Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ETHAMBUTOL HYDROCHLORIDE (UNII: QE4VW5FO07) (ETHAMBUTOL - UNII:8G167061QZ)
Teva Pharmaceuticals USA, Inc.
ETHAMBUTOL HYDROCHLORIDE
ETHAMBUTOL HYDROCHLORIDE 400 mg
ORAL
PRESCRIPTION DRUG
Ethambutol Hydrochloride Tablets USP are indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most frequently used regimens have been the following: Ethambutol Hydrochloride Tablets USP plus isoniazid Ethambutol Hydrochloride Tablets USP plus isoniazid plus streptomycin. In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, Ethambutol Hydrochloride Tablets USP should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial suscept
Ethambutol Hydrochloride Tablets USP are available as: 400 mg: White, oval-shaped, film-coated, scored, biconvex tablet. Debossed with stylized b on one side and 923/400 on the scored side. Available in bottles of 100 tablets (NDC 0555-0923-02). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. A 11/2015
Abbreviated New Drug Application
ETHAMBUTOL HYDROCHLORIDE- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- ETHAMBUTOL HYDROCHLORIDE TABLETS USP 0923 RX ONLY DESCRIPTION Ethambutol hydrochloride, USP is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus _Mycobacterium_, including _M. tuberculosis_. It is a white, crystalline powder. Freely soluble in water; soluble in alcohol and in methanol; slightly soluble in ether and in chloroform. It has the chemical formula of: (+)- 2,2’ (Ethylenediimino)-di-1-butanol dihydrochloride. The structural formula is as follows: C H N O ·2HCl M.W. 277.23 Each tablet, for oral administration, contains 400 mg of ethambutol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, gelatin, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide, and triacetin. CLINICAL PHARMACOLOGY Ethambutol hydrochloride, following a single oral dose of 25 mg/kg of body weight, attains a peak of 2 to 5 mcg/mL in serum 2 to 4 hours after administration. When the drug is administered daily for longer periods of time at this dose, serum levels are similar. The serum level of ethambutol hydrochloride falls to undetectable levels by 24 hours after the last dose except in some patients with abnormal renal function. The intracellular concentrations of erythrocytes reach peak values approximately twice those of plasma and maintain this ratio throughout the 24 hours. During the 24-hour period following oral administration of ethambutol hydrochloride approximately 50 percent of the initial dose is excreted unchanged in the urine, while an additional 8 to 15 percent appears in the form of metabolites. The main path of metabolism appears to be an initial oxidation of the alcohol to an aldehydic intermediate, followed by conversion to a dicarboxylic acid. From 2 Les hele dokumentet