E-BUTOL TABLET 400mg

Ethambutol

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

(+)-2,2'-(ethylenediimino)di-1-butanol | (+)-ethambutol | (+)-N,N'-bis(1-(hydroxymethyl)propyl)ethylenediamine | (+)-S,S-ethambutol | (2S,7S)-2,7-Diethyl-3,6-diazaoctane-1,8-diol | (S,S)-Ethambutol | EMB | Etambutol | Etambutolo | Ethambutol | Ethambutolum | S,S-Ethambutol | Ethambutol |

Description

An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)

Indication

For use, as an adjunct, in the treatment of pulmonary tuberculosis.

Mechanism of Action

Ethambutol inhibits arabinosyl transferases which is involved in cell wall biosynthesis. By inhibiting this enzyme, the bacterial cell wall complex production is inhibited. This leads to an increase in cell wall permeability.

Pharmacodynamics

Ethambutol is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. Ethambutol inhibits RNA synthesis and decreases tubercle bacilli replication. Nearly all strains of M. tuberculosis and M. kansasii as well as a number of strains of MAC are sensitive to ethambutol.

Pharmacokinetics

Absorption:

About 75% to 80% of an orally administered dose of ethambutol is absorbed from the gastrointestinal tract.

Distribution:

Not Available

Metabolism:

Hepatic. Up to 15% of administered drug is metabolized to inactive 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.

Elimination:

During the 24-hour period following oral administration of ethambutol hydrochloride 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. From 20 to 22 percent of the initial dose is excreted in the feces as unchanged drug.

Half-life

In patients with normal renal function, 3 to 4 hours. In patients with impaired renal function, up to 8 hours.

Clearance

Not Available

Toxicity

The most commonly recognized toxic effect of ethambutol is optic neuropathy, which generally is considered uncommon and reversible in medical literature. Other side effects that have been observed are pruritus, joint pain, gastrointestinal upset, abdominal pain, malaise, headache, dizziness, mental confusion, disorientation, and possible hallucinations.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

E-BUTOL TABLET 400mg was registered with Health Science Authority of Singapore by BEACONS PHARMACEUTICALS PTE LTD. It is marketed with the registration number of SIN00581P with effective from 1988-04-29.

This product contains 400mg of Ethambutol in the form of TABLET.

The medicine was manufactured by BEACONS PHARMACEUTICALS PTE LTD in SINGAPORE

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

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508APO-SULFATRIM PEDIATRIC TABLETSulfamethoxazole|TrimethoprimPOMPHARMAFORTE SINGAPORE PTE LTDActive
526B.S. SUSPENSIONSulfamethoxazole|TrimethoprimPOMAPEX PHARMA MARKETING PTE LTDActive
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678BANEOCIN POWDERBacitracin|NeomycinPOMNOVARTIS (SINGAPORE) PTE LTDActive