Description of Sofovir
Product Specification Trade Name â€“ Sovaldi Brand Name â€“ Sofovir Composition â€“ Sofosbuvir Manufactured by â€“ Hetero Healthcare.Ltd Dose â€“ Sofosbuvir 400 mg Dosage Form â€“ Tablets Pack of 28 tablets in a bottle Sofovir is a generic version of sovaldi and manufactured by Hetero healthcare.Ltd. Sofovir is type of classification of antiviral medication, it contain Sofosbuvir as active ingredient. Sofovir is prescription depended drug should be dispensed under the advice of the consultant.
Pharmacology of Sofovir
Pharmacology Pharmacodynamic:- Mechanism of action: Sofovir is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. Sofovir expose to have a high barrier to the development of resistance and inhibits the hep C NS5B protein. Thereby prevents the enzyme RNA polymerase by the cellular worker who can performs the multiplication process, Hence it stops the replication of Hepatitis C virus and decrease the amount of Hep C virus in liver. Sofovir also acts to reduce damage in liver and improves function in liver. Pharmacokinetic:- â€¢ Absorption:- Administration of Sofovir 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: Sofovir and the metabolite have no affect with high fat meal. Hence Sofovir is administrated without food is effective. â€¢ Distribution: Sofovir is approx 51-65% bound to human plasma proteins and GS-331007 metabolite has minimal human plasma protein binding. â€¢ Metabolism: In liver, Sofovir is broadly metabolized(4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203. â€¢ Elimination: Mean total recovery of the Sofovir dose was >92% and involves of approx 80%,14% and 2.5% elimination in urine, feces, expired air. Half life of Sofovir and GS-331007 were 0.4 and 27hrs.
Indication of Sofovir
Sofovir 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 Sofovir
Dose recommended for Sofovir medication is one tablet of 400mg OD (once daily) taken orally given along with food or without . Sofovir Duration for genotype 1 or 4 and 2 (CHC) is 12 weeks and Genotype 3 (CHC) is 24 weeks.
Side Effects of Sofovir
Common effects: Muscle pain; Energy loss; Rash and itchiness on skin; chronic insomnia; headache; weight loss; mental illness; fever; Diarrhae. Major side effects: Skin yellowish; difficult to breath; pharyngitis; changes in behavior; Anemia.
Contraindication of Sofovir
Sofovir 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 Sofovir
Sofovir in combination with simeprevir, daclatasvir and ledipasvir with amiodarone should not be used due to risk of irregular heartbeats. Sofovir with rifampicin (inducers of intestinal p- glycoprotein) will decrease the absorption of Sofosbuvir. Co-administration of Sofovir with anticonvulsants and the HIV protease inhibitors( Tipranavir, ritonavir) leads to decrease Sofovir concentration.
Precaution of Sofovir
ï‚§ Patients undergoing treatment for Hepatitis C with Sofovir 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, Sofovir should avoided. ï‚§ Allergic to Sofosbuvir alone, then inform your consultant. ï‚§ Sofovir Co-administration with amiodarone may occur serious bradycardia.
Usage & Safety profile of Sofovir Pregnancy & Lactation
Sofovir 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 Sofovir alone and combination treatment.
Storage of Sofovir
â€¢ Sofovir 400 mg tablet should store below 300C (860F) â€¢ Sofovir Should be placed in cool and dry place â€¢ Sofovir should be packed in original container with sealed cap â€¢ Improper storage of sofovir will affect efficacy and shelf life â€¢ Sofovir should not kept in the glove compartment of a car. Regimen can get too hot, cold, or wet .