ETHAMBUTOL HYDROCHLORIDE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Department of State Health Services, Pharmacy Branch

INN (International ime):

ETHAMBUTOL HYDROCHLORIDE

Sastav:

ETHAMBUTOL HYDROCHLORIDE 400 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

ETHAMBUTOL HCI 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 HCI plus isoniazid - ETHAMBUTOL HCI 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 HCI 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 w

Proizvod sažetak:

ETHAMBUTOL HYDROCHLORIDE TABLETS USP 100 mg – round, convex, white, film coated tablets engraved E6 on one side are supplied as follows: NDC 54879-001-00 - Carton of 10x10 Blister sheets & 54879-001-01 - Bottle of 100's 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 54879-002-00 - Carton of 10x10 Blister sheets & 54879-002-01 - Bottle of 100's 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. Langhorne, PA 19047 Iss. 08/12

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

ETHAMBUTOL HYDROCHLORIDE- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
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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 (HCI) 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 HCI, 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 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 HCI 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 diffuses into actively growing _Mycobacterium_ cells such
as tubercle bacilli.
ETHAMBUTOL appears