Product Details:
Minimum Order Quantity | 1 Bottle |
Composition | Sofosbuvir/Velpatasvir |
Treatment | Hep c |
Prescription/Non prescription | Prescription |
Manufacturer | Myan |
Form | Tablet |
Dosage Form | Tablet |
Brand | MyHep All |
Country of Origin | Made in India |
Brand Name : MyHep All Tablets
Contents : Velpatasvir and Sofosbuvir
Marketed by : MyLan Pharmaceutical
Form : Tablets
Strength : Velpatasvir 100mg and
Sofosbuvir 400 mg
Packing : Pack of 28 tablets
Product Details:
Dosage Form (If Applicable) | Tablets |
Packaging Type | Bottle Pack |
Packaging Size | 28 Tablets |
Dose | 400 mg |
Power (MG) | 400mg |
Brand | Sofokast 400mg |
Drug Name | Sofosbuvir 400 mg |
Generic Name | Sofosbuvir 400 mg |
Company | Aprazer Healthcare |
Additional Information:
Product Details:
Packaging Type | Bottles |
Form | Tablets |
Dose (Milligram) | 100mg & 400mg |
Packaging Size | 28 Tablets |
Packing Size | 28 Tablets |
Strength (mg) | 100mg & 400mg |
Company | Aprazer Healthcare |
Manufacturer | Natco |
VELAKAST TABLETS
VELAKAST is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor. Each tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. The tablets include the following inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing the following inactive ingredients: Titanium Dioxide IP and Brilliant Blue FCF, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Effect of the drug
Thanks to the powerful composition of the drug, Velakast APRAZER HEALTHCARE is widely used to fight the hepatitis C virus of genotypes 1-6. The drug may be given as a monotherapy or for combined treatment with or without cirrhosis. The high effectiveness of the drug against all genotypes of HCV is due to the presence in its composition:
Sofosbuvir: The IUPAC name for sofosbuvir is (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5(2,4-dioxo-3,4-dihydropyrimidin- 1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran- 2yl)methoxy (phenoxy)phosphorylamino)propanoate. It has a molecular formula of C22H29FN3 O9 P and a molecular weight of 529.45. Sofosbuvir is a white to off-white crystalline solid with a solubility of at least 2 mg/mL across the pH range of 2–7.7 at 37°C and is slightly soluble in water.
Velpatasvir: The IUPAC name for velpatasvir is Methyl {(1R)-2-[(2S,4S)-2-(5-{2[(2S,5S)-1-{(2S)-2-[(methoxycarbonyl) amino]-3-methylbutanoyl}-5-methylpyrrolidin-2-yl]1,11-dihydro[2]benzopyrano[4′,3′:6,7]naphtho[1,2-d]imidazol-9- yl}-1H-imidazol-2-yl)-4(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl}carbamate. It has a molecular formula of C49H54 N8 O8 and a molecular weight of 883.0. Velpatasvir is practically insoluble (less than 0.1 mg/mL) above pH 5, slightly soluble (3.6 mg/mL) at pH 2, and soluble (greater than 36 mg/mL) at pH 1.2.
Mechanism of Action
VELAKAST is a fixed-dose combination of sofosbuvir and velpatasvir which are direct-acting antiviral agents against the hepatitis C virus Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with an IC50 value ranging from 0.36 to 3.3 micromolar. GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. Velpatasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicates velpatasvir targets NS5A as its mode of action.
OVERDOSAGE
No specific antidote is available for overdose with VELAKAST. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with VELAKAST consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Hemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%. Hemodialysis is unlikely to result in significant removal of velpatasvir since velpatasvir is highly bound to plasma protein.
HOW SUPPLIED AND STORAGE
Each bottle contains 28 tablets and is closed with a child-resistant closure. Storage: Store below 30°C
Additional Information:
Product Details:
Composition | Sofosbuvir/Ledipasvir |
Treatment | Hepatitis C |
Prescription/Non prescription | Prescription |
Brand | Aprazer |
Form | Tablet |
Company | Aprazer Healthcare |
Form Of Medicines | Tablets |
Dosage Form | Tablets |
Packaging Size | 28 Tablets |
Dosage | 90mg and 400mg |
Generic | Ledipasvir and Sofosbuvir |
Manufacturer | Natco |
Condition | New |
Power (Mg) | 90mg and 400mg |
Country of Origin | Made in India |
1.0 DESCRIPTION
Composition
Each film-coated tablet Contains:
Ledipasvir 90 mg
Sofosbuvir 400 mg
Colors: Yellow oxide of Iron, Titanium Dioxide IP and FD&C Blue#2
Ledikast is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
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-1-oxobutan-2-yl]carbamate.
2.0 CLINICAL PHARMACOLOGY
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),
Effect of Food
In fasting conditions, the administration of a single dose of ledipasvir and sofosbuvir with a moderate fat (~600 kcal, 25% to 30% fat) or high fat (~1000 kcal, 50% fat) meal increased sofosbuvir AUC0-inf by approximately 2-fold, but did not significantly affect sofosbuvir Cmax. The exposures of GS-331007 and ledipasvir were not altered in the presence of either meal type. The response rates in Phase 3 trials were similar in HCVinfected subjects who received Ledipasvir + Sofosbuvir with food or without food. Ledipasvir + Sofosbuvir can be administered without regard to food.
Mechanism of Action
Ledipasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action. Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay,
Additional Information:
Product Details:
Treatment | Hepatitis C |
Prescription/Non prescription | Prescription |
Brand | Hetero |
Manufacturer | Hetero |
Form | Tablet |
Dose/Strength | 60 mg |
Packaging Size | 28 Tablets |
Composition | Daclatasvir |
Packaging Type | Bottles |
Daclatasvir 60mg Tablets are an antiviral medicine that prevents hepatitis C virus (HCV) from multiplying in your body. Daclatasvir is used to treat genotype 3 chronic hepatitis C in adults without cirrhosis. This medicine is given together with another drug called sofosbuvir. Daclatasvir may also be used for purposes not listed in this medication guide.
Features:
No side effects
Accurate composition
High purity
Product Details:
Manufacturer | Mylan |
Composition | Tenofovir Alafenamide |
Treatment | HIV |
Prescription/Non prescription | Prescription |
Dosage Form | Tablet |
Form | Tablet |
Brand | HEPBEST |