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resof




Brand : resof
Composition : Sofosbuvir
Packing : 28 tablets
Strength : 400mg
Manufactured : Dr.Reddy's .

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resof

resof is not monotherapy; it should be combined with other retroviral medicines. The therapy should be followed for 12 weeks which results as curable
resof is available in the strength of 400mg and the dosage form of
resof is film coated tablet,resof is a nucleotide prodrug analogue; it is a NS5B polymerase inhibitor with HCV prohibiting activity. resof is an active chemical component which is applicable in various brands.



resof



Safety points:

In hepatitis c treatment, monotherapy is not suggested, it is combinational therapy
The schedule and duration of the therapy should be depending upon the type of genotype of the virus and patient’s level.
The efficacy of the treatment depends on the virus and host characterization.

resof indication for

resof has prominent anti viral activity, which used to treats chronic hepatitis C viral infection. It is effective against hepatitis C of I, II, III and IV genotypes.

Pharmacology of resof

resof mechanism of action
resof, an anti-viral medicine has nucleotide prodrug that prevents the replication of hepatitis C virus by prohibiting the effect of HCV NS5B RNA polymerase. This enzyme go through intercellular metabolism to
produce GS-461203, and form pharmacologically active triphosphate. uridine
Hepatitis C virus NS5B RNA polymerase infused this metabolite into viral DNA, it acts as chain end.

Pharmacokinetic:

Absorption

resof is absorbed rapidly after oral administration
The peak plasma concentration of resof and circulating metabolite GS-331007 occurs at 0.5 to 2 hours and 2 to 4 hours respectively after administration

Effect of Food:

resof with high fat meals, causes reduction in absorption rate of the resof when compared with fasting
Whereas high fat meals do not creates effect when exposed to metabolite GS-331007. So it is not consider whether resof takes with or without food

Distribution:

resof is highly bound to blood plasma protein approximately 61-65%. The GS-331007 binding to plasma proteins is minimal.

Metabolism:

resof is highly metabolized in liver and to form nucleoside triphosphate analogue which is active (GS-461203).
The activation metabolic of route is associates sequential hydrolysis of a carboxylic acid ester molecule with cathepsin A or carboxyl esterase 1.

Elimination:

The elimination of route in metabolites occurs via Kidneys, intestines, and lungs The drug around 78% excreted as inactive metabolite, 3.5% was excreted as resof
The half life time of both resof and GS-331007 is 0.4 and 27 hours respectively.

The usual prescribed dose of resof is one tablet 400mg should be taken as a single dose, disregarding of food intake.
In the treatment of chronic hepatitis C infection;
resof should be combined with ribavirin or pegylated interferon and ribavirin. Combinational therapy:
HCG (genotype I and IV: resof + peg interferon alfa + ribavirin followed for 12 weeks
HCG genotype II: resof + ribavirin for 12 weeks HCG genotype III: resof + ribavirin for 24 weeks Ribavirin dose should be recommended on the basis of weight of the patient. It is administered orally with food.
In the condition of renal failure, ribavirin should be discontinued. There is a chance to get re-infection of HCV after transplantation; in this condition resof with ribavirin is recommended it is not more than 48 weeks.

Peg interferon dosage regimen: for
Peg interferon alpha 2a: 180 mcg SC weekly Peg interferon alpha 2b: 1.5mcg/kg/week SC, not exceed to 150mcg/week

Ribavirin dosage regimen: for
For prevention of post transplant HCV re-infection: resof + ribavirin for 48 weeks or until liver transplant.
It should be taken with food
<75 kg: 500mg PO twice daily, ≥75 kg: 600mg PO twice daily

Pediatric dose:
For hepatitis C viral infection
<12 years or <35 kg: the safety and efficacy of the drug has not been established
≥12 years or weight ≥35 kg: 400mg PO qDay with weight based ribavirin
During combination with ribavirin, it must be taken with food. resof should be taken with or without food


Amiodarone: symptomatic bradycardia occurs while taking resof with amiodarone. This combination causes serious cardiac arrest. Some other drugs like;
symptomatic bradycardia occurs while taking resof with amiodarone. This combination causes serious cardiac arrest. Some other drugs like;
Atazanavir; cobicistat: cobicistat is an inhibitor of transporters P-glycoprotein inducers and BCRP. In combination with resof leads to increase its concentration; adverse affects may produce.
Apalutamide:
Apalutamide is a P-glycoprotein inducers and BCRP. It should not be combined with resof, these concomitant can cause reduction of plasma concentration of resof and loss of anti-viral efficacy.

While using combinational therapy there is a possibilities of contraindication;
With peg-interferon
Autoimmune hepatitis, decompensated liver disease For neonates and infants

Drugs like rifampin and st. John s wort are potent P-gp inducers leads to reduce plasma concentration of resof.
Peg interferon:
Caution in renal impairment patient
Liver transplantation
Cause Myelosuppression
Flu like symptoms
Hepatic impairment


Ribavirin:
While combined with ribavirin care should be taken, because it causes fetal harm or death. Ribavirin not recommended in pregnancy period.
Hemolytic anemia, Anemia, Ocular disorders, Carcinogenic effects, Bone marrow suppression
Hypersensitivity, Pregnant women or become pregnant
Pancreatitis, Thalassemia major, sickle cell anemia Concomitant with Didanosine
Autoimmune hepatitis, decompensated liver disease,For neonates and infants

Common side effects of resof


>10% of the patient may have chance to get adverse effects while taking resof and ribavirin (12 weeks) like;
Nausea, Insomnia, Pruritus, Fatigue, Headache,
<1% has chances to get; Neutropenia, Pancytopenia, Severe depression, Bradycardia, Some healthcare professionals;
Both ribavirin and peg interferon has some adverse effects;
Based on pharmacological effects;


resof

Pregnancy and lactation:

resof is comes under the pregnancy category: B.
But when combined with ribavirin category should be X Ribavirin causes fetal death
Concomitant with ribavirin and peg interferon, it is not recommended in breastfeeding mothers.

Storage:

resof is generally stored at room temperature below 30°c (86°F)
It should be keep away from moisture, heat, and light
Keep reach out from children and pets

Missed dose:

Once patient fail to administer the dose of resof, must consult with medical practitioner and take the missed dose. Otherwise it should be skipped and follow the next drug schedule.
Do not double the dose.



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