Sovihep 400mg (Sofosbuvir)

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Sovihep 400mg (Sofosbuvir)

ManufacturerZydusBrand nameSovihepInternational trade nameSovaldiActive substanceSofosbuvirStrength400mgCategoryHepatitis C

Description of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) 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. Sovihep 400mg (Sofosbuvir 400mg) fixed dose combination structural protein inhibitors like NS5B.

Medical use /Indication of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) is used for the treatment of chronic hepatitis C viral infection associated with genotype I II,III or IV In decompensated cirrhosis, Sovihep 400mg (Sofosbuvir 400mg) tablets are combined with ribavirin Sovihep 400mg (Sofosbuvir 400mg) is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines. Sovihep 400mg (Sofosbuvir 400mg) mainly prescribed for adolescent patients, and for pediatric patients with age of 12 years or weighing at least 35kg in genotype II or III induced hepatitis C infection.

Mechanism of Action Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) is pharmacologically categorized as uridine monophosphate analogue prohibitor of HCV polymerase. The mechanism of action of Sovihep 400mg (Sofosbuvir 400mg) is basically involved in RNA replicates inhibitor. Sovihep 400mg (Sofosbuvir 400mg) is available as promedicine which gets converted into an active uridine triphosphate and inserted the active moiety into viral RNA by NS5B polymerase enzyme causes chain elimination.

Absorption of Resof 400mg (Sofosbuvir 400mg)

The peak plasma concentration time of Sovihep 400mg (Sofosbuvir 400mg) is 0.5 to 1 hour

Distribution of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) plasma protein binding capacity 61 to 65%

Metabolism of Resof 400mg (Sofosbuvir 400mg)

The metabolism of both Sovihep 400mg (Sofosbuvir 400mg) is occurs hepatically Sofosbuvir: cathepsin A, carboxyl esterase 1 or HINT1

Elimination of Resof 400mg (Sofosbuvir 400mg)

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

Side effects of Resof 400mg (Sofosbuvir 400mg)

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

Drug interaction of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) interactionwith P-gp or BCRP substrates causes increased risk of adverse effects related to these substrates. Sovihep 400mg (Sofosbuvir 400mg) with protease inhibitors or NNRTI causes decreased effect of concentration of Daclatasvir. Sovihep 400mg (Sofosbuvir 400mg) with amiodarone causes severe bradycardia. Interaction of Sovihep 400mg (Sofosbuvir 400mg) with lipid lowering medicines causes increased concentration of these medicines. Sovihep 400mg (Sofosbuvir 400mg) interaction with anti-convulsants or anti-mycobacterials causes decreased concentration of sofosbuvir. Sovihep 400mg (Sofosbuvir 400mg) interaction with st Johns wort causes decreased concentration of sofosbuvir & lead to loss of activity.

Precaution of Resof 400mg (Sofosbuvir 400mg)

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 400mg (Sofosbuvir 400mg) 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 400mg (Sofosbuvir 400mg) with P-gp inducers causes loss of activity by decreasing the sofosbuvir concentration.

Over dosage of Resof 400mg (Sofosbuvir 400mg)

No specific antidote is required for over dosage of Sovihep 400mg (Sofosbuvir 400mg) . 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 400mg (Sofosbuvir 400mg) dose should be eliminated by range of 18% over period of 4 hours of dialysis. The circulating metabolite of Sovihep 400mg (Sofosbuvir 400mg) should be expelled by separation co efficient of 53%. Daclatasvir is difficult to remove because it is widely bounds to human plasma protein.

Contraindication of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) Natdac is contraindicated to; Pregnancy while combined with ribavirin. Combination of Sovihep 400mg (Sofosbuvir 400mg) Natdac with P-gp inducers is contraindicated. Hypersensitivity reactions are produced while patients are contraindicated to ingredients of Sovihep 400mg (Sofosbuvir 400mg) Natdac tablets.

Pregnancy of Resof 400mg (Sofosbuvir 400mg)

  • Sovihep 400mg (Sofosbuvir 400mg) pregnancy category;
  • Sovihep 400mg (Sofosbuvir 400mg) pregnancy category; Sofosbuvir: B Ribavirin: X
  • The combination of Sovihep 400mg (Sofosbuvir 400mg) with ribavirin should not be suggested in pregnancy condition.

Lactation of Resof 400mg (Sofosbuvir 400mg)

While taking Sovihep 400mg (Sofosbuvir 400mg), Breast feeding should not be recommended.

Pediatric of Resof 400mg (Sofosbuvir 400mg)

In pediatric :

The recommended dosage of Sovihep 400mg (Sofosbuvir 400mg) in pediatric patients involved as; <12 years or <35kg: the safety and efficacy of the Sovihep 400mg (Sofosbuvir 400mg) tablets has not been established ≥12 years or ≥35kg: 400mg of Sovihep 400mg (Sofosbuvir 400mg) tablet should be administered with weight based ribavirin The dosage of ribavirin in weight based manner; 35 to 47 kg: 15mg/kg/day 47 to 49 kg: 600mg/day 50 to 65 kg: 800mg/day 66 to 80 kg: 1000mg/day >80kg: 1200mg/day  

Dosage of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) is used in hepatitis infection Hepatitis C viral infection :

Genotype I or IV :

400mg of Sovihep 400mg (Sofosbuvir 400mg) tablet should be taken as a single dose with combination of ribavirin and peg interferon alfa

Genotype II :

400mg of Sovihep 400mg (Sofosbuvir 400mg) tablet should be taken as a single dose with combination of ribavirin and peg interferon alfa

Genotype III : 

Sovihep 400mg (Sofosbuvir 400mg) tablet 400mg combined with ribavirin should be administered as a single dose Sovihep 400mg (Sofosbuvir 400mg) tablet should be taken with or without food Sovihep 400mg (Sofosbuvir 400mg) is a single dose therapy While combining Sovihep 400mg (Sofosbuvir 400mg) 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 Sovihep 400mg (Sofosbuvir 400mg) 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

Storage of Resof 400mg (Sofosbuvir 400mg)

Sovihep 400mg (Sofosbuvir 400mg) tablets container should be stored at room temperature at below 30℃(86 ℉) Sovihep 400mg (Sofosbuvir 400mg) container should be keep away from moisture, heat and light

Missed dose of Resof 400mg (Sofosbuvir 400mg)

In case of patients fail to take the dose of Sovihep 400mg (Sofosbuvir 400mg), 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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Active substance:
Hepatitis C
28 Tablets
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