Expiration date: 12/2025
Composition
1 caps. contains ribavirin 200 mg
Packaging
30 or 60 PCs.
Pharmacological action
Antiviral agent. Ribavirin rapidly penetrates into the cells and acts within 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 information RNA transferase, the latter being manifested by inhibition of the information RNA coating process. These diverse effects lead to a significant reduction in the amount of intracellular guanosine triphosphate, as well as suppression of viral RNA and protein synthesis. Ribavirin inhibits the replication of new virions, which reduces the viral load, selectively inhibits the synthesis of viral RNA, without suppressing the synthesis of RNA in normally functioning cells.
Indications
Treatment of chronic hepatitis C in adults (in combination with interferon alpha-2b or peginterferon alpha-2b).
Contraindications
Chronic heart failure of stage IIB-III, myocardial infarction, renal failure (CC - less than 50 ml/min), severe anemia, severe liver failure, decompensated cirrhosis of the liver, autoimmune diseases (including autoimmune hepatitis), untreatable thyroid diseases, severe depression with suicidal tendencies, children and adolescents under 18 years of age, pregnancy, lactation, hypersensitivity to ribavirin.
Dosage and administration
Ribavirin is taken orally, during meals, without chewing, with water.
For hepatitis C, it is recommended to take the drug at the rate of 15 mg per 1 kg of body weight. Patients with body weight less than 75 kg — 1,000 mg per day (400 mg morning and 600 mg in the evening), patients with body weight over 75 kg — 1200 mg daily (600 mg in the morning and evening).
The duration 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 who are immune to alpha-interferon monotherapy and with relapse of the disease-at least 6 months.
Side effect
From the Central nervous system and peripheral nervous system: headache, dizziness, General weakness, malaise, insomnia, asthenia, depression, irritability, anxiety, emotional lability, nervousness, excitement, aggressive behavior, confused consciousness, rarely-suicidal tendency, increased tone of smooth muscles, tremor, paresthesia, hyperesthesia, hypesthesia, fainting.
From the cardiovascular system: decrease or increase in blood PRESSURE, Brady or tachycardia, heartbeat, cardiac arrest.
From the hematopoietic organs: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, very rarely-aplastic anemia.
Respiratory system: dyspnea, cough, pharyngitis, shortness of breath, bronchitis, otitis media, sinusitis, rhinitis.
From the digestive system: dry mouth, decreased appetite, nausea, vomiting, diarrhea, abdominal pain, constipation, perversion of taste, pancreatitis, flatulence, stomatitis, glossitis, bleeding from the gums, hyperbilirubinemia.
On the part of the senses: lacrimal gland damage, conjunctivitis, visual impairment, hearing impairment/loss, tinnitus.
From the musculoskeletal system: arthralgia, myalgia.
From the genitourinary system: hot flashes, decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.
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.
During the treatment period, 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.
Medicines containing magnesium and aluminum compounds, simetikon 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 place protected from light, at a temperature not higher than 20 °C.
