Active substanceEthambutolEthambutol
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: ethambutol hydrochloride in terms of 100% substance 400 mg;

    Excipients: calcium hydrogen phosphate dihydrate 104.5 mg, povidone 16 mg, potato starch 18.5 mg, sodium carboxymethyl starch 5.5 mg, magnesium stearate 5.5 mg.

    Description:

    Tablets from white to white with a creamy or grayish hue 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 bacterial species. Suppresses the growth and reproduction of Mycobacterium tuberculosis, resistant to streptomycin, isoniazid, PASKaminosalicylic acid), ethionamide, kanamycin

    Pharmacokinetics:

    Absorption is high; bioavailability is 75-80%. After taking a dose of 25 mg, the maximum concentration is reached in 2-4 hours, the maximum concentration of ethambutol in the plasma is 1-5 μg / ml. Connection with plasma proteins - 20-30%.

    It penetrates well into tissues and organs, as well as into biological fluids, with the exception of ascitic and pleural (in cerebrospinal fluid only with meningitis). The greatest concentrations are created in the kidneys, lungs, saliva, urine. Penetrates into breast milk. Do not pass through the intact blood-brain barrier. Partially metabolized in the liver (15%) with the formation of inactive metabolites.

    The half-life period is 3-4 hours, with renal dysfunction 8 hours.It is excreted by the kidneys - 80-90% (50% - unchanged, 15% - in the form of inactive metabolites) and with fecal masses - 10-20% (unchanged). It is excreted in hemodialysis and peritoneal dialysis.

    Indications:

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

    Contraindications:

    - Hypersensitivity to the drug;

    - Inflammation of the optic nerve;

    - cataract;

    - diabetic retinopathy;

    - Inflammatory eye diseases;

    - severe renal insufficiency;

    - gout;

    - Pregnancy;

    - lactation period;

    - Children under 13 years.

    Dosing and Administration:

    Inside, after eating, squeezed with enough liquid.

    Adults (initial treatment period): single dose - 15 mg / kg of body weight / day; continuous treatment: usually 20 mg / kg body weight / day.

    In a repeated course of treatment in adults, 25 mg / kg 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 appoint at the rate 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 kidney diseases dosage of the drug is adjusted depending on the creatinine clearance.

    When creatinine clearance is more than 100 ml / min, the daily dose is 20 mg / kg body weight / day, 70-100 ml / min - 15 mg / kg, less than 70 ml / min - 10 mg / kg, hemodialysis 5 mg / kg , on the day of dialysis-7 mg / kg.

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

    Side effects:

    From the nervous system: weakness, headache, dizziness, confusion, orientation disorder, hallucinations, convulsions, depression, peripheral neuritis (paresthesia in the limbs, numbness, paresis, itching).

    From the sense organs: retrobulbar inflammation of the optic nerve, one-sided or bilateral (weakening of visual acuity, violation of color perception, mainly green and red colors, color blindness, presence of central or peripheral scotoma, visual field limitation).

    From the gastrointestinal tract: "metallic" taste in the mouth, nausea, vomiting, abdominal pain, lack of appetite, increased activity of "liver" transaminases.

    Allergic reactions: dermatitis, skin rash, itching, arthralgia, fever, anaphylaxis.

    Other: hyperuricemia, exacerbation of gout.
    Overdose:

    Symptoms: nausea, vomiting, hallucinations, polyneuritis.

    Treatment: symptomatic.

    Interaction:

    Strengthens the effects of anti-tuberculosis drugs, the neurotoxicity of ciprofloxacin, aminoglycosides, asparaginase, carbamazepine, lithium salts, imipenem, methotrexate, quinine. It alters the metabolism of certain trace elements, mainly zinc.

    Aluminum hydroxide reduces absorption from the digestive tract.

    Special instructions:

    It is prescribed only in combination with other anti-TB drugs.

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

    In patients with renal failure, the dose of the drug should be reduced because of the accumulation of ethambutol in the body.

    Before the start of treatment, an ophthalmic examination should be carried out: examination of the fundus, visual fields, visual acuity and color perception.

    It is necessary to monitor the function of the liver and kidneys every month, the function of the organ of vision, the picture of peripheral blood.

    Effect on the ability to drive transp. cf. and fur:During the period of treatment, one should refrain from driving vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Tablets, 400 mg.
    Packaging:

    For 10 tablets in a planar cell package.

    10 contour mesh packages together with instructions for use in a pack of cardboard.

    For 500 or 1000 tablets in a bag of polyethylene film.

    A polyethylene bag together with instructions for use in a container made of polypropylene (polyethylene) (for hospital).

    Storage conditions:

    In a dry, protected from light 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 expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000043 / 01
    Date of registration:19.01.2012
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp04.10.2015
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