Daclavir

Daclavir

daclatasvir

Manufacturer:

Pharmaniaga Manufacturing Berhad

Distributor:

Pharmaniaga Logistics

Marketer:

Pharmaniaga Marketing
Concise Prescribing Info
Contents
Daclatasvir
Indications/Uses
In combination w/ other medicines for chronic hepatitis C in adults.
Dosage/Direction for Use
60 mg once daily. Co-administered w/ strong CYP3A4 inhibitors 30 mg once daily. Co-administered w/ moderate CYP3A4 inducers 90 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ strong CYP3A4 & P-gp inducers eg, phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.
Special Precautions
Not to be given as monotherapy. Severe bradycardia & heart block. Patients w/ genotype 4 & 6 HCV infection; HBV/HCV co-infection; prior exposure to NS5A inhibitor. Perform HBV screening prior to treatment. Concomitant use w/ amiodarone. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception for 5 wk after completion of therapy. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Anaemia; headache; nausea; fatigue. Decreased appetite; insomnia, irritability; dizziness, migraine; hot flush; dyspnoea, exertional dyspnoea, cough, nasal congestion; diarrhoea, vomiting, abdominal pain, GERD, constipation, dry mouth, flatulence; rash, alopecia, pruritus, dry skin; arthralgia, myalgia.
Drug Interactions
Increased conc w/ boceprevir, simeprevir, telaprevir, atazanavir/ritonavir, dolutegravir, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, clarithromycin, telithromycin, erythromycin, dabigatran etexilate, antifungals, digoxin, Ca-channel blockers, HMG-CoA reductase inhibitors, narcotic analgesics. Decreased conc w/ efavirenz, etravirine, nevirapine, carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.
MIMS Class
ATC Classification
J05AP07 - daclatasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Presentation/Packing
Form
Daclavir FC tab 60 mg
Packing/Price
28's
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