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