Description of MyHep
Product Specification Trade Name â€“ Sovaldi Brand Name â€“ MyHep Composition â€“ Sofosbuvir Manufactured by â€“ Mylan Pharmaceutical Pvt.Ltd Dose â€“ Sofosbuvir 400 mg Dosage Form â€“ Tablets Pack of 28 tablets in a bottle MyHep is a generic version of sovaldi and manufactured by Mylan Pharmaceutical Pvt.Ltd. MyHep is type of classification of antiviral medication, it contain Sofosbuvir as active ingredient. MyHep is prescription depended drug should be dispensed under the advice of the consultant.
Pharmacology of MyHep
Pharmacodynamic:- Mechanism of action: MyHep is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. MyHep expose to have a high barrier to the development of resistance and inhibits the hep C NS5B protein. Thereby MyHep prevents the enzyme RNA polymerase by the cellular worker who can performs the multiplication process, Hence MyHep stops the replication of Hepatitis C virus and decrease the amount of Hep C virus in liver. MyHep also acts to reduce damage in liver and improves function in liver. Pharmacokinetic:- â€¢ Absorption:- Administration of MyHep 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: Myhep and the metabolite have no affect with high fat meal. Hence MyHep is administrated without food is effective. â€¢ Distribution: MyHep is approx 51-65% bound to human plasma proteins and GS-331007 metabolite has minimal human plasma protein binding. â€¢ Metabolism: In liver, MyHep is broadly metabolized(4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203. â€¢ Elimination: Mean total recovery of the MyHep dose was >92%, involves of approx 80%,14% and 2.5% eliminated in urine, feces, expired air. Half life of MyHep and GS-331007 were 0.4 and 27hrs.
Indication of MyHep
MyHep is used to for the treatment of severe Hepatitis C virus in the liver, Hepatitis C virus is a long lasting infection of liver, Sofovir 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 MyHep
Dose recommended for MyHept medication is one tablet of 400mg OD (once daily) taken orally given along with food or without . Duration of MyHep for genotype 1 or 4 and 2 (CHC) is 12 weeks and Genotype 3 (CHC) is 24 weeks.
Side Effects of MyHep
MyHep has common and serious effects Common condition:- Loss of energy Irritability Sleeping disorder Pain in muscle Diarrhae Nausea and vomiting Severe Condition:- Dysonea Pharyngitis Depression Fever and chill
Contraindication of MyHep
MyHep 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 MyHep
MyHep in combination with simeprevir, daclatasvir and ledipasvir with amiodarone should not be used due to risk of irregular heartbeats. MyHep with rifampicin (inducers of intestinal p- glycoprotein) will decrease the absorption of Sofosbuvir. Co-administration of MyHep with anticonvulsants and the HIV protease inhibitors( Tipranavir, ritonavir) leads to decrease Hepcinat concentration.
Precaution of MyHep
ï‚§ Patients undergoing treatment for Hepatitis C with MyHep will require routine check up to their physician and blood check up to be followed.. ï‚§ Risk of birth defect or harm to unborn baby, so pregnancy time, MyHep should avoided. ï‚§ Allergic to Sofosbuvir alone, then inform your consultant. ï‚§ MyHep Co-administration with amiodarone may occur serious bradycardia.
Usage & Safety profile of MyHep Pregnancy & Lactation
MyHep 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 MyHep 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 MyHep alone and combination treatment.
Storage of MyHep
â€¢ MyHep 400 mg tablet should store below 300C (860F) â€¢ MyHep Should be placed in cool and dry place â€¢ MyHep should be packed in original container with sealed cap â€¢ Improper storage of MyHep will affect efficacy and shelf life â€¢ MyHep should not kept in the glove compartment of a car. Regimen can get too hot, cold, or wet .