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Resof L - 12 weeks

HepatitisC-DrReddys-Ledipasvir-90mg-Sofosbuvir-400mg-Resof-L

Availability: In stock

Special Price $ 1199

BRAND : Resof L
STRENGTH : 400mg & 90mg
INGREDIENT : HepatitisC-DrReddys-Ledipasvir-90mg-Sofosbuvir-400mg-Resof-L
COMPANY NAME : Dr.Reddys
COUNT : 28 Tablets



Description of Resof L - 12 weeks

Resof L 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

Resof L tablet mediated as single dose therapy; which may used separately or in chronic conditions it may combined with ribavirin

Resof L tablets are sophisticated in the treatment of hepatitis C viral infection. The continuity of therapy occurs in 12 weeks.

Resof L product details 12 weeks

  • Trade name: Resof L
  • Active components: sofosbuvir & ledipasvir
  • Strength availability: 400mg & 90mg respectively
  • Mfg: Dr.Reddy’s
  • Package: 28 tablets in a container
  • Classification: Anti-hepaciviral drugs

Pharmacology of Resof L - 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

Resof L 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 Resof L 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:

Resof L 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 Resof L - 12 weeks

Dose & Dosage's of Resof L - 12 weeks

Resof L tablets containing 90mg of ledipasvir and 400mg of sofosbuvir

The usual recommended dosage of Resof L tablets are;

Genotype I

Therapy naïve with or without cirrhosis:

The usual Resof L 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 Resof L 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 Resof L 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:

Resof L 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 Resof L 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 Resof L tablet should be taken as single dose for 12 weeks

In pediatric:

Genotype I:

Treatment naïve without cirrhosis or with compensated cirrhosis:

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

Treatment experienced patients without cirrhosis:

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

Compensated cirrhosis:

One Resof L tablet should be taken as single dose for 24 weeks

Genotype IV, V or VI:

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

Missed dose:

If patients fail to take the dose of tablet Resof L, 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

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

Side Effects of Resof L - 12 weeks

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

Contraindication of Resof L - 12 weeks

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

Patients may have chance to get hypersensitivity reaction while taking Resof L tablet

Drug Interaction of Resof L - 12 weeks

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

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

Resof L tablet with amiodarone causes bradycardia in severe conditions

Co administration of Resof L with digoxin causes increase in concentration of digoxin

Resof L with anti-convulsants: reduce the effect of concentration of Resof L tablets

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

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

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

Precaution of Resof L - 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 Resof L tablet causes depletion in therapeutic effect

Usage & Safety profile of Resof L - 12 weeks Pregnancy & Lactation

Resof L tablets are comes under a pregnancy category: B1

Resof L while combining with ribavirin comes under pregnancy category: X

Resof L 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 Resof L - 12 weeks

Resof L container should be stored at room temperature not exceeding 30oC

Container should be keep away from moisture, heat and light