Nikavir® (Nikavir)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePhosphazidePhosphazide
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  • Nikavir®
    pills inwards 
    AZT PHARMA KB, LLC     Russia
  • Nikavir®
    pills inwards 
    AZT PHARMA KB, LLC     Russia
    • Dosage form: & nbsppills
    Composition:

    Active substance: phosphazide - 400 mg.

    Excipients: calcium carbonate (precipitated) - 225.5 mg; cellulose microcrystalline - 72.7 mg; silicon dioxide colloid (aerosil) - 25.5 mg; calcium stearate - 7.3 mg.

    Description:

    Tablets are white or white with a yellowish-grayish shade of color, with yellowish-grayish patches, biconvex form, with a characteristic odor.

    Pharmacotherapeutic group:antiviral [HIV] agent
    ATX: & nbsp

    J.05.A.X   Other antiviral drugs

    Pharmacodynamics:

    Active substance phosphazide belongs to the class of inhibitors of reverse transcriptase (revertase) of retroviruses, being a modified analogue of the natural thymidine nucleoside. Phosphazide, having penetrated into the infected cell, is twice phosphorylated to the active metabolite - azidothymidine triphosphate, which is inserted in place of thymidine triphosphate in the reverse-side chain of proviral DNA, which leads to inhibition of the revertase, breakage of the DNA chain, and stopping the reproduction of viral particles. On this mechanism, the therapeutic effect of the drug on reducing the concentration of HIV in the bloodpatient.

    Also, the preparation inhibits the replication of certain other retroviruses of mammals, for example, the hepatitis B virus

    Pharmacokinetics:

    Phosphazide is well absorbed from the gastrointestinal tract. The time of full absorption is 3-3.5 h; half-life from the body - 3-4 hours; the maximum concentration of phosphazide in the blood plasma - 19-22 μg / ml is reached after 4-5 hours.

    Bioavailability for oral administration is 20%. The relative bioavailability of phosphazide is 83.7%. Phosphazide penetrates the blood-brain barrier and is found in cerebrospinal fluid at a concentration of 15-64% of the initial dose. The active substance penetrates well through the placenta, so that its concentration in the blood of the umbilical cord is comparable to that in the mother's blood. Metabolism of phosphazide occurs in the liver with the formation of glucuronide, which is excreted from the body by the kidneys with urine.

    Indications:

    Treatment of HIV infection in adults in combination with other antiretroviral drugs.

    Emergency prevention of HIV infection in case of risk of infection with pricks, cuts, contact with mucous membranes and skin damage.

    Treatment of acute hepatitis B in mild and moderate form (icteric period).

    Contraindications:

    Hypersensitivity to phosphazide or to any of the excipients of the drug.

    Children under 18 years.

    Carefully:

    Severe nausea, vomiting, anemia (hemoglobin concentration below 50 g / l), increased transaminase activity (more than 5 times the upper limit of the norm), hypercreatininaemia, neutropenia (lower 0.5x109/ l), thrombocytopenia (less than 25x109/ l).

    Pregnancy and lactation:ATIC- infected pregnant women is not recommended to take the drug before 14 weeks of pregnancy; if it is necessary to use the drug during lactation it is necessary to resolve the issue of stopping breastfeeding.
    Dosing and Administration:

    Inside. The daily dose for HIV infection is 800-1200 mg in 2 or 3 divided doses.

    It is recommended to take the drug before eating and drink with a glass of water. When the central nervous system is affected by the human immunodeficiency virus, the drug

    prescribed in a daily dose of 1200 mg. If the drug is poorly tolerated, the daily dose can be reduced to 400 mg per day.

    A course of treatment. The drug is prescribed for a long, almost unlimited period, if necessary, the course can be interrupted, but the duration should be at least 12 weeks with a break between courses - no more than 12 weeks.

    To prevent infection with the human immunodeficiency virus, it is recommended to start taking the drug 400 mg 3 times a day for 4 weeks as soon as possible, but no later than 72 hours after possible infection;

    In acute hepatitis, the drug is prescribed 400 mg twice a day for 20 days. It is recommended to start taking the drug no later than 7 days after the onset of jaundice.

    Side effects:

    In the first days of taking the drug - nausea, headache, heaviness in epigastrium, diarrhea. Usually these phenomena subsequently disappear. On the part of the organs of hematopoiesis: anemia, granulocytopenia.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Cases of drug overdose are not described. Hemodialysis and peritoneal dialysis increase the excretion of the glucuronic metabolite of phosphazide.

    Interaction:

    Joint use of the drug Nikavir® with zidovudine, stavudine leads to a mutual decrease in activity against HIV.

    Co-administration with interferon alpha, didanosine, lamivudine, foscarnet results in a mutual increase in activity against HIV.

    The combined use of doxorubicin, interferon alpha, amphotericin-B, co-trimoxazole, vinblastine, vincristine, ganciclovir, dapsone, sulfadiazine, and other sulfonamides may result in a mutual enhancement of myelotoxicity, therefore additional control is required for the concentration of hemoglobin and granulocytes.

    Special instructions:

    Usually the drug is well tolerated by patients. Phosphazide - low-toxic substance. Its toxicity is 5-6 times lower than zidovudine. Assessing the tolerability of the drug, it should be borne in mind that these side effects and other symptoms and syndromes can be manifestations of not only therapy, but also of HIV infection and concomitant diseases.

    If some unwanted phenomena appear in the early stages of taking the drug, you should not abolish it, it is recommended to continue therapy under control doctor.

    Irregularity of taking the drug to patients (violation of the treatment regimen) can lead to the development of resistance (stability) of the retrovirus to it, which will result in a decrease in the effectiveness of the therapy and the need to replace the drug.

    To avoid complications, the drug is used under the supervision of a doctor.

    Therapy with the drug does not reduce the risk of transmission of HIV to other people during sexual intercourse or during blood transfusion.

    Effect on the ability to drive transp. cf. and fur:

    Studies have not been carried out, however, when deciding whether to control a car, mechanisms, one should keep in mind the patient's condition and the possibility of developing adverse reactions to Nikavir®, such as nausea, headache, diarrhea.

    Form release / dosage:

    Tablets 400 mg.

    Packaging:10 tablets in a planar cell package (blister) from the film-PVC / PVDC and foil; 6 blisters with instructions for use in a pack of cardboard.
    Storage conditions:

    In dry, dark place at a temperature of no higher than 20 ° C. Keep out of the reach of children.

    Shelf life:2 of the year. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002208
    Date of registration:29.08.2013
    The owner of the registration certificate:AZT PHARMA KB, LLC AZT PHARMA KB, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.10.2015
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