Active substanceRifampicinRifampicin
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  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    Active substance:

    Rifampicin 150 mg / 300 mg

    Excipients:

    Lactose monohydrate (85.95 mg / 113.0 mg), sodium carboxymethyl starch (5.0 mg / 10.0 mg), sodium lauryl sulfate (2.55 mg / 5.1 mg), silicon dioxide colloid (1.50 mg / 3.0 mg), calcium stearate (5.0 mg / 8.9 mg).

    Composition of gelatin capsules:

    Capsule number 0:

    Titanium dioxide (1.1667%), dye azorubin (0.7291%), dye crimson [Ponso-4R] (0.2041%), dye sunset yellow (0.2916%), bronopol (0.09%), sodium lauryl sulfate (0.1%), purified water (14.20%), gelatin (up to 100%).

    Capsule number 2:

    Titanium dioxide (1.1667%), dye azorubin (0.4083%), dye crimson [Ponso- 4R] (0.2042%), dye sunset yellow (0.1458%), bronopol (0.09%), sodium lauryl sulfate (0.1%), purified water (14.20%), gelatin (up to 100%).

    Description:

    Capsules with a dosage of 150 mg: hard gelatin capsules, size No. 2, with a red body and lid containing a brownish-red powder;

    Capsules with a dosage of 300 mg: hard gelatin capsules, size No. 0, with a red body and lid containing a brownish-red powder.

    Pharmacotherapeutic group:Antibiotic, Ansamycin
    ATX: & nbsp

    J.04.A.B   Antibiotics

    J.04.A.B.02   Rifampicin

    Pharmacodynamics:Semisynthetic broad-spectrum antibiotic, first-line anti-tuberculosis drug.At low concentrations, it has a bactericidal effect on Mycobacterium tuberculosis, Brucella spp., Chlamydia trachomatis, Legionella pneumophila, Rickettsia typhi, Mycobacterium leprae; in high concentrations - on some gram-negative microorganisms. Characterized by high activity against Staphylococcus spp. (including penicillinase-forming and many methicillin-resistant strains), Streptococcus spp., Clostridium spp., Bacillus anthracis, Gram-negative cocci: meningococci, gonococci. Gram-positive bacteria act at high concentrations. It is active with respect to intracellular and extracellularly located microorganisms. Selectively inhibits the DNA-dependent RNA polymerase of sensitive microorganisms. When the drug is monotherapy, the selection of rifampicin-resistant bacteria is observed relatively quickly. Cross-resistance with other antibiotics (with the exception of the other rifamycins) does not develop.
    Pharmacokinetics:

    Absorption - fast, eating reduces the absorption of the drug. When administered on an empty stomach 600 mg the maximum concentration in the blood reaches 10 μg / ml, the time to reach the maximum concentration in the blood is 2 - 3 hours. The connection with plasma proteins is 84% ​​91%.

    Quickly distributed to organs and tissues (the highest concentration in the liver and kidneys), Penetrates into bone tissue, concentration in the saliva - 20% of the plasma.The apparent volume of distribution is 1.6 l / kg in adults and 1.1 l / kg in children. Through the blood-brain barrier penetrates only in case of inflammation of the meninges. Penetrates through the placenta (concentration in fetal plasma - 33% of the concentration in the mother's plasma) and excreted in breast milk (breastfed babies receive no more than 1% of the therapeutic dose of the drug). Metabolized in the liver with the formation of pharmacologically active metabolite-25-0-deacetyltrifampicin. It is an autoinducer - it accelerates its metabolism in the liver, as a result of which the clearance of creatinine at a value of 6 l / h after the first dose, increases to 9 l / h after repeated administration. When ingestion is also possible induction of enzymes of the intestinal wall.

    The half-life of the drug (T1/2) after ingestion of 300 mg is about 5 hours, after taking 600 mg - 3-4 hours after taking 900 mg - 5 hours. After several days of repeated intake, bioavailability decreases, and T1/2 after repeated administration, 600 mg is shortened to 1 -2 h.

    It is deduced, mainly, with bile 80% - in the form of a metabolite; kidneys - 20%. After taking 150 - 900 mg of the drug, the amount of rifampicin excreted by the kidneys in unchanged form depends on the value of the dose taken and is 4-20%.In patients with impaired renal excretory function T1/2 lengthens only in those cases when its doses exceed 600 mg. It is excreted in peritoneal dialysis and hemodialysis. In patients with impaired hepatic function, an increase in rifampicin concentration in the plasma and lengthening T1/2.

    Indications:

    Tuberculosis of all forms and localizations in combination therapy.

    Leprosy (in combination with dapsone and clofazimine - multibacillary types of the disease).

    Infectious diseases caused by sensitive microorganisms (in cases of resistance to other antibiotics and in combination antimicrobial therapy, after excluding the diagnosis of tuberculosis and leprosy).

    Brucellosis - as part of combination therapy with the antibiotic group of tetracyclines (doxycycline).

    Meningococcal meningitis (prophylaxis in persons who were in close contact with meningococcal meningitis who fell ill, in Neisseria meningitidis bacilli carriers).

    Contraindications:

    - Hypersensitivity,

    - jaundice, recently transferred (less than 1 year) infectious hepatitis,

    - pregnancy (only for life indications), lactation period,

    - chronic renal failure,

    - pulmonary heart failure of II-III degree,

    - Children's age up to 3 years,

    - lactose intolerance, lactase deficiency, glucose-galactose malabsorption

    Pregnancy and lactation:

    Therapy during pregnancy (especially in I trimester) is possible only for health reasons. In the appointment of the last weeks of pregnancy may experience post-partum haemorrhage in the mother and the newborn bleeding. In this case, vitamin K is prescribed. The action category for the fetus is FDA-C.

    Application in the period of breastfeeding. Concentrations in human milk approach the concentrations found in serum. The decision to abolish, breastfeed, or discontinue drug treatment should be taken in consideration of the importance of treatment with the drug for the mother.

    Dosing and Administration:

    Inside, on an empty stomach, 30 minutes before meals.

    For the treatment of tuberculosis, at least one antituberculous drug is combined (isoniazid, pyrazinamide, ethambutol, streptomycin). Adults with a body weight of less than 50 kg - 450 mg / day, 50 kg or more - 600 mg / day.

    Children older than 3 years - 10-20 mg / kg per day, the maximum daily dose - 600 mg. With tuberculous meningitis,disseminated tuberculosis, spinal cord injury with neurological manifestations, with the combination of tuberculosis with HIV infection, the total duration of treatment is 9 months: the drug is used daily - the first 2 months, in combination with isoniazid, pyrazinamide and ethambutol (ipi streptomycin), 7 months in combination with isoniazid.

    In the case of pulmonary tuberculosis and detection of mycobacteria in sputum, the following 3 regimens (all of 6 months) are used:

    1. The first 2 months are as above; 4 months - daily, in combination with isoniazid.

    2. The first 2 months are as above; 4 months - in combination with isoniazid, 2-3 times during each week.

    3. Throughout the course - the reception in combination with isoniazid, pyrazinamide and ethambutol (or streptomycin) 3 times during each week. In cases where anti-TB drugs are used 2-3 times a week (as well as in case of exacerbation of the disease or inefficiency of therapy), they should be taken under the supervision of medical personnel.

    To treat multibacillary types of leprosy (lepromatous, borderline-lepromatous and borderline) adults - 600 mg once a month in combinationwith dapsone (100 mg once a day) and clofazimine (50 mg once a day + 300 mg once every 1 month); children older than 3 years - 10 mg / kg once a month in combination with dapsone (1-2 mg / kg / day) and clofazimine (50 mg every other day + 200 mg once a month).

    The minimum duration of treatment is 2 years.

    To treat pausibacillary types of leprosy (tuberculoid and border tuberculoid): adults - 600 mg once a month, in combination with dapsone - 100 mg (1 - 2 mg / kg) once a day; children older than 3 years - 10 mg / kg once a month, in combination with dapsone - 1 - 2 mg / kg / day. Duration of treatment - 6 months.

    To treat infectious diseases caused by sensitive microorganisms, it is prescribed in combination with other antimicrobial agents.

    Daily intake for adults - 0.6 - 1.2 g; for children older than 3 years - 10-20 mg / kg. Multiplicity of admission - 2 times a day.

    For treatment of brucellosis - 900 mg / day once, in the morning on an empty stomach, in combination with doxycycline; the average duration of treatment is 45 days.

    For the prevention of meningococcal meningitis - 2 times a day every 12 hours for 2 days. Single doses for adults - 600 mg; for children over 3 years old -10 mg / kg.

    Patients with impaired renal excretory function and preserved liver function need to adjust the dose only when it exceeds 600 mg / day.

    Precautions for use

    Treatment with rifampicin should be done under close medical supervision. During treatment the skin, mucus, sweat, feces, lacrimal fluid, urine becomes orange-red color. Can persistently stain soft contact lenses.

    With non-tuberculosis diseases, it is prescribed only if other antibiotics are ineffective (rapid development of resistance).

    To prevent the development of resistance, microorganisms must be used in combination with other antimicrobial agents.

    In the case of the development of the flu-like syndrome, not complicated by thrombocytopenia, hemolytic anemia, bronchospasm, dyspnea, shock and renal insufficiency, patients receiving the medication according to the intermittent schedule should consider the possibility of switching to a daily dose. In these cases, the dose is increased slowly: on the first day, 75-150 mg, and the desired therapeutic dose is reached in 3-4 days. In the event that the above serious complications are noted, rifampicin cancel. It is necessary to monitor kidney function; an additional prescription of glucocorticosteroids is possible.

    Women of childbearing age during treatment should use reliable methods of contraception (oral hormonal contraceptives and additional non-hormonal methods of contraception).

    In the preventive use of meningococcus bacilli carriers, close medical supervision of patients is necessary in order to timely identify the symptoms of the disease in the event of resistance to rifampicin. With prolonged use, systematic monitoring of the peripheral blood pattern and liver function is necessary. During the treatment period, it is impossible to apply microbiological methods for determining the concentration of folic acid and vitamin B12 in the blood serum, Alcohol and taking the drug are incompatible.

    Side effects:

    From the digestive system: nausea, vomiting, diarrhea, anorexia, erosive gastritis, pseudomembranous enterocolitis; increased activity of "hepatic" transaminase in the blood serum, hyperbilirubinemia, hepatitis;

    From the nervous system: headache, decreased visual acuity, ataxia, disorientation;

    Allergic reactions: urticaria, eosinophilia, Quincke's edema, bronchospasm, arthralgia, fever;

    From the urinary system: nephronecrosis, interstitial nephritis, hyperuricemia.

    Other: leukopenia, dysmenorrhea, myasthenia gravis, induction of porphyria, exacerbation of gout. With intermittent or irregular therapy or with the resumption of treatment after an interruption, flu-like syndrome (fever, chills, headache, dizziness, myalgia), skin reactions, hemolytic anemia, thrombocytopenic purpura, acute renal failure are possible.

    Overdose:

    Nausea, vomiting, abdominal pain, enlarged liver, jaundice, periorbital edema or swelling of the face, pulmonary edema, confusion, convulsions, mental disorders, lethargy, red man syndrome (red-orange skin, mucous membranes and sclera).

    If you suspect an overdose, the patient should be rushed to the hospital.

    FROM The aim of the help is symptomatic therapy, gastric lavage, the appointment of activated charcoal; forced diuresis.

    Features of the drug at the first admission or when it is canceled

    The drug does not have the features of the action at the first reception or upon its cancellation.

    Description of the actions of the medical worker and patient if one or several doses of the drug are missed

    You should not stop prematurely or temporarily discontinue the course of treatment started, and also take the medication irregularly.

    If you miss a dose of one dose, take the next dose of the drug at the set time or, in consultation with the doctor, take the next dose on time, when you remember about taking the drug, smoothly shifting the next time you take the drug; do not take twice the dose of the drug.

    Interaction:

    Antacids, opiates, anticholinergics and ketoconazole reduce (in the case of simultaneous ingestion) bioavailability of rifampicin.

    In patients with a previous liver disease, co-administration with isoniazid and / or pyrazinamide increases the incidence and severity of liver function disorders more than with the administration of a single rifampicin.

    Preparations of PASC containing bentonite (aluminum hydrosilicate), should be prescribed not earlier than 4 hours after taking the drug, tk. absorption impairment is possible.

    Reduces the activity of oral anticoagulants, oral hypoglycemic drugs, hormonal contraceptives,drugs foxglove, antiarrhythmic drugs (disopyramid, pirmenol, quinidine, mexiletine, tokainid), glucocorticosteroids, dapsone, hydantoins (phenytoin), hexobarbital, nortriptyline, benzodiazepines, gyul hormones, theophylline, chloramphenicol, ketoconazole, itraconazole, cyclosporin A, azathioprine, beta-adrenoblockers, slow calcium channel blockers, enalapril, cimetidine (rifampicin causes the induction of the enzyme system of the liver - the cytochrome P-450 system, accelerating the metabolism of drugs). Alcohol and drug intake are incompatible.

    Effect on the ability to drive transp. cf. and fur:The ability of the drug to influence the speed of psychomotor reactions and the ability to control transport or other technical means has not been studied. Care must be taken when driving a car and driving other vehicles.
    Form release / dosage:
    Capsules of 150 mg and 300 mg.
    Packaging:

    10 capsules per blister (PVDC / aluminum). For 2 or 10 blisters per pack of cardboard along with instructions for use. 500 blisters per carton box along with instructions for use.

    At packing at the Russian enterprise (ФГБНУ "РОНЦ them.Blokhin "or ZAO" Rafarma ") 10 blisters are placed in a pack of cardboard along with instructions for use.

    Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C. injure in places inaccessible to children.
    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013051 / 01
    Date of registration:20.12.2011 / 09.12.2014
    Expiration Date:Unlimited
    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: & nbsp01.04.2018
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