Description of Resof
Trade Name – Sovaldi
Brand Name – Resof
Composition – Sofosbuvir
Manufactured by – Dr. Reddy laboratories.Ltd
Dose – Sofosbuvir 400 mg
Dosage Form – Tablets
Pack of 28 tablets in a container
Resof is a generic version of sovaldi and manufactured by Dr.Reddy laboratories.Ltd. Resof is type of classification of antiviral medication, it contain Sofosbuvir as active ingredient. Resof is prescription depended drug should be dispensed under the advice of the consultant.
Pharmacology of Resof
Mechanism of action:
Resof is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. Resof expose to have a high barrier to the development of resistance and inhibits the hep C NS5B protein. Thereby Resof prevents the enzyme RNA polymerase by the cellular worker who can performs the multiplication process, Hence Resof stops the replication of Hepatitis C virus and decrease the amount of Hep C virus in liver. Resof also acts to reduce damage in liver and improves function in liver.
• Absorption:- Administration of Resof 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: Resof and the metabolite have no affect with high fat meal. Hence Resof is administrated without food is effective.
• Distribution: Resof is approx 51-65% bound to human plasma proteins and GS-331007 metabolite has minimal human plasma protein binding.
• Metabolism: In liver, Resof is broadly metabolized(4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203.
• Elimination: Mean total recovery of the Resof dose was >92%, involves of approx 80%,14% and 2.5% eliminated in urine, feces, expired air.
• Half life of Resof and GS-331007 were 0.4 and 27hrs.
Indication of Resof
Resof is used to for the treatment of severe Hepatitis C virus in the liver, Hepatitis C virus is a long lasting infection of liver, Resof is highly effective medicine for this infection. Therefore Resof will decrease the action of hepatitis C Virus in our body and recover the liver from infection caused by virus.
Dose & Dosage's of Resof
Resof is a dose of 400mg.It should take one tablet per day in duration of 12-24 weeks, along with or without food can be taken.
Side Effects of Resof
Resof has common and serious effects
Resof in combination with other drugs( ribavirin) along with or without a peg-interferon has a good safety form. Common side effects are fatigue, head pain, nausea, rash in skin irritability, severe dizziness, back ache, and low RBC.
Serious side effects are accordingly very common in interferon-containing drugs as compared with interferon-free ones.
Contraindication of Resof
Resof has no specific contraindications when used alone. When Resof in combination with ribavirin or peg interferon Alfa/ribavirin, or others, the contraindications also applicable to these agents are applied.
Drug Interaction of Resof
Resof in combination with simeprevir, daclatasvir and ledipasvir with amiodarone should not be used due to risk of irregular heartbeats.
Resof with rifampicin (inducers of intestinal p- glycoprotein) will decrease the absorption of Sofosbuvir.
Co-administration of Resof with anticonvulsants and the HIV protease inhibitors( Tipranavir, ritonavir) leads to decrease Resof concentration.
Precaution of Resof
• Patients undergoing treatment for Hepatitis C with Resof 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, Resof should avoided.
• Allergic to Sofosbuvir alone, then inform your consultant.
• Resof Co-administration with amiodarone may occur serious bradycardia.
Usage & Safety profile of Resof Pregnancy & Lactation
Resof 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 Resof 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 Resof alone and combination treatment.
Storage of Resof
• Resof 400 mg tablet should store below 300C (860F)
• Resof Should be placed in cool and dry place
• Resof should be packed in original container with sealed cap
• Improper storage of Resof will affect effectiveness and shelf life
• Resof should not kept in the glove compartment of a car. Regimen can get too hot, cold, or wet.