Active substanceRifampicinRifampicin
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  • Dosage form: & nbspLyophilizate for solution for injection.
    Composition:
    Composition per 1 ampoule:

    Active substance:

    Rifampicin - 0.15 g (in terms of 100% substance)

    Excipients: ascorbic acid 0.014 g, sodium sulphite 0.0028 g, sodium hydroxide 0.001 g.
    Description:Porous mass of brick or brownish-red color, marble color is allowed. without smell. Sensitive to the effects of light, oxygen and air moisture.
    Pharmacotherapeutic group:antibiotic, ansamycin.
    ATX: & nbsp

    J.04.A.B   Antibiotics

    J.04.A.B.02   Rifampicin

    Pharmacodynamics:Rifampicin - antibiotic of a broad spectrum of antimicrobial action. It has activity against mycobacteria tuberculosis and leprosy, gram-positive (especially staphylococcus) and gram-negative cocci (meningococci, gonococci); Many non-spore-forming anaerobes are sensitive to it; less active against Gram-negative bacteria (E. coli, K. pneumoniae, Salmonella, Shigella, Proteus spp., P. aeruginosa, etc.). does not affect the fungi. Resistance to rifampicin develops rapidly. Cross-resistance with other antibacterial drugs (except for rifamycin SV) has not been identified. Besides, rifampicin has a virucidal effect on rabies virus and inhibits the development of rabies encephalitis.
    Pharmacokinetics:At intravenous drip introduction the maximum concentration of rifampicin is observed by the end of infusion. At the therapeutic level, the concentration of the drug with intravenous administration is maintained for 8-12 hours, for highly sensitive pathogens - within 24 hours. Rifampicin well penetrates into the tissues and body fluids and is found in therapeutic concentrations in pleural exudate, sputum. the contents of caverns, bone tissue. The greatest concentration of the drug is created in the tissues of the liver and kidneys. It is excreted from the body with bile and urine.
    Indications:
    The main indication for the use of Rifampicin-Ferein® is tuberculosis of the lungs and other organs.

    In addition, the drug is used for various forms of leprosy and inflammatory diseases of the lungs and respiratory tract (bronchitis, pneumonia) caused by multidrug resistant staphylococci, with acute and chronic osteomyelitis; infections of the urinary and bile ducts (pyelonephritis, pyelocystitis, cholangitis, cholecystitis) and other diseases caused by susceptible to the action of Rifampicin-Ferein® pathogens. with meningococcal carriage.In connection with the possibility of rapid development of resistance to the drug during treatment, the use of Rifampicin-Ferein® for diseases of non-tuberculous etiology is undesirable.
    Contraindications:
    The use of Rifampicin-Ferein® is contraindicated in cases of hypersensitivity to the drug, liver and kidney disease, accompanied by a pronounced impairment of their function, jaundice (including mechanical), pregnancy and lactation, children under 1 year.

    Intravenous administration is contraindicated also with pulmonary heart failure 1-III degree, phlebitis.
    Dosing and Administration:
    Rifampicin-Ferein® is administered intravenously drip (intravenously administered only to adults, horizontal position of the patient is recommended).

    To prepare a solution for intravenous administration, 0.15 g of the drug is dissolved in 2.5 ml of water for injection, vigorously shaken until completely dissolved; the resulting solution is mixed with 125 ml of 5% glucose solution. The rate of administration is 60-80 drops per minute. Intravenous administration of Rifampicin-Ferein® is recommended for acute and progressive forms of destructive pulmonary tuberculosis,severe purulent-septic processes when it is necessary to quickly create high concentrations of the drug in the blood, as well as in cases when the intake of the drug inside is difficult or badly tolerated by patients.

    With intravenous administration, the daily dose is 0.45 g, with severe rapidly progressing forms - 0.6 g and administered in one session for 45-50 minutes. The duration of use of the intravenous route of administration depends on the tolerability of the drug and can be 1-1.5 months with a subsequent transition to oral administration. In the treatment of tuberculosis in diabetic patients, intravenous administration of Rifampicin-Ferein® is combined with the administration of insulin (for every 4-5 g of glucose (solvent) 2 units of insulin).

    Monotherapy for tuberculosis Rifampicin-Ferein® is often accompanied by the development of resistance of the pathogen to the antibiotic, therefore it should be administered in combination with other anti-tuberculosis drugs (streptomycin, isoniazid, ethambul, etc.). to which the sensitivity of mycobacteria of tuberculosis is preserved.

    In infections of non-tuberculous etiology, depending on the localization of the process with intravenous administration, the daily dose of Rifampicin-Ferein® is 0.3 to 0.9 g. The daily dose is divided into 2 injections.The duration of treatment is determined individually depending on the effectiveness and tolerability and can be 7-10 days. Intravenous administration should be discontinued as soon as possible to receive Rifampipine-Ferein® inside.
    Side effects:
    In the treatment of Rifampicin-Ferein®, gastrointestinal function disorders (decreased appetite, nausea, vomiting, diarrhea) are possible. These phenomena usually pass independently in 2-3 days without drug withdrawal. Rifampicin-Ferein® can have a hepatotoxic effect (an increase in the content of transaminases and bilirubin in the serum, jaundice). For the timely detection and prevention of hepatotoxic action, treatment with Rifampicin-Ferein® should be started after a study of liver function (determination of bilirubin and aminotransferase levels in the blood, timol assay), and in the process of treatment, to conduct it monthly. In patients who have had past hepatitis or who suffer from cirrhosis of the liver, these studies should be conducted every 2 weeks. Moderate dysfunctions of the liver usually have a transient nature and can disappear without drug discontinuation in the appointment of allochol, methionine, pyridoxine, vitamin B12.With increasing phenomena of liver function abnormalities, the use of Rifampicin-Ferein® should be discontinued.

    In the treatment of Rifampicin-Ferein®, the development of leukopenia and thrombocytopenia is possible. allergic reactions. The latter manifest themselves as skin rashes, eosinophilia, rarely - bronchospasm and Quincke's edema. When intermittent treatment, irregular administration of the drug, or with the resumption of treatment with Rifampicin-Ferein® after a break, severe allergic reactions may occur in the form of influenza-like fever, acute renal-hepatic insufficiency or thrombopenic purpura. These complications are sometimes preceded by signs of drug sensitization (temperature rise after taking the drug, increasing eosinophilia, bronchospasm, and positive tests by Shelley, Ouenier, etc.). To prevent these phenomena, the drug should be administered in small doses (0.15 g per day). In cases when signs of sensitization to Rifampicin-Ferein® were noted at the previous stage of treatment, it is used under the control of temperature measurement after taking the drug (within 3 hours in the first 2-3 days).With good tolerability, the dose of antibiotic can be increased to the usual therapeutic dose.

    When allergic reactions occur, Rifampicin-Ferein® is canceled and desensitizing therapy is administered (antihistamines, calcium preparations, corticosteroid hormones, etc.). In cases of severe allergic reactions, it is necessary to administer parenterally large doses of corticosteroid hormones, antihistamines, intravenous haemodes, isotonic sodium chloride solution, diuretics, etc.

    In patients using the drug, urine, tear fluid, sputum becomes orange-red.

    With the rapid intravenous administration of Rifampicin-Ferein® in patients, it is possible to lower blood pressure, as a result of which intravenous infusion of the drug should be carried out under the control of blood pressure during the administration of the drug. With prolonged intravenous administration, phlebitis may develop.
    Interaction:
    Rifampicin-Ferein® is the inducer of the microsomal enzymes of the cytochrome P-450 system; accelerates the metabolism of many drugs.

    It is not recommended simultaneous reception of Rifampicin-Ferein® with indirect anticoagulants in connection with the weakening of their effect.

    With the combined use of Rifampicin-Ferein® with oral contraceptives, the reliability of the latter decreases.

    Rifampicin-Ferein® weakens the effect of glucocorticoids.

    Rifampicin-Ferein® lowers plasma concentration and shortens the effect of oral antidiabetics; digitoxin, quinidine, cyclosporine, chloramphenicol, doxycycline, ketoconazole, itraconazole, to a lesser extent - fluconazole. Pyrazinamide delays excretion of Rifampicin-Ferein®.
    Form release / dosage:
    Lyophilizate for solution for injection 0.15 g.
    Packaging:
    For 0.15 g of rifampicin in neutral glass ampoules with a capacity of 5 ml. 5 ampoules in a contoured cell pack of a polyvinyl chloride film. 5 ampoules in a contoured cell packaging made of polyvinyl chloride film and aluminum foil printed lacquered or packaging material.

    1, 2 contour mesh packages together with the instructions for use and a knife ampoule or scarifier in a pack of cardboard.

    For 5 or 10 ampoules together with the instructions for use and a knife ampoule or scarifier in a pack with an insert with cells for ampoules in 1 or 2 rows of cardboard.When using ampoules with notches, the ampoule knife or scarifier does not enclose the fracture ring.
    Storage conditions:Protected from light at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:4 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000990 / 01
    Date of registration:11.08.2008/25.09.2015
    The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.05.2016
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