Brand name: hepcvir+ hepcdac
Composition: Sofosbuvir + Daclatasvir
Strength: 400mg; 60mg
Manufactured by: Cipla. Ltd
Dosage form: Tablets
Pack of 28 tablets in a container
Hepcvir & Hepcdac is a type of class of antiviral drugs that inhibits hepatitis C virus (HCV) from reproduction in the body. Hepcvir & Hepcdac is a combination medicine available for the treatment of chronic hepatitis C in adults with HCV genotype 1,or 3. Hepcvir & Hepcdac is combined with other antiviral drugs (ribavirin )in people is not established for HCV genotype 3 patients with cirrhosis.
Hepcdac is used with other antiviral agent for the treatment of chronic Hep C virus ( viral infection of liver which will long last in the body). It will cause serious liver problem(cirrhosis, liver cancer).
hepcdac combination with hepcvir the dose recommended is one tablet of 400mg and 60mg taken once in a day by oral route with or without food.The doctor prescribe the drug based on age, past medical history and current status of diagnosis.
Combination with Hepcvir reduce the bulk of Hepatitis virus in the body, in which it will help to fight against infection free immune system and clear the liver .Duration of treatment – 12weeks
Hepcdac Contemporaneous use with other antiviral agents (amiodarone, Sofosbuvir), It has risk of severe slowing down of heart rate. Hepcvir & Hepcdac interaction with the ribavirin or carbamazepine will inhibits HCV protein NS5A.
When Hepcvir combined with Hepcdac and ribavirin is contraindicated to pregnant women, avoid using this combination during pregnancy. Patient with hypersensitivity and renal –hepatic impairment is contraindicated.
While breast feeding the drugs pass into breast milk is unknown, therefore its recommended that mother should not breast feed during Hepcvir & Hepcdac alone and combination treatment.
Hepatitis means person affected by hepatitis C virus and target the liver, thus became inflate. Due to longer stay of virus in the body leads to severe damage to the liver occurs. It is a CYP3A and p- glycoprotein.
and stops the process of multiplication and replication of the HCV. Here by drug will prevents the virus particle duplication by its own and removes the virus from the body.
Where as Hepcvir is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. Hepcvir reveal to have a high barrier to the progress of resistance and interfere with the hepatitis C NS5B protein. Thereby Hepcvir stops the enzyme RNA polymerase which performs the multiplication process,by the cellular worker Hence Hepcvir prohibits the replication of Hepatitis C virus and lowers the amount of Hep C virus in liver. Hepcvir works to decrease the damage in liver and recover liver function.
has time to peak plasma concentration about -0.5 to 2 hr post dose .
Daclatasvir peak plasma concentration is within 2 hours post dose and bioavailability is 67%
Effect of food: Daclatasvir drug either taken with food nor without food . Sofosbuvir and the metabolite have no affect with high fat meal. Sofosbuvir is taken without food is effective.
Distribution: Daclatasvir the plasma protein binding is 99% and Sofosbuvir is approx 51-65% bound to human plasma proteins
Metabolism: Primarily Daclatasvir is metabolized in substrate of CYP3A with primary CYP isoform. In liver, Sofosbuvir broadly metabolized(4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203.
Elimination: Sofosbuvir involves elimination in urine 80%, feces 14%, expired air 2.5%.
Daclatasvir the radioactivity was recovered 88% via feces and 6.6% via urine and total elimination is > 92%.
Half life of Sofosbuvir and GS-331007 were 0.4 and 27hrs and Daclatasvir has half life elimination of 12 to 15 hours
After effect at common side of Hepcvir and Hepcdac
• Loss of hair
• Low RBC
• Loose stools
• Feeling sleepy in morning
• Head pain
• Itching/swelling(face, tongue,throat)
After effects at serious side of Hepcvir and Hepcdac:
• Chest discomfort
• Loss of memory
• Unusual weight gain or loss
• Low heartbeats
Patients undergoing treatment for Hepatitis C with Hepcdac and Hepcvir 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, both drugs combination with ribavirin should avoided.
Allergic to Hepcvir & Hepcdac alone, then inform your consultant.
Hepcdac + Hepcvir Co-administration with amiodarone may occur serious bradycardia.
Pregnancy category B for Hepcvir & Hepcdac combination, 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 ribavirin combination, pregnancy category X causes birth defect or death to the fetus. Avoid combination therapy during pregnancy.
Store at 250C , Keep reach out of children
Container should be its own original bottle. Don’t mix different drugs together.
Store the drug at cool, dry place, protect from light.
Refrigeration is necessary
While travelling in car don’t keep it in glove box, drug can get too hot, cold or wet in box.
Hepcvir & hepcdac combination has no specific antidote available, If occeurs then moniter the evidence of toxicity, immediately Seek medical emergency or call poison control for immediate treatment .
If any problem of dose missing then take it as soon as realizable , if time arrive for next dose, then leave the missed dose and continue regular schedule. by mistake don’t take extra dose at a time. Please consult with the doctor.
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