Drug profile:
Trade name: Resof Total
Composition: Sofosbuvir & Velpatasvir
Strength of the components: 400mg & 100mg respectively
Manufacturer name: Dr.Reddy’s
Package: 28 tablets in a container
Classification: Anti-hepaciviral drug.
Drug Prescribing Information of Resof Total tablets:
Resof Total is used in following conditions like;
Patients with decompensated with long-lasting Resof Total condition used in combination with ribavirin.
Resof Total tablets are used in conditions like Resof Total hepatitis C viral infection in adolescents.
HCV infection is caused by Resof Total various genotypesResof Total tablet like I, II, III, IV, V or VI.
Mechanism of Action of Resof Total:
A Resof Total tablet containing directly Resof Total acting anti-viral agents such as sofosbuvir & Velpatasvir which expels their actions by undergoing some mechanism includes;
Sofosbuvir is an inhibitor of Resof Total HCV NS5B RNA Resof Total tablet dependent RNA polymerase, an enzyme essential Resof Total tablet for viral production. Hence this inhibition Resof Total causes depletion in viral proliferation.
Velpatasvir is an inhibitor of HCV NS5A is a pan Resof Total genotype, NS5A is a protein required for HCV viral replication Resof Total thus the inhibition leads to reduce the production of HCV virus in the human body.
Absorption:
The peak concentration time of both Resof Total sofosbuvir and Velpatasvir occurs within 0.5 to 1 hour and 3 hours respectively.
The peak plasma concentration ofResof Total sofosbuvir and Velpatasvir exist in 567ng/ml & 259ng/ml respectively.
Distribution:
The human plasma protein bound to Resof Total tablet sofosbuvir and Velpatasvir with the range of 61 to 65% and >99.5% respectively.
Metabolism:
Resof Total tablet is metabolized hepatically, Resof Total with the help of cathepsin A, CES1 & HINT1.
Velpatasvir is Resof Total partially metabolized and it is excreted Resof Total tablet as an unchanged form.
Elimination:
The mean Resof Total tablet terminal half-life period Resof Total of both sofosbuvir and Velpatasvir and the circulating metabolite called GS-331007 are reaching at 0.5 hours, Resof Total 15 hours, & 27 hours respectively.
Sofosbuvir by metabolism; Velpatasvir through bile inResof Total unchanged form & GS-331007 through glomerular filtration and Resof Total active tubular secretion.
Urine:
Sofosbuvir: 80%; Velpatasvir: 14%
Feces:
Sofosbuvir: 0.4%; Velpatasvir: 94%
When to take the Tablet Resof Total:
To administer the Resof Total tablets frequently at the Resof Total tablet same time every day, as a single dose.
If concomitant with ribavirin, Resof Total tablet must be taken with food.
Gastric pH increasing drugs causes depletion in effect of serum concentration of Velpatasvir, to avoid these complications consume the antacids, H2 antagonist and proton pump inhibitors before the dose of Resof Total.
Dosage Regimens of Resof Total tablets:
Before initiating the therapy, Resof Total patients should be examined by counting the hepatitis B surface antigen and hepatitis B core antibody (HBsAg & Anti-HBc) to prevent the problem like reactivation of HBV infection.
Resof Total containing fixed-dose combination drugs like 400mg of sofosbuvir and 100mg of Velpatasvir.
Recommended Resof Total tablets in patients with chronic Resof Total tablet HCV infection related to genotypes like I, II, III, IV, V or VI.
Patients with child Pugh A: one tablet of Resof Total should be administered as a single dose.
Patients with Resof Total tablet chronic cirrhosis or Resof Total decompensated (child B or C): Resof Total tablets should be combined with ribavirin.
The ribavirin dosage should Resof Total tablet be administered on the basis of the weight of the patients.
No dosage adjustment is required for renal impaired patients.
Drug Called side effects:
Some effects may occur during the therapy of Resof Total tablets;
Anemia
Nausea
Insomnia
Asthenia
Elevate lipase level
Depression
Headache
Fatigue
Rash
Elevation of creatinine kinase
Life-threatening condition like Resof Total tablet severe symptomatic bradycardia occurs while co-administration with Resof Total tablet amiodarone.
Drug Interaction of Resof Total:
Resof Total tablets are Resof Total P-gp & BCRP drug Resof Total tablet transporters substrate while combining Resof Total with P-gp Resof Total tabletinducers causes depletion in plasma concentration of Resof Total tablet leads to reduce the curative effect.
Resof Total tablet concurrently used with anti-mycobacterials causes depletion of Resof Total tablet.
Resof Total tablet tablet combined with HIV Resof Total anti-retroviral agents leads to cause decrease the serum concentration of Velpatasvir.
Resof Total tablet tablet combining with Resof Total HMG CoA reductase agents leads to increase the concentration of these agents.
Resof Total tablet concomitant Resof Total tablet with acid-reducing agents causes the decrease in the effect of concentration of Velpatasvir.
Resof Total with amiodarone causes serious bradycardia.
Resof Total tablet combined with digoxin Resof Total tablet causes increasing the serum concentration of digoxin.
Resof Total tablet tablet with anticonvulsants causes depletion of the effect of concentration of Resof Total tablet.
Food -Drug Interactions:
No food-drug interaction occurs, the herbal product like st. Johns wort combining with Resof Total causes decreasing the therapeutic effect of Resof Total.
Possible Contraindications:
The anaphylactic reaction occurs while patients are contraindicated to the components present in Resof Total tablet.
Resof Total tablets while using alone it is safe if it is combined with ribavirin which is contraindicated in pregnant women.
Safety Measures:
While taking Resof Total tablet some adverse effects occur,Resof Total to avoid these conditions some precautions should be taken.
After completion of therapy, Resof Totalreactivation of HBV infection occurs in the patients who are co-infected with HCV/HBV infections, to avoid these conditions investigate the patient by measuring HBsAg and anti-HBc.
Ribavirin with Resof Total tablets in chronic condition causes ill to pregnant women cause fetal harm.
Care should be taken in renal and hepatic impaired patients.
Serious bradycardia occurs while combining with amiodarone.
Reduction in the therapeutic effect of Resof Total , while the concomitant use of Resof Total with P-gp inducers.
Pregnancy and Lactation:
Resof Total used alone then its pregnancy category comes under B1; safe to use.
Storage and Handling:
Keep the container away from moisture, heat, and light.
Missed dose:
Resof Total is not a normal drug, it is prescription Resof Total medicine used only by the patients who are all having a valid prescription.
If patient fail to take the dose of Resof Total tablet, must get advice from the physician and take the medicine within the time because it is single dose therapy.
Overdosage:
No distinct antidote is applicable for overdosing of Resof Total tablets; once the overdose occurs to confirm the presence of toxicity.
Treatment:
Another method is Hemodialysis can competently eliminate the dominant circulating metabolite of sofosbuvir, GS-331007 Resof Total with eradicating ration of 53%.
Hence Velpatasvir is highly bound to the human plasma protein; it is not cleared by hemodialysis and gives incredible results.
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