Active substanceTerizidone + PyridoxineTerizidone + Pyridoxine
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  • Dosage form: & nbspcapsules
    Composition:

    One capsule contains:

    active substances: terizidone - 300 mg, pyridoxine hydrochloride 10 mg;

    auxiliary substances: ludipress LCE [lactose monohydrate 94.7% - 98.3%, povidone (colidon 30) 3% - 4%] - 70 mg, talc - 12 mg, magnesium stearate - 8 mg;

    hard gelatine capsules:

    titanium dioxide E 171 - 1.0%, dye sameleza oxide yellow Е 172 - 0,5%, gelatin - up to 100 %.

    Description:

    Gelatin capsules № 00, cornyellow and yellow. The contents of capsule powder from white to white with a yellowish tint of color. Conglomerates are allowed, which when pressed easily turn into powder.

    Pharmacotherapeutic group:anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.K.03   Terizidone

    A.11.H.A.02   Pyridoxine (vitamin B6)

    Pharmacodynamics:

    Terizidone

    Terizidone is a bacteriostatic antibiotic with a wide spectrum of action. Terizidone active with respect to Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, and Staphylococcus aureus and Staphylococcus epidermidis. To this preparation are also sensitive Enterococcus faecalis, Escherichia coli, Citrobacter, Enterobacter, Morganella morganii, Klebsiella pneumoniae and Pseudomonas aeruginosa. Cases of development of secondary resistance are rare. Between terizidone and others anti-tuberculosis drugs are not cross-resistant.

    Pyridoxine hydrochloride

    Vitamin product. Participates in the metabolism. It is necessary for the normal operation of the central and peripheral nervous systems. Provides

    neuroprotective action.

    Pharmacokinetics:

    Terizidone

    After oral administration, the drug is almost completely absorbed from the gastrointestinal tract (70-90%). The maximum concentration in plasma is achieved in 2-3 hours. Food intake does not affect the rate of absorption. The level of the minimum effective concentration for mycobacteria tuberculosis is 10-40 mg / l, for staphylococci 8-32 mg / l, for gram-negative bacteria having a clinical value of 20-250 mg / l. The half-life (T1 / 2) is 21 hours.

    It spreads in tissues and body fluids, lungs, bile, ascitic fluid, pleural effusion and synovial fluid, lymph and sputum.
    It penetrates well into the cerebrospinal fluid (80-100%) of the concentration in the serum, a higher concentration in the CSF is created by inflammatory changes in the meninges.

    In organism terizidone is metabolized slightly. From 60 to 70% of the drug is excreted by the kidneys unchanged; a small amount is excreted through the intestine and a small part in the form of metabolites.

    Pyridoxip hydrochloride
    After taking the drug quickly absorbed throughout the small intestine, a greater amount is absorbed in the jejunum. Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). Pyridoxalphosphate with plasma proteins binds to 90%.
    It penetrates well into all tissues; accumulates mainly in the liver, less in the muscles and central nervous system. Penetrates through the placenta, with breast milk. The half-life period (T1 / 2) is 15-20 days.
    It is excreted by the kidneys (with intravenous injection - with bile 2%), as well as during hemodialysis.

    Indications:Tuberculosis (various forms and localizations) in the complex treatment of drug-resistant forms of tuberculosis.
    Contraindications:

    - hypersensitivity, including cycloserine;

    -organic diseases of the central nervous system, including cerebrosclerosis;

    - epilepsy;

    -psychic disorders;

    - alcoholism;

    - pregnancy;

    - lactation period;

    - children's age till 14 years.

    Carefully:

    - elderly age;

    - chronic heart failure;

    - chronic renal failure.

    Pregnancy and lactation:
    Dosing and Administration:

    Inside, daily, regardless of food intake.

    For adults and children (over 14 years): with a body weight of up to 60 kg - a daily dose of 600 mg (1 capsule 2 times a day);

    with a body weight of 60 - 80 kg - a daily dose of 900 mg (1 capsule 3 times a day).

    For adults with a body weight of more than 80 kg - a daily dose of 1200 mg (2 capsules 2 times a day). The duration of the course of treatment is from 3 to 4 months.

    When creatinine clearance is less than 30 ml / min dose and the frequency of drug intake is recommended to decrease.
    Side effects:

    From the nervous system: headache, dizziness, increased excitability, tremor, insomnia and a sense of intoxication. In isolated cases - epileptimorphic convulsions, depression, psychosis.

    From the digestive system: rarely - abdominal pain, flatulence, diarrhea.

    Allergic reactions (rarely).

    Overdose:

    Symptoms: increased neurotoxicity, including epileptomorphic seizures, a violation of the function of the gastrointestinal tract.

    Treatment: symptomatic, Activated carbon, antiepileptic drugs. For the prevention of neurotoxic effects, anticonvulsant and sedative drugs are administered. Hemodialysis is effective.

    Interaction:

    Ethanol increases the risk of epileptic seizures.

    Ethionamide increases the risk of side effects from the central nervous system, especially convulsive syndrome.

    Isoniazid increases the incidence of dizziness, drowsiness.

    Special instructions:

    Terizidone can cause the development of deficiency of vitamin B12 and / or folic acid.

    In these cases, the dose of vitamin B12 and / or folic acid should be increased.

    Monthly monitoring of blood and urine tests, liver function parameters: ALT (alanine aminotransferase), ACT (aspartate aminotransferase), bilirubin concentration. The use of the drug on the background of alcohol intake is associated with an increased incidence of side effects,up to the development of seizures, so during the intake of the drug should be avoided the use of alcoholic beverages.

    It is necessary to monitor the patient's condition: health workers monitoring patients in the hospital, as well as members of the family of outpatients who receive terizidone, should be informed about the possibility of developing side reactions from the central nervous system and instructed about the need to immediately inform the attending physician if depression or changes in the behavior of the patient occur.

    Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Capsules 300 mg + 10 mg.

    Packaging:

    10 capsules per contour cellforging from a polyvinyl chloride film or polyvinyl chloride / polyvinylidene chloridealuminum foil and aluminum foilcoded.

    10 contour packs together with instructions for use put in a pack of cardboard.

    Storage conditions:

    In the dark place at a pacenot higher than 25 ° С.

    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:LSR-010230/08
    Date of registration:19.12.2008
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Information update date: & nbsp25.09.2015
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