Medicinal Products

DEXAMBUTOL 500 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Ethambutol
laboratory: Serp

Coated tablet
Box of 50
All forms

Indication

- Curative treatment of active pulmonary or extrapulmonary tuberculosis.
- Treatment of primary symptomatic tuberculosis infection.
- Chemoprophylaxis: ethambutol may be used for chemoprophylaxis in case of contraindication to the use of antituberculous agents recognized in this indication.
In this case, ethambutol should always be used in combination with a major anti-tuberculosis drug.
- Treatment of sensitive atypical mycobacterial infections (sensitivity determined by the MIC). This treatment is based on a combination of active antibiotics.

Dosage DEXAMBUTOL 500 mg Film-coated tablet Box of 50

General rules for the treatment of tuberculosis.
The curative treatment of tuberculosis must respect the following main rules:
- a well-conducted and well-monitored treatment is, with the lasting negation of bacteriological examinations, the essential criterion of cure.
- the treatment should be administered only after bacteriological evidence of tuberculosis.
The bacteriological examination systematically includes the direct examination, the cultivation and the antibiogram.
However, if there is urgency or if the lesions are typical and the bacilloscopy negative despite its repetition, the treatment can be instituted and will be reconsidered when the culture is available.
- Effective treatment must:
. combine 3 antituberculous drugs (first-line treatment) with the results of the antibiogram and for at least two months to avoid the emergence of resistance, then two anti-tuberculosis drugs (maintenance treatment).
. Combine 4 antituberculosis drugs if there is a history of treated TB or relapse.
. the attack phase can be continued up to 3 months if the result of the antibiogram is not available.
. use the most active anti-tuberculosis drugs (bactericidal at effective doses, but adapted to prevent overdose).
. be administered in a single daily dose, continuously and for at least 6 months in the case of an initial three-or-four-month treatment including at least rifampicin and pyrazinamide; 9 months in case of initial triple therapy of two months not including these two antibiotics.
Dosage:
The usual dose is:
- Adult: 15 to 20 mg / kg / day.
It can be increased to 25 mg / kg / day:
. in case of relapse,
. in case of resistance of Koch's bacillus to other antibiotics.
This dose should only be prescribed for a short period (less than or equal to 2 months) depending on the indications and requires increased monitoring of the patient (see precautions for use).
- Child: 25 to 30 mg / kg / day.
- Infant: we can recalculate the dose according to the body surface, knowing that the average adult dose of 1.73 m² is 1200 mg / day, which corresponds for an infant weighing less than 10 kg, to 40 mg / kg / day.
The tablets will be crushed and mixed with food or a drink.
- Inadequate renal:
. creatinine clearance> 100 ml / min: 15 to 20 mg / kg / day;
. creatinine clearance between 70 and 100 ml / min: 15 mg / kg / day;
. creatinine clearance <70 ml / min: 10 mg / kg / day;
. under hemodialysis: 5 mg / kg / day;
. the day of dialysis: 7 mg / kg / day.
In this case, it is desirable to adjust the dosage after serum assay of the product.
This medication will be given orally in a single daily dose.

ANSM alert of 08/04/2013:

The CHMP recommended that the following antituberculosis regimens be used in children from the age of 3 months, in accordance with the doses recommended by the WHO:

Active substances

Recommended doses * for children from the age of 3 months (based on the body weight of the child)

Ethambutol (EMB)

20 (15-25) mg / kg

* The highest doses are recommended for the treatment of severe forms of the disease

These dosages may, however, be adjusted on a case-by-case basis within the specialized services taking into account the factors influencing the pharmacokinetics of the drugs (nutritional status, enzymatic maturity, age, etc.).

It should be noted that in view of the insufficiency of the data, it was not possible to issue dosing recommendations in children less than 3 months of age, nor to propose specific dosing regimens for rifabutin.

Against indications

This drug is contraindicated in case of: - known hypersensitivity to ethambutol,
- of optic neuritis.

Dexambutol side effects

- Rarely : ocular disorders with axial or peraxial optic neuritis type, with reduced visual acuity, central scotoma and dyschromatopsia for green and red.
- Exceptionally : various digestive disorders, anorexia, allergic skin rashes, hyperuricemia, leucopenia.

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