Myhep LVIR (Sofosbuvir and Ledipasvir)

Sofosbuvir and Ledipasvir
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Myhep LVIR (Sofosbuvir and Ledipasvir)

ManufacturerMylanBrand nameMyhep LVIRInternational trade nameHarvoniActive substanceSofosbuvir and LedipasvirStrength400mg & 90mgCategoryHepatitis C

Description of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) 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.

Medical use /Indication of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

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.

Side effects of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

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.

Drug interaction of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg), an inhibition of P-gp or BCRP medicine transporters, this concomitant use causes increase intestinal absorption of these substrates. Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + P-gp strong inducers lead to diminish the Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) plasma concentration causes loss of therapeutic efficacy of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg). Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + warfarin causes alteration in INR values, monitor the prothrombin time during this combination. Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + gastric regulators, causes diminishing ledipasvir plasma concentration, do not administer Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) tablet concurrently with gastric regulators. Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + anti-arrhythmic agents lead to produce plasma concentration elevation of these medicines. Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + anti-convulsants or anti-mycobacterials may cause depletion of plasma concentration of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + anti-retroviral medicines, increases the plasma concentration of these medicines. Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + st Johns wort causes decreasing the plasma concentration of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + HMG CoA reductase inhibitors cause elevation of plasma concentration of these medicines.

Precaution of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

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 (Sofosbuvir 400mg & Ledipasvir 90mg). 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.

Over dosage of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

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 of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) with ribavirin is contraindicated to pregnancy condition Hypersensitivity reactions produces, if patients are contraindicated to the component present in the Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg).

Pregnancy of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

Pregnancy category of; Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg): B Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) + ribavirin: X

Ribavirin is contraindicated to pregnancy condition, causes embryo fetal damage leads to death.

Lactation of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

While taking Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg), Breast feeding should not be recommended.

Pediatric of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

Genotype I

Without cirrhosis or with compensated cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) should be administered orally afor 12 weeks. Therapy experienced without cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) should be administered orally for 12 weeks. Therapy experienced compensated cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) 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 (Sofosbuvir 400mg & Ledipasvir 90mg) tablet should be administered orally for 12 weeks. Renal impairment patients; Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) 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).

Dosage of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

The usual advised dose of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) is one tablet should be administered as once a day. In HIV-1 co infected patients, Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) dosage 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 (Sofosbuvir 400mg & Ledipasvir 90mg) is one tablet should be taken orally as a single dose for 12 weeks.

Genotype I

Without cirrhosis or compensated cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) should be taken alone as a single dose followed for 12 weeks
Therapy experienced without cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) should be taken as a single agent for once a day for 12 weeks
Therapy experienced with compensated cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) tablet should be used for 24 weeks
In decompensated cirrhosis: Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) 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 (Sofosbuvir 400mg & Ledipasvir 90mg) tablet should be combined with ribavirin for 12 weeks.
Genotype IV, V or VI :
Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) 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 (Sofosbuvir 400mg & Ledipasvir 90mg) should be administered with or without food.

Storage of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg) tablet container should be kept at temperature below 30 ℃ Protect from light Keep the container away from moisture & heat.

Missed dose of Myhep LVIR (Sofosbuvir 400mg & Ledipasvir 90mg)

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.

 

Brand name:
Myhep LVIR
International trade name:
Harvoni
Active substance:
Sofosbuvir and Ledipasvir
Strength:
400mg & 90mg
Category:
Hepatitis C
Manufacturer:
Mylan
Packaging:
28 Tablets
Product form:
Tablet

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