DACLATA

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DACLATA Product Information Leaflets
Brand Name:
Daclatasvir
Generic Name:
DACLATA (Daclatasvir 60mg)

DESCRIPTION:

Daclata (Daclatasvir) is an inhibitor of HCV nonstructural protein 5A (NS5A). Daclatasvir is freely soluble in water (>700 mg/mL).

COMPOSITION:

Daclata 30mg Tablets: Each film coated tablet contains: Daclatasvir dihydrochloride equivalent to daclatasvir .......... 30mg. Daclata 60mg Tablets: Each film coated tablet contains: Daclatasvir dihydrochloride equivalent to daclatasvir .......... 60mg.

INDICATIONS:

Daclata is indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. It's use is limited in: Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving daclatasvir in combination with sofosbuvir for 12 weeks.

DOSAGE & ADMINISTRATION:

The recommended dosage of Daclata is 60 mg, taken orally, once daily in combination with sofosbuvir for 12 weeks. Daclatasvir may be taken with or without food. The optimal duration of Daclatasvir and sofosbuvir for patients with cirrhosis has not been established. If sofosbuvir is permanently discontinued in a patient receiving Daclata with sofosbuvir, then Daclata should also be discontinued.

CONTRAINDICATIONS:

It is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of Daclatasvir. Contraindicated drugs include, Anticonvulsants drugs (phenytoin, carbamazepine, Antimycobacterial agents (rifampin), Herbal products St. John's wort (Hypericum perforatum).

UNDESIRABLE EFFECTS:

The reported adverse events are; Serious symptomatic bradycardia, headache and fatigue, nausea and diarrhea. The laboratory abnormalities which includes transient, asymptomatic lipase elevations of greater than 3 times the upper limit of normal (ULN).

PRESENTATION:

Daclata 30mg tablets: Alu. Alu. blister pack of 4 x 7's. Daclata 60mg tablets: Alu. Alu. blister pack of 4 x 7's.

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, the effects on the breastfed infant, or the effects on milk production is available. Daclatasvir is present in the milk of lactating rats. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Daclatasvir and any potential adverse effects on the breastfed infant from Daclatasvir or from the underlying maternal condition.

Patients should consult with their physician before taking any medicine.