Daclacee 60 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Daclatasvir |
| Company | Jenphar bangladesh ltd |
Indications
Daclacee is indicated in combination with Sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Pharmacology
Daclatasvir is a direct acting antiviral agent (DAA) against the Hepatitis C Virus (HCV). Daclatasvir is an inhibitor of NS5A, a nonstructural protein encoded by HCV. Daclatasvir binds to the N-terminus of NS5A and inhibits both viral RNA replication and virion assembly.
Dosage & Administration
- Recommended Dosage: The recommended dose of Daclatasvir is 60 mg once daily, to be taken orally with or without meals.
- Daclatasvir must be administered in combination with other medicinal products.
Interaction
- Potential for Other Drugs to Affect Daclacee: Daclacee is a substrate of CYP3A.
- Potential for Daclacee to Affect Other Drugs: Daclacee is an inhibitor of P-glycoprotein transporter (P-gp), organic anion transporting polypeptide (OATP) 1B1 and 1B3, and breast cancer resistance protein (BCRP).
Contraindications
Daclatasvir is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of Daclatasvir.
Side Effects
The following serious adverse reactions are described below and elsewhere in the labeling: Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone.
Pregnancy & Lactation
No data with Daclatasvir in pregnant women are available to inform a drug-associated risk. No information regarding the presence of Daclatasvir in human milk.
Precautions & Warnings
Risk of adverse reactions or loss of virologic response due to drug interactions. The concomitant use of Daclacee and other drugs may result in known or potentially significant drug interactions.
Use in Special Populations
- Elderly: No dose adjustment of Daclacee is required for patients aged ≥65 years.
- Renal impairment: No dose adjustment of Daclacee is required for patients with any degree of renal impairment.
- Hepatic impairment: No dose adjustment of Daclacee is required for patients with mild, moderate, or severe hepatic impairment.
- Paediatric population: The safety and efficacy of Daclacee in children and adolescents aged below 18 years have not yet been established.
Overdose Effects
There is no known antidote for overdose of Daclacee. Treatment of overdose with Daclacee should consist of general supportive measures.
Therapeutic Class
Hepatic viral infections (Hepatitis C)
Storage Conditions
Store at room temperature below 30°C, protect from light, keep out of the reach of children.