ETHAMBUTOL

StockNo	Product description
EB0280-408-08	ETHAMBUTOL TABL 250 MG X 50

 

COMPOSITION:
Ethambutol dihydrochloride 250 mg in one tablet

ACTION:
A synthetic diamine derivative with a bacteriostatic effect. Ethambutol forms chelate complexes with the bivalent metal ions (copper and zinc) participating in RNA biosynthesis or stabilization. It has a specific bacteriostatic action on the tuberculosis bacteria resistant to isoniazide and streptomycin. Resistance to the preparation has been observed only in rare cases, and there is no cross-resistance when combined with other antituberculosis drugs.

PHARMACOKINETICS:
The preparation possesses a good intestinal resorption (70-80 %), the maximum plasma level is reached after 2-3 h, decreasing by 10 % after 24 h. it is bound in about 40 % to the plasma proteins, and is excreted in the urine and feces in an unchanged form.

INDICATIONS:
Ethambutol is applied in all forms of pulmonary tuberculosis as a drug of first line in combination with other tuberculostatics. It is effective also in other forms of extrapulmonary tuberculosis, with the exception of renal and ocular tuberculosis.

CONTRAINDICATIONS:
The preparation should not be applied to patients with lesions of the optic nerve and other ocular diseases, severe renal insufficiency, hypersensitivity and pregnancy.

PRECAUTIONS:
The values of urea and residual blood and urine nitrogen should be controlled in case of prolonged application of the preparation. Administration of 10 000 IU vitamin A per day for 30 days is recommended as prophylactic treatment of the vision functions.

DOSAGE AND ADMINISTRATION:
The preparation is applied orally in a dose of 15 mg per kg body weight once a day as initial treatment. In patients with advanced form of tuberculosis, the preparation is applied in a dose of 25 mg per 1 kg body weight during the first days, combined with other antituberculosis drugs. During the next days the dose is reduced to 15 mg per 1kg body weight, preserving the dosage of the other antituberculosis preparation.

MEDICINAL FORM AND PACKAGE:
Tablets of 250 mg in packs of 50.

STORAGE:
At moderate temperature (15-30° C) in a place protected from moisture.

EXPIRY:
2 (two) years.