Medicinal Products

DEXAMBUTOL INH 400 mg / 150 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Ethambutol, Isoniazid
laboratory: Serb

Coated tablet
Box of 50
All forms

Indication

- Curative treatment of active pulmonary or extrapulmonary tuberculosis.
- Treatment of primary symptomatic tuberculosis infection.
- Treatment of sensitive atypical mycobacterial infections (sensitivity determined by the MIC). The treatment of atypical mycobacterial infections is based on a combination of active antibiotics.

Dosage DEXAMBUTOL INH 400 mg / 150 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:
Isoniazid: the usual dosage in the absence of the dosage of its blood level is:
- Adult: 4 to 5 mg / kg / day.
- Child: 10 mg / kg / day
Ethambutol: 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.
- Inadequate renal:
. creatinine clearance> 100 ml / min: 15 to 20 mg / kg / day of ethambutol;
. creatinine clearance between 70 and 100 ml / min: 15 mg / kg / day of ethambutol;
. creatinine clearance <70 ml / min: 10 mg / kg / day ethambutol;
. under hemodialysis: 5 mg / kg / day of ethambutol;
. the day of dialysis: 7 mg / kg / day of ethambutol.
In this case, it is desirable to adjust the dosage after serum assay of the product.
The combination of isoniazid and ethambutol will account for renal failure, stage of treatment, and serum isoniazid at the third hour.
This medication will be given orally in a single daily dose.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in case:
- known hypersensitivity to ethambutol and isoniazid,
- optic neuritis,
- severe hepatic insufficiency.
NOT RECOMMENDED :
This drug is not recommended:
- during lactation: isoniazid and ethambutol are weakly bound to plasma proteins and the passage into breast milk is demonstrated, with concentrations equivalent to maternal plasma concentrations. Since there is a potential risk of acetylation failure in the neonate and given the neurotoxicity and hepatotoxicity of isoniazid, breastfeeding is not recommended.
- and in combination with carbamazepine and disulfiram.

Dexambutol Inh side effects

From ethambutol :
- 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 cutaneous rashes, hyperuricemia, leucopenia.
Due to isoniazid :
- Nausea, vomiting, epigastric pain.
- Fever, myalgia, arthralgia or anorexia.
- Many toxic effects are related to hypersensitivity and / or high doses (greater than 10 mg / kg).
- Hepatotoxicity: relatively frequent elevation of transaminases. Rare acute hepatitis (with or without jaundice), some of which may be severe.
Hepatotoxicity is increased by combination with rifampicin by an enzyme induction mechanism.
Other enzyme inducers may have the same effect (barbiturates).
- Neurotoxicity: it seems due to the active ingredient itself due to pyridoxine deficiency:
. Peripheral neuropathy, reported by distal paresthesia, which occurs mainly in slow acetylators, malnutrition and ethyl alcohol;
. psychic disorders with neuropsychic excitation type: hyperactivity, euphoria, insomnia;
. Optic convulsions, neuritis and atrophy have been reported;
. in predisposed terrain, and particularly when combined with ethionamide, manic attacks, acute delusions or depressions have been noted;
- Hypersensitivity reactions: fever, rash, acne, jaundice or hepatic, lymphadenitis, eosinophilia, blood dyscrasia.
- Other: rheumatoid syndrome, algodystrophy (shoulder-hand syndrome), lupus syndrome.

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