Hepatitis C Medicines

Product Details:

Sofokast Tablet
Composition: Each film coated tablet Contains:Sofosbuvir 400 mgColours: Red Oxide of iron & Titanium Dioxide IP
The medicinal product "Sofosbuvir" is treated with chronic form of hepatitis C. Complex therapy with the use of this drug and other medications is prescribed for adult patients. The drug also treats patients with HIV and co-infections.The active component of the tablets is sophosbuvir. They are coated and contain 400 mg of the basic substance. The package contains 28 tablets.
Indications for use of the drug
The drug "Sofosbuvir" is prescribed for patients with hepatitis C, when the disease has passed into a chronic form. A combined approach is used for the effectiveness of treatment. It is possible to use medicament in cases when the patient has HIV in addition to hepatitis.
Contraindications to taking the drug "Sofosbuvir"
The drug is not used for hypersensitivity to substances that are present in its composition. Despite the fact that the drug does not affect fertility, it is rarely prescribed to women in their reproductive years. The use of the drug during pregnancy and breastfeeding is not recommended, as it can be harmful to the child. When pregnancy occurs, the combination of Sofosbuvira with such drugs as Interferon alfa and Ribavirin may have a negative effect on its course. For this reason, during the period of treatment, the child's bearing is undesirable. The experiments, during which the drug "Sofosbuvir" was tested in animals, showed that this drug has a slight negative impact on the offspring. Before you start taking it, you should carefully study the instructions for the drug and consult with a specialist.
Side Effect
Side effects are fully dependent on those drugs that are used in addition to Sofosbuvir, t. the main component can cause only headache and mild weakness. 
We describe the possible negative effects with different combinations of Sofosbuvira in the course of treatment at 12 weeks:
Ribavirin, more than 10% of cases . Blood can decrease the concentration of hemoglobin and increase the bilirubin index, insomnia, nausea may occur.
Ribavirin, up to 10% . Anemia, depression, dyspnea, cough, disorders in the digestive tract, hair loss, itching on the skin, cramps, pains in the joints and back and some others.
Interferon alfa and Ribavirin, more than 10% of cases . There is anemia, a decrease in the number of platelets and lymphocytes, impaired appetite, dizziness, insomnia, shortness of breath, diarrhea, vomiting, nausea, increased bilirubin, myalgia, joint pain, irritability, rashes and itching on the skin, fever,
Interferon alfa and ribavirin, less than 10% . Depression, anxiety, weight loss, migraine, impaired vision, memory and concentration, constipation, reflux, cramps, back and chest pain, asthenia, hair loss.
How Supplied / Storage and Handling
Sofokast tablets are available in bottle pack of 28 tablets along with one silicagel bag and closed  with child-resistant closure, housed in a carton along with leaflet.
Store between 15°C and 30°C 
Dispense only in original containerDo not use if seal over bottle opening is broken or missing

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• Delivery Time: 1 to 10 Days

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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, 

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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

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MyHep All Tablets Details :

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

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Positioning ourselves to meet variegated market demands, we are readily engaged as trader, supplier and exporter of Hepbest 25mg Tenofovir Alafenamide Tablets in New Delhi, Delhi, India. Tenofovir is also used to treat chronic (long term) HBV in adults and children 12 years of age and older. Tenofovir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and HBV in the blood.

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