Support in USA : 1-978- 707-9553 / Support in India : +91- 9987711567

  • Apple Pharmaceuticals

Ledihep - 12 weeks

HepatitisC-Zydus-Ledipasvir-90mg-Sofosbuvir-400mg-Ledihep

Availability: In stock

Special Price $ 749

BRAND : Ledihep
STRENGTH : 400mg & 90mg
INGREDIENT : HepatitisC-Zydus-Ledipasvir-90mg-Sofosbuvir-400mg-Ledihep
COMPANY NAME : Zydus
COUNT : 28 Tablets



Description of Ledihep - 12 weeks

Ledihep consists of active components like sofosbuvir and ledipasvir, these fixed dose combination used to treat chronic hepatitis C virus in adolescents and children who are have at least 12 years or 77 pounds

Ledihep tablets are sophisticated in the treatment of hepatitis C viral infection. The continuity of therapy occurs in 12 weeks. Ledihep tablet mediated as single dose therapy; which may used separately or in chronic conditions it may combined with ribavirin

Ledihep product details 12 weeks

  • Trade name: Ledihep
  • Active components: sofosbuvir & ledipasvir
  • Strength availability: 400mg & 90mg respectively
  • Mfg: Zydus hepatica
  • Package: 28 tablets in a container
  • Classification: Anti-hepaciviral drugs

Pharmacology of Ledihep - 12 weeks

Mechanism of action:

Sofosbuvir:

It is a nucleotide inhibitor; especially prohibits HCV NS5B RNA polymerase, Sofosbuvir is metabolized into active form which is known as triphosphate uridine analogue. Sofosbuvir is inserted into viral RNA by NS5B polymerase and performed as chain terminator. Sofosbuvir is interfere in viral replication process

Ledipasvir: It is a NS5A, which is a protein essential for viral multiplication and association of HCV virions. Ledipasvir interfere with NS5A protein activity and terminates the viral replication

Ledihep pharmacokinetics for 12 weeks

Absorption:

After oral administration, sofosbuvir was absorbed very fastly

The peak median plasma concentration of sofosbuvir was observed in-between 0.8 to 1 hour; ledipasvir peak plasma concentration occurs in 4 to 4.5 hours after drug intake; circulating metabolite GS-331007, its peak plasma concentration occurs between 3.5 to 4 hours after oral administration

Effect of food:

The response rate of Ledihep tablets did not alter by food, so it may administer with or without food in HCV infected patients

Distribution:

The human plasma protein bound of ledipasvir nearly >99.8%; sofosbuvir occurs nearly 61 to 65% and the circulating metabolite GS-331007 was minimal

Metabolism:

Ledihep tablets are metabolized in liver; whereas sofosbuvir metabolized into active pharmacological form like triphosphate uridine analogue.

The metabolic pathway occurred by hydrolysis with the help of catalyst cathepsin A which is followed by phosphorylation

Dephosphorylation leads to form circulating metabolite called GS-331007 which has poor Anti-HCV activity

Elimination:

Sofosbuvir excreted as 80%, 14% & 2.5% through urine, feces & exhaled air respectively

Ledipasvir excreted in feces and urine; almost 70% of unchanged form of ledipasvir eliminated through feces.

The terminal half life period of sofosbuvir ledipasvir and metabolite GS-331007 are 0.5, 47 & 27 hours

Indication of Ledihep - 12 weeks

Dose & Dosage's of Ledihep - 12 weeks

Ledihep tablets containing 90mg of ledipasvir and 400mg of sofosbuvir

The usual recommended dosage of Ledihep tablets are;

Genotype I

Therapy naïve with or without cirrhosis:

The usual Ledihep dose is one tablet to be taken for 12 weeks as a single dose

It should be administered with or without food

Therapy experienced without cirrhosis:

The usual Ledihep dose is one tablet to be taken for 12 weeks as a single dose

It should be administered with or without food

Therapy experienced with cirrhosis:

The usual Ledihep dose is one tablet to be taken for 24 weeks as a single dose

It should be administered with or without food

Therapy experienced with decompensated cirrhosis:

Ledihep tablet should be combined with ribavirin for 12 weeks

Genotype I or IV:

Treatment naïve or experienced liver transplant recipients without cirrhosis or compensated cirrhosis:

One Ledihep tablet should be combined with ribavirin for 12 weeks

Genotype IV, V or VI:

Treatment naïve or experienced liver transplant recipients without cirrhosis or compensated cirrhosis:

One Ledihep tablet should be taken as single dose for 12 weeks

In pediatric:

Genotype I:

Treatment naïve without cirrhosis or with compensated cirrhosis:

One Ledihep tablet should be taken as a single dose for 12 weeks

Treatment experienced patients without cirrhosis:

One Ledihep tablets should be taken as a single dose for 12 weeks

Compensated cirrhosis:

One Ledihep tablet should be taken as single dose for 24 weeks

Genotype IV, V or VI:

Without cirrhosis or with compensated cirrhosis: one Ledihep tablet to be taken as a single dose for 12 weeks.

Missed dose:

If patients fail to take the dose of tablet Ledihep, must consult the physician and take the medicine as soon as possible otherwise the missed dose should be skipped and follow the regular dosing schedule

Ledihep tablet is a prescription medicine; it is used only by the guidance of medical practitioner

Side Effects of Ledihep - 12 weeks

  • Chest pain or discomfort       
  • Headache
  • Diarrhea
  • Irritability
  • Loss of strength
  • Muscle pain
  • Nausea
  • Trouble sleeping
  • Loss of appetite
  • Anemia
  • Increased lipase
  • Dizziness or fainting
  • Irregular heartbeat
  • Trouble breathing
  • Increased bilirubin
  • Hepatitis B reactivation
  • Myalgia
  • Elevated creatine kinase
  • Unusual tiredness
  • Cough

Contraindication of Ledihep - 12 weeks

Since combined with ribavirin causes fetal harm, contraindicated to pregnancy conditions

Patients may have chance to get hypersensitivity reaction while taking Ledihep tablet

Drug Interaction of Ledihep - 12 weeks

Some anti-retroviral agents may causes reduction in effect of concentration of Ledihep while combination

Ledipasvir is drug transporter inhibitors, while co administration of these substrates with Ledihep tablets may causes increased intestinal absorption

P-gp inducers (st. Johns wort): concomitant with Ledihep tablets leads to reduce the plasma concentration of Ledihep which causes depletion in therapeutic effect

Ledihep tablet with anti-mycobacterials: may leads to reduce concentration of Ledihep tablet

Ledihep tablet with acid reducing agents causes decrease in effect of concentration of ledipasvir

Ledihep tablet with amiodarone causes bradycardia in severe conditions

Co administration of Ledihep with digoxin causes increase in concentration of digoxin

Ledihep with anti-convulsants: reduce the effect of concentration of Ledihep tablets

Precaution of Ledihep - 12 weeks

Risks related with ribavirin combination therapy

Caution with use in renal impairment and hepatic impairment patients

Serious bradycardia occurs while concomitant with amiodarone

Concurrent use of PgP inducers and Ledihep tablet causes depletion in therapeutic effect

Usage & Safety profile of Ledihep - 12 weeks Pregnancy & Lactation

Ledihep tablets are comes under a pregnancy category: B1

Ledihep while combining with ribavirin comes under pregnancy category: X

Ledihep as monotherapy in 12 weeks therapy i.e.; it used alone means it is safe in pregnancy, if it is combined with ribavirin causes fetal harm even to death

Breast feeding is not recommended for 12 weeks therapy

Storage of Ledihep - 12 weeks

Ledihep container should be stored at room temperature not exceeding 30oC

Ledihep Container must be keep away from moisture, heat and light