ASTRAPHARM #Preparations_for_the_treatment_of_infections #Antiviral_agents #HEALTH_CARE
Product description
Ribavirin-Astrafarm capsules are indicated for the treatment of chronic hepatitis C (CHC) in combination with other preparations.
Composition
Active substance: ribavirin;
1 capsule contains ribavirin in terms of 100% substance 200 mg;
Excipients: microcrystalline cellulose, potato starch, magnesium stearate, colloidal anhydrous silicon dioxide;
The composition of the capsule shell: gelatin, titanium dioxide (E 171), indigo carmine blue (E 132), quinoline yellow (E 104).
Contraindications
Hypersensitivity to ribavirin or to any of the excipients.
Severe heart disease, including unstable and uncontrolled forms, that are observed within 6 months before starting treatment.
Severe debilitating diseases.
Chronic renal failure or creatinine clearance <50 ml / min and / or conditions requiring hemodialysis.
Severe liver dysfunction (Child-Pugh grade B or C) or decompensated liver cirrhosis.
The appointment of peginterferon alfa-2b is contraindicated in patients co-infected with hepatitis C / HIV virus, with liver cirrhosis and impaired liver function> 6 points according to the Child-Pugh classification.
Anamnestic or clinical evidence of a severe mental disorder, such as severe depression, suicidal ideation or attempted suicide in children.
History of autoimmune hepatitis or other autoimmune diseases (due to combination with peginterferon alpha-2b or interferon alpha-2b).
Hemoglobinopathies (eg, thalassemia, sickle cell disease).
Pregnancy period. Treatment with Ribavirin-Astrafarm can be started only after receiving a negative pregnancy test immediately before starting treatment.
Breastfeeding period.
Men whose women are pregnant.
Mode of application
The therapy should be carried out by a physician experienced in the treatment of chronic hepatitis C. The preparation Ribavirin-Astrafarm should be taken 2 times a day (morning and evening) while eating. Due to the teratogenic potential of ribavirin, the capsules should not be broken.
Ribavirin should be used in combination with peginterferon alfa-2a or interferon alfa-2a. The exact dose and duration of the preparation depends on the interferon used.
For additional information regarding dosage and duration of use, see the instructions for medical use of peginterferon alfa-2a or interferon alfa-2a in the case of using ribavirin in combination with one of these preparations.
Application features
Pregnant
Contraindicated.
Children
Regarding the use of the preparation Ribavirin-Astrafarm, children need to assess the benefit / risk ratio in each individual case.
Drivers
Carefully.
Overdose
The maximum level of ribavirin overdose during clinical trials is known to be 10 g (50 capsules of 200 mg) together with 39 million IU of interferon alfa-2b in the form of a solution for injection (13 subcutaneous injections of 3 million IU). This amount was taken by the patient for the purpose of suicide during the day. The patient was followed up for 2 days in the emergency department; during this time, no adverse reactions associated with overdose have been identified.
Due to the large volume of distribution, ribavirin is not significantly eliminated by hemodialysis.
Treatment: preparation withdrawal, symptomatic therapy.
Side effects
A characteristic feature of the safety profile of ribavirin is hemolytic anemia that occurs during the first weeks of therapy. Hemolytic anemia associated with the use of ribavirin can lead to a deterioration in cardiac function and / or a worsening of existing cardiac pathology. In some patients, an increase in the level of uric acid and indirect bilirubin associated with hemolysis was also observed.
Interaction
Didanosine. The simultaneous administration of ribavirin and didanosine is not recommended. The exposure of didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) in vitro increases with the simultaneous use of didanosine and ribavirin. The combined use of these preparations can lead to fatal liver failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia or lactic acidosis.
Azathioprine. Ribavirin, inhibiting inosine monophosphate dehydrogenase, can affect the metabolism of azathioprine, which can lead to the cumulation of 6-methylthioinosine monophosphate associated with myelotoxicity in patients receiving azathioprine. Avoid the simultaneous use of the preparation Ribavirin-Astrafarm and peginterferon alfa-2a with azathioprine. In some cases, with the advantage of the simultaneous use of ribavirin and azathioprine over the potential risk, careful monitoring of hematological parameters is recommended in order to detect myelotoxicity, with the development of which treatment with these preparations should be discontinued.
Storage conditions
Keep out of the reach of children.
Shelf life is 2 years.
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