Description of Myhep Lvir
Brand Name : MyHep LVIR
Content : Ledipasvir and sofosbuvir
Strength : Ledipasvir 90 mg ; Sofosbuvir 400 mg
Manufactured by : Mylan pharmaceutical Pvt.Ltd
Trade name : Harvoni
Dosage Form : Tablets
Packed container with 28 tablets
MyHep LVIR is a antiviral drug which contain fixed-dose combination tablet of Ledipasvir and Sofosbuvir that administrated through mouth. MyHep LVIR marketed by Mylan Pharmaceutical Pvt.Ltd MyHep LVIR is a prescription medicine ,the medicine purchased by a patient with valid prescription obtained from doctor. MyHep LVIR package is a pack of 28 tablet in a container.
Pharmacology of Myhep Lvir
Mechanism of action
MyHep LVIR (ledipasvir) is a HCV NS5A polymerase inhibitor, which is mainly required for viral multiplication. Ledipasvir mode of action targets NS5A protein which used for resistance selection in cell culture and cross-resistance studies.
Sofosbuvir(MyHep LVIR) is a hepatitis C virus NS5B RNA dependent and polymerase that used for viral reproduction. A nucleotide prodrug (Sofosbuvir) which undergoes intracellular metabolism to form uridine analog triphosphate. It will inhibit the viral replication and blocks the new production of HCV. Sofosbuvir (MyHep LVIR) acts as chain terminator by NS5B polymerase.
Absorption: MyHep LVIR ( ledispavir/Sofosbuvir) and predominant circulating metabolite (GS-331007) have been subjected to healthy adult with chronic hepatitis C.
Median Peak Plasma Concentration(MPPC)
DRUGS RANGE(hrs post dose)
Sofosbuvir 0.8-1(absorbed quickly)
Effect with food: For fasting conditions- Single dose of MyHep LVIR
administration with moderate fat or high fat meal increased Sofosbuvir have no significant effect. Therefore MyHep LVIR response rate was equal in phase trials and HCV infected patient can administrated with or without food.
Distribution MyHep LVIR (ledipasvir) bound to human plasma protein is >99.8% where as Sofosbuvir(MyHep LVIR) is approx 61-65% (human plasma protein bound). For metabolite GS-331007 the protein binding is minimal in human plasma.
Metabolism: MyHep LVIR (Ledipasvir) metabolism was observed by human is CYP1A2,CYP2C8,CYP2C9,CYP2C19,CYP2D6,CYP3A4
Extensively Sofosbuvir ( MyHep LVIR ) metabolized in the Hepato (liver) in which it form pharmacologically active nucleoside analog triphosphate GS-461203
Elimination: Ledipasvir (MyHep LVIR) 90mg oral dose mean total elimination of the radioactivity in feces and urine was approx 87% and half life of 47hrs administration
MyHep LVIR (Sofosbuvir 400mg) oral dose mean total elimination dose was >92%, be found in approximately of 80%,14% and 2.5% eliminate through feces,urine and expired air while in metabolite dose of 78% eliminated in urine. The half life of Sofosbuvir and GS-331007 is 0.5-27hrs respectively.
Indication of Myhep Lvir
~ MyHep LVIR used for treatment of long lasting hepatitis C ( liver viral infection ).
~ MyHep LVIR also used with combination of another (antiviral drug) ribavirin.
~ MyHep LVIR acts by reducing the quantity of hepatitis C virus in our body
~ MyHep LVIR recover the liver from infection by fighting against infection in immune system.
Dose & Dosage's of Myhep Lvir
~ MyHep LVIR should take One tablet administrated once in a day, orally with or without food
~ Avoid taking antacids within 4 hours of MyHep LVIR
~ If you feel better than also continue the MyHep LVIR tablet
~ Do not skip the dose during treatment of MyHep LVIR
Side Effects of Myhep Lvir
MyHep LVIR involves Common effects:
* Appetite loss
* Difficulty to concentrate
* Irregular heartbeat
* Weakness & head pain
* Serious effects
* Discomfort in chest
* Loss of consciousness
Contraindication of Myhep Lvir
* MyHep LVIR has a contraindications with other antiviral drugs as follows:
* Allergic to the ledispavir/Sofosbuvir
* Child and adolescence to 18 years
* Pregnancy and breast feeding.
Drug Interaction of Myhep Lvir
Drug-drug interaction by MyHep LVIR with Pgp-inducers Rifampicin,by continuse use will reduce blood concentration and therapeutic action.
Interaction with H2 receptors and proton pump inhibitors will decrease the ledipasvir concentration hence take the medicine before 2 hrs dose of MyHep LVIR.
MyHep LVIR with amiodarone will leads to reduce heart rate hence stop this combination of treatment.
Precaution of Myhep Lvir
Avoid MyHep LVIR,If allergic to ledipasvir/Sofosbuvir
~ If you are in treatment with another medicine or contains Sofosbuvir.
~ Avoid MyHep LVIR during pregnancy, planning for pregnancy or breast feeding
~ Avoid MyHep LVIR, if you are affected by kidney or liver problems
~ Avoid using MyHep LVIR, if you have allergic to food, medicines or other substance
Usage & Safety profile of Myhep Lvir Pregnancy & Lactation
MyHep LVIR with Ribavirin will affect the Birth Defects And Fetal Death. In Animal Studies, it have been Shown Interferons have Abortifacient Effects. Avoid in Pregnant women And Male Partner.
Negative Pregnancy Test Prior To Initiating Therapy for pregnant women should monitored.
Use 2 Effective Methods Of Contraception And check Monthly Pregnancy Tests.
Storage of Myhep Lvir
* MyHep LVIR is stored in a closed container. Keep away from heat, moisture and direct light.
* Kept at room temperature and reach out of children.
* Keep it in original bottle and do not freeze it.
* MyHep LVIR is Stored under 300C.