Ribavirin-SZ, 400 mg capsules, 60 pcs.

Hepatitis

Triple therapy:

The treatment of chronic hepatitis C virus (hepatitis C virus genotype 1) in combination with boceprevir and peginterferon alfa-2b in adult patients (18 years and older) with compensated liver disease who have not previously received antiviral therapy or in patients in whom prior antiviral treatment has been ineffective.

Double therapy:

The treatment of chronic viral hepatitis C in adult patients and children from 3 to 18 years only in combination with interferon alfa-2b or peginterferon alfa-2b. Ribavirin-SZ is not used as monotherapy.

Patients who have not previously received therapy

Adults

• Double therapy – treatment of chronic hepatitis C virus in combination with peginterferon alfa-2b in adult patients with compensated cirrhosis and/or clinically stable HIV infection.

Children 3 to 18 years of age

• Dual therapy – treatment of chronic viral hepatitis C in combination with interferon alfa-2b (Intron® A) or peginterferon alfa-2b in pediatric patients (3 years and older) seropositive for hepatitis C virus RNA, with no signs of decompensated liver disease, who have not been treated previously.

When deciding whether to treat pediatric patients, it is important to keep in mind that combination therapy may cause growth retardation in some pediatric patients. The decision to prescribe treatment must be made on a case-by-case basis (see section “Special Indications”).

Patients who have previously received therapy

Adults

• Triple therapy – treatment of chronic hepatitis C virus (hepatitis C virus genotype 1) in combination with peginterferon alfa-2b and boceprevir in adult patients with compensated liver disease in whom previous antiviral therapy has been ineffective;
• double therapy – treatment of chronic viral hepatitis C in adult patients in combination with interferon alfa-2b who were previously treated with interferon alfa monotherapy (with normalization of ALT activity by the end of treatment) and who subsequently relapsed into disease.

The guidelines for medical use of interferon alfa-2b, peginterferon alfa-2b and boceprevir should also be considered when prescribing combination therapy.

Active ingredient

Composition

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

It has no effect on hepatic enzymatic activity involving cytochrome P450.

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

Directions for use

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 3 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).

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 the end 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 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 grounds for discontinuation of 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 machinery

Patients who are tired, drowsy, or disoriented during treatment should refrain from driving and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

– Hypersensitivity to ribavirin or any other component of the drug;

– Pregnancy and breastfeeding (see section “Administration during pregnancy and breastfeeding”).

– children less than 3 years of age and a body weight of less than 25 kg.

– severe heart disease, including unstable and uncontrolled forms that have existed for at least 6 months prior to treatment (see section “Special Precautions. Special Indications);

– severe depression, suicidal thoughts or attempts, including those based on medical history (only for children from 3 to 18 years);

– chronic renal failure, creatinine clearance below 50 ml/min, need for hemodialysis;

– severe liver function impairment (Child-Pugh grades B or C) or decompensated cirrhosis;

– hemoglobinopathies (e.g., thalassemia, sickle cell anemia);

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– cirrhosis with liver failure in patients with HCV/HIV co-infection (Child-Pugh index > 6);

– thyroid disease if not amenable to drug correction;

– autoimmune hepatitis or other autoimmune diseases;

– rare hereditary diseases such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

– patients with severe debilitating illnesses.

– Cardiovascular disease (not in the categories listed as contraindications);

– Severe lung disease (e.g., chronic obstructive pulmonary disease);

– Diabetes mellitus with ketoacidotic coma;

– disorders related to the clotting system (e.g., thrombophlebitis, pulmonary embolism) or significant suppression of the hematopoietic function of the bone marrow;

– combined treatment with HAART (highly active antiretroviral therapy) in concomitant HIV infection (due to toxic effects on the mitochondrial system and an increased risk of lactate acidosis);

– severe depression, suicidal thoughts or attempts, including those based on history (only for adults).

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.

Pregnancy use

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