Active substanceIsoniazid + Rifampicin + [Pyridoxine]Isoniazid + Rifampicin + [Pyridoxine]
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  • Protub®-2
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  • Tubavit
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    VALENTA PHARM, PAO     Russia
  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains:

    active substances:

    Rifampicin in terms of active substance - 150 mg

    Isoniazid - 100 mg

    Pyridoxine hydrochloride-10 mg;

    Excipients: microcrystalline cellulose - 308.60 mg, copovidone - 23.43 mg, silicon colloidal dioxide (aerosil) - 11.72 mg, magnesium stearate - 6.25 mg, croscarmellose sodium (impellose) - 15.00 mg;

    excipients of the shellgiprolase (hydroxypropylcellulose) 3.50 mg, copovidone 1.50 mg, Opadrai II (series 85) (partially hydrolysed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc, iron stain red oxide E 172, aluminum lacquer based on the dye sunset yellow E 110, dye crimson (Ponso 4R) E 124) - 20.00 mg.

    Description:
    round, biconcave, film-coated tablets; two layers are visible on the cross section: the shell is red-brown and the core is brownish-red with white impregnations.

    Pharmacotherapeutic group: anti-tuberculosis drug combined.
    ATX: & nbsp

    J.04.A.M.02   Isoniazid in combination with rifampicin

    Pharmacodynamics:

    Tubavit® is a combined antituberculous drug.

    Rifampicin - broad spectrum antibiotic. Inhibits the synthesis of DNA-dependent RNA polymerase. Has a high activity against mycobacteria, including Mycobacterium tuberculosis, and some gram-positive pathogens. Activity against gram-negative microorganisms is lower. It is not characterized by cross-resistance to other antibiotics and chemotherapeutic agents.

    Isoniazid - isonicotinic acid hydrazine - antituberculous agent, has increased specific activity in relation to Mycobacterium tuberculosis as in vivo, and in vitro, including strains resistant to anti-tuberculosis antibiotics.

    Pyridoxine - plays an important role in the metabolism; is necessary for the normal functioning of the central and peripheral nervous system. In the phosphorylated form pyridoxine is the coenzyme of a large number of enzymes acting on a non-oxidative exchange of amino acids. Participates in the exchange of tryptophan, methionine, cysteine, glutamic and other amino acids. It plays an important role in the exchange of histamine.Promotes the normalization of lipid metabolism.

    At reception quickly and completely enough is absorbed from a gastrointestinal tract (GIT). The maximum concentration in the plasma is reached by 2 hours and lasts up to 8 hours.

    Penetrates the fluid and body tissues.

    Rifampicin and isoniazid metabolized in the liver; excretion is carried out with bile and urine.

    Indications:Tuberculosis of the lungs and other organs; leprosy; Infectious and inflammatory diseases of the lungs and respiratory tract (bronchitis, pneumonia) caused by multiresistant staphylococci; osteomyelitis; urinary and bile duct infection; acute gonorrhea; Other diseases caused by drug-susceptible pathogens.
    Contraindications:Hypersensitivity to the components of the drug, children under 3 years (for this dosage form), pregnancy (I trimester) and lactation period, acute liver disease, jaundice, kidney disease with a decrease in excretory function.
    Carefully:Pregnancy (II-III trimesters), liver and kidney disease, diabetes mellitus, advanced age, emaciated patients.
    Pregnancy and lactation:Contraindicated in the first trimester of pregnancy and lactation (breastfeeding). If pregnancy occurs during the treatment period, the drug should be discontinued. The use of the drug in the II - III trimester of pregnancy is recommended only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
    Dosing and Administration:
    Inside. Tablets should be swallowed whole, not breaking and not chewing. The daily dose is set taking into account the patient's body weight. It is recommended to take the entire daily dose in 1 dose, on an empty stomach.

    Adults with a body weight of less than 40 kg - 3 tablets; 40-49 kg - 4 tablets; 50-64 kg - 5 tablets; 65 kg or more - 6 tablets.

    Children: 10-15 mg / kg / day (in terms of isoniazid). With a body weight of 40 kg or more, the drug is administered in the same doses as for adults.
    Side effects:

    Related to rifampicin:

    From the digestive system: nausea, vomiting, diarrhea, decreased appetite, erosive gastritis, pseudomembranous enterocolitis; increase in the level of "hepatic" transaminases in the serum, hyperbilirubinemia, hepatitis.

    From the central nervous system: headache, impaired coordination of movements, reduced visual acuity, disorientation.

    From the urinary system: nephronecrosis, interstitial nephritis.

    Allergic reactions: skin rash, itching, Quincke's edema, bronchospasm, fever, urticaria, eosinophilia.

    Other: arthralgia; rarely - leukopenia, menstrual irregularity, induction of porphyria, muscle weakness, hyperuricemia, exacerbation of gout.

    Isoniazid-related:

    From the digestive system: nausea, vomiting, constipation, a rapidly increasing activity of "liver" transaminases in the blood plasma during the first month of treatment, gastralgia, toxic hepatitis. Rarely - persistent increase in enzyme activity.

    From the central nervous system: headache, dizziness, rarely excessive fatigue or weakness, irritability, euphoria, mood changes, depression. Epileptic patients may experience seizures. When using high doses of isoniazid - peripheral neuropathy, manifested by paresthesias of the skin of the hands, feet; hyperreflexia, tremor, convulsions, toxic encephalopathy,psychosis; insomnia; neuritis and atrophy of the optic nerve.

    From the cardiovascular system: palpitation, angina, increased blood pressure.

    On the part of the hematopoiesis system: agranulocytosis, hemolytic, sideroblastic and aplastic anemia; thrombocytopenia, eosinophilia.

    From the side of the hemostasis system: acidosis.

    Allergic reactions: skin rash, itching, hyperthermia, "lupus-like" syndrome, purpura, lymphadenopathy, vasculitis, arthralgia.

    Other: very rarely - gynecomastia, menorrhagia, a tendency to bleeding and hemorrhage.

    With an irregular reception or with the resumption of treatment after a break, flu-like syndrome (fever, chills, headache, dizziness, myalgia), skin reactions, hemolytic anemia, thrombocytopenic purpura, acute renal failure are possible.

    Associated with pyridoxine:

    Allergic reactions.

    Overdose:

    Rifampicin. Symptoms: pulmonary edema, lethargy, confusion, convulsions.

    Treatment: symptomatic; gastric lavage, the appointment of activated charcoal; forced diuresis.

    Isoniazid. Symptoms: dizziness, dysarthria, lethargy, disorientation, hyperreflexia, peripheral polyneuropathy, liver dysfunction, metabolic acidosis, hyperglycemia, glucosuria, ketonuria, convulsions (1-3 hours after drug administration), coma.

    Treatment: peripheral polyneuropathy (vitamins B6, B1, B12, ATP, glutamic acid, nicotinamide, massage, physiotherapy procedures); cramps - (intramuscularly, vitamin B6 - 200-250 mg, intravenously 40% dextrose solution - 20 ml, intramuscularly 25% solution of magnesium sulfate - 10 mg, diazepam); abnormal liver function (methionine, lipid, ATP, vitamin B12).

    Interaction:Rifampicin. Reduces the activity of oral anticoagulants, oral hypoglycemic drugs, hormone contraceptives, digitalis drugs, antiarrhythmic drugs (disopyramide, pirmenol, quinidine, mexiletine, tokainid), glucocorticosteroids, dapsone, phenytoin, hexobarbital, nortriptyline, benzodiazepines, sex hormones, theophylline, chloramphenicol, ketoconazole, itraconazole, cyclosporine A, azathioprine, beta adrenoblockers,blockers of slow calcium channels, enalapril, cimetidine (rifampicin causes the induction of certain enzyme systems of the liver, accelerates metabolism). Antacids, opiates, anticholinergic drugs and ketoconazole reduce (in the case of simultaneous ingestion) bioavailability of rifampicin. Isoniazid and / or pyrazinamide increase the frequency and severity of liver function disorders to a greater extent than with the appointment of a single rifampicin, in patients with a previous liver disease. Paraaminosalicylic acid preparations containing bentonite (aluminum hydrosilicate) should be administered no earlier than 4 hours after taking the drug; absorption impairment is possible.

    Isoniazid. When combined with paracetamol, hepato- and nephrotoxicity increases; isoniazid induces a system of cytochrome P450, which increases the metabolism of paracetamol to toxic products.

    Ethanol increases the hepatotoxicity of isoniazid and speeds up its metabolism.

    Reduces the metabolism of theophylline, which can lead to an increase in its concentration in

    blood.

    Reduces metabolic transformations and increases the concentration in the blood of alfentanil. Cycloserine and disulfiram enhance the adverse central effects of isoniazid.

    Increases hepatotoxicity of rifampicin.

    Combination with pyridoxine reduces the risk of peripheral neuritis. Caution should be combined with potentially neuro-, hepato- and nephrotoxic drugs because of the risk of side effects. Enhances the effect of derivatives of coumarin and indandione, benzodiazepines, carbamazepine, theophylline, as reduces their metabolism by activating the cytochrome P450 system.

    Glucocorticosteroids accelerate metabolism in the liver and reduce active concentrations in the blood.

    It suppresses the metabolism of phenytoin, which leads to an increase in its concentration in the blood and an increase in the toxic effect (correction of the dosing regimen of phenytoin may be necessary, especially in patients with slow acetylation of isoniazid). Pyridoxine. Strengthens the action of diuretics; weakens the activity of levodopa. Isonicotin hydrazide, penicillamine, cycloserine and estrogen-containing oral contraceptives weaken the effect of pyridoxine.
    Special instructions:
    Assign as part of complex therapy, usually at the initial stage of the tuberculosis process.

    In the process of treatment, it is necessary to control the activity of "hepatic" transaminases, uric acid in the plasma.

    When there are signs of impaired liver function, it is necessary to stop taking the drug.

    After discontinuing the course of treatment, it is necessary to resume taking the drug with caution, because of the risk of developing hepato- and nephrotoxicity.

    When applying the drug, it is possible to stain saliva, sputum, urine and tear fluid in an orange-red color.

    During the treatment it is necessary to additionally prescribe vitamin D for the prevention of metabolic disorders of calcium and phosphorus.
    Effect on the ability to drive transp. cf. and fur:Given the possible occurrence of side effects from the central nervous system, care should be taken when driving vehicles or other potentially dangerous mechanisms.
    Form release / dosage:Tablets, film-coated, 100 mg + 150 mg +10 mg.
    Packaging:
    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    3 or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.
    Storage conditions:In the dark place at a temperature of no higher than 20 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.

    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000711
    Date of registration:23.07.2010
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp15.05.2016
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