 33261-396-02 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 AIDAREX PHARMACEUTICALS LLC ---------- SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH TABLETS 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 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. It has the following structural formula: 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. The metabolism of sulfamethoxazole occurs predominately by N -acetylation, although the glucuronide conjugate has been identified. The principal 1 10 11 3 3 14 18 4 3 4 metabolites of trimethoprim are the 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. Approximately 70% of sulfamethoxazole and 完全なドキュメントを読む