Ribavirin-Vertex, 200 mg capsules 30 pcs

Ribavirin triphosphate (RTF) is a potent inhibitor of inosine monophosphate dehydrogenase (IMP dehydrogenase), viral RNA polymerase and viral mRNA guanylyltransferase. Inhibition of the latter stops mRNA capping, resulting in significant depletion of intracellular guanosine triphosphate stores and inhibition of viral RNA and protein synthesis. Ribavirin also integrates into the viral genome, causing lethal mutations, with a subsequent reduction in the pathogenicity of the virus.

Ribavirin inhibits replication of new virions, which ensures reduction of viral load, selectively inhibits synthesis of viral RNA without suppressing RNA synthesis in normally functioning cells.

Ribavirin is effective against hepatitis C virus. Although the mechanism of action is completely unclear, it is thought that ribavirin triphosphate, which accumulates as it is phosphorylated, competitively suppresses guanosine triphosphate formation, thereby reducing viral RNA synthesis. It is also believed that the mechanism of synergistic action of ribavirin and interferon alfa-2b or peginterferon alfa-2b against hepatitis C virus is caused by the enhanced phosphorylation of ribavirin by interferon.

The DNA viruses most sensitive to ribavirin are herpes simplex virus, adenoviruses, CMV, smallpox group viruses, Marek’s disease; RNA viruses – influenza A, B, paramyxoviruses (parainfluenza, mumps, Newcastle disease), reoviruses, arenaviruses (Lassa fever virus, Bolivian hemorrhagic fever virus), bunyaviruses (Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus), hantaviruses (hemorrhagic fever virus with renal or pulmonary syndrome), oncogenic RNA viruses.

. Only when administered in prodromal period of hemorrhagic fever with renal syndrome it reduces severity of disease course, reduces duration of symptoms (fever, oliguria, pain in lumbar region, abdomen, headache), improves laboratory indexes of renal function (decreases degree of creatinine and blood urea), reduces risk of hemorrhagic complications and unfavorable results of disease.

DNA viruses insensitive to ribavirin are Varicella zoster, pseudorabies virus, natural cowpox; RNA viruses are enteroviruses, rhinoviruses, Semliki forest encephalitis virus.

Indications

Oral (in combination with interferon alpha-2b or peginterferon alpha-2b):

Chronic hepatitis C (in patients not previously treated with interferon alfa-2b or peginterferon alfa-2b;

In an exacerbation after a course of interferon alfa-2b or peginterferon alfa-2b monotherapy;

in patients who are unresponsive to interferon alfa-2b or peginterferon alfa-2b monotherapy).

Active ingredient

Composition

Active substances:

ribavirin 200 mg.

Associates:

milk sugar (lactose),

corn starch,

polyvinylpyrrolidone (povidone),

aerosil (colloidal silicon dioxide),

calcium octadecanoate (calcium stearate).

Composition of the shell:

gelatin,

water,

sodium lauryl sulfate,

Methylparaben,

propylparaben,

titanium dioxide dye.

How to take, the dosage

The drug is taken orally, without chewing and with water, at the same time as a meal.

Patients with hepatitis C should take ribavirin at a rate of 15 mg per 1 kg body weight, which is 800-1200 mg per day – 2-3 capsules in the morning and 2-3 capsules in the evening.

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

The duration of combination therapy with ribavirin and interferon alpha is usually 24 to 48 weeks. For previously untreated patients, the course duration is at least 24 weeks, and for patients with genotype 1 the course duration is 48 weeks.

In patients who are unresponsive to interferon alpha monotherapy or who relapse, the course is at least 6 months.

Interaction

When ribavirin and interferon alpha are used together, synergism is noted.

In clinical use of different drugs in therapeutic doses in combination with ribavirin, no significant interactions have been found.

The administration of ribavirin during treatment with Zidovudine and/or Stavudine in concurrent HIV infection is accompanied by a decrease in phosphorylation of these drugs, which leads to HIV viremia and requires a change in treatment regimen.

There have been no interactions between ribavirin and non-nucleoside reverse transcriptase inhibitors or protease inhibitors. Therefore, co-administration of ribavirin and these drugs for treatment of patients co-infected with HIV and hepatitis C is possible.

Drugs containing magnesium and aluminum compounds, simethicone decrease bioavailability of the drug.

Special Instructions

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

Laboratory studies (clinical blood count with leukocyte count and platelet count, determination of electrolytes, creatinine content, liver function tests) should be performed before the start of therapy, at 2 and 4 weeks, and regularly thereafter.

In treatment with ribavirin the maximum decrease in hemoglobin is in most cases observed after 4-8 weeks from the start of treatment. If hemoglobin decreases below 110 mg/ml, the dose of ribavirin should be temporarily reduced by 400 mg per day; if hemoglobin decreases below 100 mg/ml, the dose should be reduced to 50% of the initial dose. In most cases, the recommended dose changes provide hemoglobin recovery. If hemoglobin drops below 85 mg/ml, the drug should be stopped.

In case of acute manifestation of hypersensitivity (urticaria, angioedema, bronchospasm, anaphylaxis) the drug should be stopped immediately. Transient rashes are not a reason for discontinuing treatment.

Perhaps due to impairment of renal function in elderly patients, renal function, particularly creatinine clearance, must be determined before using the drug.

Impact on ability to drive and operate vehicles and other mechanisms requiring increased concentration

Persons who are tired, drowsy or disoriented during treatment should refrain from driving and engaging in potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

With caution: women of childbearing age (pregnancy is undesirable); decompensated diabetes (with episodes of ketoacidosis); chronic obstructive pulmonary disease; pulmonary embolism; chronic heart failure; thyroid disease (including thyrotoxicosis).including thyrotoxicosis; blood clotting disorders; thrombophlebitis; myelodepression; hemoglobinopathy (including thalassemia, sickle cell anemia); depression; suicidal tendencies (including in anamnesis).

Side effects

Nervous system disorders: headache, insomnia, neuropsychiatric asthenization, depression.

Cardiovascular system: decreased blood pressure, bradycardia, cardiac arrest.

Hematopoietic disorders: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia.

Digestive system disorders: decreased appetite, nausea, hyperbilirubinemia.

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

Others: hair loss.

Overdose

Symptoms: possible increase in the severity of side effects.

Treatment: drug withdrawal, symptomatic therapy.

Pregnancy use

It is contraindicated during pregnancy and lactation.

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