Ethambutol Hydrochloride

Trade Names:
Myambutol
- Tablets 100 mg
- Tablets 400 mg

Pharmacology

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Inhibits synthesis of 1 or more metabolites, causing impairment of cell metabolism, arrest of multiplication, and cell death.

Pharmacokinetics

Absorption

The T _max is reached in 2 to 4 h.

Metabolism

Primarily metabolized in the liver to a dicarboxylic acid derivative.

Elimination

Approximately 50% excreted unchanged in the urine; 8% to 15% excreted as metabolites; 20% to 22% excreted unchanged in the feces.

Indications and Usage

Treatment of pulmonary tuberculosis in combination with 1 or more other antituberculous agents.

Contraindications

Patients with known optic neuritis; hypersensitivity to any component of the product.

Dosage and Administration

PO In patients not previously treated with antituberculous therapy, administer 15 mg/kg as a single dose every 24 h. In patients who have received previous antituberculous treatment, administer 25 mg/kg as a single dose every 24 h.

General Advice

Administer without regard to meals. Administer with food if GI upset occurs.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

The absorption of ethambutol may be delayed or reduced; separate the administration times by several hours.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Malaise; headache; dizziness; mental confusion; disorientation; possible hallucinations; numbness and tingling of extremities.

EENT

Decreased visual acuity.

GI

Anorexia; nausea; vomiting; GI upset; abdominal pain.

Hematologic

Eosinophilia.

Hepatic

Transient liver function impairment.

Metabolic

Elevated serum uric acid; precipitation of acute gout.

Respiratory

Pulmonary infiltrates.

Miscellaneous

Hypersensitivity (including anaphylactoid reactions; dermatitis; pruritus); fever; joint pain.

Precautions

Pregnancy

Category B .

Children

Safety and efficacy not established in children younger than 13 yr of age.

Renal Function

Reduced dosage is necessary.

Visual effects

Unilateral or bilateral changes in visual acuity may occur. Evaluation of changes is more difficult in patients with visual defects such as cataracts, diabetic retinopathy, or optic neuritis. Ensure that ophthalmoscopy, finger perimetry, and color discrimination are evaluated prior to and periodically during therapy.

Patient Information

• Review dosing schedule and prescribed length of therapy with patient.
• Emphasize to patient that treatment will be lengthy and that the entire course of treatment must be completed to avoid relapse or development of resistance.
• Advise patient to take each dose without regard to meals, but to take with food if GI upset occurs.
• Instruct patient to immediately report the following to health care provider: change in vision, visual abnormalities.

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