Active substanceIsoniazid + Rifampicin + [Pyridoxine]Isoniazid + Rifampicin + [Pyridoxine]
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    VALENTA PHARM, PAO     Russia
  • Dosage form: & nbspcoated tablets
    Composition:
    Each tablet coated with a coating contains: Active substances:

    Rifampicin 150 mg

    Isoniazid 100 mg

    Pyridoxine hydrochloride 10 mg

    Auxiliary substances: Tablet core: Corn starch, silicon dioxide colloid, microcrystalline cellulose, talc, sodium carboxymethyl starch, sodium lauryl sulfate, stearic acid, magnesium stearate, purified water,

    Film shell: Acetone, cellacephate, polyethylene glycol, isopropyl alcohol, methylene chloride, hypromellose, iron III red oxide, titanium dioxide, liquid light paraffin, sodium lauryl sulfate.
    Description:Round, biconvex tablets, covered with a film membrane of dark brown color, without the line of division. On the fracture core of the tablet is dark brown with white impregnations.
    Pharmacotherapeutic group:Anti-tuberculosis drug combined
    ATX: & nbsp

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

    Pharmacodynamics:
    Rifacombe contains a combination of two antituberculous drugs andvitamin B6. 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 - has increased specific activity against Mycobacterium tuberculosis both in vivo and in vitro, including strains resistant to anti-tuberculosis antibiotics.

    Vitiman B6 (pyridoxine) - plays an important role in the metabolism; is necessary for the normal functioning of the central and peripheral nervous system. In the phosphorylene form pyridoxine is a coenzyme of a large number of enzymes acting on a non-oxidative exchange of amino acids. It plays an important role in the exchange of histamine. Promotes the normalization of lipid metabolism.

    At reception quickly and completely enough are absorbed from the digestive tract. 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; lepra, infectious and inflammatory diseases of the lungs and respiratory tract (bronchitis, pneumonia) caused by multidrug-resistant staphylococci, with osteomilitis, infections of the urine and biliary tract, acute gonorrhea, and other diseases that are susceptible to the drug pathogens.
    Contraindications:Individual intolerance to the drug. Children's age (up to 2 years), pregnancy and lactation period, jaundice, kidney disease with a decrease in excretory function, acute liver disease, hypersensitivity to the drug.
    Carefully:
    liver disease, diabetes mellitus, advanced age, and malnourished patients.

    Dosing and Administration:
    Inside. Adults: The daily dose is set taking into account the patient's body weight. 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.

    It is recommended to take the entire daily dose in 1 reception on an empty stomach.
    Side effects:

    associated with rifampicin.

    From the digestive system: nausea, vomiting, diarrhea, increased levels of "liver" transaminases, hyperbilirubinemia, decreased appetite, erosive gastritis, pseudomembrane enterocolitis, hepatitis.

    From the side of the central nervous system and sensory organs: headache, impaired coordination of movements, visual impairment, disorientation.

    From the urinary system: interstitial nephritis.

    Allergic reactions: skin rash, itching, swelling of the Quincke, bronchospasm; fever,

    urticaria, eosinophilia.

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

    associated with isoniazid.

    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. Rare persistent increase in enzyme activity is rare.

    From the side of the central nervous system: headache, dizziness, rarely - unusual fatigue or weakness, irritability, euphoria, mood changes, depression. Epileptic patients may experience seizures.When using high doses of isoniazid - peripheral neuropathy, manifested paresthesia of the skin of the hands; hyperreflexia, tremor, convulsions, toxic encephalopathy, toxic 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: "lupus-like" syndrome, skin rash, purpura, lymphadenopathy, vasculitis, itching, hyperthermia, arthralgia.

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

    associated with vitamin B6.

    Allergic reactions.

    When receiving an irregular or when resuming treatment after a break can flu-like syndrome (fever, chills, headache, dizziness, myalgia), skin reactions, hemolytic anemia, thrombocytopenic purpura, acute renal failure.

    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, abnormal liver function, metabolic acidosis, gyrrlikemia, glucosuria, ketonuria, seizures (1-3 hours after drug administration), coma.

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

    Interaction:

    With rifampicin.

    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, ceclosporin A, azathioprine, beta adrenoblockers, slow calcium channel blockers, 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.

    With isoniazid.

    Isoniazid. When combined with paracetamol, hepatotoxicity and nephrotoxicity increase; 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 strengthens 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 increased toxic effect (correction of the dosing regimen of phenytoin may be necessary, especially in patients with slow acetylation of isoniazid).

    With vitamin B6.

    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.
    Form release / dosage:
    The tablets covered with a cover, 100 mg + 150 mg.
    Packaging:
    10 tablets into aluminum foil strips.

    10 strips in a cardboard box together with instructions for use.
    Storage conditions:
    List B.

    In a dry, dark place at a temperature below 25 ° C. In a place inaccessible to children.
    Shelf life:
    2 years. Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N 016074/01
    Date of registration:13.04.2010
    The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India
    Information update date: & nbsp15.05.2016
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