Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)
Physicians Total Care, Inc.
TRIMETHOPRIM
TRIMETHOPRIM 100 mg
ORAL
PRESCRIPTION DRUG
For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichiacoli, 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 the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the results of these tests. Trimethoprim tablets are contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.
Trimethoprim Tablets USP, 100 mg are scored, oval-shaped, white tablets imprinted DAN DAN and 5571 supplied in Dispense in a tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F) in a dry place. [See USP controlled room temperature.]
Abbreviated New Drug Application
TRIMETHOPRIM - TRIMETHOPRIM TABLET PHYSICIANS TOTAL CARE, INC. ---------- TRIMETHOPRIM TABLETS USP REVISED: JUNE 2006 RX ONLY DESCRIPTION Trimethoprim is a synthetic antibacterial available as 100 mg tablets for oral administration. Trimethoprim is 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to cream colored, odorless, bitter compound. The structural formula is represented below: C H N O M.W. 290.32 Trimethoprim Tablets USP, 100 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate and stearic acid. 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 plasma concentrations of approximately 1 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 half-life of trimethoprim, which requires either dosage regimen adjustment or not using the drug in such patients (seeDOSAGE AND ADMINISTRATION). During a 13-week study of trimethoprim administered at a daily dosage of 200 mg (50 mg q.i.d.), the mean minimum steady-state concentration of the drug was 1.1 mcg/mL. Steady-state concentrations were achieved within 2 to 3 days of chronic administration, and were maintained throughout the experimental period. Excretion of trimethoprim is primarily by the kidneys through glomerular filtration and tu Lugege kogu dokumenti