Description of Hepcvir
Product Specification Trade Name :Sovaldi Brand Name :Hepcvir Composition : Sofosbuvir Manufactured by Cipla.Ltd Dose :400 mg Dosage Form: Tablet Pack of 28 tablets in a bottle Hepcvir is a generic version of sovaldi and manufactured by Cipla.Ltd. Hepcvir is type of classification of antiviral medication, it contain Sofosbuvir as active ingredient. Hepcvir is prescription depended drug should be dispensed under the advice of the consultant.
Pharmacology of Hepcvir
Mechanism of action: Hepcvir is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. Hepcvir expose to have a high barrier to the development of resistance and inhibits the hep C NS5B protein. Thereby Hepcvir prevents the enzyme RNA polymerase by the cellular worker who can performs the multiplication process, Hence Hepcvir stops the replication of Hepatitis C virus and decrease the amount of Hep C virus in liver. Hepcvir also acts to reduce damage in liver and improves function in liver.
Absorption:- Administration of Hepcvir was absorbed with peak plasma concentration of obtained at -0.5 to 2 hr post dose and in metabolite GS-331007 peak plasma concentration obtained between 2 to 4 hrs post dose. Effect of food: Hepcvir and the metabolite have no affect with high fat meal. Hence MyHep is administrated without food is effective.
Distribution: Hepcvir is approx 51-65% bound to human plasma proteins and GS-331007 metabolite has minimal human plasma protein binding.
Metabolism: In liver, Hepcvir is broadly metabolized(4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203.
Elimination: Mean total recovery of the Hepcvir dose was >92%, involves of approx 80%,14% and 2.5% eliminated in urine, feces, expired air. Half life of Hepcvir and GS-331007 were 0.4 and 27hrs.
Indication of Hepcvir
Hepcvir is used to for the treatment of severe Hepatitis C virus in the liver, Hepatitis C virus is a long lasting infection of liver, Hepcvir is highly effective medicine for this infection. Therefore Hepcvir will decrease the action of hepatitis C Virus in our body and recover the liver from infection caused by virus.
Dose & Dosage's of Hepcvir
*Hepcvir is a 400mg tablet *Take one tablet in once daily *Take it same time regularily *Take with or without food. *Hepcvir is administer through mouth(oral cavity)
Side Effects of Hepcvir
Hepcvir has common and serious effects Nausea and vomiting Chills and fever Pharyngtitis Skin in pale colour Lumbar pain Myalgia Weakness Sleeping trouble Diarrhea
Contraindication of Hepcvir
Hepcvir has no specific contraindications when used alone. When Hepcvir in combination with ribavirin or peg interferon Alfa/ribavirin, or others, the contraindications also applicable to these agents are applied.
Drug Interaction of Hepcvir
Hepcvir in combination with simeprevir, daclatasvir and ledipasvir with amiodarone should not be used due to risk of irregular heartbeats. Hepcvir with rifampicin (inducers of intestinal p- glycoprotein) will decrease the absorption of Sofosbuvir. Co-administration of Hepcvir with anticonvulsants and the HIV protease inhibitors( Tipranavir, ritonavir) leads to decrease Hepcvir concentration.
Precaution of Hepcvir
Patients undergoing treatment for Hepatitis C with Hepcvir will require routine check up to their physician and blood check up to be followed.. Risk of birth defect or harm to unborn baby, so pregnancy time, Hepcvir should avoided. Allergic to Sofosbuvir alone, then inform your consultant. Hepcvir Co-administration with amiodarone may occur serious bradycardia.
Usage & Safety profile of Hepcvir Pregnancy & Lactation
Hepcvir alone assigned a pregnancy category B, In all trimester there are no adequate and well tolerated studies in pregnant women, Since animal reproduction trial has no risks and adverse effect to the fetus. But Hepcvir combination with ribavirin, assigned a pregnancy category X leads to birth defect and death to the fetus. Avoid combination therapy during pregnancy. While breast feeding the drugs pass into breast milk is unknown, therefore its recommended that mother should not breast feed during Hepcvir alone and combination treatment.
Storage of Hepcvir
Hepcvir 400 mg tablet should store below 300C (860F) Hepcvir Should be placed in cool and dry place Hepcvir should be packed in original container with sealed cap Improper storage of Hepcvir will affect effectiveness and shelf life Hepcvir should not kept in the glove compartment of a car. Regimen can get too hot, cold, or wet .