Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ETHAMBUTOL HYDROCHLORIDE (UNII: QE4VW5FO07) (ETHAMBUTOL - UNII:8G167061QZ)
Lupin Pharmaceuticals, Inc.
ETHAMBUTOL HYDROCHLORIDE
ETHAMBUTOL HYDROCHLORIDE 100 mg
ORAL
PRESCRIPTION DRUG
Ethambutol hydrochloride is 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 plus isoniazid - Ethambutol 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 should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in-vitro studies. Antituberculous drugs used with ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized. Ethambutol hydrochloride is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgement determines that it may be used. Ethambutol hydrochloride is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
Ethambutol Hydrochloride Tablets USP, 100 mg are available as white to off-white, round, biconvex, film-coated tablets, debossed with ‘LU’ on one side and ‘C31’ on the other side. They are supplied as follows: NDC 68180-280-01 Bottles of 100’s Ethambutol Hydrochloride Tablets USP, 400 mg are available as white to off-white, round, biconvex, film-coated tablets debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘C32’ on other side. They are supplied as follows: NDC 68180-281-01 Bottles of 100’s NDC 68180-281-02 Bottles of 500’s NDC 68180-281-13 4 x 14’s unit dose blisters Store at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container defined in as the USP using a child-resistant closure.
Abbreviated New Drug Application
ETHAMBUTOL HYDROCHLORIDE- ETHAMBUTOL HYDROCHLORIDE TABLET LUPIN PHARMACEUTICALS, INC. ---------- ETHAMBUTOL HYDROCHLORIDE TABLETS USP 100 MG AND 400 MG RX ONLY DESCRIPTION Ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus _Mycobacterium_, including _M. tuberculosis. _Ethambutol hydrochloride is a white, crystalline powder, It is freely soluble in water; soluble in alcohol and in methanol. The structural formula is: C H N O •2HCl M.W. 277.23 (+)-2,2’ (Ethylenediimino)-di-1-butanol dihydrochloride Each tablet, for oral administration, contains 100 mg or 400 mg Ethambutol Hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone and talc. Film coating contains: ethyl cellulose, hypromellose, macrogol, propylene glycol, talc and titanium dioxide. 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 falls to undetectable levels by 24 hours after the last dose except in some patients with abnormal renal function. The intercellular 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 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 20 to 22 percent of the initial dose is excreted in the feces as unchanged drug. No drug accumulation has been observed with consecutive Soma hati kamili