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See related Copegus tab information |
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Manufacturer |
Roche |
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Distributor |
Hong Kong: DKSH |
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Contents |
Ribavirin |
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Indications |
In combination w/ peginterferon α-2a in the treatment of previously untreated chronic hepatitis C in adults. In combination therapy with α-interferon for treatment of chronic hepatitis C in adult patients who have previously responded to interferon-α monotherapy but who have subsequently relapsed; chronic hepatitis C that has been demonstrated histologically, by elevated transaminases & by presence HCV RNA in serum, in interferon-naive adult patients w/ compensated liver disease, elevated ALT & fibrosis or high inflammatory activity. |
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Dosage |
In combination w/ peginterferon α-2a Genotype 1 w/ & w/o RVR <75 kg 1,000 mg for 48 wk; ≥75 kg 1,200 mg for 48 wk. Genotype 4 w/ & w/o RVR <75 kg 1,000 mg for 48 wk; ≥75 kg 1,200 for 48 wk. Treatment for 24 wk may be considered in patients infected w/ genotype 1 w/ low viral load (LVL) (≤800,000 IU/mL) at baseline w/ RVR & genotype 4 w/ RVR. Genotype 2/3 800 mg for 24 wk. In combination w/ interferon-α Patient <75 kg 1,000 mg for 24 or 48 wk; ≥75 kg 1,200 mg for 24 or 48 wk. To be taken orally in 2 divided doses (morning & evening). |
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Administration |
Should be taken with food (Swallow whole, do not chew/crush.). |
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Contraindications |
Hypersensitivity. Planned or possible pregnancy in female patients or in female partners of male patients. Hemoglobinopathies. Hepatic decompensation; HIV-HCV patients w/ cirrhosis & Child-Pugh score ≥6. |
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Special Precautions |
Must not be used alone. Assess cardiac status prior to initiating & during treatment. Cardiac function may deteriorate or symptoms of coronary disease exacerbated. Discontinue if acute hypersensitivity reaction eg urticaria, angioedema, bronchoconstriction, anaphylaxis develops. Discontinue if liver function deteriorates. Renal impairment. May affect ability to drive or operate machinery when used in combination w/ interferon-α or peginterferon-α. Teratogenic risk. Nursing mothers. Monthly pregnancy test during treatment & for 6 mth thereafter for female patients & female partners of male patients. |
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Adverse Drug Reactions |
Anemia, insomnia, irritability, depression, anorexia, headache, dizziness, dyspnea, cough, nausea, diarrhea, abdominal pain, alopecia, pruritus, dry skin, arthralgia, myalgia, asthenia, concentration impairment, dermatitis, fatigue, pyrexia, rigors, inj site reaction, pain.
View ADR Monitoring Form |
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Drug Interactions |
Al-, Mg- & simethicone-containing antacids reduce bioavailability. Zidovudine, stavudine, didanosine.
View more drug interactions with Copegus |
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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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ATC Classification |
J05AB04 - ribavirin ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Copegus tablet |
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Copegus 200 mg x 42's |
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Copegus 200 mg x 168's |
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Manufacturer: |
Roche |
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Distributor: |
Hong Kong: DKSH |
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