Ebutol (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

J04AK02 (Ethambutol)

Active Substance

Ethambutol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Antitubercular agent

Pharmacological Action

Second-line antituberculosis agent. It has a bacteriostatic effect only on Mycobacterium tuberculosis, including strains resistant to streptomycin, kanamycin, isoniazid, PAS, and ethionamide.

The mechanism of action has not been precisely established. Apparently, Ethambutol, penetrating into mycobacteria, disrupts RNA synthesis. It is active only against intensively dividing bacteria. Resistance of Mycobacterium tuberculosis to ethambutol develops relatively slowly.

Pharmacokinetics

After oral administration, absorption from the gastrointestinal tract is 80%, the remainder of the dose is excreted in the feces unchanged. Food intake has little effect on absorption.

After a single dose of 25 mg/kg, the C_max of ethambutol in blood plasma is reached after 4 hours and is 5 µg/ml; after 24 hours, the concentration is less than 1 µg/ml.

Ethambutol is distributed in most tissues, including the lungs, kidneys, and red blood cells. It penetrates into the cerebrospinal fluid when the meninges are inflamed.

Ethambutol is partially metabolized in the liver to inactive aldehyde and dicarboxylic derivatives, which are excreted in the urine.

The T_1/2 is 3-4 hours. It is excreted mainly in the urine unchanged, 8-15% as inactive metabolites.

Indications

All forms of pulmonary and extrapulmonary tuberculosis (as part of combination therapy).

MAC infection.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A15	Respiratory tuberculosis, bacteriologically and histologically confirmed
A17	Tuberculosis of nervous system
A18	Tuberculosis of other organs
A31.0	Pulmonary infection due to Mycobacterium

ICD-11 code	Indication
1B10.0	Respiratory tuberculosis, bacteriologically or histologically confirmed
1B11.Z	Tuberculosis of nervous system, unspecified
1B12	Tuberculosis of other systems and organs
1B21.0	Pulmonary infection due to nontuberculous mycobacterium

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer Ebutol tablets orally once daily, with or without food. The standard daily dose is 15-25 mg/kg of body weight. For intermittent therapy, administer a dose of 50 mg/kg twice per week. Alternatively, use a dose of 25-30 mg/kg three times per week.

Calculate the exact dose based on the patient’s current body weight. Do not exceed the maximum daily dose of 2.5 grams for adults. Initiate therapy at the lower end of the dosage range for patients with a higher risk of adverse effects.

Use Ebutol only as part of a combination antituberculosis regimen. Never use it as monotherapy due to the rapid development of bacterial resistance. The total duration of treatment is determined by the treating physician based on the clinical presentation and treatment response.

Perform a baseline ophthalmological examination before starting treatment. Monitor visual acuity, color vision, and visual fields monthly during therapy and for several months after discontinuation. Immediately discontinue therapy if patients develop visual disturbances such as blurred vision, red-green color blindness, or constriction of visual fields.

Adjust the dosing frequency in patients with impaired renal function according to creatinine clearance. For patients undergoing hemodialysis, administer the dose after the dialysis session. Regularly monitor renal function and liver enzymes throughout the treatment course.

Adverse Reactions

From the central and peripheral nervous system: dizziness, depression, peripheral neuritis, retrobulbar neuritis, impaired color perception (mainly green and red), reduction in central and peripheral visual fields, occurrence of scotomas.

From the digestive system: nausea, vomiting, loss of appetite.

From the musculoskeletal system: arthritis.

Allergic reactions: skin rash.

Contraindications

Optic neuritis, cataract, diabetic retinopathy, inflammatory eye diseases, pregnancy, renal impairment, children under 13 years of age, hypersensitivity to ethambutol.

Use in Pregnancy and Lactation

Use during pregnancy is contraindicated.

Ethambutol crosses the placental barrier and is excreted in breast milk.

Experimental studies have established the teratogenic effect of ethambutol.

Use in Renal Impairment

Contraindicated in renal impairment.

Pediatric Use

Contraindicated in children under 13 years of age.

Special Precautions

At the beginning of treatment, an increase in cough and an increase in the amount of sputum are possible.

Ethambutol should be used only in combination with other antituberculosis drugs. In combination with isoniazid and rifampicin, it is highly effective in the treatment of tuberculosis.

During long-term therapy, it is necessary to regularly monitor visual functions, the picture of peripheral blood, as well as the functional state of the liver and kidneys.

Drug Interactions

With simultaneous use with aluminum hydroxide, the absorption of ethambutol from the gastrointestinal tract decreases.

There is evidence of a possible increase in optical neuropathy caused by ethambutol when used in combination with isoniazid.

Under the influence of ethambutol, a change in zinc metabolism is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer