ribavirin 200 mg
1 INDICATIONS AND USAGE Ribavirin tablets in combination with PEGASYS ® (peginterferon alfa-2a) are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating ribavirin tablets combination therapy with PEGASYS ® : This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm 3 . This indication is based on achieving undetectable HCV RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. Safety and efficacy data are not available for treatment longer than 48 weeks. The safety and efficacy of ribavirin tablets and PEGASYS ® therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy. The safety and efficacy of ribavirin tablets therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. Ribavirin tablets should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered. Ribavirin tablets are a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with PEGASYS ® in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (1)
aurobindo pharma limited
OVAL PINK F 10
F 10 OVAL PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIBAVIRIN Tablets USP, 200 mg are light pink colored, capsule shaped, film-coated tablets debossed with ‘F’ on one side and ‘10’ on the other side. Bottles of 168 NDC 65862-207-68 Bottles of 500 NDC 65862-207-05 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed.
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