Monograph Details
|
|
Infections & Infestations
> Viral infections
|
|
REBETOL ORAL SOLUTION |
| Manufacturer |
|
Schering Corporation |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Nucleoside analogue. |
| Generic Name |
|
Ribavirin 40mg/mL; liq; bubble-gum flavor. |
| Also |
|
• REBETOL
|
| Indications |
|
Chronic hepatitis C: in combination with recombinant interferon alfa-2b (Intron A), in patients ≥3 years of age with compensated liver disease previously untreated with interferon alpha or in patients who have relapsed after interferon alpha therapy. |
| Children |
|
Genotype 1: treat for 48 weeks (reevaluate after 24 weeks). Genotype 2/3: treat for 24 weeks. Give consistently with regard to food. <3yrs: not recommended. ≥3yrs: 15mg/kg per day in divided doses (AM & PM). Use soln if ≤25kg or cannot swallow caps. 25–36kg: 200mg twice daily (AM & PM). 37–49kg: 200mg in AM and 400mg in PM. 50–61kg: 400mg twice daily (AM & PM). >61kg: as adult. Dose adjustments: see literature. |
| Adults |
|
Interferon-naive: treat for 24–48 weeks. Relapse: Treat for 24 weeks. Give consistently with regard to food. With Intron A: ≥18yrs (≤75kg): 400mg in AM and 600mg in PM; >75kg: 600mg twice daily (AM & PM). With PEG-Intron: <66kg: 400mg twice daily (AM & PM); 66–85kg: 400mg in AM and 600mg in PM; 86–105kg: 600mg twice daily (AM & PM); >105kg: 600mg in AM and 800mg in PM. Dose adjustments: see literature. |
| Contraindications |
|
Autoimmune hepatitis. Hemoglobinopathies (eg, thalassemia major, sickle-cell anemia): not recommended. Male partners of pregnant women. Pregnancy (Cat.X). |
| Precautions |
|
Renal impairment (CrCl <50 mL/min), significant or unstable cardiac disease: not recommended. Women of childbearing potential: obtain negative pregnancy test immediately before starting therapy. Women of childbearing potential and men: use 2 forms of effective contraception during and for 6 months following treatment. Do baseline CBC (and at weeks 2 and 4 or more often if needed), WBCs with differential, platelets, blood chemistry, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Reduce dose or discontinue if severe reactions or hematologic abnormalities occur. Discontinue if cardiovascular status deteriorates. Psychiatric disorders: temporarily reduce dose if mild depression occurs; discontinue if severe depression or suicidal ideation/attempt occurs. Autoimmune disorders. Organ transplant. Pancreatitis (discontinue if occurs). Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus or HIV infection. Maintain adequate hydration. Elderly. Nursing mothers: not recommended. |
| Interactions |
|
Avoid alcohol. May antagonize stavudine, zidovudine. Concomitant didanosine: not recommended. |
| Adverse Reactions |
|
Anemia, other hematological disorders, flu-like symptoms, cardiac and pulmonary events, psychiatric effects, dizziness, GI upset, alopecia, rash, pruritus, diabetes, pancreatitis, dental and periodontal disorders. |
| How Supplied |
Caps—42, 56, 70, 84
Soln—100mL |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
