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Basic Drug Info
Drug Name:Rebetol
Manufacturer:Schering Corporation
Other Info:

Manufactured by:Schering CorporationKenilworth, NJ 07033 USACopyright © 2001, 2002, 2003, Schering Corporation.

All rights reserved.Rev.

12/07B-XXXXXXXX



Clinical Trials:


Indications and Usage
REBETOL® (ribavirin, USP) Capsules and Oral Solution are indicated in combination with INTRON® A (interferon alfa-2b, recombinant) for Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients 18 years of age and older who have relapsed following alpha interferon therapy.REBETOL Capsules are indicated in combination with PegIntron™ (peginterferon alfa-2b) Powder for Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.The safety and efficacy of REBETOL Capsules or Oral Solution with interferons other than INTRON A or PegIntron products have not been established.
Liver diseases -- Pathological processes of the LIVER.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

Contraindications
Warnings

Based on results of clinical trials ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection; therefore, REBETOL® Capsules or Oral Solution must not be used alone.

The safety and efficacy of REBETOL Capsules and Oral Solution have only been established when used together with INTRON® A as a combination therapy or with PegIntron™ Injection.There are significant adverse events caused by REBETOL/INTRON A or PegIntron therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes.

Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up.

The INTRON A and PegIntron package inserts should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

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