Description of Hepcinat
Trade Name – Sovaldi
Brand Name – Hepcinat
Composition – Sofosbuvir
Manufactured by – Natco Pharma.Ltd
Dose – Sofosbuvir 400 mg
Dosage Form – Tablets
Pack of 28 tablets in a bottle
Hepcinat is a generic version of sovaldi and manufactured by Natco Pharma.Ltd. Hepcinat is type of classification of antiviral medication, it contain Sofosbuvir as active ingredient. Hepcinat
is prescription depended drug should be dispensed under the advice of the consultant.
Pharmacology of Hepcinat
Mechanism of action:
Hepcinat is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. Hepcinat expose to have a high barrier to the development of resistance and inhibits the hep C NS5B protein. Thereby Hepcinat prevents the enzyme RNA polymerase by the cellular worker who can performs the multiplication process, Hence Hepcinat stops the replication of Hepatitis C virus and decrease the amount of Hep C virus in liver. Hepcinat also acts to reduce damage in liver and improves function in liver.
• Absorption:- Administration of Hepcinat 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: Hepcinat and the metabolite have no affect with high fat meal. Hence Hepcinat is administrated without food is effective.
• Distribution: Hepcinat is approx 51-65% bound to human plasma proteins and GS-331007 metabolite has minimal human plasma protein binding.
• Metabolism: In liver, Hepcinat is broadly metabolized(4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203.
• Elimination: Mean total recovery of the Hepcinat dose was >92% and involves of approx 80%,14% and 2.5% elimination in urine, feces, expired air.
Half life of Hepcinat and GS-331007 were 0.4 and 27hrs.
Indication of Hepcinat
Hepcinat is used to for the treatment of severe Hepatitis C virus in the liver, Hepatitis C virus is a long lasting infection of liver, Hepcinat is highly effective medicine for this infection. Therefore it will decrease the action of hepatitis C Virus in our body and recover the liver from infection caused by virus.
Dose & Dosage's of Hepcinat
Dose recommended for Hepcinat medication is one tablet of 400mg OD (once daily) taken orally given along with food or without . Hepcinat Duration for genotype 1 or 4 and 2 (CHC) is 12 weeks and Genotype 3 (CHC) is 24 weeks.
Side Effects of Hepcinat
Hepcinat has common and serious effects
o Energy loss
o Depressive disorder
o Yellowish skin
o Changes in mood
o Low red blood cell
o Fever and chills
Contraindication of Hepcinat
Hepcinat has no specific contraindications when used alone. When Sofovir in combination with ribavirin or peginterferon alfa/ribavirin, or others, the contraindications also applicable to these agents are applied.
Drug Interaction of Hepcinat
Hepcinat in combination with simeprevir, daclatasvir and ledipasvir with amiodarone should not be used due to risk of irregular heartbeats.
Hepcinat with rifampicin (inducers of intestinal p- glycoprotein) will decrease the absorption of Sofosbuvir.
Co-administration of Hepcinat with anticonvulsants and the HIV protease inhibitors( Tipranavir, ritonavir) leads to decrease Hepcinat concentration.
Precaution of Hepcinat
Patients undergoing treatment for Hepatitis C with Hepcinat 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, Hepcinat should avoided.
Allergic to Sofosbuvir alone, then inform your consultant.
Hepcinat Co-administration with amiodarone may occur serious bradycardia.
Usage & Safety profile of Hepcinat Pregnancy & Lactation
Hepcinat 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 by 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 Hepcinat alone and combination treatment.
Storage of Hepcinat
• Hepcinat 400 mg tablet should store below 300C (860F)
• Hepcinat Should be placed in cool and dry place
• Hepcinat should be packed in original container with sealed cap
• Improper storage of Hepcinat will affect efficacy and shelf life
• Hepcinat should not kept in the glove compartment of a car. Regimen can get too hot, cold, or wet .