Hepatitis C Medicine

• 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.

Spegra Tablets is a prescription drug and should be used under proper medical guidance and advice.

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.