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ETHAMBUTOL

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame. 


To promote this objective, not only we distribute and market our Anti-Tuberculosis range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Ethambutol tablet which contains Ethambutol hydrochloride B.P. 400 mg

ETHAMBUTOL

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Details

COMPOSITION:

Each film coated tablet contains:

Ethambutol Hydrochloride BP         400 mg

Excipients                                         q.s.

Colour: Titanium Dioxide

CHEMISTRY: (2S, 2ˊS)-2, 2ˊ-(Ethylenediimino)dibutan-1-ol dihydrochloride.

CATEGORY: Antituberculous agent.

PHARMACOLOGY

PHARMACODYNAMICS:

Ethambutol Hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis.

Ethambutol Hydrochloride diffuses into actively growing mycobacterium cells such as tubercle bacilli. Ethambutol Hydrochloride appears to inhibit the synthesis of one or more metabolites, thus causing impairment of cell metabolism, arrest of multiplication and cell death.

PHARMACOKINETICS:

 

Ethambutol Hydrochloride, following a single oral dose of 25 mg/kg of body weight, attains a peak of 2 to 5 micrograms/mL in serum 2 to 4 hours after administration.

During the 24-hour period following oral administration of Ethambutol 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.

 

INDICATIONS:

Ethambutol tablets are 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.

DOSAGE AND ADMINISTRATION:

Ethambutol tablets should not be used alone in initial treatment or in retreatment.

Ethambutol tablets should be administered on a once every 24-hour basis only.

Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

 

Initial Treatment: In patients, who have not received previous antituberculous therapy, administer Ethambutol tablets 15 mg/kg (7 mg/ lb) of body weight, as a single oral dose once every 24 hours.

 

Retreatment:

In patients who have received previous antituberculous therapy, administer Ethambutol tablets 25 mg/kg (11 mg/lb) of body weight as a single oral dose once every 24 hours.

Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in-vitro tests.

Suitable drugs usually consist of those not previously used in the treatment of the patient.

After 60 days of Ethambutol tablets administration, decrease the dose to 15 mg/kg (7mg/ lb) of body weight and administer as a single oral dose once every 24 hours.

 

During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised. 

CONTRAINDICATIONS:

Ethambutol tablets are 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 tablets are contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).

 

WARNINGS AND PRECAUTIONS:

 

Ethambutol tablets may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported.

Liver toxicities including fatalities have been reported.

 

PRECAUTIONS:

Patients with decreased renal function need the dosage reduced as determined by serum levels of Ethambutol tablets, since the main path of excretion of this drug is by the kidneys.

Because this drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination.

As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.

 

INTERACTIONS:

It is recommended to avoid concurrent administration of Ethambutol tablets with aluminum hydroxide containing antacids for at least 4 hours following Ethambutol administration.

PREGNANCY AND LACTATION:

 

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Ethambutol tablets should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Nursing Mothers:

Ethambutol hydrochloride is excreted into breast milk. The use of Ethambutol tablets should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.

Pediatric Use:

Ethambutol tablets is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.

Geriatric Use:

There are limited data on the use of Ethambutol tablets in the elderly.

Effect to Drive & Use the Machine:

Ethambutol tablets may cause visual disturbances that can impair the ability to drive and to use machines.

 

ADVERSE DRUG REACTIONS:

Ethambutol tablets may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with Ethambutol therapy may be characterized by one or more of the following events: decreased visual acuity, scotoma, color blindness and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis.

Patients should be advised to report promptly to their physician any change of visual acuity.

OVERDOSAGE:

No specific antidote, but gastric lavage should be employed if necessary.

PRESENTATION: Blister of 10 tablets

STORAGE: Store in a cool and dry place. Protect from light.  

 
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