Etambusin® (Ethambusin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceEthambutolEthambutol
Similar drugsTo uncover
  • Eckox
    pills inwards 
    McLeodz Pharmaceuticals Co., Ltd.     India
  • EMB-Fatol 400
    pills inwards 
    Rimzer Artsynaimitel, AG     Germany
  • Kombutol
    pills inwards 
    Lupine Co., Ltd.     India
  • Li-Butol
    pills inwards 
    FARMGID CJSC     Russia
  • Etambusin®
    pills inwards 
    SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products     Russia
  • Ethambutol
    pills inwards 
    Shraya Life Senses Pvt. Ltd.     India
  • Ethambutol
    pills inwards 
    FARMASINTEZ, JSC (Irkutsk)     Russia
  • Etambutol STADA
    pills inwards 
    NIZHFARM, JSC     Russia
  • Etambutol-Acry®
    pills inwards 
    AKRIKHIN HFK, JSC     Russia
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: ethambutol hydrochloride 0.2072 g / 0.4144 g (based on dry matter 0.2000 g / 0.4000 g);

    Excipients: potato starch 0.0417 g / 0.0834 g, lactose monohydrate (sugar milk) 0.0391 g / 0.0794 g, talc 0.0080 g / 0.0160 g, povidone 12.6 thousand (polyvinylpyrrolidone low molecular weight medical 12600 ± 2700) 0.0202 g / 0.0404 g, calcium stearate 0.0032 g / 0.0064 g

    Description:

    Tablets are round planar with a risk and a facet of white color.

    Pharmacotherapeutic group:anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.K.02   Ethambutol

    Pharmacodynamics:

    Etambusin® - an anti-tuberculosis preparation for ingestion, acts bacteriostatically; penetrates into actively growing mycobacterial cells, inhibiting the synthesis of ribonucleic acids (RNA),violates the cellular metabolism, causes the cessation of reproduction and the death of bacteria. It is active only for intensively dividing cells. Suppresses the growth and reproduction of mycobacterium tuberculosis, resistant to streptomycin, isoniazid, para-aminosalicylate (PASK), ethionamide, kanamycin. With monotherapy, the resistance of mycobacteria develops rapidly enough.

    Pharmacokinetics:

    Absorption is high; bioavailability - 75-80%. After oral administration of a dose of 25 mg / kg, the time to reach the maximum concentration (TcmOh) - 2-4 hours, the maximum concentration (CmOh) -1-5 mcg / 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. Half-life (T1/2 ) - 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 intestine - 10-20% (unchanged). It is excreted in hemodialysis and peritoneal dialysis.

    Indications:

    Tuberculosis (all forms) in combination therapy.

    Etambusin® is prescribed only in combination with other anti-tuberculosis drugs.

    Contraindications:

    Hypersensitivity to ethambutol, components of the drug; optic neuritis, cataract, diabetic retinopathy; deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; inflammatory eye diseases, gout, children's age (up to 13 years), chronic renal failure (CRF), pregnancy, the period of breastfeeding.

    Pregnancy and lactation:

    Contraindicated use of the drug during pregnancy and during breastfeeding.

    Dosing and Administration:

    Take inside once a day, after breakfast.

    In the initial treatment, the drug is administered at a dose of 15 mg / kg once a day. At the repeated course of treatment - 25 mg / kg once a day, for 2 months, then switch to taking the drug at a dose of 15 mg / kg once a day. It is possible to use the drug at a dose of 50 mg / kg body weight 2 times a week or 25-30 mg / kg body weight 3 times a week.

    Children over the age of 13 - 15-25 mg / kg once a day after breakfast. The highest daily dose is 1 g.

    With renal insufficiency the dose is adjusted depending on the creatinine clearance: when creatinine clearance is more than 100 ml / min, the daily dose is 20 mg / kg; 70-100 ml / min - 15 mg / kg; less than 70 ml / min - 10 mg / kg; in patients on hemodialysis, 5 mg / kg; on the day of dialysis - 7 mg / kg.

    Side effects:

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

    From the digestive system: decreased appetite, nausea, vomiting, gastralgia, impaired liver function - increased activity of "hepatic" transaminases.

    From the nervous system and sensory organs: weakness, headache, dizziness, impaired consciousness, disorientation, hallucinations, depression, peripheral neuritis (paresthesia in the extremities, numbness, paresis, pruritus), optic neuritis (decreased visual acuity, visual field limitation, impaired color perception (mainly green and red colors), color blindness, scotoma).

    Other: hyperuricemia, exacerbation of gout.

    Overdose:

    Symptoms: nausea, vomiting, hallucinations, polyneuritis.

    Treatment: symptomatic.

    Interaction:

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

    Special instructions:

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

    The drug should be used by conducting control ophthalmic studies, taking into account the possibility of visual impairment on the ground of inflammation of the optic nerve. This action depends on the dosage and duration of the treatment and can touch one eye or two.

    It should be borne in mind that side effects are reversible and disappear within a few weeks after discontinuation of treatment.

    The drug is not prescribed to children who can not carry out control studies concerning visual acuity, visual field assessment and color perception.

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

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

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, 200 mg and 400 mg.

    Packaging:

    10 tablets in contour mesh packaging, 30, 50, 100 tablets in cans of polymeric.

    Each jar, 5, 10 contour squares with instructions for use is placed in packs of cardboard.

    120 contour cell packs with an equal number of instructions for medical use are placed in carton boxes for delivery to hospitals.

    Storage conditions:

    In a dry, protected from light place, at a temperature not exceeding 20 ° ะก.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000809 / 01-2001
    Date of registration:13.04.2010
    The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp04.10.2015
    Illustrated instructions
      Instructions
      Up