Rebetol - the antiviral drug for the pharmacological treatment of chronic hepatitis C.
Structure and Composition
According to the instructions issued in the form of Rebetol capsules for oral administration. The active ingredient - ribavirin. In 1 capsule contains 200 mg of the drug ribavirin. Also included in the Rebetola auxiliaries: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide, gelatin.
Rebetol is produced in PVC blisters (10 capsules in blister pack 1). The carton of 14 blisters.
Pharmacological action Rebetola
According to the instructions Rebetol has antiviral action. This drug is a derivative of nucleoside analogues, which are active against certain viruses. However Rebetol monotherapy against HCV is not effective. This preparation must be combined with interferon alfa-2b or pegylated interferon alpha 2b, a combination of drugs more effectively than the use of interferon alfa-2b or peginterferon alfa-2b as the sole therapeutic agent. The exact mechanism of action is unknown Rebetola.
After oral administration of Rebetol manual is well absorbed and rapidly distributed in the body. This drug does not bind to serum proteins. Repeated reception Rebetol accumulates in serum in large quantities. According to the instructions Rebetola its pharmacokinetics in patients with hepatic failure is not different from that in healthy individuals.
Rebetol administered in combination with interferon alfa-2b or peginterferon alfa 2bv the following cases:
- Treatment of patients with chronic viral hepatitis C, if they have not received appropriate therapy and who have no signs of decompensation of the disease, with higher rates of ALT, seropositive result for hepatitis C virus RNA, as well as the presence of fibrosis, or severe inflammatory activity;
- Treatment of patients with chronic hepatitis C who have previously been treated with interferon alfa / peginterferon alfa and had a positive result on therapy (normalization of ALT to the end of the course), if they relapsed disease.
Rebetol is appointed with peginterferon alfa-2b in the following situations:
- treatment of patients with chronic hepatitis C who have no signs of decompensation, with elevated ALT levels, the result of a seropositive HCV RNA at existing hepatic fibrosis or significant activity of the process, if they have not previously received treatment. Also included patients with HIV infection (clinically stable).
Hypersensitivity to the ingredients of the drug, severe cardio - vascular system, thyroid disease (which can not be correct dosage), chronic renal failure (with the need for dialysis), hemoglobinopathies (sickle - cell anemia, thalassemia), decompensated cirrhosis, severe depression, autoimmune diseases, pregnancy and lactation, children under 18 years.
Precautions Rebetol may be imposed for severe respiratory diseases (such as asthma), diabetes with ketoatsidoticheskaya coma, inhibition of hematopoiesis function, or coagulation disorders (eg, pulmonary embolism, thrombophlebitis).
Dosing and Administration
According to the instructions Rebetol should be taken orally during a meal at a dosage of 800-1400 mg per day (depending on body weight). The drug is taken in two doses - in the morning and evening. Interferon alfa-2b administered simultaneously by injection of 3 million IU three times per week (or peginterferon alfa-2b at a dose of 1, 5 mg / kg body weight one time in 7 days). Duration of treatment is determined individually Rebetol and can last up to 1 year.
Side effects Rebetola
Review Rebetol can often cause side reactions, but since it is always administered in combination with interferon preparations (which also causes unwanted effects), then identify the exact frequency of adverse events is not possible.
When applying Rebetola patients may often (10% of cases) viral infections occur (pharyngitis, rhinitis, etc.), 1% of cases observed fungal infections, otitis media, herpes infections, genitourinary infections. Rarely (0, 01%) having pneumonia.
In the opinion of Rebetol often causes disorders of the hematopoietic system (anemia, neutropenia, lymphopenia), very rare (at 0, 01% of cases), this drug can cause aplastic anemia, thrombocytopenic purpura.
Since the immune system is very rare (0, 001% of the time) may cause Rebetol sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis, hypersensitivity reactions.
Endocrine system 1% of active drug may promote hypothyroidism, hyperthyroidism. Rarely (0, 01% of cases) receiving Rebetola provoking the development of diabetes.
Metabolism, reviews, Rebetol often causes anorexia (10.1% of cases), often contributes to the development of hyperglycemia, hypocalcemia, and there were cases increase appetite and thirst occurrence.
From the mental state of the reception Rebetola, reviews, in 10% of cases lead to depression, insomnia, emotional lability. In 1% of cases occurred suicidal thoughts, aggressive behavior, nervousness, insomnia, apathy, loss of libido.
From the nervous system Rebetol in 10% of cases cause headaches, dizziness, impaired concentration. In 1% of cases, the drug provoked the appearance of paresthesias, tremor, ataxia, dysphonia, hyperesthesia, migraine, taste perversion.
Cardio - vascular system is often the drug (1% of cases) caused heart rate, decreased / increased blood pressure. At 0, 1% of the cases occurred cardiomyopathy, arrhythmias.
The respiratory system in 10% of cases, according to reviews, Rebetol, causes shortness of breath and cough. Less commonly (1% of cases) the drug contributed to the emergence of sinusitis, bronchitis, nasal bleeding, swelling of the mucous membranes of the nose and rhinorrhea.
From the digestive system Rebetol often (10%) can cause nausea, vomiting, diarrhea, dry mouth. Less commonly (1% of cases) it causes disease, colitis, abdominal pain, glossitis, flatulence. At 0, 1% of the drug contributes to the appearance of pancreatitis.
With the genitourinary system Rebetol, reviews, may cause 1% of frequent urination, polyuria. Rarely (0, 1%) drug helps symptoms of renal dysfunction.
From the body of Rebetol, reviews, 1% of cases receiving calls blurred vision, eye pain, and conjunctivitis. At 0, 01% of the observed hemorrhages in the retina, retinopathy, optic neuritis, papilledema.
For the skin and fatty tissue the drug can cause itching, dry skin, rash (10% of cases). Less commonly (1%) was observed when taking Rebetola dermatitis, abrasions, photosensitivity.
Known one case of overdose with this drug when the patient received 10 grams (50 capsules) Rebetola in one day. No reactions associated with overdose, it has not been registered. Treatment of symptomatic him
Special instructions for use Rebetola
Treatment with this drug should be conducted under the supervision of a physician. The drug has embryotoxic and teratogenic, so the appointment of its women of childbearing age need to be convinced of the absence of pregnancy.