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Resof-400mg

PRODUCT DETAILS

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

for MORE INFORMATION !!!

Resof 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. Resof fixed dose combination structural protein inhibitors like NS5B.

INDICATION

Resof is used for the treatment of chronic hepatitis C viral infection associated with genotype I II, III or IV In decompensated cirrhosis, Resof tablets are combined with ribavirin Resof is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines. Resof 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 Resof 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

Resof is used in hepatitis infection Hepatitis C viral infection :
Genotype I or IV : 400mg of Resof tablet should be taken as a single dose with combination of ribavirin and peg interferon alfa
Genotype II : One tablet of Resof should be administered as a single dose by concomitant with ribavirin
Genotype III : Resof tablet 400mg combined with ribavirin should be administered as a single dose Resof tablet should be taken with or without food Resof is a single dose therapy While combining Resof 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 Resof 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 Resof 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 Resof with P-gp inducers causes loss of activity by decreasing the sofosbuvir concentration.

DRUG INTERACTION

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

CONTRAINDICATION

Resof 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

The recommended dosage of Resof in pediatric patients involved as; <12 years or <35kg: the safety and efficacy of the Resof tablets has not been established ≥12 years or ≥35kg: 400mg of Resof 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

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

Resof tablets container should be stored at room temperature at below 30℃(86 ℉) Resof 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 Resof, 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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