Viroclear 400 mg | Anti viral drugs | Chronic Hepatitis
Viroclear 400 mg | Anti viral drugs | Chronic Hepatitis
- Viroclear contains an anti viral agent known as Sofosbuvir The anti-viral agents are most probably used for treating chronic hepatitis C viral infection caused by genotypes I, II, III or IV. Viroclear 400mg fixed dose combination structural protein inhibitors like NS5B.
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| Viroclear 400mg , Viroclear 400mg tablet |
INDICATION
- Viroclear 400mg is used for the treatment of chronic hepatitis C viral infection associated with genotype I II, III or IV In decompensated cirrhosis, Viroclear 400mg tablet are combined with ribavirin Viroclear is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines. Viroclear 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.
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 Viroclear 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.
DOSAGE
Viroclear is used in hepatitis infection Hepatitis C viral infection :
- Genotype I or IV : 400mg of Viroclear tablet should be taken as a single dose with combination of ribavirin and peg interferon alfa
- Genotype II : One tablet of Viroclear 400mg should be administered as a single dose by concomitant with ribavirin
- Genotype III : Viroclear 400mg tablet combined with ribavirin should be administered as a single dose Viroclear tablet should be taken with or without food Viroclear is a single dose therapy While combining Viroclear 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 Viroclear 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
MECHANISM
- 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.
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 Viroclear 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 Viroclear 400mg tablet with P-gp inducers causes loss of activity by decreasing the sofosbuvir concentration.
DRUG INTERACTION
- Viroclear 400mg interaction with P-gp or BCRP substrates causes increased risk of adverse effects related to these substrates. Viroclear with protease inhibitors or NNRTI causes decreased effect of concentration of Daclatasvir. Viroclear with amiodarone causes severe bradycardia.
- Interaction of Viroclear 400mg tablet with lipid lowering drugs causes increased concentration of these drugs. Viroclear interaction with anti-convulsants or anti-mycobacterials causes decreased concentration of sofosbuvir.
- Viroclear 400mg interaction with st Johns wort causes decreased concentration of sofosbuvir & lead to loss of activity.
CONTRAINDICATION
- Viroclear 400mg is contraindicated to; Pregnancy while combined with ribavirin. Combination of Viroclear Natdac with P-gp inducers is contraindicated. Hypersensitivity reactions are produced while patients are contraindicated to ingredients of Viroclear Natdac tablets.
OVERDOSAGE
- The recommended dosage of Viroclear 400mg in pediatric patients involved as; <12 years or <35kg: the safety and efficacy of the Viroclear 400mg tablet has not been established ≥12 years or ≥35kg: 400mg of Viroclear 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
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| Viroclear 400mg , Viroclear 400mg tablet |
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
- Viroclear 400mg tablet container should be stored at room temperature at below 30℃(86 ℉) Viroclear 400mg 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 Viroclear 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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