Strides Pharma Science


Concise Prescribing Info
In combination w/ other medicinal products for chronic hepatitis C (CHC) in adults.
Dosage/Direction for Use
1 tab once daily. Patient w/ genotype 1 or 4 CHC In combination w/ ribavirin & peginterferon α for 12 wk. Patient w/ genotype 2 CHC In combination w/ ribavirin for 12 wk. Patient w/ genotype 3 CHC In combination w/ ribavirin & peginterferon α for 12 wk or w/ ribavirin only for 24 wk. Patient w/ genotype 1, 2, 3 or 4 CHC awaiting liver transplant In combination w/ ribavirin until liver transplant. Liver transplant recipient in combination w/ ribavirin Initially 400 mg in 2 divided doses, may be titrated up to max: 1,000 mg daily for patient <75 kg & 1,200 mg daily for patient ≥75 kg, for 24 wk.
Should be taken with food: Swallow whole, do not chew/crush/split.
Hypersensitivity. Concomitant use w/ potent P-glycoprotein (P-gp) inducers eg, rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb, phenytoin.
Special Precautions
Not recommended for monotherapy. Severe bradycardia & heart block w/ another direct-acting antiviral & concomitant amiodarone; underlying cardiac comorbidities. Patients w/ genotype 1 & 4, 5 or 6 HCV infection; HCV/HBV co-infection. Not recommended w/ telaprevir or boceprevir; moderate P-gp inducers eg, oxcarbazepine, modafinil. Concomitant use w/ β-blockers. Post-liver transplant patients. May affect ability to drive & use machines. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease requiring hemodialysis; decompensated cirrhosis; advance hepatic disease. Women of childbearing potential should use effective contraception. Avoid use during pregnancy. Not to be used during lactation. Not recommended in childn & adolescents <18 yr. Elderly.
Adverse Reactions
Fatigue, headache, nausea, insomnia.
Drug Interactions
Decreased plasma conc w/ potent (eg, rifampicin, St. John's wort, carbamazepine, phenytoin) & moderate (eg, oxcarbazepine, modafinil) P-gp inducers. Monitor INR w/ vit K antagonists.
MIMS Class
ATC Classification
J05AP08 - sofosbuvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Virso FC tab 400 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in