Ribavirin - instructions for use, analogs, reviews and release forms (capsules and tablets 200 mg) of the drug for the combined treatment of chronic hepatitis C in conjunction with interferon alpha in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Ribavirin. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Ribavirin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of ribavirin in the presence of existing structural analogues.Use for combined treatment of chronic hepatitis C in conjunction with Interferon alpha in adults, children, as well as in pregnancy and lactation.

Ribavirin antiviral agent. Quickly penetrates into the cells and acts inside the virus-infected cells. Intracellularly, 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 information RNA, the latter being manifested by inhibition of the coating process by an RNA-envelope. These various effects lead to a significant decrease in the amount of intracellular guanosine triphosphate, as well as suppression of the synthesis of viral RNA and protein. Ribavirin inhibits the replication of new virions, which reduces viral load, selectively inhibits the synthesis of viral RNA, without suppressing the synthesis of RNA in normally functioning cells.

The most active against DNA viruses is the respiratory syncytial virus, the Herpes simplex virus types 1 and 2 (herpes simplex), adenoviruses, CMV, smallpox viruses,Marek's disease; RNA viruses - influenza A, B viruses, paramyxoviruses (parainfluenza, mumps, Newcastle disease), reoviruses, arenaviruses (Lassa fever virus, Bolivian hemorrhagic fever), bunyaviruses (Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus), hantaviruses (hemorrhagic fever virus with renal or pulmonary syndrome) paramyxoviruses, oncogenic RNA viruses.

When treating hemorrhagic fever with kidney syndrome reduces the severity of the disease, reduces the duration of symptoms (fever, oliguria, pain in the lumbar region, abdomen, headache), improves laboratory indicators of kidney function, reduces the risk of hemorrhagic complications and an unfavorable outcome of the disease.

Ribavirin is immune to DNA viruses - Varicella zoster, pseudorabies virus, cowpox; RNA viruses - enteroviruses, rhinoviruses, encephalitis virus of the forest Semliki.

Composition

Ribavirin + excipients.

Pharmacokinetics

After ingestion, ribavirin is easily and almost completely absorbed from the digestive tract. Absolute bioavailability is approximately 45-65%, which, apparently, is associated with metabolism during the "first passage" through the liver. Ribavirin does not bind to plasma proteins.The metabolism of ribavirin is carried out by reversible phosphorylation and by cleavage - deibosylation and amide hydrolysis to form a triazole carboxyl metabolite. Removing ribavirin from the body is slow. Ribavirin and its metabolites - triazolcarboxamide and triazolecarboxylic acid - are excreted from the body with urine. Only about 10% of the dose is excreted with feces.

After ingestion of a single dose of the drug together with a high-fat diet, the bioavailability of ribavirin increased (Cmax and AUC increased by 70%). Apparently, this is due to a slowdown in the ribavirin transport or a change in the pH of the gastric contents. The significance of this phenomenon for the clinic is not defined. Nevertheless, in order to achieve the maximum concentration of ribavirin in the blood plasma, it is recommended to take the drug along with the food.

Indications

In the combination therapy with interferon alpha 2b:

• recurrence of chronic hepatitis C in patients older than 18 years who had previously been treated with interferon alfa with a prolonged effect (ALT normalization by the end of the treatment course);
• chronic hepatitis C, confirmed histologically, previously untreated,without signs of decompensation of liver function, with increased ALT, seropositivity to RNA virus of hepatitis C, in the presence of fibrosis or severe inflammatory activity.

For inhalation use: inpatient treatment of infants and children of early childhood suffering from severe lower respiratory infections caused by the respiratory syncytial virus.

Forms of release

Capsules 200 mg.

Tablets 200 mg.

Instructions for use and dosing regimen

The drug is taken orally at a dose of 1-1.2 g per day, divided into 2 doses (morning and evening). The dose depends on the patient's body weight. With a body weight of 75 kg and below, the drug is prescribed in a daily dose of 1 g in 2 divided doses: 2 capsules of 200 mg in the morning and 3 capsules of 200 mg in the evening; with a body weight above 75 kg, the daily dose is 1.2 g in 2 divided doses: 3 200 mg capsules in the morning and 3 200 mg capsules in the evening.

The duration of treatment depends on the clinical course of the disease.

The recommended duration of treatment for patients with relapse after the previous treatment is 6 months, and for untreated patients - at least 24 weeks. In the latter case, treatment should be extended for a further 24 weeks (up to 48 weeks in total) to patients with genotype 1,who had a high concentration of hepatitis C RNA virus in the blood before the start of treatment, and by the end of the first 24 weeks of treatment, the hepatitis C virus RNA had ceased to be detected.

Side effect

• reduction of hemoglobin due to hemolysis;
• the appearance of mild anemia, leukopenia, granulocytopenia, thrombocytopenia;
• possibly a dysfunction of the thyroid gland (change in the content of TSH);
• skin rash;
• hives;
• angioedema;
• bronchospasm;
• anaphylaxis;
• arterial hypotension;
• change in laboratory indicators.

Contraindications

• severe heart disease (including unstable and resistant to therapy forms) for up to 6 months before starting Ribavirin therapy;
• Thyroid disease, resistant to therapy;
• hemoglobinopathy (including thalassemia, sickle cell anemia);
• chronic renal failure (QC less than 50 ml / min), severe depression, suicidal thoughts or suicide attempts (including in history);
• severe impairment of liver function or decompensated liver cirrhosis;
• autoimmune diseases (including autoimmune hepatitis);
• pregnancy;
• lactation period;
• increased sensitivity to ribavirin and other components of the drug.

Application in pregnancy and lactation

Contraindicated use of the drug Ribavirin during pregnancy and lactation (breastfeeding).

Treatment with ribavirin should not be started until a negative pregnancy test result is obtained, which should be performed immediately before starting the drug.

Sick women of childbearing age who take Ribavirin, as well as their sexual partners, must use effective methods of contraception during therapy and for at least 4 months after the end.

Monthly during this entire period it is necessary to conduct pregnancy tests. If the pregnancy occurs during treatment or within 4 months after the end, the patient should be informed of the significant risk of teratogenic exposure to ribavirin on the fetus.

Sick men and their partners - women of childbearing age should also use reliable methods of contraception. Ribavirin accumulates intracellularly and is excreted from the body very slowly.To exclude the possible teratogenic effects of ribavirin, each partner should use an effective contraceptive during treatment, and at least 7 months after the end. Men should use a condom to minimize the risk of getting ribavirin into the vagina.

It is not known whether any component of ribavirin is excreted in breast milk.

Due to the high risk of adverse effects of ribavirin on the baby, breastfeeding should be discontinued before the drug is started.

In experimental animal studies, ribavirin has been shown to have embryotoxic and teratogenic effects at doses significantly lower than those recommended for clinical use. In animals, ribavirin caused sperm changes at doses below the therapeutic dose.

Use in children

Safety and effectiveness of the drug in the treatment of children and adolescents is not established. Therefore, use in patients under the age of 18 years is not recommended.

special instructions

The safety and efficacy of combination therapy has been studied only with the use of ribavirin with interferon alpha 2b.

With caution, after an appropriate examination and only under the supervision of a cardiologist, Ribavirin should be prescribed to patients with heart disease, anemia that occurs when the drug is taken (a decrease in hemoglobin levels below 10 g / dl was observed in 14% of patients receiving ribavirin during clinical trials), may worsen heart failure and / or worsening of the symptoms of the disease. If symptoms of worsening of the cardiovascular system appear, treatment should be stopped.

Ribavirin should be used with caution in patients with severe lung diseases (in particular, chronic obstructive pulmonary diseases), with diabetes mellitus with ketoacidosis, with blood clotting disorders (including thrombophlebitis, pulmonary embolism), with severe myelodepression.

For allergic reactions (urticaria, angioedema, bronchospasm, anaphylaxis), ribavirin should be immediately withdrawn and appropriate treatment should be prescribed. Transient skin rash is not a reason to interrupt treatment.

Since the functional capacity of the kidneys and liver can decrease with age, older patients need to investigate their function before starting Ribavirin.

Control of laboratory indicators

Laboratory tests (clinical blood count with calculating the leukocyte count and platelet count, electrolyte analysis, determination of serum creatinine content, functional liver tests) should be performed before treatment, then at the 2nd and 4th week of treatment, and then regularly, as needed.

In the event of serious adverse events or abnormalities in laboratory parameters during the use of the drug, the dose should be adjusted or the drug should be stopped until the elimination of adverse events.

Impact on the ability to drive vehicles and manage mechanisms

Persons who experience fatigue, drowsiness, or disorientation in the treatment of ribavirin should refrain from performing work requiring increased attention and speed of psychomotor reactions (including driving, controlling mechanisms).

Drug Interactions

With the simultaneous administration of ribavirin in a dose of 600 mg with an antacid drug containing magnesium and aluminum compounds or simethicone, the AUC decreased by 14%.

With simultaneous use of ribavirin and interferon, alpha 2b drug interaction was not detected.

Ribavirin inhibits the phosphorylation of zidovudine and stavudine. The clinical significance of these data has not been fully established. However, they suggest that simultaneous use of ribavirin with zidovudine or stavudine may lead to an increase in the concentration of RNA-HIV in the blood plasma. Therefore, careful monitoring of plasma RNA-HIV concentrations in patients treated with ribavirin in combination with either of these agents is recommended. When the concentration of RNA-HIV in the plasma increases, the use of ribavirin in combination with reverse transcriptase inhibitors should be reviewed.

Evidence of the interaction of ribavirin with non-nucleoside reverse transcriptase inhibitors or protease inhibitors is not available. Therefore, ribavirin can be administered together with these agents for the treatment of patients with co-infection with HIV and viral hepatitis C.

The possibility of drug interaction or other interaction with ribavirin may persist for up to 2 months after discontinuation of its use due to delayed excretion.

Analogues of the drug Ribavirin

Structural analogs for the active substance:

• Arviron;
• Vero Ribavirin;
• Virazole;
• Devirs;
• Rebetol;
• Ribavin;
• Ribavirin Meduna;
• Ribavirin Lipint;
• Ribavirin SZ;
• Ribavirin FPO;
• Ribamidyl;
• Ribapeg;
• Trivorin.

Analogues for the pharmacological group (antiviral agents):

• Avonex;
• Agenerase;
• Alloferon;
• Algeron;
• Algiers;
• Altevir;
• Alfaron;
• Alfaferon;
• Amiksin;
• Anaferon;
• Anaferon child;
• Baraklid;
• Valcite;
• Videx;
• Wiktrelis;
• Viramune;
• Viracept;
• Viread;
• Virocomb;
• Virolam;
• Viferon;
• Woodist;
• Wallferon;
• Genfaxon;
• Genferon;
• Gepon;
• Herpferon;
• Hyaferon;
• Hyporamine;
• Groprinosin;
• Devirs;
• Didanosine;
• Zidovudine;
• Isoprinosine;
• Ingavirin;
• Inter;
• Interferon alfa-2 human recombinant;
• Interferon gamma recombinant human;
• Intron A;
• Inferon;
• Kagocel;
• Lavomax;
• Lamivudine;
• Lokferon;
• Midantan;
• Nevirapine;
• Norvir;
• Realdiron;
• Reaferon;
• Relenza;
• Remantadine;
• Riluzole;
• Rimantadine;
• Ritonavir;
• Roferon A;
• Stavudine;
• Tenofovir;
• Tyloron;
• Timaside;
• Trizivir;
• Fladex;
• Hide;
• Eberon alpha;
• Extavia;
• Erazaban;
• Efavirenz.

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