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Brand : Hepcinat
Composition : Sofosbuvir
Packing : 28 tablets
Strength : 400mg
Manufactured : Natco .

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Hepcinat

Hepcinat is a nucleotide prodrug analogue; it is a NS5B polymerase inhibitor with HCV prohibiting activity. Hepcinat is an active chemical component which is applicable in various brands.
Hepcinat is not monotherapy; it should be combined with other retroviral medicines. The therapy should be followed for 12 weeks which results as curable
Hepcinat is available in the strength of 400mg and the dosage form of Hepcinat is film coated tablet



Hepcinat



Hepcinat indication for

Hepcinat has prominent anti viral activity, which used to treats chronic hepatitis C viral infection. It is effective against hepatitis C of I, II, III and IV genotypes.

Safety points:

In hepatitis c treatment, monotherapy is not suggested, it is combinational therapy
The schedule and duration of the therapy should be depending upon the type of genotype of the virus and patient’s level.
The efficacy of the treatment depends on the virus and host characterization.

Pharmacology of Hepcinat

Hepcinat mechanism of action
Hepcinat, an anti-viral medicine has nucleotide prodrug that prevents the replication of hepatitis C virus by prohibiting the effect of HCV NS5B RNA polymerase. This enzyme go through intercellular metabolism to
produce GS-461203, and form pharmacologically active triphosphate. uridine
Hepatitis C virus NS5B RNA polymerase infused this metabolite into viral DNA, it acts as chain end.

Pharmacokinetic:

Absorption

Hepcinat is absorbed rapidly after oral administration
The peak plasma concentration of Hepcinat and circulating metabolite GS-331007 occurs at 0.5 to 2 hours and 2 to 4 hours respectively after administration

Effect of Food:

Hepcinat with high fat meals, causes reduction in absorption rate of the Hepcinat when compared with fasting
Whereas high fat meals do not creates effect when exposed to metabolite GS-331007. So it is not consider whether Hepcinat takes with or without food

Distribution:

Hepcinat is highly bound to blood plasma protein approximately 61-65%. The GS-331007 binding to plasma proteins is minimal.

Metabolism:

Hepcinat is highly metabolized in liver and to form nucleoside triphosphate analogue which is active (GS-461203).
The activation metabolic of route is associates sequential hydrolysis of a carboxylic acid ester molecule with cathepsin A or carboxyl esterase 1.

Elimination:

The elimination of route in metabolites occurs via Kidneys, intestines, and lungs The drug around 78% excreted as inactive metabolite, 3.5% was excreted as Hepcinat
The half life time of both Hepcinat and GS-331007 is 0.4 and 27 hours respectively.

The usual prescribed dose of Hepcinat is one tablet 400mg should be taken as a single dose, disregarding of food intake.
In the treatment of chronic hepatitis C infection;
Hepcinat should be combined with ribavirin or pegylated interferon and ribavirin. Combinational therapy:
HCG (genotype I and IV: Hepcinat + peg interferon alfa + ribavirin followed for 12 weeks
HCG genotype II: Hepcinat + ribavirin for 12 weeks HCG genotype III: Hepcinat + ribavirin for 24 weeks Ribavirin dose should be recommended on the basis of weight of the patient. It is administered orally with food.
In the condition of renal failure, ribavirin should be discontinued. There is a chance to get re-infection of HCV after transplantation; in this condition Hepcinat with ribavirin is recommended it is not more than 48 weeks.

Peg interferon dosage regimen: for
Peg interferon alpha 2a: 180 mcg SC weekly Peg interferon alpha 2b: 1.5mcg/kg/week SC, not exceed to 150mcg/week

Ribavirin dosage regimen: for
For prevention of post transplant HCV re-infection: Hepcinat + ribavirin for 48 weeks or until liver transplant.
It should be taken with food
<75 kg: 500mg PO twice daily, ≥75 kg: 600mg PO twice daily

Pediatric dose:
For hepatitis C viral infection
<12 years or <35 kg: the safety and efficacy of the drug has not been established
≥12 years or weight ≥35 kg: 400mg PO qDay with weight based ribavirin
During combination with ribavirin, it must be taken with food. Hepcinat should be taken with or without food


Amiodarone: symptomatic bradycardia occurs while taking Hepcinat with amiodarone. This combination causes serious cardiac arrest. Some other drugs like;
symptomatic bradycardia occurs while taking Hepcinat with amiodarone. This combination causes serious cardiac arrest. Some other drugs like;
Atazanavir; cobicistat: cobicistat is an inhibitor of transporters P-glycoprotein inducers and BCRP. In combination with Hepcinat leads to increase its concentration; adverse affects may produce.
Apalutamide:
Apalutamide is a P-glycoprotein inducers and BCRP. It should not be combined with Hepcinat, these concomitant can cause reduction of plasma concentration of Hepcinat and loss of anti-viral efficacy.

While using combinational therapy there is a possibilities of contraindication;
With peg-interferon
Autoimmune hepatitis, decompensated liver disease For neonates and infants

Drugs like rifampin and st. John s wort are potent P-gp inducers leads to reduce plasma concentration of Hepcinat.
Peg interferon:
Caution in renal impairment patient
Liver transplantation
Cause Myelosuppression
Flu like symptoms
Hepatic impairment

Hypersensitivity, Pregnant women or become pregnant
Pancreatitis, Thalassemia major, sickle cell anemia Concomitant with Didanosine
Autoimmune hepatitis, decompensated liver disease, For neonates and infants
Ribavirin:
While combined with ribavirin care should be taken, because it causes fetal harm or death. Ribavirin not recommended in pregnancy period.
Hemolytic anemia, Anemia, Ocular disorders, Carcinogenic effects, Bone marrow suppression

Common side effects of Hepcinat


>10% of the patient may have chance to get adverse effects while taking Hepcinat and ribavirin (12 weeks) like;
Nausea, Insomnia, Pruritus, Fatigue, Headache,
<1% has chances to get; Neutropenia, Pancytopenia, Severe depression, Bradycardia, Some healthcare professionals;
Both ribavirin and peg interferon has some adverse effects;
Based on pharmacological effects;


Hepcinat

Pregnancy and lactation:

Hepcinat is comes under the pregnancy category: B.
But when combined with ribavirin category should be X Ribavirin causes fetal death
Concomitant with ribavirin and peg interferon, it is not recommended in breastfeeding mothers.

Storage:

Hepcinat is generally stored at room temperature below 30°c (86°F)
It should be keep away from moisture, heat, and light
Keep reach out from children and pets

Missed dose:

Once patient fail to administer the dose of Hepcinat, must consult with medical practitioner and take the missed dose. Otherwise it should be skipped and follow the next drug schedule.
Do not double the dose.



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