Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)
Golden State Medical Supply, Inc.
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, 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 the empiric selection of therapy. For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli , Proteus mirabilis , Klebsiella pneumoniae , Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus . Cultures and susceptibility tests should be performed to determine the susceptibility of
Trimethoprim tablets, USP, 100 mg: White, round, convex tablet, debossed "9", scored, "3" on one side and debossed "21 58" on the other, in bottles of 100. NDC 51407-257-01 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.
New Drug Application
TRIMETHOPRIM- TRIMETHOPRIM TABLET GOLDEN STATE MEDICAL SUPPLY, INC. ---------- TRIMETHOPRIM TABLETS, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Trimethoprim is a synthetic antibacterial available in tablet form for oral administration. Each scored white tablet contains 100 mg trimethoprim. Trimethoprim is 5-[(3,4,5-trimethoxyphenyl)methyl]-2,4-pyrimidinediamine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the molecular formula C H N O . The structural formula is: INACTIVE INGREDIENTS Colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. CLINICAL PHARMACOLOGY Trimethoprim is rapidly absorbed following oral administration. It exists in the blood as unbound, protein-bound, and metabolized forms. Ten to twenty percent of trimethoprim is metabolized, primarily in the liver; the remainder is excreted unchanged in the urine. The principal metabolites of trimethoprim are the 1- and 3-oxides and the 3'- and 4'- hydroxy derivatives. The free form is considered to be the therapeutically active form. Approximately 44% of trimethoprim is bound to plasma proteins. Mean peak serum concentrations of approximately 1.0 mcg/mL occur 1 to 4 hours after oral administration of a single 100 mg dose. A single 200 mg dose will result in serum levels approximately twice as high. The half-life of trimethoprim ranges from 8 to 10 hours. However, patients with severely impaired renal function exhibit an increase in the 14 18 4 3 half-life of trimethoprim, which requires either dosage regimen adjustment or not using the drug in such patients (see DOSAGE AND ADMINISTRATION). During a 13 week study of trimethoprim administere Läs hela dokumentet