Ribavirin-SZ, 200 mg capsules 120 pcs

Ribavirin C3 is an antiviral drug. It quickly penetrates cells and acts inside virus-infected cells. Intracellularly, ribavirin is easily phosphorylated by adenosine kinase to mono-, di- and triphosphate metabolites.

Ribavirin triphosphate is a strong competitive inhibitor of inosine monophosphate dehydrogenase, influenza virus RNA polymerase and guanylyl RNA informational transferase, the latter manifested by inhibition of the informational RNA envelope coating process.

These diverse effects result in a significant decrease in intracellular guanosine triphosphate as well as suppression of viral RNA and protein synthesis. Ribavirin inhibits the replication of new virions, which provides a reduction in viral load, selectively inhibits viral RNA synthesis without suppressing RNA synthesis in normally functioning cells.

The most active against DNA viruses – respiratory syncytial virus, Herpes simplex viruses types 1 and 2, adenoviruses, CMV, smallpox viruses, Marek’s disease; RNA viruses – influenza A, B, paramyxoviruses (parainfluenza, epidemic parotitis, 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) paramyxoviruses, oncogenic RNA viruses.

In treatment of hemorrhagic fever with renal syndrome it reduces disease severity, decreases duration of symptoms (fever, oliguria, pains in the lumbar region, abdomen, headache), improves laboratory indexes of renal function and decreases the risk of hemorrhagic complications and unfavorable results of disease.

Ribavirin is insensitive to DNA viruses – Varicella zoster, pseudorabies virus, natural cowpox; RNA viruses – enteroviruses, rhinoviruses, Semliki forest encephalitis virus.

Indications

Hepatitis

Chronic viral hepatitis C (in combination with interferon alfa-2b or peginterferon alfa-2b):

• in primary patients not previously treated with interferon alfa-2b or peginterferon alfa-2b;
• in patients who are unresponsive to interferon alfa-2b or peginterferon alfa-2b monotherapy.

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Active ingredient

Ribavirin

Composition

Active ingredient:

• Ribavirin 200 mg.

• Excipients:

• lactose monohydrate (milk sugar) – 96 mg,

• colloidal silica (aerosil) – 2 mg,

• magnesium stearate – 2 mg.

Composition of the capsule body:

• titanium dioxide,

• gelatin.

Capsule cap composition:

• titanium dioxide,

• gelatin.

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How to take, the dosage

The drug is taken orally with meals. The capsules are swallowed whole without chewing and with water.

The recommended dose is 0.8-1.2 g/day in 2 doses (morning and evening).

Interferon alfa-2b is indicated concomitantly – by injection 3 million ME three times a week or peginterferon alfa 2b – by injection 1.5 mcg/kg once a week. In combination with interferon alfa-2b in case of body weight less than 75 kg a dose of ribavirin is 1 g/day (0.4 g in the morning and 0.6 g in the evening); above 75 kg – 1.2 g/day (0.6 g in the morning and 0.6 g in the evening). In combination with peginterferon alfa-2b the dose of ribavirin in body weight less than 65 kg is 0.8 g/day (0.4 g in the morning and 0.4 g in the evening), in body weight 65-85 kg – 1 g/day (0.4 g in the morning and 0.6 g in the evening), over 85 kg – 1.2 g/day (0.6 g in the morning and 0.6 g in the evening).

The duration of treatment is 24 to 48 weeks; with at least 24 weeks for previously untreated patients and 48 weeks for patients with genotype 1 virus. In patients resistant to interferon alfa monotherapy, and also in case of relapse – at least 6 months to 1 year (depending on the clinical course of the disease and the response to ongoing therapy).

Interaction

Medicinal products containing magnesium and aluminum compounds, simethicone decrease the bioavailability of the drug (AUC decreases by 14%, which has no clinical significance).

In co-administration with interferon alpha-2b or peginterferon alpha-2b – synergism of action.

The use of ribavirin during treatment with zidovudine and/or stavudine is accompanied by a decrease in their phosphorylation, which may lead to HIV viremia and require a change in the treatment regimen.

It increases the concentration of phosphorylated metabolites of purine nucleosides (including didanosine, abacavir) and the associated risk of lactacidosis.

There is no effect on hepatic enzymatic activity involving cytochrome P450.

Concomitant ingestion of high-fat foods increases the bioavailability of ribavirin (AUC and C_max are increased by 70%).

Special Instructions

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 investigations (clinical blood count with leukocyte formula 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 ribavirin dose should be temporarily reduced by 400 mg/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 discontinued.

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.

With regard to possible worsening of renal function in elderly patients, renal function tests, particularly CK, should be performed before using the drug.

Impact on driving and operating ability

Patients 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

• Chronic heart failure II-III stage.
• Myocardial infarction;
• Kidney failure (CK less than 50 ml/min);
• Hepatic failure;
• hepatic cirrhosis in decompensation stage;
• severe anemia;
• autoimmune diseases (incl.ч. autoimmune hepatitis;
• not treatable thyroid disease;
• Severe depression with suicidal intentions;
• children and adolescents under 18 years of age;
• pregnancy;
• lactation period;
• hypersensitivity.

With caution, use the drug in decompensated diabetes mellitus (with bouts of ketoacidosis); chronic obstructive pulmonary disease; pulmonary embolism; chronic heart failure; thyroid diseases (including Thyrotoxicosis); blood clotting disorders; thrombophlebitis; myelodepression; hemoglobinopathy (including thalassemia, sickle cell anemia); depression, suicidal tendencies (including in anamnesis), women of reproductive age (pregnancy is not desired), elderly patients.

Side effects

Nervous system disorders: headache, dizziness, insomnia, depression, irritability, anxiety, emotional lability, nervousness, agitation, aggressive behavior, confusion; rarely – suicidal tendency, increased smooth muscle tone, tremor, paresthesia, hyperesthesia, hypoesthesia, fainting.

Visually: lesion of the lacrimal gland, conjunctivitis, visual impairment.

Hearing organ: impairment/loss of hearing, tinnitus.

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

Hematopoietic system 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.

Reproductive system: decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.

Muscular system disorders: arthralgia, myalgia.

Allergic reactions: skin rash, erythema, urticaria, hyperthermia, angioedema, bronchospasm, anaphylaxis, photosensitization, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Others: general weakness, malaise, asthenia, hair loss, conjunctivitis, alopecia, hair texture disorders, dry skin, hypothyroidism, chest pain, thirst, fungal infection, viral infection, flu-like syndrome, sweating, lymphadenopathy, flushes.

Overdose

Symptoms: possible increase in the severity of side effects.

Treatment: discontinue the drug, conduct symptomatic therapy.

Similarities

Devirs, Ribavirin