Ribavirin 200 MG Oral Capsule
1 INDICATIONS AND USAGE Ribavirin is a nucleoside analogue indicated in combination with interferon alfa- 2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. ( 1.1 ) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. 1.1 Chronic Hepatitis C (CHC) Ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease [see Warnings and Precautions ( 5.9 , 5.10 ), and Use in Specific Populations ( 8.4 )]. The following points should be considered when initiating ribavirin capsules combination therapy with PegIntron ® or INTRON A ® : Combination therapy with ribavirin /PegIntron is preferred over ribavirin /INTRON A as this combination provides substantially better response rates [see Clinical Studies ( 14 ) ]. Patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see Clinical Studies ( 14 ) ]. No safety and efficacy data are available for treatment duration lasting longer than one year.
Zydus Pharmaceuticals (USA) Inc.
CAPSULE WHITE ZA 12 200mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
RIBAVIRIN capsules USP, 200 mg are white to off-white granular powder filled in size '0' hard gelatin capsules with white colored cap printed with "ZA-12" in black ink and white colored body printed with "200mg" in black ink and are supplied as follows: NDC 68382-260-04 in bottle of 42 capsules NDC 68382-260-07 in bottle of 56 capsules NDC 68382-260-09 in bottle of 70 capsules NDC 68382-260-12 in bottle of 84 capsules NDC 68382-260-13 in bottle of 140 capsules NDC 68382-260-03 in bottle of 168 capsules NDC 68382-260-28 in bottle of 180 capsules NDC 68382-260-10 in bottle of 1000 capsules NDC 68382-260-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Dispense in a tight container. Storage Conditions: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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