ETHAMBUTOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

ETHAMBUTOL HYDROCHLORIDE

Composition:

ETHAMBUTOL HYDROCHLORIDE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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: Unit dose packages of 100 (10 x 10) NDC 68084-280-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETHAMBUTOL HYDROCHLORIDE- ETHAMBUTOL HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
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ETHAMBUTOL HYDROCHLORIDE TABLETS USP
RX ONLY
8228001/0222F
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:
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 single daily
doses of 25 mg/kg in patients with normal kidney function, although
marked
accu