Etambutol STADA - instructions for use, dose, side effects, contraindications

Excipients: potato starch, microcrystalline cellulose, povidone (polyvinylpyrrolidone low molecular weight medical), gelatin, talc, silicon dioxide colloid (aerosil), stearic acid.

Description:

Tablets are white or white with a creamy shade of color flat-cylindrical with a facet and a risk.

Pharmacotherapeutic group:anti-tuberculosis drug

ATX: & nbsp

J.04.A.K.02 Ethambutol

Pharmacodynamics:

Etambutol is a chemotherapeutic agent with a bacteriostatic effect on typical and atypical mycobacteria tuberculosis.Penetrates into actively growing cells of mycobacteria, inhibiting the synthesis of RNA, disrupts cellular metabolism, causes the cessation of reproduction and the death of bacteria. It is active only for intensively dividing cells. Affects intracellular and extracellular kinds bacteria. Suppresses the growth and reproduction of mycobacterium tuberculosis, resistant to streptomycin, isoniazid, PASK, ethionamide, kanamycin.

With monotherapy, the resistance of mycobacteria develops rapidly enough. Primary resistance to the drug has about 1% of patients.

Pharmacokinetics:

Etambutol is rapidly absorbed from the digestive tract. The minimum inhibitory concentration is 1 mg / ml. After oral administration of a single dose of 25 mg / kg of body weight after 2-4 hours, the maximum serum concentration is 2-5 μg / ml, after 24 hours the concentration is less than 1 μg / ml.

Connection with blood plasma proteins - 20-30%. It penetrates well into tissues and organs, as well as biological fluids, with the exception of ascitic and pleural (in cerebrospinal fluid only with meningitis). Do not pass through the intact blood-brain barrier. Ethambutol is well absorbed in lung tissue and can reach a concentration 5-9 times higher than in serum. Intracellular concentration in erythrocytes is twice as high as in serum.

The greatest concentrations are created in the kidneys, lungs, saliva, urine. Penetrates into breast milk. Penetrates through the placenta. In fetal blood, the concentration of ethambutol is approximately 30% of the concentration of the drug in the mother's blood.

Partially metabolized in the liver with the formation of inactive metabolites. The half-life is 3-4 hours, with renal insufficiency extended to 8 hours. It is excreted by the kidneys - 80-90% (more than 50% - unchanged, 8-15% - in the form of inactive metabolites) and with mildew (unchanged). It is excreted in hemodialysis and peritoneal dialysis.

Indications:

Tuberculosis (all forms).

Contraindications:

- Pincreased sensitivity to the drug;

- inflammation of the optic nerve;

- cataract;

- diabetic retinopathy;

- inflammatory diseases of the eyes;

- chronic renal failure;

- gout;

- pregnancy;

- lactation period;

- children's age (up to 13 years).

Dosing and Administration:

Inside.

When conducting initial treatment in adults - 15 mg / kg of body weight once a day. In the course of a repeated course of treatment, 25 mg / kg of body weight once a day for 2 months, then 15 mg / kg once a day.

The dose can be increased to 30 mg / kg of body weight per day (but not more than 2.0 g) during the initial treatment period, with relapse of the disease, with the resistance of Koch sticks to other anti-tuberculosis drugs.

Children from the age of 13 prescribe from the calculation of 15-25 mg / kg body weight (but not more than 1.0 g) once, after breakfast. The full course of treatment lasts 9 months.

With renal failure, the dose is adjusted depending on the creatinine clearance:

Creatinine clearance (ml / min)	Daily dose
Over 100	20 mg / kg bw / day
70-100	15 mg / kg bw / day
below 70	10 mg / kg bw / day
in hemodialysis	5 mg / kg bw / day
on dialysis day	7 mg / kg bw / day

In patients who have previously taken drugs with tuberculostatic action, the resistance of bacteria develops more often. In such cases ethambutol should be taken with at least one or two antituberculosis drugs that the patient had not previously taken and for which no bacterial resistance was noted.

In complex therapy with ethambutol, isoniazid, para-aminosalicylic acid (PASC), streptomycin, cycloserine, pyrazinamide and ethionamide.

Side effects:

From the nervous system and sensory organs: weakness, headache, dizziness, confusion, orientation disorder, hallucinations, depression, convulsions; peripheral neuritis (paresthesia in the limbs, numbness, paresis, itching); inflammation of the optic nerve, one-sided or bilateral (decreased visual acuity, color disturbance, mostly green and red, color blindness, central or peripheral scotoma, visual field limitation). The occurrence of visual impairments depends on the duration of treatment and the existing diseases of the eyeball. If they occur, ethambutol treatment should be discontinued. The vision changes are usually reversible, after the cessation of treatment disappear after a few weeks in some cases - several months. In exceptional cases, changes in the eyeball are irreversible due to atrophy of the optic nerve.

Allergic reactions: skin rash, itching, joint pain, fever, leukopenia, anaphylaxis.

From the digestive system: decreased appetite, nausea, vomiting, metallic taste in the mouth, abdominal pain, impaired liver function - increased activity of "liver" transaminases;

Other: an increase in the level of uric acid in the serum, the phenomenon of urate diathesis, exacerbation of gout.

Overdose:

Symptoms: nausea, vomiting, gullycognition, polyneuritis.

Treatment: symptomatic.

Interaction:

Strengthens the effects of anti-tuberculosis drugs, the neurotoxicity of ciprofloxacin, aminoglycosides, asparaginase, carbamazepine, lithium salts, imipenem, methotrexate, quinine.

Aluminum hydroxide reduces the absorption of ethambutol from the digestive tract.

It alters the metabolism of certain trace elements, mainly zinc.

Special instructions:

Assign only in combination with other anti-TB drugs.

At the beginning of treatment, it is possible to increase cough, increase the amount of sputum.

When performing long-term therapy, it is necessary to regularly monitor the general blood test, the function of the eye organ (examination of the fundus, visual fields, visual acuity and color perception), the functional state of the liver, kidneys.

Effect on the ability to drive transp. cf. and fur:

Because of the possibility of visual impairment (reduced visual acuity, visual field limitation, color perception in relation to green and red) during ethambutol treatment, one should refrain from driving a car and servicing moving mechanical equipment.

Form release / dosage:Tablets, 400 mg.

Packaging:

For 10 tablets in a planar cell package.

For 100 tablets in a polymer bank.

Bank or 10 contour mesh packages together with instructions for use in a cardboard bundle.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N001508 / 01

Date of registration:13.08.2008

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

MAKIZ-PHARMA, LLC Russia

SKOPINSKY FARM ZAVOD, ZAO Russia

Representation: & nbspMAKIZ-PHARMA, LLCMAKIZ-PHARMA, LLCRussia

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Etambutol STADA (Ethambutol STADA)