Рифампицин-Ферейн®
Producer: CJSC Bryntsalov-A Russia
Code of automatic telephone exchange: J04AB02
Release form: Liquid dosage forms. Lyophilisate for preparation of solution for injections.
General characteristics. Structure:
Active ingredient: 0,15 g of rifampicin in 1 ampoule.
Excipients: ascorbic acid, sodium sulfite, sodium hydroxide.
Antibiotic of a broad spectrum of activity.
Pharmacological properties:
Pharmacodynamics. It has activity concerning mycobacteria of tuberculosis and leprosy, gram-positive (especially stafilokokk) and gram-negative cocci (meningokokk, gonokokk); many asporous anaerobe bacterias are sensitive to it; is less active concerning gram-negative bacteria (Е. coli, To. pneumoniae, Salmonella, Shigella, Proteus spp., P. aeruginosa, etc.), does not affect mushrooms. Rifampicin resistance develops quickly. Cross stability with other antibacterial drugs (except SV Rifamycinum) is not revealed. Besides, rifampicin has virulitsidny effect on a rhabdovirus and suppresses development of rabichesky encephalitis.
Pharmacokinetics. At intravenous drop administration the maximum concentration of rifampicin is observed by the end of infusion. At the therapeutic level concentration of drug at intravenous administration is maintained within 8-12 hours, concerning highly sensitive activators - within 24 hours. Rifampicin well gets into fabrics and liquids of an organism and it is found in therapeutic concentration in pleural exudate, a phlegm, contents of cavities, a bone tissue. The greatest concentration of drug is created in tissues of a liver and kidneys. Out of an organism it is brought with bile and urine.
Indications to use:
The main indication to use of Rifampitsina-Fereyn® is the pulmonary tuberculosis and other bodies.
Besides, drug is used at various forms of a leprosy and at inflammatory diseases of the lungs and respiratory tracts (bronchitis, pneumonia) caused by polyresistant stafilokokka at acute and chronic osteomyelitis; infections of urinary and biliary tract (pyelonephritis, a pyelocystitis, a cholangitis, cholecystitis) and other diseases caused by activators, sensitive to action of Rifampitsina-Fereyn®, at a meningococcal carriage. Due to a possibility of bystry development of stability to drug in the course of treatment, use of Rifampitsina-Fereyn® at diseases of not tubercular etiology is undesirable.
Route of administration and doses:
Рифампицин-Ферейн® enter intravenously kapelno (intravenously enter only the adult, horizontal position of the patient is recommended).
For preparation of solution for intravenous administration, 0,15 g of drug dissolve in 2,5 ml of water for injections, vigorously stir up before full dissolution; the received solution mix 5% of solution of glucose from 125 ml. Rate of administering of 60-80 drops in a minute. Intravenous administration of Rifampitsina-Fereyn® is recommended at ostroprogressiruyushchy and common forms of a destructive pulmonary tuberculosis, heavy is purulent - septic processes in need of bystry creation of high concentration of drug in blood, and also in cases when administration of drug is inside complicated or is badly transferred by patients.
At intravenous administration the daily dose makes 0,45 g, at the severe quickly progressing forms - 0,6 g also are entered in one step within 45-50 minutes. Duration of use of an intravenous way of introduction depends on portability of drug and can make 1-1,5 months with the subsequent transition to intake.
At treatment of tuberculosis at patients with a diabetes mellitus, intravenous administration of Rifampitsina-Fereyn® is combined with administration of insulin (on each 4-5 g of glucose (solvent) - 2 PIECES of insulin).
Monotherapy of tuberculosis of Rifampitsinom-Fereyn® often is followed by development of resistance of the activator to an antibiotic therefore it is necessary to appoint it in combination with other antituberculous remedies (streptomycin, an isoniazid, Ethambutolum, etc.) to which sensitivity of mycobacteria of tuberculosis is kept.
At infections of not tubercular etiology depending on localization of process at intravenous administration the daily dose of Rifampitsina-Fereyn® makes from 0,3 to 0,9 g. The daily dose is divided into 2 introductions. Duration of treatment is established individually depending on efficiency and portability and can make 7-10 days. Intravenous administration should be stopped as soon as an opportunity for reception of Rifampitsina-Fereyn® inside appears.
Side effects:
At treatment of Rifampitsinom-Fereyn® disorders of function of digestive tract (a loss of appetite, nausea, vomiting, a diarrhea) are possible. These phenomena usually pass independently in 2-3 days without drug withdrawal. Рифампицин-Ферейн® can have a hepatotoxic action (increase in content of transaminases and bilirubin in blood serum, jaundice).
For early detection and the prevention of a hepatotoxic action treatment of Rifampitsinom-Fereyn® should be begun after the research of function of a liver (determination of level of bilirubin and aminotransferases in blood, a thymol turbidity test), and in the course of treatment to carry out it monthly. At the patients who had hepatitis in the past or having cirrhosis, these researches have to is spent each 2 weeks. Moderate abnormal liver functions usually have passing character and can disappear without drug withdrawal at purpose of Allocholum, methionine, a pyridoxine, B12 vitamin. At the accruing phenomena of an abnormal liver function use of Rifampitsina-Fereyn® should be stopped.
At treatment of Rifampitsinom-Fereyn® development of a leukopenia and thrombocytopenia, allergic reactions is possible. The last are shown in the form of skin rashes, an eosinophilia, is rare - a bronchospasm and a Quincke's edema. At intermittent treatment, irregular administration of drug or when resuming treatment of Rifampitsinom-Fereyn® after a break heavy allergic reactions in the form of grippozopodobny fever, an acute renal liver failure or a trombopenichesky purpura can be observed. These complications are preceded sometimes by signs of a medicinal sensitization (rise in temperature after administration of drug, the accruing eosinophilia, a bronchospasm, and also positive tests of Shelley, Uanye, etc.). For the prevention of these phenomena it is necessary to appoint drug in small doses (0,15 g a day). In cases when at the previous stage of treatment sensitization signs to Rifampitsinu-Fereyn® were noted, it is applied under control of measurement of temperature after administration of drug (within 3 hours in the first 2-3 days). At good tolerance the dose of an antibiotic can be increased to usual therapeutic.
At emergence of allergic reactions of Rifampitsin-Fereyn® cancel and carry out the desensibilizing therapy (antihistamines, calcium drugs, corticosteroid hormones, etc.). In cases of heavy allergic reactions it is necessary to enter parenterally high doses of corticosteroid hormones, antihistamines, intravenously - Haemodesum, isotonic solution of sodium chloride, diuretics, etc.
At the patients using drug, urine, the lacrimal liquid, the phlegm gains orange-red color.
At bystry intravenous administration of Rifampitsina-Fereyn® at patients the lowering of arterial pressure is possible owing to what intravenous infusion of drug should be carried out under control of arterial pressure during administration of drug. At long intravenous administration development of phlebitis is possible.
Interaction with other medicines:
Рифампицин-Ферейн® is the inductor of microsomal enzymes of system of R-450 cytochrome; accelerates metabolism of many medicines.
The concomitant use of Rifampitsina-Fereyn® with indirect anticoagulants in connection with easing of their effect is not recommended.
At combinative use of Rifampitsina-Fereyn® with oral contraceptives reliability of the last decreases.
Рифампицин-Ферейн® weakens effect of glucocorticoids.
Рифампицин-Ферейн® reduces concentration in a blood plasma and shortens action of peroral antidiabetic means; digitoxin, quinidine, cyclosporine, chloramphenicol, doxycycline, a ketokonazol, an itrakonazol, to a lesser extent - a flukonazola. Pyrazinamidum detains removal of Rifampitsina-Fereyn®.
Contraindications:
Use of Rifampitsina-Fereyn® is contraindicated at hypersensitivity to drug, the diseases of a liver and kidneys which are followed by the expressed disturbance of their function, jaundice (including mechanical), pregnancy and feeding by a breast, to children 1 years are younger.
Intravenous administration is contraindicated also at a pulmonary heart of the I-III degree, phlebitis.
Storage conditions:
Period of validity - 2 years. Not to use after the term specified on the label. List B. In protected from light and the place, unavailable to children, at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
Lyophilisate for preparation of solution for injections of 0,15 g. On 0,15 g of rifampicin in ampoules of neutral glass with a capacity of 5 ml. 5 ampoules in a blister strip packaging from a film polyvinyl chloride. 5 ampoules in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished or a packing material. 1, 2 blister strip packagings together with the application instruction and a knife ampoule or the scarificator in a pack from a cardboard. On 5 or 10 ampoules together with the application instruction and a knife ampoule or the scarificator in a pack with an insert with cells for ampoules in 1 or 2 rows from a cardboard. When using ampoules with notches, a break ring the knife ampoule or the scarificator is not put.