Expiration date: 11/2025

Composition

1 capsule contains: ribavirin 200 mg.

Excipients: milk sugar (lactose), corn starch, polyvinylpyrrolidone (povidone), Aerosil (silicon dioxide colloidal), calcium octadecanoate (calcium stearate).

Shell composition: gelatin, water, sodium lauryl sulfate, methylparaben, propylparaben, dye-titanium dioxide.

Packaging

The package contains 30 capsules.

Pharmacological action

Ribavirin is a synthetic analog of nucleosides with a pronounced antiviral effect. It has a wide range of activity against various DNA and RNA viruses.

Ribavirin easily penetrates into virus-affected cells and is rapidly phosphorylated by intracellular adenosine kinase into ribavirin mono -, di -, and triphosphate. These metabolites, especially ribavirin triphosphate, have pronounced antiviral activity.

The mechanism of action of ribavirin is not well understood. However, ribavirin is known to inhibit inosine monophosphate dehydrogenase (IMP), this effect leads to a marked decrease in the level of intracellular guanosine triphosphate (GTP), which, in turn, is accompanied by suppression of the synthesis of viral RNA and specific virus proteins. Ribavirin inhibits replication of new virions, which reduces the viral load. Ribavirin selectively inhibits viral RNA synthesis without inhibiting RNA synthesis in normally functioning cells. Ribavirin is effective against many DNA and RNA viruses.

The most sensitive to ribavirin DNA viruses are: Simplex herpes virus, Poks-virus, Virus of Marek's illness.

Viruses that are insensitive to ribavirin are: Varicella Zoster, Pseudorabies, Cow smallpox.

The most sensitive to ribavirin RNA viruses are: Influenza A, B, Paramyxovirus (parainfluenza, epidemic parotite, Nucasl's illness), Reoviruses, RNA tumoral viruses.

Insensitive to for the ribavirin RNA viruses include: Enteroviruses, Rhinovirus, Semlicy Forest.

Ribavirin has activity against the hepatitis C virus (HCV). The mechanism of action of ribavirin against HCV is not fully understood. It is assumed that ribavirin triphosphate, which accumulates as it phosphorylates, competitively suppresses the formation of guanosine triphosphate, thereby reducing the synthesis of viral RNAS. It is also believed that the mechanism of synergistic action of ribavirin and alpha-interferon against HCV is due to increased phosphorylation of ribavirin by interferon.

Indications

Chronic hepatitis C, treatment is carried out in combination with alpha-interferon:

• In primary patients not previously treated with alpha interferon.
• In case of exacerbation after a course of alpha-interferon monotherapy.
• In patients who are immune to alpha-interferon monotherapy.

Contraindications

• Hypersensitivity.
• Pregnancy.
• Lactation.
• Chronic heart failure IIB-III art.
• Heart attack.
• Renal failure (creatinine clearance-less than 50 ml / min).
• Severe anaemia.
• Liver failure .
• Decompensated cirrhosis of the liver .
• Autoimmune diseases (including autoimmune hepatitis).
• Unresponsive to treatment thyroid disease.
• Severe depression with suicidal intentions.
• Children and youth (up to 18 years).

With caution:

• Women of reproductive age (pregnancy is undesirable).
• Decompensated diabetes mellitus (with attacks of ketoacidosis).
• Chronic obstructive pulmonary disease.
• Pulmonary embolism.
• Chronic heart failure.
• Diseases of the thyroid gland (including thyrotoxicosis).
• Blood clotting disorders. Thrombophlebitis.
• Myelodepression.
• Hemoglobinopathy (including thalassemia, sickle cell anemia).
• Depression.
• The tendency to suicide (including in history).

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Dosage and administration

The drug is taken orally, without chewing and drinking water, simultaneously with food intake.

Patients with hepatitis C are recommended to take ribavirin at the rate of 15 mg per 1 kg of body weight, which corresponds to 800-1200 mg per day, i.e. 2-3 capsules in the morning and 2-3 capsules in the evening.

The usual recommended dose for patients with body weight less than 75 kg is 1000 mg per day (2 capsules in the morning and 3 capsules in the evening), patients weighing more than 75 kg it is recommended to take 1200 mg per day (3 capsules morning and 3 capsules in the evening).

The duration of combined therapy with ribavirin and alpha-interferon is usually 24 to 48 weeks. In this case, for previously untreated patients, the course duration is at least 24 weeks, and in patients with genotype 1 virus, the course duration is 48 weeks.

In patients who are immune to alpha-interferon monotherapy, as well as in cases of relapse, the duration of the course is at least 6 months.

Side effect

From the nervous system: headache, insomnia, asthenic syndrome, depression.

From the cardiovascular system: lowering blood pressure, bradycardia, cardiac arrest.

From the hematopoietic organs: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia.

Digestive system: decreased appetite, nausea, hyperbilirubinemia.

Allergic reactions: urticaria, angioedema, bronchospasm, anaphylaxis, skin rash.

Other: hair loss.

Special instruction

The teratogenicity of the drug should be taken into account.men and women of reproductive age should use effective contraceptives during treatment and for 7 months after the end of therapy.

Laboratory tests (clinical blood analysis with calculation of the leukocyte formula and platelet count, determination of electrolytes, creatinine content, liver function tests) should be performed before starting therapy, for 2 and 4 weeks, and then regularly.

In the course of ribavirin treatment, the maximum decrease in hemoglobin content is observed in most cases after 4-8 weeks from the beginning of treatment. With a decrease in hemoglobin below 110 mg/ml, the ribavirin dose should be temporarily reduced by 400 mg per day, with a decrease in hemoglobin below 100 mg / ml, the dose should be reduced to 50% of the original. In most cases, the recommended dose changes ensure that the hemoglobin level is restored. If the hemoglobin decreases below 85 mg/ml, the drug should be discontinued.

In case of acute hypersensitivity (urticaria, angioedema, bronchospasm, anaphylaxis), the drug should be stopped immediately. Transient rashes do not serve as a reason for interrupting treatment.

Influence on the ability to drive vehicles and control mechanisms: during treatment, people experiencing fatigue, drowsiness or disorientation should refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Use in elderly patients: due to possible deterioration of renal function in elderly patients, it is necessary to determine renal function, in particular creatinine clearance, before using the drug .

Drug interaction

When ribavirin and alpha-interferon are used together, there is a synergy of their action. No significant interactions were found in the clinical use of various drugs in therapeutic doses in combination with ribavirin. The administration of ribavirin during treatment with Zidovudine and / or Stavudine with simultaneous HIV infection is accompanied by a decrease in the phosphorylation of these drugs, which leads to HIV viremia and requires a change in the treatment regimen. There was no interaction between ribavirin and non-nucleoside reverse transcriptase inhibitors or protease inhibitors. Therefore, it is possible to use ribavirin and these drugs together to treat patients with combined HIV infection with hepatitis C. Drugs containing magnesium and aluminum compounds, simeticon, reduce the bioavailability of the drug.

Overdose

Symptoms: may increase the severity of side effects.

Treatment: withdrawal of the drug, symptomatic therapy.

Storage conditions

In a dry, dark place at a temperature not higher than 25°C.

Shelf life

2 years.