Hepcinat plus is an direct acting antiviral drug which contain Sofosbuvir 400mg and daclatasvir 60mg as active ingredients. Hepcinat plus is manufactured by Natco Pharma Ltd. Both the drug is prescription depended can be purchased only against a valid prescription of a doctors. It is packed with 28 tablets in a container.
Hepcinat plus, for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 3 infection, with or without ribavirin.
In adult recommended dosage of Sofosbuvir is 400 mg and daclatasvir is 60 mg and administrated one tablet of Hepcinat plus, orally, once in a day
Given with or without food.
For genotype 1
Hepcinat plus, without cirrhosis or with compensated cirrhosis ( child-pugh A)for 12weeks. Hepcinat plus and ribavirin combination is used for decompensated cirrhosis (child – pugh B or C) and Posttransplant
For genotype 3
Hepcinat plus without cirrhosis for 12weeks Hepcinat plus and ribavirin combination used for compensated or decompensated ( child-pugh B or C) cirrhosis and Posttransplant for 12weeks.
( Overdose of Hepcinat plus: No specific antidote available, If overdose occur, patient should be monitor the development of toxicity and supportive and symptomatic care should be monitor. Seek medical emergency or call poison control for immediate treatment. )
Mechanism of action:
Hepcinat plus which contain Sofosbuvir 400mg is a nucleotide polymerase inhibitor and includes in direct acting antiviral drug. sofosbuvir expose to have a high barrier to the growth of resistance and inhibits the hep C NS5B protein. Thereby Sofosbuvir interfere with the enzyme RNA polymerase by the cellular worker who can performs the multiplication process, Hence Sofosbuvir stops the replication of Hepatitis C virus and decrease the amount of Hep C virus in liver. Sofosbuvir also acts to reduce damage in liver and improves function in liver. Hepcinat plus also contain daclatasvir is an direct acting antiviral drug which is indicated for the patient affected by hepatitis c virus infection. It will targets the Hep C virus and stops the numerous steps in reproduction process of HCV by the way it interfere with the virus particles from making copies themselves, and helps the body to remove virus from the blood.
Sofosbuvir 400mg has Peak plasma concentration is 0.5 to 2 hr post dose for Sofosbuvir 400mg and in metabolite GS-331007 peak plasma concentration obtained between 2 to 4 hrs post dose, where as In Daclatasvir 60mg peak plasma concentration is within 2 hours post dose and bioavailability is 67%
Mean total recovery of the Sofosbuvir 400mg dose was >92% and involves of approx 80%, 14% and 2.5% elimination in urine, feces, expired air. While single dose administration of Daclatasvir 60mg the radioactivity was recovered 88% via feces and 6.6% via urine Half life of Sofosbuvir 400mg and GS-331007 were 0.4 and 27hrs and Daclatasvir 60mg has half life elimination of 12 to 15 hours .
Sofosbuvir 400mg is approx 51-65% bound to human plasma proteins and GS-331007 metabolite has minimal human plasma protein binding. And in Daclatasvir 60mg the plasma protein binding is 99%
In liver, Sofosbuvir 400mg is broadly metabolized In liver, (4% and >90%) to convert into pharmacologically active nucleoside analog triphosphate GS-461203. Daclatasvir 60mg metabolism based on the substrate of CYP3A with primry CYP isoform
Serious side effects of Hepcinat plus
Memory loss and confusion
Common effects of Hepcinat plus
Pain in head
When administrating Hepcinat plus with combination with amiodarone will cause some side effects on heart and seek medical help if you have:
Dyspnea, pain in chest
Pregnancy category B for Hepcinat plus combination, In all trimester there are no sufficient and well established 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.
When Hepcinat plus and ribavirin is contraindicated to pregnant women, avoid using these combination during pregnancy. Patient with hypersensitivity and renal –hepatic impairment is contraindicated.
Tell your healthcare providers that you are allergic to daclatasvir , Sofosbuvir or have any other allergies before using the medicine. It may composed of inactive ingredients, that can be cause allergic problems or other reaction. Talk to your pharmacist for more details.
Especially if you have kidney disease, liver disease other than hepatitis C, inform your consultant about past medical history before having daclatasvir / sofosbuvir
Drugs should given with prescription only, without prescription drugs should not be issued.
Combination of Hepcinat plus and amiodarone may cause bradycardia
Hepcinat combination with daclatasvir, simeprevir, ledipasvir with amiodarone will leads to risk in irregular heartbeats. It should avoid the combinations,
While breast feeding the drugs pass into breast milk is unknown, therefore its recommended that mother should not breast feed during Hepcinat plus alone and combination treatment.
Store at 250C (exact condition allowed between 150C and 300C
Container should be its own original bottle. Don’t mix different drugs together.
Keep it in cool, dry place and refrigeration is necessary, protect from light.
While travelling in car don’t keep it in glove box, drug can get too hot, cold or wet in box.
Keep reach out of children.
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