MYAMBUTOL- ethambutol hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MYAMBUTOL 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, ie, initial treatment, the most frequently used regimens have been the following: MYAMBUTOL plus isoniazid MYAMBUTOL 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, MYAMBUTOL 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 MYAMBU

Product summary:

MYAMBUTOL® (Ethambutol Hydrochloride) Tablets USP 400 mg – round, convex, white, scored, film coated tablets engraved with M to the left and 7 to the right of the score on one side are supplied as follows: NDC: 70518-2691-00 30 in 1 BLISTER PACK Store at controlled room temperature 20° to 25°C (68° to 77°F). Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application

Summary of Product characteristics

MYAMBUTOL- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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MYAMBUTOL
DESCRIPTION
MYAMBUTOL ethambutol hydrochloride is an oral chemotherapeutic agent
which is
specifically effective against actively growing microorganisms of the
genus
_Mycobacterium_, including _M. tuberculosis._ The structural formula
is:
MYAMBUTOL 100 and 400 mg tablets contain the following inactive
ingredients: Gelatin,
Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl
Sulfate, Sorbitol,
Stearic Acid, Sucrose, Titanium Dioxide and other ingredients.
CLINICAL PHARMACOLOGY
MYAMBUTOL, following a single oral dose of 25 mg/kg of body weight,
attains a peak of
2 to 5 mg/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
MYAMBUTOL 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 MYAMBUTOL
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
accumulation has been demonstrated in patients with renal
insufficiency.
MYAMBUTOL diffuses into actively growing _mycobacterium_ cells such as
tubercle bacilli.
MYAMBUTOL appears to inhibit the synthesis of one or more metabolites,
thus causing
impairment of cell metabolism, arrest of multiplication, and cel