Ripafex (Rifapex)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceRifapentinRifapentin
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  • Ripafex
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    Lupine Co., Ltd.     India
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    on 1 tablet.

    Active substance: Rifapentin 150 mg

    Excipients: microcrystalline cellulose (RANQ PH 102), sodium carboxymethyl starch, pregelatinized starch, sodium ascorbate, sodium lauryl sulfate, disodium edetate, giprolose (Klucel EXF), Silica colloidal dioxide (Aerosil 200), calcium stearate.

    Sheath: hypromellose (Methocel E5 LVP), hypromellose (Methocel El5 LVP), macrogol 4000, titanium dioxide, talc, iron oxide dye red (Sicopharm Red 30), simethicone emulsion (30%).

    Description:
    red-brown color round, film-coated tablets with a dividing notch on one side and smooth on the other side.

    View of the break:

    tablets on the kink of dark red-brown color.
    Pharmacotherapeutic group:Antituberculous means, antibiotic-ansamycin.
    ATX: & nbsp

    J.04.A.B   Antibiotics

    J.04.A.B.05   Rifapentin

    Pharmacodynamics:
    Rifapentin is a derivative of rifamycin and has approximately the same microbiological activity profile as rifampicin, inhibits DNA-dependent RNA polymerase in sensitive strains of Mycobacterium tuberculosis, but not in mammalian cells. Within the limits of therapeutic concentrations rifapentin shows bactericidal action against both extracellular and intracellular bacteria of M. tuberculosis.

    In the treatment of tuberculosis, resistant bacteria, present in small numbers among a large population of sensitive microorganisms, can multiply rapidly and become predominant. The sensitivity of M. tuberculosis isolates to isoniazid, rifampicin, pyrazinamide, ethambutol, rifapentin and other antituberculosis drugs should be assessed. If the test results indicate resistance to any of these drugs and the patient does not respond to treatment, then the regimen should be changed. There is a high level of cross-resistance of M. tuberculosis between rifapentin and other rifamycins, whereas M. tuberculosis bacteria resistant to rifampicin and rifapentin do not have cross-resistance to other non-infective drugs of the non-fefamycin series, such as isoniazid and streptomycin.

    Pharmacokinetics:
    Bioavailability after taking a single dose of 600 mg is 70%. After taking 600 mg, the maximum concentration of rifapentin in plasma is reached after 5-6 hours.

    The degree of binding to plasma proteins rifapentine and its active metabolite 25-dezatsetilrifapentina 97.7 and 93.2% respectively. With urine, 17% of rifapentin and related compounds are excreted. The half-life of rifapentin is approximately 14-17 hours.
    Indications:First identified drug-sensitive tuberculosis (all forms); in the acute stage of tuberculosis and in the stage of aftercare.
    Rifapentine administered in combination therapy, in combination with other anti-TB drugs, not belonging to the rifamycin group.
    Contraindications:
    - Hypersensitivity to rifamycins.

    - Diseases of the liver and gastrointestinal tract in the acute phase.

    - Pregnancy, lactation.

    - Thrombophlebitis.

    - Children under 12 years.
    Carefully:
    - in patients with severe atherosclerosis,

    - with the carrier of hepatitis B and C.
    Dosing and Administration:
    Inside, 1 time per day, regardless of food intake. The daily dose of rifapentin 10 mg / kg body weight - 2-3 times a week.

    Simultaneously with rifapentin in the acute phase of treatment, first-line anti-tuberculosis drugs are prescribed: isoniazid, ethambutol, pyrazinamide in doses corresponding to the instructions for the use of these drugs.

    If necessary, intramuscularly administered streptomycin, or with its stability, kanamycin.

    When intolerance of one of the drugs prescribed with rifapentin, it can be replaced by protionamide, cycloserine or levofloxacin.
    Side effects:

    Allergic reactions: fever, dermatitis, eosinophilia, anaphylactic shock.

    From the gastrointestinal tract, nausea, vomiting, diarrhea. Increased activity of "liver" transaminases, drug-induced hepatitis, jaundice.

    On the part of the blood system: thrombocytopenia, leukopenia, anemia.

    Overdose:
    Symptoms: nausea, vomiting, diarrhea, increased activity of "liver" transaminases, hepatitis, jaundice, thrombocytopenia, leukopenia, anemia.

    Treatment: gastric lavage, symptomatic therapy, prescription of choleretic preparations, diuretics.
    Interaction:
    Rifapentin induces enzymes of the cytochrome P 450 system; accelerates the metabolism of drugs.

    Pyrazinamide slows the excretion of rifapentin.

    Isoniazid with rifapentin, protionamide with rifapentin - synergists; when combined, antimicrobial activity increases.

    It is not recommended simultaneous administration of rifapentin with PASK, t. PASK disrupts the absorption of rifapentin.

    Patients taking antacids are recommended to take rifapentin not less than 1 hour or 2 hours after taking antacids.

    Simultaneous intake of alcohol can increase the risk of liver damage.
    Special instructions:
    Rifapentin may impart a reddish-orange color to urine, skin and secreted fluids.

    Patients receiving rifapentin, do not wear contact lenses. During treatment with rifapentin it is necessary:

    monthly blood tests, urine tests; determination of the activity of "liver" transaminases; bilirubin direct and indirect.

    Clinical material for the cultivation of mycobacteria and determining their sensitivity should be taken before the start of treatment, as well as during treatment after a two to three-day break in treatment and to monitor the therapeutic response.

    Rifapentin can not be combined with drugs belonging to the rifamycin group. Oral contraceptives in combination with rifapentin are ineffective. Other contraceptives should be used.

    When prescribing prednisolone, cardiac glycosides (digitalis derivatives), phenazepam together with rifapentin, one should take into account the decrease in the concentration of these drugs.
    Form release / dosage:Tablets, film-coated, 150 mg.
    Packaging:For 8 tablets in aluminum / aluminum strip, laminated with polyethylene. 1 or 8 strips are placed in a cardboard box together with instructions for use. For 100 tablets in a plastic bag, followed by a high density polyethylene container and instructions for use. Packing for hospitals. For 100 or 500 tablets in a polyethylene bag, followed by a high density polyethylene container, together with instructions for use.
    Storage conditions:In a dry place, at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.

    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002590/09
    Date of registration:02.04.2009
    The owner of the registration certificate:Lupine Co., Ltd.Lupine Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspLUPIN LIMITEDLUPIN LIMITED
    Information update date: & nbsp20.05.2016
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