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:

STI Pharma LLC

INN (International Name):

Ethambutol Hydrochloride

Composition:

Ethambutol Hydrochloride 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ETHAMBUTOL HCl 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: ETHAMBUTOL HCl plus isoniazidETHAMBUTOL HCl 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 HCl 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 HCl 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 HCl 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 judgment determines that it may be used. ETHAMBUTOL HCl is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).

Product summary:

Ethambutol hydrochloride Tablets USP 100 mg – round, convex, white, film coated tablets engraved E6 on one side are supplied as follows: NDC 54879-001-01 - Bottle of 100 400 mg – round, convex, white, scored, film coated tablets engraved with E to the left and 7 to the right of the score on one side are supplied as follows: NDC 54879-002-01 - Bottle of 100 Store at controlled room temperature 20 ° to 25 ° C (68 ° to 77 ° F). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured For & Distributed by: STI Pharma LLC. Newtown, PA 18940 Revised 07/2017 Code No.:GUJ/DRUGS/G-1500

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ETHAMBUTOL HYDROCHLORIDE- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM
COATED
STI PHARMA LLC
----------
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_. The structural formula is:
ETHAMBUTOL HYDROCHLORIDE (HCL) 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
ETHAMBUTOL HCL, 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 HCL 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
HCl
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.
ETHAMBUTOL HCl diffuses into actively growing _Mycobacterium_ cells
such as tubercle
bacilli. ETHAMBUTOL HCl appears to inhibit the synthesis of