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Hepcinat-400mg

PRODUCT DETAILS

Brand Name : Hepcinat
Active components : Sofosbuvir
Strength of the components : 400mg
Manufactured by : Natco pharma
Category : Anti-viral drugs
Package : 28 tablets in a container of each product

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Hepcinat contains an anti viral agent known as Sofosbuvir The anti-viral agents is most probably used for treating chronic hepatitis C viral infection caused by genotypes I, II, III or IV. Hepcinat fixed dose combination structural protein inhibitors like NS5B.

INDICATION

Hepcinat contains an anti viral agent known as Sofosbuvir The anti-viral agents is most probably used for treating chronic hepatitis C viral infection caused by genotypes I, II, III or IV. Hepcinat fixed dose combination structural protein inhibitors like NS5B.

MECHANISM

Hepcinat – Sofosbuvir Sofosbuvir is pharmacologically categorized as uridine monophosphate analogue prohibitor of HCV polymerase. The mechanism of action of Sofosbuvir is basically involved in RNA replicates inhibitor. Sofosbuvir is available as prodrug which gets converted into an active uridine triphosphate and inserted the active moiety into viral RNA by NS5B polymerase enzyme causes chain elimination.

DOSAGE

Hepcinat is used in hepatitis infection Hepatitis C viral infection :
Genotype I or IV : 400mg of Hepcinat tablet should be taken as a single dose with combination of ribavirin and peg interferon alfa
Genotype II : One tablet of Hepcinat should be administered as a single dose by concomitant with ribavirin
Genotype III : Hepcinat tablet 400mg combined with ribavirin should be administered as a single dose Hepcinat tablet should be taken with or without food Hepcinat is a single dose therapy While combining Hepcinat with ribavirin must be administered with food; not in empty stomach
The dosage of ribavirin should be based on patients’ weight :
<75kg: 500mg should be administered as twice daily with food ≥75kg: 600mg should be taken as twice daily with food Hepcinat with ribavirin used in genotype I, II, III or IV
The dosage of peg interferon alfa :
Peginterferon alfa 2a: 180mcg SC weekly Peginterferon alfa 2b: 1.5mcg/kg/week SC; should not exceed as 150mcg/week

ADME

Absorption:
The peak plasma concentration time of Sofosbuvir is 0.5 to 1 hour
Distribution :
Sofosbuvir plasma protein binding capacity 61 to 65%
Metabolism :
The metabolism of both Hepcinat is occurs hepatically Sofosbuvir: cathepsin A, carboxyl esterase 1 or HINT1
Elimination :
Half life of Sofosbuvir is 0.4 hour & GS-331007: 27 hours Sofosbuvir: 80% through urine, 14% through feces.

PRECAUTIONS

Risk of HBV reactivation :
This fatal case is occurs in the patient who is receiving anti-HCV therapy. Prevent the problem by measuring HBsAg & anti-HBc levels of patients before starting the treatment. Hepatic function test should be monitored frequently and maintain the hepatic enzymes. Initiate the HBV infection management for the patients.
Loss of virological response :
Due to advancement of resistance of Daclatasvir it should be combined with other abnti-viarl agents like sofosbuvir for better activity.
Bradycardia :
Avoid concurrent use of Hepcinat with amiodarone Monitor the ECG Provide alternative medication for reducing the cardiac issues Counsel the patients before initiate the therapy about the risk associated with these combination.
Risk related to ribavirin :
Ribavirin is contraindicated to pregnancy because it causes fetal harm even to death.
Combination of P-gp inducers :
The combination of Hepcinat with P-gp inducers causes loss of activity by decreasing the sofosbuvir concentration.

DRUG INTERACTION

Hepcinat interactionwith P-gp or BCRP substrates causes increased risk of adverse effects related to these substrates. Hepcinat with protease inhibitors or NNRTI causes decreased effect of concentration of Daclatasvir. Hepcinat with amiodarone causes severe bradycardia. Interaction of Hepcinat with lipid lowering drugs causes increased concentration of these drugs. Hepcinat interaction with anti-convulsants or anti-mycobacterials causes decreased concentration of sofosbuvir. Hepcinat interaction with st Johns wort causes decreased concentration of sofosbuvir & lead to loss of activity.

CONTRAINDICATION

Hepcinat while combining with ribavirin causes some fetal deformity or otherwise leads to death, in such cases it is contraindicated to pregnant women Anaphylactic reaction occurs while patients taking Sofovir tablets, due to component present in the product

OVERDOSAGE

No specific antidote is required for over dosage of Sofosbuvir . In case of over dosage, patient should be provided with general supportive management. Manifestation due to over dosage condition should be monitored. Over dosage should be treated by undergoing hemodialysis. Sofosbuvir dose should be eliminated by range of 18% over period of 4 hours of dialysis. The circulating metabolite of sofosbuvir should be expelled by separation co efficient of 53%. Daclatasvir is difficult to remove because it is widely bounds to human plasma protein.

SIDE EFFECTS

Symptomatic bradycardia while combining with amiodarone, Headache, Fatigue, Nausea, Diarrhea, Insomnia, Dizziness, Influenza like syndrome, Rash, Pyrexia, Neutropenia , Myalgia, Irritability, Severe depression, Pancytopenia.

STORAGE

Hepcinat tablets container should be stored at room temperature at below 30℃(86 ℉) Hepcinat container should be keep away from moisture, heat and light

LACTATION

Breast feeding should not be recommended.

MISSED DOSE

In case of patients fail to take the dose of Hepcinat, must be consult with medical practitioner & follow the dose. Prevent the missed dose by following the regular dosing schedule. Avoid self medication

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