HEPATITIS C

• 100% safe
• Safe to consume
• Free from impurities

Other Details: 28 Tablets

Sofosbuvir With Velpatasvir is a two-drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing the viral NS5A inhibitor velpatasvir and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase. It is the first treatment, that works for all genotypic, and is taken entirely by mouth. A single tablet regimen is used for adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Sofosbuvir With Velpatasvir is an oral fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor and velapatasvir, an NS5A replication complex inhibitor. Sofosbuvir is approved for the treatment of genotype 1, 2, 3 and 4 HCV infection with different regimens and durations dependent on the HCV genotype. Velpatasvir (formerly GS-5816) is a novel NS5A inhibitor that has potent invitro anti-HCV activity across all genotypes at the picomolar level. The combination of sofosbuvir-velpatasvir is the first once-daily single-tablet regimen with pangenotypic activity.

Sofosbuvir With Velpatasvir is available as a coformulated, once-daily single-pill combination of sofosbuvir 400 mg and velpatasvir 100 mg. The recommended dose is one tablet once daily, taken with or without food.

• Renal Impairment: For patients with mild to moderate renal impairment, no dosage adjustment of sofosbuvir-velpatasvir is recommended. There are insufficient data regarding the safety and efficacy of sofosbuvir-velpatasvir in patients with severe renal impairment (eGFR less than 30 ml/min/1.73m2) or end-stage renal disease requiring hemodialysis. Accordingly, no dosage recommendation has been given for patients with severe renal impairment or end-stage renal disease requiring dialysis.
• Hepatic Impairment: For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), no dosage adjustment for sofosbuvir-velpatasvir is recommended. For patients with decompensated cirrhosis who are receiving sofosbuvir-velpatasvir and ribavirin, clinical and laboratory monitoring is recommended.

Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: Amiodarone is not recommended for use with Sofosbuvir With Velpatasvir due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Risk of Reduced Therapeutic Effect Due to Concomitant Use of Sofosbuvir With Velpatasvir with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John's wort, and carbamazepine are not recommended for use with Sofosbuvir With Velpatasvir as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

With our in-depth knowledge and rich industry experience in this field, we are highly engaged in exporting, retailing, wholesaling and supplying a qualitative NATDAC Tablet for our esteemed clients. Processed employing advanced technology and using premium quality chemical compounds, offered tablet should only be used under proper medical guidance and advice. In order to maintain the effectiveness, our quality examiners test this tablet on various parameters. 

Features:

• Highly effective
• Long shelf life
• Balanced composition

Other Details: 28 Tablets.

• Ledihep is a prescription drug and should be used under proper medical guidance and advice
• The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers

• Dacihep is a prescription drug and should be used under proper medical guidance and advice
• The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers
• Keep all medicines out of the reach of children and away from pets,never share your medicines with others,and use this medication only for the indication prescribed

• Accurate composition
• Hygienically packed
• Effectiveness

Other Details: 28 Tablets.

Additional Information:

• Item Code: 400mg

Brand Name LEDIKAST
Contents Ledipasvir and Sofosbuvir
Marketed by Aprazer Health Care
Manufactured by Natco Pharma Limited
Strength - Each film-coated tablet Contains 90 mg Ledipasvir and 400 mg Sofosbuvir
Form Tablets
Packing Pack of 28 Tablet

Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. The tablet includes the following inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet is film-coated with a coating material containing the following inactive ingredients Yellow Oxide of Iron, polyethylene glycol, polyvinyl alcohol, talc, FD&C Blue #2 and titanium dioxide IP. -

Ledipasvir The IUPAC name for ledipasvir is Methyl [(2S)-1-{(6S)-6-[5-(9,9-difluoro-7-{2-[(1R,3S,4S)-2-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2azabicyclo[2.2.1] hept-3-yl]-1H-benzimidazol-6-yl}-9H-fluoren-2-yl)-1H-imidazol-2-yl]-5-azaspiro[2.4] hept-5-yl}-3-methyl-

2.1 Mechanism of Action

Ledikast is a fixed-dose combination of ledipasvir and sofosbuvir which are directacting antiviral agents against the hepatitis C virus.

2.2 Pharmacodynamics

Cardiac Electrophysiology

Ledipasvir at a dose of 120 mg twice daily (2.67 times the maximum recommended dosage) and sofosbuvir 400 mg (maximum recommended dosage) and 1200 mg (three times the maximum recommended dosage) does not prolong QTc in clinical trials -

2.3 Pharmacokinetics

Absorption

The pharmacokinetic properties of ledipasvir, sofosbuvir, and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration, ledipasvir median peak concentrations were observed 4 to 4.5 hours post-dose. Sofosbuvir was absorbed quickly and the peak median plasma concentration was observed ~0.8 to 1 hour post dose. Median peak plasma concentration of GS-331007 was observed between 3.5 to 4 hours post-dose.

Based on the population pharmacokinetic analysis in HCV-infected subjects, geometric mean steady-state AUC0-24 for ledipasvir (N=2113), sofosbuvir (N=1542), and GS-331007 (N=2113) were 7290, 1320, and 12,000 ng-hr/mL. Steady-state Cmax for ledipasvir, sofosbuvir, and GS-331007 were 323, 618, and 707 ng/mL. Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and subjects with HCV infection. Relative to healthy subjects (N=191)

Ledipasvir is >99.8% bound to human plasma proteins. After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.51

Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 g/mL to 20 g/mL. Protein binding of GS-331007 was minimal in human plasma. After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.

Daclatasvir 400 mg +Sofosbuvir 90 mg is used in the treatment of chronic hepatitis C virus (HCV) infection.

Velpatasvir Sofosbuvir ( Tab Velasof ) by Hetero is a combination of sofosbuvir and velpatasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It is also used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover.

Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

Sofosbuvir 400 mg Velpatasvir 100 mg Indication :

Velasof ( Sofosbuvir 400 mg velpatasvir 100 mg) is used alone or with ribavirin to treat chronic hepatitis C. Sofosbuvir is in a class of antiviral medications called nucleotide hepatitis C virus (HCV) NS5B polymerase inhibitors. Velpatasvir is in a class of antiviral medications called HCV NS5A replication complex inhibitors.

The combination of sofosbuvir and velpatasvir works by stopping the virus that causes hepatitis C from spreading inside the body.