Active substanceProthionamideProthionamide
Similar drugsTo uncover
  • Petya
    pills inwards 
  • Prothionamide
    pills inwards 
    ATOLL, LLC     Russia
  • Prothionamide
    pills inwards 
  • Prothionamide
    pills inwards 
    FORTYUN MED, LTD     Russia
  • Prothionamide
    pills inwards 
  • Prothionamide
    pills inwards 
    VALENTA PHARM, PAO     Russia
  • Prothionamide
    pills inwards 
  • Prothionamide
    pills inwards 
    Lupine Co., Ltd.     India
  • Protomide
    pills inwards 
  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: protionamide 250 mg;

    Excipients: acacia gum, gelatin, starch, sodium carboxymethyl starch, silicon colloidal dioxide, talc purified, magnesium stearate, hydroxypropylmethylcellulose (hypromellose);

    composition of the shell: povidone K-30, dye quinoline yellow, titanium dioxide, diethyl phthalate.
    Description:

    Yellow, round, biconvex tablets, coated with a shell, with a characteristic slight specific odor.

    Pharmacotherapeutic group:anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.D.01   Prothionamide

    Pharmacodynamics:

    Anti-tuberculosis drug II series.It acts bacteriostatically, it blocks the synthesis of mycolic acids, which are the most important structural component of the mycobacterium tuberculosis cell wall. Has the properties of a nicotinic acid antagonist. In high concentrations, it breaks the synthesis of the protein of the microbial cell and acts bactericidal.

    Effective against mycobacteria tuberculosis, resistant to drugs of the I series.

    The use in combination with other anti-tuberculosis drugs reduces the likelihood of developing tuberculosis resistance.

    Pharmacokinetics:

    Prothionamide is rapidly absorbed in the gastrointestinal tract, creating a maximum concentration of the drug in the blood plasma 2-3 hours after ingestion. Penetrates into healthy and pathologically altered tissues (tubercular foci and caverns in the lungs, serous and purulent pleural effusion, cerebrospinal fluid with meningitis). In the body it is partially converted into sulfoxide, which has tuberculostatic activity. Partially excreted unchanged (up to 15-20% of the dose) with urine and feces.

    Indications:

    Prothionamide is used to treat all forms of tuberculosis, including, with the resistance of the pathogen to other anti-tuberculosis drugs (I series) or their intolerance.

    Contraindications:Protinamide should not be used with individual hypersensitivity to the components of the drug, during pregnancy and lactation, acute gastritis, peptic ulcer and duodenal ulcer, erosive ulcerative colitis, acute hepatitis, cirrhosis, chronic alcoholism.
    Carefully:Diabetes mellitus, severe hepatic insufficiency.
    Dosing and Administration:

    Take the drug inside after eating.

    Adults appoint 0.25 g 3 times a day; with good tolerance - 0.5 g 2 times a day.

    In patients older than 60 years and with a body weight of less than 50 kg the daily dose should not exceed 0.75 g (more often prescribed 0.25 g 2 times a day).

    Children appoint at the rate of 10-20 mg / kg body weight per day.

    Side effects:

    Side effects of protionamide are manifested from the gastrointestinal tract, liver, skin, endocrine and nervous system.

    From the digestive system: loss of appetite, nausea, vomiting, diarrhea, dryness or hypersalivation, metallic taste in the mouth. After the withdrawal of the drug, these phenomena tend to quickly pass.

    Often during the treatment there is a rise in the blood level of transaminases.Rare violations of liver function with signs of hepatitis and jaundice are rare. Hepatotoxicity of the drug depends on the existing violations of the liver, such as liver damage due to alcoholism or postoperative interventions. These side effects are noted especially in combination therapy with isoniazid, rifampicin and pyrazinamide.

    Skin Reactions are rare, in some cases described pellagrope-like reactions, respectively, with a combination of skin manifestations and disorders from the central nervous system.

    Sometimes noted endocrine system disorders. Along with the development of hypoglycemia (a decrease in blood sugar of less than 50 mg%) in diabetic patients, the development of gynecomastia (an increase in mammary glands in men) is described. Rarely there is a violation of the menstrual cycle and impotence, as well as hypothyroidism (a decrease in the functions of the thyroid gland).

    From the nervous system: insomnia, agitation, depression, anxiety, rarely - dizziness, drowsiness, headache, weakness, impaired concentration, mental disorders, in single cases - paresthesia. Rarely, optic neuritis.In some cases, allergic reactions and disorders of the bone marrow are described.

    From the cardiovascular system: tachycardia, orthostatic hypotension.
    Interaction:

    When combination therapy of tuberculosis should be taken into account the additive hepatotoxic effect of certain drugs. This is especially true for the combination of a protionamide with isoniazid, rifampicin and pyrazinamide.

    Simultaneous reception with other antituberculosis drugs acting on the central nervous system, such as isoniazid or cycloserine, can lead to an increase in side effects from the central nervous system,

    In a combination with isoniazid cases of polyneuropathy are described.

    Simultaneous reception of alcohol leads to depression of the central nervous system. In certain cases, when taking protionamide, it is necessary to reduce the dose of insulin or oral antidiabetic drugs used for oral administration.

    Special instructions:

    Joint use of protinamide and alcohol should be avoided because of the danger of a state of central nervous system depression (associated with an increase in the toxic effect of alcohol).

    With the combined use of a protionamide with isoniazid and cycloserine, special attention should be paid to the possibility of mental disorders.

    Because the drug is constantly used in combination with other antituberculous drugs, regular monitoring of serum tranasmases, gamma-glutamate transferase and alkaline phosphatase is necessary. In patients with diabetes, blood glucose levels need to be monitored at least once a month.

    Cutaneous and especially mucosal reactions may be the first signs of pellagruide-like side effects. This should be regarded as the reason for the necessary withdrawal of the drug.

    Form release / dosage:

    Tablets, film-coated, 250 mg.

    Packaging:

    10 tablets in a strip of aluminum foil.

    5 or 10 strips with instructions for use are placed in a cardboard pack.

    When packaged in a Russian company (ZAO "Rafarma") 5 or 10 strips with instructions for use are placed in a cardboard pack.

    Storage conditions:

    In 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:П N012173 / 01
    Date of registration:11.02.2008
    The owner of the registration certificate:McLeodz Pharmaceuticals Co., Ltd. McLeodz Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspAdvansd Trading, OOOAdvansd Trading, OOO
    Information update date: & nbsp09.09.2015
    Illustrated instructions
      Instructions
      Up