Description
Release form
Capsules
Packing
120 pcs.
Pharmacological action
Ribavirin C3 – an antiviral agent. It quickly penetrates cells and acts inside virus-infected cells. Intracellular ribavirin is readily phosphorylated by adenosine kinase to mono-, di- and triphosphate metabolites. Ribavirin triphosphate is a strong competitive inhibitor of inosine monophosphate dehydrogenase, RNA polymerase of influenza virus and guanylyl transferase of messenger RNA, the latter is manifested by inhibition of the process of coating with messenger RNA coat. These diverse effects lead to a significant reduction in the amount of intracellular guanosine triphosphate, as well as the suppression of the synthesis of viral RNA and protein. Ribavirin inhibits the replication of new virions, which reduces the viral load, selectively inhibits the synthesis of viral RNA, without inhibiting RNA synthesis in normally functioning cells.
Most active against DNA viruses – respiratory syncytial virus, Herpes simplex virus types 1 and 2, adenoviruses, CMV, smallpox viruses, Marek’s disease RNA viruses – influenza A, B viruses, paramyxoviruses (parainfluenza, mumps, Newcastle diseases), reoviruses, arenaviruses (Lass fever virus, Bolivian hemorrhagic fever), bunyaviruses (Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus), hantaviruses (hemorrhagic fever virus with renal pulmonary syndrome) Russ, oncogenic RNA viruses.
In the treatment of hemorrhagic fever with renal syndrome, it reduces the severity of the disease, reduces the duration of symptoms (fever, oliguria, pain in the lumbar region, abdomen, headache), improves laboratory parameters of kidney function, reduces the risk of hemorrhagic complications and an unfavorable outcome of the disease.
DNA viruses are insensitive to ribavirin – Varicella zoster, pseudorabies virus, natural cowpox RNA viruses – enteroviruses, rhinoviruses, Semlica forest encephalitis virus.
Indications
Chronic viral hepatitis C (in combination with interferon alfa-2b or peginterferon alfa-2b):
in primary patients, previously not treated with interferon alfa-2b or peginterferon alfa-2b
during exacerbation after a course of monotherapy with interferon alfa-2b or peginterferon alfa-2b
in patients immune to monotherapy with interferon alfa-2b or peginterferon alfa-2b.
Contraindications
chronic heart failure IIb-III Art.
myocardial infarction
renal failure (CC less than 50 ml / min)
liver failure
liver cirrhosis at the stage of decompensation
severe anemia
autoimmune diseases (including autoimmune hepatitis) severe disease intentions
childhood and adolescence under 18
pregnancy
lactation
hypersensitivity.
Caution is advised to prescribe a drug for decompensated diabetes mellitus (with attacks of ketoacidosis) of chronic obstructive pulmonary disease of pulmonary thromboembolism, chronic heart failure, thyroid diseases (including thyrotoxicosis), blood coagulation disorders, thrombophlebitis in hemoglobin depression. including thalassemia, sickle cell anemia) depression, suicidal tendency (including history) to women of reproductive age (pregnancy is undesirable) for elderly patients.
Composition
Active ingredient: ribavirin 200 mg.
Excipients: lactose monohydrate (milk sugar) – 96 mg, colloidal silicon dioxide (aerosil) – 2 mg, magnesium stearate – 2 mg.
Capsule body composition: titanium dioxide, gelatin.
Composition of capsule cap: titanium dioxide, gelatin.
Dosage and administration of
The drug is taken orally, with meals. Capsules are swallowed whole without chewing and drinking with water.
Recommended dose is 0.8-1.2 g / day in 2 divided doses (morning and evening).
At the same time, interferon alfa-2b is administered s / c at 3 million ME 3 times a week or peginterferon alfa-2b is s / c 1.5 mcg / kg once a week. When combined with interferon alfa-2b with a patient weighing up to 75 kg, the 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). When combined with peginterferon alfa-2b with a patient weighing less than 65 kg, the dose of ribavirin is 0.8 g / day (0.4 g in the morning and 0.4 g in the evening), with a body weight of 65-85 kg – 1 g / day (0.4 g in the morning and 0.6 g in the evening), more than 85 kg – 1.2 g / day (0.6 g in the morning and 0.6 g in the evening).
Duration of treatment – 24 – 48 weeks, while for previously untreated patients – at least 24 weeks, in patients with genotype 1 virus – 48 weeks. In patients immune to interferon alfa monotherapy, as well as in relapse, at least 6 months-1 year (depending on the clinical course of the disease and response to the therapy).
Side effects of the
From the nervous system: headache, dizziness, insomnia, depression, irritability, anxiety, emotional lability, nervousness, agitation, aggressive behavior, confused consciousness rarely – suicidal tendency, increased smooth muscle tone, tremor, paresthesia, hyperesthesia, hypesthesia, fainting.
From the side of the organ of vision: damage to the lacrimal gland, conjunctivitis, visual impairment.
On the part of the organ of hearing: impaired / loss of hearing, tinnitus.
From the cardiovascular system: decreased or increased blood pressure, bradycardia or tachycardia, palpitations, cardiac arrest.
From the hemopoietic system: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia is extremely rare – aplastic anemia.
From the 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, taste perversion, pancreatitis, flatulence, stomatitis, glossitis, bleeding from the gums, hyperbilirubinemia.
From the reproductive system: decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.
From the musculoskeletal system: arthralgia, myalgia.
Allergic reactions: skin rash, erythema, urticaria, hyperthermia, angioedema, bronchospasm, anaphylaxis, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Other: general weakness, malaise, asthenia, hair loss, conjunctivitis, alopecia, impaired hair structure, dry skin, hypothyroidism, chest pain, thirst, fungal infection, viral infection, flu-like syndrome, sweating, lymphadenopathy, hot flashes.
Drug Interactions
Medicines containing magnesium and aluminum compounds, simethicone reduce the bioavailability of the drug (AUC decreases by 14%, which has no clinical significance).
When combined with interferon alfa-2b or peginterferon alfa-2b – synergistic action.
The use of ribavirin during treatment with zidovudine and / or stavudine is accompanied by a decrease in their phosphorylation, which can lead to HIV viremia and require a change in treatment regimen.
Increases the concentration of phosphorylated metabolites of purine nucleosides (including didanosine, abacavir) and the associated risk of lactic acidosis.
Does not affect the enzymatic activity of the liver with the participation of cytochrome P450.
Concurrent high-fat meals increase the bioavailability of ribavirin (AUC and Cmax increase by 70%).
Overdose
Symptoms: may increase the severity of side effects.
Treatment: drug withdrawal, symptomatic therapy.
Storage Conditions
The product should be stored out of reach of children, protected from light at a temperature not exceeding 25 ° C.
The Expiration of
is 3 years.
active substance
Ribavirin
Conditions of release from drugstores
Prescription pptro4 apl4 TMP
