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myhep-Lvir

PRODUCT DETAILS

Brand Name : Myhep Lvir
Active components : sofosbuvir & Ledipasvir
Strength of the components : 400mg & 90mg
Manufactured by : Mylan Pharmaceuticals
Category : Anti-hepaciviral drugs
Package : 28 tablets in a container

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Myhep Lvir tablet should be used for both adults & pediatric patients with the age of 12 years or older or weight of at least 35kg. Used for; Genotype I, 4, 5, or 6 with compensated cirrhosis or without cirrhosis Genotype 1 infection with compensated cirrhosis or without cirrhosis Liver transplantation condition, genotype 1 with decompensated cirrhosis by use of ribavirin Genotype 1 or 4 without cirrhosis or with compensated cirrhosis by use of ribavirin Pediatric patients, HCV infection related to genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis.

DOSAGE

The usual advised dose of Myhep Lviris one tablet should be administered as once a day. In HIV-1 co infected patients, Myhep Lvirdosage consideration is; Patient without cirrhosis: (adult or pediatric of 12 years of age or older with genotype I, IV, V or VI Chronic HCV) The prescribed dose of Myhep Lvir is one tablet should be taken orally as a single dose for 12 weeks

Genotype I

Without cirrhosis or compensated cirrhosis: Myhep Lvir should be taken alone as a single dose followed for 12 weeks
Therapy experienced without cirrhosis: Myhep Lvir should be taken as a single agent for once a day for 12 weeks
Therapy experienced with compensated cirrhosis: Myhep Lvir tablet should be used for 24 weeks
In decompensated cirrhosis: Myhep Lvir should be combined with ribavirin to be used, followed for 12 weeks

Genotype I to IV

In liver transplantation patients with compensated cirrhosis or without cirrhosis: Myhep Lvir tablet should be combined with ribavirin for 12 weeks.
Genotype IV, V or VI :
Myhep Lvir tablets should be administered alone for 12 weeks for Without cirrhosis or with compensated cirrhosis patients: On the basis of body weight the dose of ribavirin should be calculated <75kg: 1000mg; ≥75kg: 1200mg Ribavirin should be administered with food. Myhep Lvir should be administered with or without food.

PHARMACOKINETICS

Peak plasma concentration of Myhep Lvir :
Sofosbuvir: 0.8 to 1 hour & GS331007: 3.5 to 4 hours; ledipasvir: 4 to 4.5 hours No effect produced, while Myhep Lvirshould be administered with or without food.
Plasma protein binding capacity of Myhep Lvir :
Sofosbuvir: 61 to 65% & GS-331007: minimal binding effect, ledipasvir: >99.8%
Metabolism of Myhep Lvir :
Sofosbuvir: hepatic metabolism with cathepsin A, or carboxyl esterase 1 & ledipasvir: mediated by CYP1A2, 2C8, 2C9, 2C19, 2D6 & 3A4.
Elimination of Myhep Lvir :
Major route of elimination is through urine & feces. Ledipasvir through urine by 87%; sofosbuvir through urine by 80%, feces by 14% & exhaled air by 3.5%
Half life period of Myhep Lvir :
Sofosbuvir 0.4%, GS-331007: 27 hours & ledipasvir: 47 hours.

WORK AS

Ledipasvir is a solid prohibitor of perpetual hepatitis C viral relating non structural 5A protein which is a viral phosphoprotein. The essential part of ledipasvir in hostile to viral action instrument; Restraint of; Replication Virion assembly Secretion The mechanism of sofosbuvir associated with against viral movement is; Sofosbuvir is prohibitor of nucleotide analogue of hepatitis C viral disease identified with non basic 5B polymerase. This catalyst is in charge of interceding the HCV RNA duplication. The dynamic type of sofosbuvir is in triphosphate shape, which included diminishing the common cell uridine nucleotide and is coordinated by HCV RNA polymerase into the broadened RNA preliminary strand, which is closed in viral chain end.

SAFETY MEASURES

Hepatitis B reoccurrence :
This condition is mostly occurs in patients who are undergoing anti-viral therapy & fail to receive the anti-hepatitis B viral treatment. Monitor the HBsAg & anti-HBc counts before the therapy Hepatic function test should be performed Start the anti-hepatitis B treatment.
Bradycardia :
This severity is due to combination of amiodarone with Myhep Lvirtreatment. To avoid the problem patient ECG should be monitored. Patient should be counseled before initiate the treatment about the exposure of risk due to amiodarone. Provide supportive management.
Drug interactions :
The combination of Myhep Lvirwith P-gp inducers (potent), causes decreasing the plasma concentration of component of Myhep Lvir.
Risk due to ribavirin :
Ribavirin causes fetal damage and leads to death. Contraindicated to pregnancy

IN PEDIATRIC

Genotype I

Without cirrhosis or with compensated cirrhosis: Myhep Lvir should be administered orally afor 12 weeks. Therapy experienced without cirrhosis: Myhep Lvir should be administered orally for 12 weeks. Therapy experienced compensated cirrhosis: Myhep Lvir tablet should be administered orally for 12 weeks.

Genotype IV, V or VI

Therapy naïve or experienced without cirrhosis or with compensated cirrhosis: Myhep Lvir tablet should be administered orally for 12 weeks. Renal impairment patients; Myhep Lvir dosage adjustment should not be allowed in severe renal damaged condition. Due to greater exposure of sofosbuvir metabolite causes final stage of renal disease (ERSD).

DRUG INTERACTION

Myhep Lvir an inhibition of P-gp or BCRP drug transporters, this concomitant use causes increase intestinal absorption of these substrates. Myhep Lvir+ P-gp strong inducers lead to diminish the Myhep Lvirplasma concentration causes loss of therapeutic efficacy of Myhep Lvir. Myhep Lvir+ warfarin causes alteration in INR values, monitor the prothrombin time during this combination. Myhep Lvir+ gastric regulators, causes diminishing ledipasvir plasma concentration, do not administer Myhep Lvirtablet concurrently with gastric regulators. Myhep Lvir+ anti-arrhythmic agents lead to produce plasma concentration elevation of these drugs. Myhep Lvir+ anti-convulsants or anti-mycobacterials may cause depletion of plasma concentration of Myhep Lvir. Myhep Lvir+ anti-retroviral drugs, increases the plasma concentration of these drugs. Myhep Lvir+ st Johns wort causes decreasing the plasma concentration of Myhep Lvir. Myhep Lvir+ HMG CoA reductase inhibitors cause elevation of plasma concentration of these drugs.

OVERDOSAGE

The over dosage condition should be overcome by; Provide supportive management. Monitor the manifestations. Treated by Hemodialysis Ledipasvir does not eliminate by hemodialysis process, because of ledipasvir has large protein binding capacity. The circulating metabolite of sofosbuvir is eliminated from the body by processing with hemodialysis with the range of 54%.

CONTRAINDICATION

Myhep Lvir with ribavirin is contraindicated to pregnancy condition Hypersensitivity reactions produces, if patients are contraindicated to the component present in the Myhep Lvir.

MISSED DOSE

In case of missed dose occurrence during the therapy, patient must be consult with medical practitioner and follow the instructions. Maintain the regular dosing schedule.

SIDE EFFECTS

Fatigue, Headache, Nausea, Diarrhea, Insomnia, Elevation of bilirubin, Elevation of lipase, Elevation of creatine kinase, Severe bradycardia, HBV reactivation, Chest pain, Dizziness, Trouble in breathing.

WARNING

The regular antagonistic delivered amid or after finish of treatment are; Introduction of HBV restoration in HCV/HBV co contaminated patients. To avoid the problem by counting the patients HBsAg & anti-HBc values before initiate the treatment with Myhep Lvir. Monitor the hepatic function test periodically before, during & after completion of treatment. Patient should be provided with supportive management for preventing the hepatitis B viral infection reoccurrence.

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