Ribavirin-Vertex, 200 mg capsules 60 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

Orally (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 exacerbation after a course of interferon alfa-2b or peginterferon alfa-2b monotherapy;
in patients who are not susceptible to interferon alfa-2b or peginterferon alfa-2b monotherapy).

Active ingredient

Composition

Active substance:

Ribavirin – 200 mg.

Auxiliary substances:

Milk sugar (lactose),

Corn starch,

Polyvinylpyrrolidone (povidone),

aerosil (colloidal silicon dioxide),

calcium octadecanoate (calcium stearate).

Capsules are hard gelatin:

gelatin,

water,

sodium lauryl sulfate,

methylparaben,

propylparaben,

titanium dioxide dye

How to take, the dosage

Ribavirin is taken orally with food, without chewing, with water.

In patients with hepatitis C, it is recommended to take 15 mg per 1 kg of body weight. For patients with body weight less than 75 kg – 1000 mg per day (400 mg in the morning and 600 mg in the evening), for patients with body weight more than 75 kg – 1200 mg per day (600 mg in the morning and in the evening).

The duration of the course of combined therapy with alpha-interferon is 24-48 weeks.

For previously untreated patients – at least 24 weeks; for patients with genotype I virus – 48 weeks; for patients unresponsive to alpha-interferon monotherapy and with relapse of the disease – 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.

Medications 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 investigations (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.

When using the drug, those who are tired, drowsy or disoriented should refrain from driving and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

The use in elderly patients: Due to possible worsening of renal function in elderly patients, renal function, particularly creatinine clearance, should be determined before using the drug.

Contraindications

Chronic heart failure stage IIB-III, myocardial infarction, renal failure (CK – less than 50 ml/min), severe anemia, severe liver failure, decompensated liver cirrhosis, autoimmune diseases (including autoimmune hepatitis. autoimmune diseases (including autoimmune hepatitis), non-treatable thyroid diseases, severe depression with suicidal tendencies, children and adolescents under 18 years old, pregnancy, lactation, hypersensitivity to ribavirin.

Side effects

CNS and peripheral nervous system disorders: headache, dizziness, general weakness, malaise, insomnia, asthenia, depression, irritability, anxiety, emotional lability, nervousness, agitation, aggressive behavior, confused consciousness; rarely – suicidal tendency, increased smooth muscle tone, tremor, paresthesia, hyperesthesia, hypoesthesia, fainting.

Cardiovascular system: decreased or increased BP, brady or tachycardia, palpitations, cardiac arrest.

Hematopoietic disorders: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia; very rarely – aplastic anemia.

Respiratory system disorders: dyspnea, cough, pharyngitis, dyspnea, bronchitis, otitis media, sinusitis, rhinitis.

Digestive system disorders: dry mouth, decreased appetite, nausea, vomiting, diarrhea, abdominal pain, constipation, perversion of taste, pancreatitis, flatulence, stomatitis, glossitis, gum bleeding, hyperbilirubinemia.

Sensory organs: lacrimal gland involvement, conjunctivitis, visual impairment, hearing impairment/loss, tinnitus.

Muscular system disorders: arthralgia, myalgia.

Urogenital system disorders: hot flashes, decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.

Overdose

Symptoms: possible increase in the severity of side effects.
Treatment: cancellation of the drug, symptomatic therapy.

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