Resof (Sofosbuvir)

DESCRIPTION

Resof  is belongs to anti-hepatitis C viral medicine, containing active components known as Sofosbuvir and available in the strength of 400mg respectively.

Sofosbuvir which expels its work by stopping the virus which may causes hepatitis C viral infection from spreading inside the body. Resof  tablet is not a curable; it is only used to control the spreading of disease.

MECHANISM OF ACTION

The components in Resof  tablets are involved in inhibiting non structural protein which is essential for viral multiplication. Sofosbuvir is a NS5B inhibitor, Resof  is a directly acting anti-hepatitis C viral agent. Sofosbuvir leads to produce pharmacologically active uridine analog triphosphate by intracellular metabolism. Sofosbuvir is inserted into viral HCV DNA by NS5B polymerase and act as a chain terminator.

ADME PROPERTIES

The peak plasma concentration time of Sofosbuvir is 0.5 to 1 hour respectively. The effect of food with Resof  tablet determines as; With moderate meal: Sofosbuvir increases to 60%; increases to 34% With high fat meal: Sofosbuvir increases to 78%; increases to 21% Flowing metabolite high serum time is between 2 to 4 hours

The human plasma protein bound; Sofosbuvir is 61 to 65%. The metabolism of Resof  occurs; Sofosbuvir: cathepsin A, or carboxyl esterase The elimination of Resof  occurs via;

SThe terminal half life of Resof  tablets; Sofosbuvir: 0.5 hours; GS331007: 25 hours Elimination of Sofosbuvir in urine at 80%; feces at 14% ofosbuvir: Glomerular filtration, active tubular secretion

DOSAGE MANAGEMENT

IN ADULTS

400mg of Resof  The prescribed dose of Resof  by blend with different meds; Considerate obtain with genotype I, IV, V or VI ceaseless hepatitis C viral disease: Resof  is joined with ribavirin and peg interferon alfa ought to be taken as a once a day. Resof  and ribavirin ought to be taken if there should be an occurrence of patients are bothersome to take peg interferon alfa.

PATIENTS ENDURED WITH GENOTYPE II CEASELESS HEPATITIS C

Resof  ought to be joined with ribavirin as a solitary dose Patients with genotype III hepatitis: Resof  joined with ribavirin and peg interferon alfa and it ought to be taken as a solitary dose Generally Resof  with ribavirin ought to be taken as single dose In liver transplantation: Resof  ought to be simultaneously utilized with ribavirin as a single dose until liver transmission.

IN PEDIATRIC

The usual dose Resof  tablet for the children at age 12 or weight of at least 35kg; Without cirrhosis or with child Pugh A or compensated in patients: One tablet of Resof  should be combined with weight based ribavirin as a single dose given for 12 weeks. For the patients with decompensated cirrhosis: Combine with ribavirin for 24 weeks the patients should be used One tablet The dosage of ribavirin; Based on body weight of the patients, the dosage of ribavirin should be recommended. < 75kg given 1000mg of ribavirin. At least 75kg given 1200mg of ribavirin. Ribavirin must be administered with food. Dosage adjustment should not be recommended in renal and hepatic impairment patients.

SIDE EFFECTS

RESOF  CAUSES UNDESIRABLE EFFECTS
Headache Fatigue Nausea Asthenia Insomnia Anemia HBV reactivation Elevation of lipase & amylase levels Elevation of creatine kinase Cardiac disorder like bradycardia while concomitant with amiodarone Angioedema Skin rashes

PRECAUTION

Exposure of hepatitis B viral infection occurs in HBV/HCV co infections Serious symptomatic bradycardia while concomitant with amiodarone Risk of depletion of therapeutic effect occurs due to combination of Resof  with P-gp inducers or CYP3A4 inducers Fetal adverse occurs while concomitant with ribavirin For all these conditions, withhold or discontinue the therapy with Resof  tablets.               

DRUG INTERACTION

Resof  is a substrate of P-gp and BCRP transporters. While utilizing Resof  with P-gp or BCRP solid inducers like rifampicin or st Johns wort may causes diminishing the plasma convergence of Resof  . Accordingly the outcomes consumption of restorative impact of Resof  Resof  co organization with P-gp or BCRP inhibitors, causes expanding the plasma convergence of Resof  Resof  with comforting medication like modafinil causes diminishing the impact of grouping of Resof  .

While joining with Resof  with amiodarone, no impact of fixation happens yet symptomatic bradycardia happens Resof  with vitamin K rival, vary the impact of vitamin K adversary Resof  with anticonvulsants like phenytoin, Phenobarbital or carbamazepine causes diminishing the impact of Resof  Resof  with hostile to mycobacterials causes consumption essentially of grouping of Sofovir

CONTRAINDICATION

Resof  is contraindicated to patients who are taking in combination with ribavirin. Ribavirin is contraindicated to pregnancy condition.

PEDIATRIC

The potency of Resof  tablet has not been established in pediatric patients Renal & hepatic impairment patients: The safety of Resof  tablets has not been established.

PREGNANCY & LACTATION

Pregnancy category of Resof  : B Pregnancy category of Resof  & ribavirin: X Ribavirin is not recommended for pregnancy condition. While Resof  joined with ribavirin in ceaseless condition, ribavirin has pregnancy classification X; which implies causes fetal harm even to death While concomitant with ribavirin, breast feeding should not be suggested.

STORAGE 

Resof  tablet to be kept at the temperature below 30°C Protect the container away from moisture, heat and light.

OVER DOSAGE

The over dosage of Resof  tablets; If it occurs manage with supportive measures, and hemodialysis should be recommended for eliminating the components of Resof  and its metabolite. Sofosbuvir is removed with the coefficient of 53%; Velpatasvir is highly bounds to human plasma protein and it is difficult to eliminate.

MISSED DOSE

If Resof  does is mised to take, must consult with medical practitioner and follow the instruction. Or missed dose should be swapped and continue the regular dosing schedule.