Description of Sofovir - 12 weeks
Product Index: Trade name: Sofovir Active component: Sofosbuvir Strength: 400mg Mfg: Hetero labs Pack: 28 tablets in a container Category: Anti-viral drug Sofovir description: 12 weeks Sofovir 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 Sofovir is a prescription medicine; it is taken by the patients only under the supervision of medical practitioner Sofovir is not a monotherapy; it is usually combined with some other anti-viral medicines Sofovir tablets is a film coated tablet contains active component Sofosbuvir 400mg
Pharmacology of Sofovir - 12 weeks
Sofovir mechanism of action Sofovir, 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 Sofovir tablets are absorbed well after oral administration The peak concentration of Sofovir 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 Sofovir 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 Sofovir tablets are highly bound to blood plasma protein approximately 61-65%. The GS-331007 binding to plasma proteins is minimal. Metabolism: Sofovir 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 Sofovir - 12 weeks
Sofovir 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: Sofovir 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 Sofovir - 12 weeks
Before starting the therapy, examine the patients who are all receiving the Tablet Sofovir 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 naÃ¯ve without cirrhosis or with compensated cirrhosis: Sofovir tablet + peginterferon Alfa + ribavirin 12 weeks Genotype II: Therapy naÃ¯ve and therapy experienced without cirrhosis or with compensated, cirrhosis: Sofovir tablet + ribavirin for 12 weeks Genotype III: Treatment naÃ¯ve and therapy experienced without cirrhosis or with compensated cirrhosis: Sofovir tablet + ribavirin 24 weeks Sofovir 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: Sofovir is recommended for the patients with 12 years of age and older or weighing at least 35 kg; Genotype II: Therapy naÃ¯ve & therapy experienced without cirrhosis or with compensated cirrhosis: Sofovir tablet + ribavirin 12 weeks Genotype III: Therapy naÃ¯ve & therapy experienced without cirrhosis or with compensated cirrhosis: Sofovir tablet + ribavirin 24 weeks Sofovir 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: Sofovir tablet + ribavirin for 48 weeks or until liver transplant. It should be taken with food <75 kg: 500mg PO twice daily â‰¥75 kg: 600mg PO twice daily Missed dose: Once patient fail to administer the dose of Sofovir 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 Sofovir - 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 Sofovir - 12 weeks
While taking Sofovir tablets with peg-interferon Alfa or ribavirin it may contraindicated to some patients Majorly in pregnancy conditions Hypersensitivity reactions occur
Drug Interaction of Sofovir - 12 weeks
Sofovir tablet with amiodarone: causes serious bradycardia While combining with anti-convulsants like phenytoin, Phenobarbital, carbamazepine; causes decrease the effect of concentration of Sofosbuvir Sofovir with anti-mycobacterials: reduce the effect of concentration of Sofovir tablet Sofovir tablets concomitant with herbal products: decrease in effect of concentration of Sofovir tablet HIV proteases inhibitors: with Sofovir tablets causes reduction of effect of concentration of Sofovir tablet
Precaution of Sofovir - 12 weeks
Risk of hepatitis B virus reactivation in patientâ€™s co infected with HCV and HBV Serious symptomatic bradycardia occurs during concomitant with amiodarone Risk of reduce therapeutic effects due to use with P-gp inducers Risk associated with combinational therapies
Usage & Safety profile of Sofovir - 12 weeks Pregnancy & Lactation
Generally Sofovir 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 Sofovir - 12 weeks
Sofovir 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.