Description of Hepcinat LP
Brand Name : Hepcinat LP
Content : Ledipasvir and sofosbuvir
Strength : Ledipasvir 90 mg ; Sofosbuvir 400 mg
Manufactured by : Natco Pharma.Ltd
Trade name : Harvoni
Dosage Form : Tablets
Packed container with 28 tablets
Hepcinat LP is a antiviral drug which contain fixed-dose combination tablet of Ledipasvir and Sofosbuvir that administrated through mouth. Hepcinat LP marketed by Natco pharma Ltd . Hepcinat LP is a prescription medicine ,the medicine purchased by a patient with valid prescription obtained from doctor. Hepcinat LP package is a pack of 28 tablet in a container.
Pharmacology of Hepcinat LP
Mechanism of action:
Hepcinat LP (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( hepcinat LP) 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 acts as chain terminator by NS5B polymerase.
Absorption – 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 Hepcinat LP administration with moderate fat or high fat meal increased Sofosbuvir have no significant effect. Therefore Hepcinat LP response rate was equal in phase trials and HCV infected patient can administrated with or without food.
Distribution: Hepcinat LP (ledipasvir) bound to human plasma protein is >99.8% where as Sofosbuvir( Hepcinat LP) is approx 61-65% (human plasma protein bound). For metabolite GS-331007 the protein binding is minimal in human plasma.
Metabolism: Hepcinat LP (Ledipasvir) metabolism was observed by human is CYP1A2,CYP2C8,CYP2C9,CYP2C19,CYP2D6,CYP3A4
Extensively sofosbuvir(Hepcinat LP) metabolized in the Hepato (liver) in which it form pharmacologically active nucleoside analog triphosphate GS-461203
Elimination: Ledipasvir (Hepcinat LP) 90mg oral dose mean total elimination of the radioactivity in feces and urine was approx 87% and half life of 47hrs administration
Hepcinat LP (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 Hepcinat LP
* Hepcinat LP used for treatment of long lasting hepatitis C ( liver viral infection ).
* Hepcinat LP also used with combination of another (antiviral drug) ribavirin.
* Hepcinat LP acts by reducing the quantity of hepatitis C virus in our body
* Hepcinat LP recover the liver from infection by fighting against infection in immune system.
Dose & Dosage's of Hepcinat LP
Hepcinat LP should take One tablet administrated once in a day, orally with or without food
Avoid taking antacids within 4 hours of Hepcinat LP
If you feel better than also continue the Hepcinat LP tablet
Do not skip the dose during treatment of Hepcinat LP
Side Effects of Hepcinat LP
• Appetite loss
• Difficulty to concentrate
• irregular heartbeat
• Weakness & head pain
• Discomfort in chest
• Loss of consciousness
Contraindication of Hepcinat LP
Hepcinat LP 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 Hepcinat LP
Drug-drug interaction by Hepcinat LP with Pgp-inducers Rifampicin,by continuse use will decrease 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 Hepcinat LP
Hepcinat LP with amiodarone will leads to reduce heart rate hence stop this combination of treatment.
Precaution of Hepcinat LP
Avoid Hepcinat LP ,If allergic to ledipasvir/Sofosbuvir
If you are in treatment with another medicine or contains Sofosbuvir.
Avoid Hepcinat LP during pregnancy, planning for pregnancy or breast feeding
Avoid Hepcinat LP if you are affected by kidney or liver problems
Avoid using Hepcinat LP if you have allergic to food,medicines or other substsnce
Usage & Safety profile of Hepcinat LP Pregnancy & Lactation
Hepcinat LP 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 monitoried.
Use 2 Effective Methods Of Contraception And check Monthly Pregnancy Tests.
Storage of Hepcinat LP
Hepcinat LP 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.
Stored under 300C.