International generic name

Ethambutol

Drug form and composition

Tablets. One tablet contains 250 mg Ethambutol hydrochloride.

Indications

Ethambutol is indicated in patients with all forms of the pulmonary tuberculosis, in combination with rifampicin and isoniazid. It is effective in some extrapulmonary forms of tuberculosis also (except renal and ophthalmic).

Dosage and administration

Ethambutol in adults is used orally in dose 25 mg per kg body weight, once per 24 h during the first two months of the treatment, followed by 15 mg per kg body weight/24 h, combined with isoniazid and rifampicin. Estimated per kilogram body weight dose Ethambutol is administered depending on the creatine clearance as follows: in creatine clearance lower than 50 ml per a minute - at intervals greater than 24 hours; in clearance 10-50 ml per a minute - at 36 hours intervals, and in creatine clearance lower than 10 ml per a minute - at 48 hours intervals. In children older than 13 years the preparation is used in dose 15 mg per kg, once daily.

Contraindications

Hypersensitivity to the preparation; visual nerve disorders and other ocular diseases; severe renal failure; pregnancy and nursing.

Special warnings and precautions

During the treatment with Ethambutol the serum creatine level and creatine clearance should be monitored. It is advisable to administer concomitant Vitamin A therapy, in order to prevent the visual side effects.

Drug interactions

Ethambutol may be administered simultaneously with other tuberculostatics.

Adverse reactions

In about 30% of the cases Ethambutol leads to development of retrobulbar neuritis of the ophthalmic nerve, central or periaxial scotoma with visual field restriction. Usually the retina remains intact. Described side effects are seen with doses higher than 25 mg /kg body weight/ 24 hours. They become apparent 2-3 mounts after the treatment commencement and usually are reversible. Rarely allergy reactions, gastrointestinal disorders, dizziness, headache, arthralgia, and hyperuricemia may appear.

Pharmacological mechanisms

Ethambutol is an anti-tuberculosis medicine, acting by inhibition of the biosynthesis of the arabinogalactan and arabinomanan, due to inhibition of the decaprenil - R - arabinose activity. Ethanbutol possesses bacteriostatic effect both on the sensitive and resistant to the other tuberculostatics tubeculous bacteria, as well as on the photochromogene non-typical mycobacterium. It shows no activity on the fungus, viruses, and other bacteria. No cross-resistance to other anti-tuberculosis medicines is registered so far. In concomitant treatment with isoniazid Ethambutol reduces the risk of development of resistance. Its anti-microbial activity is evident on proliferating cells, because of disturbing function of the cell polyamines (spermidine and spermine). It formats also helate complexes with the bivalent ions, participating in biosynthesis and stabilization of the DNA.

Supplied

Ethambutol is an anti-tuberculosis medicine, acting by inhibition of the biosynthesis of the arabinogalactan and arabinomanan, due to inhibition of the decaprenil - R - arabinose activity. Ethanbutol possesses bacteriostatic effect both on the sensitive and resistant to the other tuberculostatics tubeculous bacteria, as well as on the photochromogene non-typical mycobacterium. It shows no activity on the fungus, viruses, and other bacteria. No cross-resistance to other anti-tuberculosis medicines is registered so far. In concomitant treatment with isoniazid Ethambutol reduces the risk of development of resistance. Its anti-microbial activity is evident on proliferating cells, because of disturbing function of the cell polyamines (spermidine and spermine). It formats also helate complexes with the bivalent ions, participating in biosynthesis and stabilization of the DNA.

Expiry

50 tablets of 250 mg.