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See related Copegus film-coated tab information |
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Manufacturer |
Roche |
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Distributor |
DKSH |
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Contents |
Ribavirin |
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Indications |
In combination w/ peginterferon α-2a or interferon α-2a, for the treatment of chronic hepatitis C in previously untreated serum HCV-RNA positive adults, including those w/ compensated cirrhosis. In combination w/ peginterferon α-2a for the treatment of patients who failed previous treatment w/ interferon α (pegylated or non-pegylated) alone or in combination therapy w/ ribavirin. |
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Dosage |
Depends on viral genotype. Genotype 1, 4: 1,000-1,200 mg daily for 48 wk. Adult <75 kg 1,000 mg daily: 2 tab morning & 3 tab evening, >75 kg 1,200 mg daily: 3 tab morning & evening. Genotype 2, 3: 800 mg daily for 24 wk (2 tab morning & evening). Taken in 2 divided doses (morning & evening). HIV-HCV co-infection 800 mg for 48 wk, regardless of genotype. |
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Administration |
Should be taken with food |
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Contraindications |
Hemoglobinopathies, hepatic decompensation & pregnancy. |
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Special Precautions |
Teratogenic risk; perform routine mthly pregnancy tests during & 6 mth thereafter. Preexisting significant or unstable disease. Assess & monitor cardiac status prior to & during therapy. Assess clinical status & hepatic function in HIV-HCV co-infection; discontinue use if Child-Pugh score ≥7. Renal impairment. Perform standard hematologic tests prior to initiating therapy & at 2 & 4 wk of therapy & periodically thereafter. |
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Adverse Drug Reactions |
Headache, fatigue, myalgia, pyrexia, rigors, insomnia, nausea, irritability, alopecia, pruritus, arthralgia, asthenia, diarrhea, dermatitis, dry skin, anorexia, depression.
View ADR Monitoring Form |
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Pregnancy Category (US FDA) |
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Copegus film-coated tablet |
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Copegus 200 mg x 42's |
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Manufacturer: |
Roche |
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Distributor: |
DKSH
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