Pharmaniaga Manufacturing Berhad


Pharmaniaga Logistics
Concise Prescribing Info
In combination w/ other medicinal products for adults w/ chronic HCV infection.
Dosage/Direction for Use
200 mg once daily. Patient w/o cirrhosis In combination w/ sofosbuvir for 12 wk. Patient w/ compensated cirrhosis In combination w/ sofosbuvir for 24 wk.
May be taken with or without food: Swallow whole, do not chew/crush/split.
Hypersensitivity. Co-administration w/ potent P-gp inducers eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, St. John's wort.
Special Precautions
Not to be given as monotherapy. Patients w/ HCV genotypes 2, 4, 5 & 6; previously failed therapy w/ NS5A-containing regimen. HCV/HBV co-infection; perform HBV screening prior to initiation. Diabetic patients. Not to be taken by patients w/ fructose intolerance. Not recommended w/ concomitant use of moderate P-gp inducers eg, oxcarbazepine, rifapentine. May affect ability to drive & use machines. Renal impairment (>1.5 x ULN) or ESRD; severe hepatic impairment, decompensated cirrhosis; post-liver transplant patients. Women of childbearing potential should use effective contraception prior to & for 1 mth after last dose. Not recommended during pregnancy & lactation. Not recommended in childn & adolescents <18 yr. Elderly ≥65 yr.
Adverse Reactions
In combination w/ sofosbuvir: Pyrexia. Insomnia; headache, dizziness, lethargy, somnolence; dyspepsia, nausea, diarrhoea, abdominal pain, vomiting, constipation; pruritus, rash, dermatitis; fatigue; increased AST.
Drug Interactions
Increased exposure of BCRP substrates eg, rosuvastatin. Decreased plasma conc w/ strong (eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, St. John's wort) & moderate (eg, oxcarbazepine, rifapentine) P-gp inducers. Changes in liver function w/ vit K antagonists. Decreased conc w/ medicinal products increasing gastric pH eg, antacids, H2-receptor antagonists. Increased conc of rosuvastatin, simvastatin, atorvastatin, fluvastatin. Caution w/ digoxin, dabigatran etexilate, pravastatin, pitavastatin.
MIMS Class
ATC Classification
J05AP - Antivirals for treatment of HCV infections ; Used in the treatment of hepatitis C viral infections.
Ravida tab 200 mg
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