Description of Hepcinat - 12 weeks
Trade name: Hepcinat Active component: Sofosbuvir Strength: 400mg Mfg: Natco pharmaceuticals Pack: 28 tablets in a container Category: Anti-viral drug Hepcinat description: 12 weeks Hepcinat is a brand of generic Sofosbuvir, a nucleotide inhibitor analogue of hepatitis C virus NS5B polymerase; key enzyme which is interfering with HCV RNA multiplication Hepcinat is a prescription medicine; it is taken by the patients only under the supervision of medical practitioner Hepcinat is not a monotherapy; it is usually combined with some other anti-viral medicines Hepcinat tablets is a film coated tablet contains active component Sofosbuvir 400mg
Pharmacology of Hepcinat - 12 weeks
Hepcinat mechanism of action for 12 weeks Hepcinat, it is an anti-viral drug contains Sofosbuvir which is nucleotide prodrug that hinder the multiplication of hepatitis C virus by obstruct the effect of HCV NS5B RNA polymerase This polymerase enzyme endures intercellular metabolism to form GS-461203, an active uridine triphosphate analogue HCV NS5B RNA polymerase incorporated this metabolite into viral DNA, which is act as a chain terminator Pharmacokinetic: Absorption: The Hepcinat tablets are absorbed well after oral administration The peak concentration of Hepcinat tablet (Sofosbuvir and GS-331007) in the blood plasma was approximately occurred at Sofosbuvir: 0.5-2 hours and GS-331007:2-4 hours, after the drug intake. Effect of Food: While taking Hepcinat tablets with high fat meals, it leads to diminish the absorption rate of the drug Sofosbuvir when compared with fasting. High fat meal, creates no effect when exposed to the metabolite GS-331007, so it is not take to consider while drug taken with meals. Distribution: The Hepcinat tablets are highly bound to blood plasma protein approximately 61-65%. The GS-331007 binding to plasma proteins is minimal. Metabolism: Hepcinat is highly metabolized in liver and to form active triphosphate a nucleoside analogue (GS-461203). The metabolic route of activation associates sequential hydrolysis of a carboxylic acid ester molecule with cathepsin A or carboxyl esterase 1. The metabolite GS-331007 by Dephosphorylation, is cannot be completely rephosphorylated and has no activity against HCV Excretion: The route of elimination of metabolites occurs through Kidneys, intestines, and lungs The drug around 78% excreted as inactive metabolite, 3.5% was excreted as Sofosbuvir The half life time of both Sofosbuvir and GS-331007 is 0.4 and 27 hours respectively.
Indication of Hepcinat - 12 weeks
Hepcinat tablets is primarily indicated for the treatment of adults patients with advanced hepatitis C HCV infection by combining with other anti-viral drugs Genotype I or IV infection without cirrhosis or with compensated cirrhosis with the combination of pegylated interferon and ribavirin Genotype II or III infection without cirrhosis or with compensated cirrhosis by combination with ribavirin In pediatrics: Hepcinat is used in pediatric patients with the conditions like; Chronic HCV genotype II or III infection in patients having 12 years and older or weight of 35 kg
Dose & Dosage's of Hepcinat - 12 weeks
Before starting the therapy, examine the patients who are all receiving the Tablet Hepcinat by counting the HBsAg and Anti-HBc The usual recommended adult and pediatric dose is 400mg of tablet should be taken as a single dose with or without food HCV/HIV co infected patients; dosage recommendations Genotype I or IV: Treatment naÃƒÂ¯ve without cirrhosis or with compensated cirrhosis: Hepcinat tablet + peginterferon Alfa + ribavirin 12 weeks Genotype II: Therapy naÃƒÂ¯ve and therapy experienced without cirrhosis or with compensated, cirrhosis: Hepcinat tablet + ribavirin for 12 weeks Genotype III: Treatment naÃƒÂ¯ve and therapy experienced without cirrhosis or with compensated cirrhosis: Hepcinat tablet + ribavirin 24 weeks Hepcinat tablets are concomitant with ribavirin: In the treatment of HCV in adult patients who are affected with Hepatocellular cancer for 48 weeks or until liver transplant In pediatric: Hepcinat is recommended for the patients with 12 years of age and older or weighing at least 35 kg; Genotype II: Therapy naÃƒÂ¯ve & therapy experienced without cirrhosis or with compensated cirrhosis: Hepcinat tablet + ribavirin 12 weeks Genotype III: Therapy naÃƒÂ¯ve & therapy experienced without cirrhosis or with compensated cirrhosis: Hepcinat tablet + ribavirin 24 weeks Hepcinat should be taken with or without food While combining with ribavirin, it must be taken with food Peg interferon dosage: Peg interferon alpha 2a: 180 mcg SC weekly Peg interferon alpha 2b: 1.5mcg/kg/week SC, not exceed to 150mcg/week Ribavirin dosage: For prevention of post transplant HCV re-infection: Hepcinat tablet + ribavirin for 48 weeks or until liver transplant. It should be taken with food <75 kg: 500mg PO twice daily Ã¢â€°Â¥75 kg: 600mg PO twice daily Missed dose: Once patient fail to administer the dose of Hepcinat tablets, must consult with medical practitioner and take the missed dose. Otherwise it should be skipped and follow the next drug schedule. Do not double the dose.
Side Effects of Hepcinat - 12 weeks
Fatigue Headache Nausea Insomnia Pruritus Anemia Asthenia Rash Loss of appetite Chills Influenza like syndrome Pyrexia Diarrhea Neutropenia Myalgia Irritability Bilirubin increased, creatine kinase increased, lipase increased
Contraindication of Hepcinat - 12 weeks
While taking Hepcinat tablets with peg-interferon Alfa or ribavirin it may contraindicated to some patients Majorly in pregnancy conditions Hypersensitivity reactions occur
Drug Interaction of Hepcinat - 12 weeks
Hepcinat tablet with amiodarone: causes serious bradycardia While combining with anti-convulsants like phenytoin, Phenobarbital, carbamazepine; causes decrease the effect of concentration of Sofosbuvir Hepcinat with anti-mycobacterials: reduce the effect of concentration of Hepcinat tablet Hepcinat tablets concomitant with herbal products: decrease in effect of concentration of Hepcinat tablet HIV proteases inhibitors: with Hepcinat tablets causes reduction of effect of concentration of Hepcinat tablet
Precaution of Hepcinat - 12 weeks
Risk of hepatitis B virus reactivation in patientÃ¢â‚¬â„¢s co infected with HCV and HBV Serious symptomatic bradycardia when co administered with amiodarone Risk of reduce therapeutic effects due to use with P-gp inducers Risk associated with combinational therapies
Usage & Safety profile of Hepcinat - 12 weeks Pregnancy & Lactation
Generally Hepcinat tablet is comes under the pregnancy category: B But when combined with ribavirin category should be X Ribavirin causes fetal death Concomitant with ribavirin and peg interferon, it is not recommended in breastfeeding mothers.
Storage of Hepcinat - 12 weeks
Hepcinat tablet container is generally stored at room temperature below 30oc (86oF) It should be keep away from moisture, heat, and light Keep reach out from children and pets.