Nikavir - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Nikavir

Nikavir: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Nikavir

ATX code: J05AX

Active ingredient: phosphazide (Phosphazide)

Manufacturer: LLC "AZT PHARMA KB" (Russia)

Description and photo update: 09.10.2019

Nikavir is an antiviral drug that inhibits HIV reverse transcriptase (human immunodeficiency virus).

Release form and composition

The drug is available in the form of tablets - round, white or white with a yellow-gray tint and yellowish-grayish blotches with a specific odor:

• dosage 200 mg: flat-cylindrical tablets with beveled and scored (10 pcs. in blisters / blisters, in a cardboard box 6 packs / blisters);
• dosage 400 mg: biconvex tablets (10 pcs. in blisters / blisters, in a cardboard box 2 packages / blisters).

Each pack also contains instructions for the use of Nikavir.

1 tablet contains:

• active substance: phosphazide - 200 mg or 400 mg;
• auxiliary components: calcium carbonate (precipitated), aerosil (colloidal silicon dioxide), microcrystalline cellulose, calcium stearate.

Pharmacological properties

Pharmacodynamics

Nikavir is an antiviral drug with anti-HIV activity, the therapeutic effect of which is based on a decrease in the concentration of HIV in the patient's blood. The mechanism of action of the drug is due to the unique property of the active substance - phosphazide (which is a modified analogue of the natural nucleoside thymidine), to inhibit the reverse transcriptase of retroviruses, revertase. Having penetrated into an infected cell, phosphazide is twice phosphorylated to form an active metabolite - azidothymidine triphosphate, which is then incorporated instead of thymidine triphosphate into the DNA (deoxyribonucleic acid) DNA chain synthesized by revertase (deoxyribonucleic acid) of the HIV provirus, which causes inhibition of revertase, breaking the DNA chain and stopping the reproduction of viral particles.

Along with this, phosphazide inhibits the replication of hepatitis B virus and other mammalian retroviruses.

Pharmacokinetics

After oral administration, phosphazide is well absorbed from the gastrointestinal tract. The relative bioavailability is 83.7%. When administered orally, its absolute bioavailability is 20%. For complete absorption of phosphazide, 3–3.5 hours are required. The maximum plasma concentration is reached within 4–5 hours and amounts to 0.019–0.022 mg / ml.

The substance crosses the blood-brain barrier, penetrates well through the placenta. The concentration of phosphazide in the blood of the umbilical cord is comparable to that in the mother's blood. In cerebrospinal fluid, its level can reach 15 to 64% of the initial dose.

It is metabolized in the liver to form glucuronide, which is then excreted from the body through the kidneys. The half-life is 3-4 hours.

Indications for use

The use of Nikavir is indicated for the treatment of the following diseases:

• HIV infection - therapy for adult patients (included in the regimen with other antiretroviral drugs);
• acute hepatitis B in mild to moderate form (icteric period).

In addition, the drug is prescribed as an emergency prevention of HIV infection at the risk of occupational infection against the background of damage to the skin (injection, cut) and the ingress of biological fluids of patients on the mucous membranes.

Contraindications

Absolute:

• pregnancy in the first trimester;
• breast-feeding;
• under 3 years of age for the treatment of HIV infection;
• age up to 18 years - for other indications;
• hypersensitivity to the components of the drug.

Patients with severe nausea, vomiting, anemia (hemoglobin level in the blood below 50 g / l), an increase of more than 5 times the activity of transaminases relative to the upper limit of normal (ULN), hypercreatininemia, neutropenia (the number of neutrophils in the peripheral blood less than 0.5 x 10 ⁹ / l), thrombocytopenia (platelet count less than 25 x 10 ⁹ / l).

Nikavir, instructions for use: method and dosage

Nikavir tablets are taken orally, before meals, with a sufficient amount (200 ml) of water.

Recommended daily dosage for the treatment of HIV infection:

• adults: 600-1200 mg, divided into 2 or 3 doses;
• children aged 13 to 18 years: 200 mg 3 times a day;
• children 3-13 years old: at the rate of 10 mg per 1 kg of body weight per day, divided into 2-3 doses.

The minimum therapy is prescribed for a 12-week course. After a break, which should last no more than 12 weeks, the drug should be resumed. Treatment is long-term and not limited to specific terms. With HIV affecting the central nervous system, it is necessary to prescribe Nikavir at a dose of 1200 mg per day. If the patient does not tolerate treatment well, then the daily dose of the drug can be reduced to 400 mg.

In acute hepatitis B, it is recommended to start taking it within the first 7 days from the onset of jaundice at a dose of 400 mg 2 times a day. The duration of the course is 20 days.

It is recommended to begin prophylaxis of HIV infection no later than 3 days after the alleged infection. Nikavir is prescribed at a dose of 400–600 mg 3 times a day. The duration of the preventive course is 28 days.

Side effects

• on the part of the hematopoietic organs: granulocytopenia, anemia;
• other reactions: at the beginning of treatment - heaviness in the epigastrium, nausea, diarrhea, headache (usually the listed phenomena subsequently disappear).

Overdose

Symptoms of a phosphazide overdose have not been established.

During therapy, it should be borne in mind that the use of hemodialysis or peritoneal dialysis enhances the excretion of the glucuronic metabolite of phosphazide.

special instructions

The toxicity of phosphazide is 5-6 times lower than that of zidovudine, treatment with the drug is usually well tolerated by patients. Therefore, when evaluating side effects or exacerbating other symptoms and syndromes, it should be borne in mind that they may be not only a consequence of therapy, but also manifestations of HIV infection and concomitant diseases.

Not all undesirable phenomena that occur at an early stage of Nikavir use can serve as a reason for its cancellation. It is recommended to continue treatment under the supervision of a physician.

Violation of the therapeutic regimen (irregular intake of pills) can cause the development of resistance of the retrovirus to phosphazide and reduce the clinical effectiveness of the treatment.

Taking the medication should be accompanied by close medical supervision.

When prescribing the drug, the doctor must inform the patient that while taking Nikavir, the risk of transmitting HIV to other people through blood transfusion or sexual intercourse remains.

Influence on the ability to drive vehicles and complex mechanisms

During the period of treatment, the decision on the possibility of admitting the patient to driving vehicles and complex mechanisms should be made by the doctor, taking into account the patient's condition and individual tolerance of Nikavir.

Application during pregnancy and lactation

It is not recommended to use Nikavir for the treatment of HIV-infected women during the first trimester of pregnancy.

Prescribing the drug during lactation is contraindicated; if necessary, breastfeeding should be discontinued.

Pediatric use

The use of Nikavir for the treatment of HIV infection in children under the age of three is contraindicated.

It is contraindicated to prescribe the drug for the treatment of acute hepatitis B in patients under 18 years of age due to the lack of data on use.

For violations of liver function

It is recommended to take Nikavir with caution if the activity of transaminases exceeds VGN by more than 5 times.

Drug interactions

• zidovudine, stavudine: the combination of Nikavir with these agents causes a mutual decrease in the pharmacological activity of drugs against HIV;
• interferon alfa, lamivudine, didanosine, foscarnet: against the background of concomitant therapy with one of the listed agents, a mutual increase in activity against HIV occurs;
• interferon alpha, doxorubicin, amphotericin B, vinblastine, vincristine, co-trimoxazole, dapsone, ganciclovir, sulfadiazine and other sulfonamides: if necessary, combination therapy with each of these drugs should carefully monitor the level of hemoglobin and the concentration of granulocytes due to the increased risk of mutual enhancement of myelotoxicity …

Analogs

Analogues of Nikavir are Kaletra, Kivexa, Epivir TriTiSi, Didanosine, Videx, Fadinosin, Viramune.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 20 ° C in a dark place.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Nikavir

From the few reviews about Nikavir, patients can learn that, in addition to the side effects declared by the manufacturer, while taking the drug, such undesirable reactions as renal colic may occur.

Experts say that Nikavir is not inferior to foreign counterparts in terms of effectiveness, but causes a much smaller number of side effects.

Price for Nikavir in pharmacies

The price of Nikavir for a package containing 20 tablets in a dose of 200 mg can range from 693 rubles; for a package containing 60 tablets at a dose of 400 mg - from 1945 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!