Velpaclear 12 Weeks Abbott Tablets Uses, Side Effect, Price india.

1. VELPACLEAR 12 WEEKS Drug profile Velpaclear is an oral used tablet, for severe chronic hepatitis C viral infection. Velpaclear contains fixed dose combination medicine like sofosbuvir and Velpatasvir. Velpaclear tablet containing 400mg of sofosbuvir and 100mg of Velpatasvir. Velpaclear tablets are used as single dose for 12 weeks Prescribing information of Velpaclear for 12 weeks The prescribing advice of Velpaclear for the patients; Velpaclear is involved in the conditions such as; In the treatment of chronic hepatitis C viral infection associated with genotype I, II, III, IV, V or VI. It may used in two conditions like; 1.Patients without cirrhosis or with compensated cirrhosis (child Pugh A) 2.Patients with decompensated cirrhosis (child Pugh B or C), concurrently used with ribavirin Trade name: Velpaclear Active components: Sofosbuvir & Velpatasvir Strength of the components: 400mg & 100mg Mfg: Abbott Package: 28 tablets in a container

2. Category: Anti-hepaciviral drugs VELPACLEAR 12 WEEKS Mechanism of Velpaclear for 12 weeks Velpaclear has sofosbuvir & Velpatasvir, in which sofosbuvir is consider as nucleotide associated with HCV NS5B polymerase prohibitor, whereas Velpatasvir is consider as NS5A prohibitor Mechanism involved in this two components are includes as; Sofosbuvir: Sofosbuvir is a directly acting anti-viral drug, NS5B RNA dependent RNA polymerase. This enzyme is required for hepatitis viral replication; sofosbuvir is a prodrug which endures into intracellular metabolism to form pharmacologically active metabolite known as uridine triphosphate GS- 461203. This metabolite is inserted into hepatitis C viral RNA by NS5B polymerase and acts as chain terminator. Velpatasvir is a NS5A prohibitor, a protein responsible for viral production Absorption

3. The effect of food with Velpaclear is determined as; With moderate meal compared to fasted state: sofosbuvir increased to 60% & Velpatasvir increased to 34% With high fat meal: sofosbuvir increased to 78% & Velpatasvir increased to 21% The peak plasma time of sofosbuvir reaches within 0.5 to 1 hour and Velpatasvir occurs within 3 hours Distribution In Velpaclear , human plasma protein bounding capacity with sofosbuvir occurs at 61 to 65% & Velpatasvir >99.5% The blood plasma ratio of sofosbuvir is 0.7 & Velpatasvir is 0.52 to 0.67 Metabolism Velpaclear is metabolized highly in liver. The metabolism of sofosbuvir occurs with the help of cathepsin A, CES1, HINT1 & Velpatasvir is metabolized by various cytochrome isoenzymes like CYP2B6, CYP2C8 & CYP3A4 Excretion The major route of elimination of; Sofosbuvir is occurred through 8% in urine and 14% in feces; Velpatasvir 0.4% in urine & 94% in feces as an unchanged form The terminal half life period of Velpaclear tablet; Sofosbuvir: 0.51 hours Velpatasvir: 15 hours

4. When to take the Velpaclear tablet 12 weeks Velpaclear tablet is used as a single dose; it should be taken with or without food Velpaclear is continued for 12 weeks for improved healing Dosage regimens of Velpaclear for 12 weeks Before starting the therapy, patient must examine by measuring hepatitis B antigen & hepatitis B core antibody, to avoid the reaction of HBV infection The recommended dosage of Velpaclear is one tablet should be taken as a single dose for 12 weeks The recommended dosage regimen in HCV associated with genotype I, II, III, IV, V or VI In new patients & already treated patients without cirrhosis and with compensated cirrhosis: The recommended dosage is one tablet of Velpaclear followed for 12 weeks with or without food In new or already treated patients with child Pugh B or C (decompensated cirrhosis): The recommended dosage of Velpaclear tablet is one tablet should be combined with ribavirin and followed for 12 weeks Dosage adjustment should not be followed in both renal and hepatic impaired patients The dosage of ribavirin is recommended on the basis of body weight of the patients; Less than 75kg: 1000mg per day

5. At least 75kg: 1200mg per day In pediatric patients, safety and efficacy has not been established Velpaclear caused side effects Velpaclear tablets are taken for the period of 12 weeks, in this condition some adverse effects occurs includes as; Anemia Diarrhea Elevation of lipase level Asymptomatic creatine kinase elevation Fatigue Insomnia Headache Reactivation of HBV infection occurred in HBV/HIV-1 co infected patients Bradycardia occurs severely in case of concomitant with amiodarone Increasing bilirubin level occurred in 12 weeks therapy After therapy, cardiac disorders occurs Skin rashes, sometimes angioedema like inflammated angioedema Asthenia Drug interaction Velpaclear with these drugs may have chance to cause increasing the exposure of these drugs

6. If Velpaclear tablet combined with anti-cancer drug this may cause increasing the effect of concentration of these drugs Velpaclear tablet with anti-convulsants like carbamazepine, phenytoin or Phenobarbital causes decreasing the exposure ofVelpaclear If Velpaclear concomitant with HMG CoA reductase inhibitors causes increasing the exposure of these drugs Velpaclear tablets concurrently used with herbal products like st. Johns wort causes depleting the effect of concentration ofVelpaclear Velpaclear not co administered with acid reducing drugs, because it may cause decreasing the effect of concentration of Velpatasvir Amiodarone combined with Velpaclear tablets, causes serious bradycardia Digoxin with Velpaclear causes increasing the exposure of digoxin Velpaclear is a substrate of P-gp & BCRP transporters, Velpaclear concurrently used with P-gp inducers or potent inducers of CYP2B6 or CYP3A4 (rifampin, st. Johns wort) causes decreasing in plasma concentration of Velpaclear and thus leads to decrease the therapeutic effect of Velpaclear Velpatasvir is an P-gp & BCRP drug transporter inhibitor, whereas concomitant use of Velpaclear with these drugs may have chance to cause increasing the exposure of these drugs Food drug interaction Food does not interact with Velpaclear tablets, but herbal product like st. Johns wort combined with Velpaclear causes decreasing the therapeutic effect of Velpaclear

7. Possible contraindications of Velpaclear for 12 weeks Velpaclear tablets causes hypersensitivity reactions in some patients who are contraindicated to the component present inVelpaclear tablet In chronic condition, Velpaclear combined with ribavirin followed for 12 weeks, in such condition ribavirin is contraindicated to pregnancy condition Safety measures Serious fetal abnormality occurs while concomitant use with ribavirin During or after the therapy, some adverse effects may occurs There is a chance of reduction of therapeutic effect of Velpaclear while combining with P-gp inducers Serious symptomatic bradycardia occurs while combining with amiodarone, to avoid this problem patient must counsel about the risk of bradycardia, or substitute viable therapy has been taken Pregnancy and lactation in Velpaclear 12 weeks Velpaclear tablet used alone for acute condition, pregnancy condition is B1; safe to use Whereas in decompensated cirrhosis, pregnancy condition is categorized as X due to combination with ribavirin. Ribavirin is contraindicated in pregnancy condition Storage and handling Velpaclear tablet container should be stored at room temperature below 30oC (86oF)

8. Container should be keep away from heat, light and moisture Missed dose Velpaclear is a prescription medicine; it should not be used without valid prescription If patient fail to take the dose of Velpaclear tablet, must consult with physician and take the dose as soon as possible Otherwise the missed dose should be skipped and follow the regular dosing schedule Over dosage The over dosage of Velpaclear for 12 weeks should not have definite antidote, if it occurs the patients must be investigate with the occurrence of toxicity. The clinical status of the patients who are affected with over dose should be periodically monitored The another method of treating the over dosage of Velpaclear is hemodialysis, to expels the excess amount of components present in Velpaclear with an eradication co efficient of 53%; whereas Velpatasvir is highly bound to human plasma protein and it is difficult to remove CONTACTS Phone : +919940472902 USA Toll-Free Call : +18882264402 Email:millionhealthpharmaceuticals@gmail.com WEBSITE: https://millionpharma.us/