Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
TRIMETHOPRIM HYDROCHLORIDE (UNII: 9XE000OU9B) (TRIMETHOPRIM - UNII:AN164J8Y0X)
FSC Laboratories, Inc
TRIMETHOPRIM HYDROCHLORIDE
TRIMETHOPRIM 50 mg in 5 mL
ORAL
PRESCRIPTION DRUG
PRIMSOL Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. For the treatment of acute otitis media due to susceptible strains of Streptococcus pneumoniae and Haemophilus influenzae. NOTE: Moraxella catarrhalis isolates were found consistently resistant to trimethoprim in vitro. Therefore, when infection with Moraxella catarrhalis is suspected, the use of alternative antimicrobial agents should be considered. PRIMSOL is not indicated for prophylactic or prolonged administration in otitis media at any age. 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 the bacteria to trimethoprim
PRIMSOL (trimethoprim hydrochloride oral solution) is a dye-free, alcohol-free, bubble gum flavored, oral solution containing trimethoprim hydrochloride equivalent to 50 mg of trimethoprim in each 5 mL. NDC 13551-501-01: 20 mL (3/4 ounce) NDC 13551-501-05: 473 mL (1 Pint) Store between 15-25°C (59-77°F). Dispense in tight, light-resistant glass or PET plastic containers as defined in USP. Protect from light.
New Drug Application
PRIMSOL- TRIMETHOPRIM HYDROCHLORIDE SOLUTION FSC LABORATORIES, INC ---------- PRIMS OL SOLUTION (TRIMETHOPRIM HYDROCHLORIDE ORAL SOLUTION) DYE-FREE, ALCOHOL-FREE, FLAVORED SOLUTION, 50 MG TRIMETHOPRIM PER 5 ML DESCRIPTION PRIMSOL (trimethoprim hydrochloride oral solution) is a solution of the synthetic antibacterial trimethoprim in water prepared with the aid of hydrochloric acid. Each 5 mL for oral administration contains trimethoprim hydrochloride equivalent to 50 mg trimethoprim and the inactive ingredients bubble gum flavor, fructose, glycerin, methylparaben, monoammonium glycyrrhizinate, povidone, propylparaben, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water and hydrochloric acid and/or sodium hydroxide to adjust pH to a range of 3.0 - 5.0. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine. Trimethoprim is a white to cream-colored, odorless, bitter compound with a molecular formula of C H N O and a molecular weight of 290.32 and the following structural formula: 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 plasma concentrations approximately twice as high. The mean half-life of trimethoprim is approximately 9 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 (see DOSAGE AND ADMINISTRATION s Прочитайте повний документ