Dacatec

Dacatec Dosage/Direction for Use

daclatasvir

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Full Prescribing Info
Dosage/Direction for Use
Treatment with Dacatec (Daclatasvir) should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Posology: The recommended dose of Dacatec (Daclatasvir) is 60 mg once daily, to be taken orally with or without meals.
Dacatec (Daclatasvir) must be administered in combination with other medicinal products. The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Dacatec (Daclatasvir).
Recommended regimens and treatment duration are provided in Table. (See Table 1.)

Click on icon to see table/diagram/image

Dose modification of Dacatec (Daclatasvir) to manage adverse reactions is not recommended. If treatment interruption of components in the regimen is necessary because of adverse reactions, Dacatec (Daclatasvir) must not be given as monotherapy.
There are no virologic treatment stopping rules that apply to the combination of Dacatec (Daclatasvir) with sofosbuvir.
It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR); therefore discontinuation of treatment is recommended in these patients. The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are presented in Table. (See Table 2.)

Click on icon to see table/diagram/image

The dose of Dacatec (Daclatasvir) should be reduced to 30 mg once daily when coadministered with strong inhibitors of CYP3A4 and 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Patients should be instructed that, if they miss a dose of Dacatec (Daclatasvir), the dose should be taken as soon as possible if remembered within 20 hours of the scheduled dose time. However, if the missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next dose taken at the appropriate time.
Method of administration: Dacatec (Daclatasvir) is to be taken orally with or without meals. Patients should be instructed to swallow the tablet whole. The film-coated tablet should not be chewed or crushed due the unpleasant taste of the active substance.
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