Description of Ledviclear - 12 weeks
Brand Name : Ledviclear
Content : Ledipasvir and sofosbuvir
Strength : Ledipasvir 90 mg ; Sofosbuvir 400 mg
Manufactured by : Abbott india Ltd.
Trade name : Harvoni
Dosage Form : Tablets
Packed container with 28 tablets
Ledviclear is a antiviral drug which contain fixed-dose combination tablet of Ledipasvir and Sofosbuvir that administrated through mouth. Ledviclear marketed by Abbott india Ltd . Ledviclear is a prescription medicine ,the medicine purchased by a patient with valid prescription obtained from doctor. Ledviclear package is a pack of 28 tablet in a container.
Pharmacology of Ledviclear - 12 weeks
Mechanism of action
Ledviclear (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(Ledviclear) 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 (Ledviclear) acts as chain terminator by NS5B polymerase.
Absorption –Ledviclear( 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 Ledviclear administration with moderate fat or high fat meal increased Sofosbuvir have no significant effect. Therefore Ledviclear response rate was equal in phase trials and HCV infected patient can administrated with or without food.
Distribution: Ledviclear (ledipasvir) bound to human plasma protein is >99.8% where as Sofosbuvir(Ledviclear) is approx 61-65% (human plasma protein bound). For metabolite GS-331007 the protein binding is minimal in human plasma.
Metabolism: Ledviclear (Ledipasvir) metabolism was observed by human is CYP1A2,CYP2C8,CYP2C9,CYP2C19,CYP2D6,CYP3A4
Extensively sofosbuvir(Ledviclear) metabolized in the Hepato (liver) in which it form pharmacologically active nucleoside analog triphosphate GS-461203
Elimination: Ledipasvir (Ledviclear) 90mg oral dose mean total elimination of the radioactivity in feces and urine was approx 87% and half life of 47hrs administration
Ledviclear (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 Ledviclear - 12 weeks
* Ledviclear used for treatment of long lasting hepatitis C ( liver viral infection ).
* Ledviclear also used with combination of another (antiviral drug) ribavirin.
* Ledviclear acts by reducing the quantity of hepatitis C virus in our body
* Ledviclear recover the liver from infection by fighting against infection in immune system.
Dose & Dosage's of Ledviclear - 12 weeks
Ledviclear should take One tablet administrated once in a day, orally with or without food
Avoid taking antacids within 4 hours of Ledviclear
If you feel better than also continue the Ledviclear tablet
Do not skip the dose during treatment of Ledviclear
Side Effects of Ledviclear - 12 weeks
Ledviclear involves Common effects:
• Appetite loss
• Difficulty to concentrate
• irregular heartbeat
• Weakness & head pain
• Discomfort in chest
• Loss of consciousness
Contraindication of Ledviclear - 12 weeks
Ledviclear 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 Ledviclear - 12 weeks
* Ledviclear used for treatment of long lasting hepatitis C ( liver viral infection ). * Ledviclear also used with combination of another (antiviral drug) ribavirin. * Ledviclear acts by reducing the quantity of hepatitis C virus in our body * Ledviclear recover the liver from infection by fighting against infection in immune system.
Precaution of Ledviclear - 12 weeks
Avoid Ledviclear,If allergic to ledipasvir/Sofosbuvir
If you are in treatment with another medicine or contains Sofosbuvir.
Avoid Ledviclear during pregnancy, planning for pregnancy or breast feeding
Avoid Ledviclear if you are affected by kidney or liver problems
Avoid using Ledviclear if you have allergic to food, medicines or other substance
Usage & Safety profile of Ledviclear - 12 weeks Pregnancy & Lactation
Ledviclear 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 Ledviclear - 12 weeks
Ledviclear 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.
Ledviclear is Stored under 300C.