Cimivir (Sofosbuvir 400mg)

DESCRIPTION

Cimivir 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. Cimivir tablet is not a curable; it is only used to control the spreading of disease.

MECHANISM OF ACTION

The components in Cimivir tablets are involved in inhibiting non structural protein which is essential for viral multiplication. Sofosbuvir is a NS5B inhibitor, Cimivir 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 Cimivir 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 Cimivir occurs; Sofosbuvir: cathepsin A, or carboxyl esterase The elimination of Cimivir occurs via;

SThe terminal half life of Cimivir 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 Cimivir The prescribed dose of Cimivir by blend with different meds; Considerate obtain with genotype I, IV, V or VI ceaseless hepatitis C viral disease: Cimivir is joined with ribavirin and peg interferon alfa ought to be taken as a once a day. Cimivir 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

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

IN PEDIATRIC

The usual dose Cimivir 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 Cimivir 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

CIMIVIR 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 Cimivir with P-gp inducers or CYP3A4 inducers Fetal adverse occurs while concomitant with ribavirin For all these conditions, withhold or discontinue the therapy with Cimivir tablets.               

DRUG INTERACTION

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

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

CONTRAINDICATION

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

PEDIATRIC

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

PREGNANCY & LACTATION

Pregnancy category of Cimivir : B Pregnancy category of Cimivir & ribavirin: X Ribavirin is not recommended for pregnancy condition. While Cimivir 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 

Cimivir 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 Cimivir tablets; If it occurs manage with supportive measures, and hemodialysis should be recommended for eliminating the components of Cimivir 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 Cimivir 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.