ETHAMBUTOL HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ETHAMBUTOL HYDROCHLORIDE (UNII: QE4VW5FO07) (ETHAMBUTOL - UNII:8G167061QZ)

Beschikbaar vanaf:

Teva Pharmaceuticals USA, Inc.

INN (Algemene Internationale Benaming):

ETHAMBUTOL HYDROCHLORIDE

Samenstelling:

ETHAMBUTOL HYDROCHLORIDE 400 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ETHAMBUTOL HYDROCHLORIDE- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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