Sovihep

Sovihep contains an anti-viral agent known as sofosbuvir Sovihep is a single fixed dose combination of two nonstructural protein inhibitors like NS5B. Sofosbuvir is used with other antiviral drugs to prevent hepatitis c viral infection. Sovihep is a prescription drug used under the supervision of medical practioners

Sofosbuvir

Sovihep

400mg

Zydus




Sovihep therapeutic indication

Sovihep is used for the treatment of chronic hepatitis C viral infection. In decompensated cirrhosis, Sovihep tablets are combined with ribavirin The major limitation of use during Sovihep therapy;

In hepatitis C viral genotype III infected patients with cirrhosis getting Daclatasvir in combination with sofosbuvir for 12 weeks leads to cause reduction of sustained virological response rate frequently.

Sovihep mechanism of action

Sovihep – 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.




Sovihep ADME properties

The peak plasma concentration time of sofosbuvir is 0.5 to 1 hour

Sofosbuvir plasma protein binding capacity 61 to 65%

The metabolism of both Sovihep is occurs hepatically Sofosbuvir: cathepsin A, carboxyl esterase 1 or HINT1

Sofosbuvir half life is 0.4 hour & GS-331007: 27 hours Sofosbuvir: 80% through urine, 14% through feces.

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Sovihep
Brand Sovihep
Ingredients Sofosbuvir
Strength 400mg
Manufactured Zydus
Rating

The usual dosage of Sovihep by combination with other medicines; Patient obtained with genotype I, IV, V or VI chronic hepatitis C viral infection: Sovihep is combined with ribavirin and peg interferon alfa should be taken as a single dose for 12 weeks Sovihep and ribavirin should be taken in case of patients are undesirable to take peg interferon alfa for 24 weeks

Patients suffered with genotype II chronic hepatitis C:
Sovihep should be combined with ribavirin as a single dose for 12 weeks

Patients with genotype III hepatitis:
Sovihep combined with ribavirin and peg interferon alfa and it should be taken as a single dose for 12 weeks Otherwise Sovihep with ribavirin should be taken as single dose for 24 weeks

In liver transplantation:
Sovihep should be concurrently used with ribavirin as a single dose until liver transmission.

In pediatric:

Sovihep tablet is recommended for the children at age 12 or weight of at least 35kg; In without cirrhosis or with child Pugh A or compensated: The recommended dosage is one tablet of Sovihep should be combined with weight-based ribavirin as a single dose for 12 weeks

In decompensated cirrhosis:
The prescribed dosage of Sovihep is one tablet should be used with ribavirin for 24 weeks

Ribavirin dosage:
Ribavirin is prescribed to consume in two divided doses only with food Initial dose 600mg slowly increased up to 100mg per day in weight less than 75kg 1200mg should be taken per day with the weight at least 75kg

In pediatric ribavirin dosage;
<47kg: 15mg/kg/day 47 to 49kg: 600mg/day 50 to 65kg: 800mg/day 66 to 80kg: 1000mg/day >80kg: 1200mg/day No dosage adjustment is followed in the therapy using Sovihep in case of renal and hepatic impairment.

Administration

GenerallySovihep is administered with or without food. Sovihep is taken as a single dose The patients should give tablet by crushing or chewing the tablet, swallow the tablet as whole with some water

Over dosage

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.

Sovihep adverse effects

Symptomatic bradycardia while combining with amiodarone Headache, Fatigue, Anemia, Increased AST, ALT, Increased bilirubin, Increased lipase, Nausea, Diarrhea, Insomnia, Dizziness, Somnolence

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 Sovihep 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 Sovihep with P-gp inducers causes loss of activity by decreasing the sofosbuvir concentration.

Sovihep drug interactions

  • Sovihep is a substrate of P-gp& BCRP transporters. While using Sovihep with P-gp or BCRP strong inducers like rifampin or st Johns wort may causes decreasing the plasma concentration of sofosbuvir. Thus the results depletion of therapeutic effect of Sovihep
  • Sovihep co administration with P-gp or BCRP inhibitors, causes increasing the plasma concentration of Sovihep
  • Sovihep with analeptic drug like modafinil causes decreasing the effect of concentration of Sovihep.
  • While combining with Sovihep with amiodarone, no effect of concentration occurs but symptomatic bradycardia occurs
  • Sovihep with vitamin K antagonist, fluctuate the effect of vitamin K antagonist
  • Sovihep with anticonvulsants like phenytoin, Phenobarbital or carbamazepine causes decreasing the effect of Sovihep
  • Sovihep with anti-mycobacterials causes depletion in effect of concentration of Sovihep

Contraindications


Sovihep is contraindicated to; Pregnancy while combined with ribavirin. Combination of Sovihep with P-gp inducers is contraindicated.

Hypersensitivity reactions are produced while patients are contraindicated to ingredients of Sovihep tablets.

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Sovihep uses in

Sovihep pregnancy category; Sofosbuvir: B Ribavirin: X The combination of Sovihep with ribavirin should not be suggested in pregnancy condition because the combination will harm the fetal.

Breast feeding should not be recommended.

In case of patients missed to take the dose of drug, should be consult with medical practitioner & follow the dose immediately. Or Prevent the missed dose by continuing the regular dosing schedule. Avoid self medication




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