Rebetol

Rebetol – antiviral drug.

Form of release and structure

Dosage form – capsules: the size No. 1, firm gelatinous, with an opaque surface of white color, on the case a blue strip and a text blue ink "200 mg", on a lid – a blue strip and the letters "SP", in capsules – white powder (on 10 pieces in the blister, in a cardboard box of 14 blisters).

Active ingredient of Rebetol – рибавирин, in 1 capsule – 0,2 g.

Auxiliary components: magnesium stearate, cellulose microcrystallic, sodium of a kroskarmelloz, lactose monohydrate.

Structure of a cover of the capsule: titanium dioxide, gelatin.

The structure blackened: ethanol, shellac, n-butanol, isopropanol, ammonium hydroxide, blue aluminum varnish FD&C No. 2, propylene glycol.

Indications to use

Combination therapy with peginterferon alpha 2b or interferon alpha 2b:

• Chronic hepatitis C at patients with the favorable response (normalization of activity of alaninaminotranspherase (ALT)) to earlier carried out therapy by interferon alpha 2b or peginterferon alpha 2b (at emergence of a recurrence of a disease);
• Chronic hepatitis C (earlier not treated, in the absence of symptoms of a decompensation of function of a liver, with a seropozitivnost to the RNA-containing hepatitis C virus, a superactivity of ALT, with the expressed inflammatory activity or fibrosis).

Contraindications

• Age up to 18 years;
• Steady against treatment, the unstable and other severe forms of a heart disease diagnosed within 6 months (at least) prior to therapy by drug;
• Sickemia, thalassemia and other types of hemoglobinopathies;
• Pathologies of a thyroid gland, steady against therapy;
• Severe forms of abnormal liver functions, dekompensirovanny cirrhosis;
• Autoimmune hepatitis and other autoimmune diseases;
• The expressed diseases of kidneys, including a chronic renal failure (the clearance of creatinine (CC) is less than 50 ml/min.) with need of carrying out a hemodialysis;
• Period of pregnancy and breastfeeding;
• Heavy depression, attempts of a suicide, suicide thoughts (including the anamnesis);
• Individual intolerance of a ribavirin and other components of drug.

With care appoint Rebetol sick with other heart diseases, a diabetes mellitus with tendency to ketoacidosis, heavy pathologies of lungs (including chronic obstructive diseases of lungs), considerable oppression of the hemopoietic function of marrow, disturbances of coagulability of blood (including an embolism of a pulmonary artery, thrombophlebitis), at a combination to highly active anti-retrovirus therapy (VAART) at patients with the accompanying HIV infection (because of increase in risk of development of lactic acidosis).

Route of administration and dosage

Capsules accept inside during food.

The doctor appoints a dose taking into account the patient's weight.

The daily dose of Rebetol can make from 0,8 g to 1,2 g, it is divided into 2 receptions (in the morning and in the evening). Drug is appointed in a combination with interferon alpha 2b (hypodermic (п / to) by injections on 3 million international units (ME) 3 times a week) or peginterferon alpha 2b (п / to – from calculation for 0,0000015 g to 1 kg of body weight of the patient once a week).

The recommended daily mode of dosing of a ribavirin for a combination with interferon alpha 2b:

• Weight of sick 75 kg or below: 1 – morning of 0,4 g and evening of 0,6 g;
• Weight is more than 75 kg: 1,2 – in the morning and in the evening on 0,6 g.

The recommended daily drug dosing for a combination with peginterferon alpha 2b:

• The weight of the patient is up to 65 kg: 0,8 – in the morning and in the evening on 0,4 g;
• Weight is from 65 to 85 kg: 1 – morning of 0,4 g and evening of 0,6 g;
• Weight is more than 85 kg: 1,2 – in the morning and in the evening on 0,6 g.

The recommended duration of use of a combination therapy no more than 12 months, a course of treatment is appointed individually depending on portability of drugs, clinical disease and therapeutic effect.

In 6 months of treatment of the patient has to undergo inspection on definition of the virologic answer. Lack of the virologic answer is the basis for the termination of a combination therapy.

At development of serious undesirable effects or emergence of deviations in indicators of laboratory researches during Rebetol's reception dose adjustment or temporary cancellation of therapy before complete cessation of symptoms of the undesirable phenomena is required.

The doctor makes correction of the mode of dosing on the basis of laboratory indicators of a hemoglobin content, number of leukocytes, thrombocytes, neutrophils, the content of the connected and free bilirubin in blood serum, concentration of creatinine, activity of alaninaminotranspherase and aspartate aminotransferase.

In the absence of improvement in a condition of the patient after dose adjustment, use of a combination therapy should be cancelled.

Side effects

• System of a hemopoiesis: hemolysis – the main toxic action (usually in itself is not the reason of cancellation of therapy); perhaps – moderately expressed anemia, a neutropenia, a leukopenia, thrombocytopenia, a granulocytopenia; in some cases – development of aplastic anemia (at a combination with interferon alpha 2b);
• Cardiovascular system: heartbeat, thorax pains, decrease or increase in the arterial pressure (AP), faint, tachycardia;
• Nervous system: sleeplessness, depression, irritability, headache, dizziness, concern, paresthesias, tremor, confusion of consciousness, hyperesthesia, hypesthesia, decrease in concentration of attention, nervousness, emotional lability, agressive behavior, contagious excitation; seldom – suicide thoughts or attempts (at a combination to interferon alpha 2b or peginterferon alpha 2b);
• Endocrine system: hypothyroidism, functional disorder of a thyroid gland (disturbance of level of thyritropic hormone);
• Alimentary system: a food faddism, nausea, vomiting, an abdominal pain, diarrhea, a lock, anorexia, dyspepsia, pancreatitis (at a combination with interferon alpha 2b), stomatitis, a meteorism, an odontorrhagia, a glossitis;
• Reproductive system: disturbance of a menstrual cycle, decrease in a libido, inflows, menorrhagia, amenorrhea, prostatitis;
• Sense bodys: conjunctivitis, defeat of the lacrimal gland, vision disorder, sonitus, decrease or hearing loss;
• Respiratory system: short wind, cough, pharyngitis, bronchitis, rhinitis, sinusitis;
• Musculoskeletal system: increase in a tone of unstriated muscles, mialgiya, arthralgia;
• Laboratory indicators: in some cases – passing increase in maintenance of an indirect bilirubin and uric acid (at hemolysis);
• Dermatological reactions: a xeroderma, an itch, rash, an alopecia, disturbance of structure of hair, an erythema, eczema, reactions of the raised photosensitivity, a herpes infection; in some cases – Stephens-Johnson's syndrome, a mnogoformny erythema, a toxic epidermal necrolysis (at a combination with interferon alpha 2b and peginterferon alpha 2b);
• Others: allergic reactions, an indisposition, thirst, dryness in a mouth, average otitis, weakness, a fever, a grippopodobny syndrome, fever, the increased sweating, weight reduction of a body, an adynamy, a viral infection, a fungal infection, a lymphadenopathy, pain in the place of an injection.

Development of side effects at the combined treatment can be connected with each of the used drugs separately or their combination.

Special instructions

Rebetol it is necessary to appoint only in a combination with interferon alpha 2b or peginterferon alpha 2b, safety and efficiency of use with other interferona is not established.

Use of interferon alpha 2b or peginterferon alpha 2b should be begun after attentive studying of the instruction attached to them.

Extra care is recommended to be shown at purpose of drug the patient with heart pathologies as the risk of development of anemia in this category of patients against the background of administration of drug considerably increases and can cause an exacerbation of a disease and/or heart failure. Therefore in case of deterioration in symptoms from cardiovascular system reception of capsules should be cancelled.

The basis for the termination of treatment is emergence of symptoms of a bronchospasm, a small tortoiseshell, a Quincke's disease, an anaphylaxis.

At tranzitorny skin rash treatment can be continued.

Treatment of patients of advanced age should be begun only after the research of function of kidneys.

Use of drug is shown to women of childbearing age only after receiving a negative take of the test for pregnancy which is carried out before the direct beginning of therapy. During treatment and within 6 months after its termination they have to use effective methods of contraception and monthly carry out tests for pregnancy. These precautionary measures are caused by great risk of teratogenic impact of a ribavirin on a fruit in case of approach of pregnancy during the period and within 6 months after treatment.

Sick men have to use condoms not to allow conception during therapy.

For confirmation of the diagnosis the histologic research of a liver can be required.

Carrying out regular laboratory blood analyses with calculation of number of thrombocytes and a leukocytic formula, the analysis of electrolytes, determination of level of creatinine in blood serum, functional trials of a liver is required. The analysis is carried out prior to treatment, after the second and fourth week of therapy, then it is regular, as required.

Rebetol can cause in patients drowsiness, a disorientation, fatigue therefore during use of a combination therapy it is recommended to refrain from control of vehicles and mechanisms.

Medicinal interaction

At simultaneous use of a combination therapy of Rebetol with interferon alpha 2b and peginterferon alpha 2b:

• The antiacid means containing симетикон, compounds of aluminum or magnesium: reduce bioavailability of a ribavirin, however interaction is not considered clinically significant;
• Zidovudine, ставудин: can cause increase in concentration of the human immunodeficiency virus (HIV) in a blood plasma (careful monitoring of indicators of level of content of RNA (RNA) of HIV in plasma is required and in case of their increase it is necessary to reconsider further use of this combination);
• Didanozin, абакавир and other purine analogs of nucleosides: increase risk of development of lactic acidosis.

The possibility of medicinal interaction with Rebetol remains within two months after his cancellation.

Terms and storage conditions

To store at a temperature up to 30 °C. To protect from children.

Period of validity – 2 years.