Copeg 200 mg (Capsule)

Indications

• Treatment of chronic hepatitis C (CHC) virus infection
• Combination therapy with other antiviral drugs
• Compensated liver disease
• Adult CHC patients coinfected with HIV

Pharmacology

• Inhibitory action against respiratory syncytial virus, influenza virus, and herpes simplex virus
• Mechanism of action not clear
• Interference with viral nucleic acid synthesis
• Responsibility of mono- and triphosphate derivatives for antiviral action

Dosage & Administration

• Recommended treatment duration of 24 to 48 weeks
• Assessment of virologic response after 24 weeks
• Safety and efficacy data for treatment duration
• Different dosage regimens for genotype and weight categories

Interaction

• Potential interactions with nucleoside reverse transcriptase inhibitors
• Concomitant use with azathioprine
• Reported induction of severe pancytopenia and increased risk of myelotoxicity

Contraindications

• Contraindicated in pregnant women
• Potential fetal harm
• Contradiction in patients with hemoglobinopathies
• Reports of fatal hepatic failure and other adverse reactions in combination with didanosine

Side Effects

• Common adverse reactions in adults and pediatric subjects
• Psychiatric and central nervous system effects
• Ocular and dental disorders
• Growth inhibition in children and adolescents

Pregnancy & Lactation

• Pregnancy Category X
• Embryocidal and/or teratogenic effects in animal studies
• Not known excretion in human milk
• Potential for serious adverse reactions in nursing infants

Precautions & Warnings

• Avoid use in pregnancy and for 6 months post-treatment
• Requirement of negative pregnancy test prior to therapy
• Use of contraception and monthly pregnancy tests
• Importance of preventing pregnancy in male patients' partners

Use in Special Populations

• Safety and effectiveness not established in pediatric patients below 3 years
• Greater risk of toxic reactions in patients with impaired renal function
• Dose adjustments based on creatinine clearance

Therapeutic Class

• Hepatic viral infections (Hepatitis C)

Storage Conditions

• Keep out of the reach of children
• Store in a cool & dry place
• Protection from light

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