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Ribastad 200
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Ribastad 200 contains ribavirin which is a synthetic nucleoside and guanosine analog that shows in vitro activity against some RNA and DNA viruses and then inhibits protein synthesis and viral replication. Ribastad 200 is indicated for the treatment of hepatitis C, haemorrhagic fevers.

Pack size Box of 14 tablets, 28 tablets
Shelf-life 24 months
Composition Ribavirin
Dosage forms and strengths Film-coated tablet: 200 mg
Product code :

PRESCRIBING INFORMATION

Indications:

Chronic hepatitis C in patients with cirrhosis compensation not receiving interferon or reoccurrence of interferon alpha-2b therapy: Co-administered with interferon alpha-2b or peginterferon alpha-2b. This phase is effective for HCV-HIV co-infection.

Several kinds of viral haemorrhagic fevers: Lassa fever, Haemorrhagic fevers with renal syndrome, pulmonary syndrome, Crimean-Congo haemorrhagic fevers.

Dosage:

Chronic hepatitis C: Ribavirin is used with interferon for oral use:

  • Adults: 800 mg/day, in two divided doses. Dose adjustment depends on body-weight (up to 1200 mg/day for those > 85 kg)
  • Children > 3 years of age: 15 mg/kg body-weight/day, in two divided doses.

Ribavirin is always used with interferon (3 – 5 million IU, injected 3 times a week) or peginterferon (1.5 µg/kg, injected once a week).

In those with hepatitis C infection alone (mono-infection), patients with viral genotype 1, 4: should generally be treated for 48 weeks and those with genotype 2 or 3 for 24 weeks; data on genotypes 5 or 6 are insufficient to make recommendations. In co-infection with HIV, treatment should generally be given for 48 weeks regardless of genotype.

In cases of reoccurrence treated with interferon: Continue the treatment with ribavirin within 24 weeks. Discontinuation of therapy should be considered if the patient has failed to detect HCV RNA levels after 24 weeks of therapy.

  • Haemorrhagic fevers (Lassa fever, viral fever):
  • Prophylaxis: Adults with risk of high exposure: Orally use 500 – 600 mg, with 6-hour-interval for 7 – 10 days.

Children 6 – 9 years of age: Orally use 400 mg, with 6-hour-interval for 7 – 10 days. Children < 6 years of age, doses have not been determined.

Usage:

Ribastad 200 is administered orally twice a day, regardless of meals. However, ribavirin is absorbed better after taking fatty-meals.

Hypersensitivity to ribavirin or to any of the excipients of the product.

Pregnant women, women of childbearing potential and their partners who have intercourse with them; Women who are breast-feeding; A history of myocardial ischaemia, severe pre-existing cardiac disease, unstable or uncontrolled cardiac disease, in the previous six months; Severe renal disease; Haemoglobinopathies.

Concomitant of ribavirin and peginterferon alpha or interferon alpha for patients with psychiatric disorders, autoimmune hepatitis, severe hepatic impairment, decompensated cirrhosis, cirrhosis with chronic HCV infection, decompensated cirrhosis-HIV co-infection prior and during the treatment.

Concomitant of ribavirin and didanosine.

Headache, fatigue, weight loss, nausea, anorexia, diarrhea, abdominal pain, vomiting, dry mouth, constipation, decreased hemoglobin, anaemia, neutropenia,…

Caution should be exercised when ribavirin is used for patients less than 18 years of age.

Either male patients or their female partners of childbearing age must, therefore, be counselled to use a form of effective contraception during treatment with ribavirin and for 6 – 7 months after treatment has been concluded.

Several symptoms related to psychiatric disorders in patients receiving ribavirin and interferon alpha-2b co-administration.

Ribavirin induces blood disorders, examination should be taken before the treatment.

Breast-feeding women should not use the drug.

Patients should be aware of how they react to drug before driving or operating machinery.