Description
Product Features:
| Product Name | : Sofosvel |
| Generic Name | : Sofosbuvir Velpatasvir |
| Manufacturer | : Beacon Pharma Ltd |
| Indication | : Chronic hepatitis C |
| Formulation | : Tablet |
| Strength | : 400 mg |
| Quantity | : 28 Tablets |
| Storage | : Room temperature |
| Registrations | : Export Only |
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Sofosvel (Sofosbuvir Velpatasvir) is the global first generic oral tablet for pan-genotypic Chronic Hepatitis C treatment. This combination of drug has approved by US FDA & European Commission for treatment of patients with all genotypic Chronic Hepatitis C virus infection. Sofosvel use without cirrhosis or with compensated cirrhosis, and patients with advanced cirrhosis (Decompensated).
Sofosvel indicate for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infections
- With or without cirrhosis or with compensated cirrhosis
- With decompensated cirrhosis for use in combination with Ribavirin
Sofosbuvir+Velpatasvir is a direct-acting antiviral agent against the hepatitis C virus. It is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
It indicate for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
Indications
Sofosbuvir and Velpatasvir combination is indicated for the prevention of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection-
- Without cirrhosis or with compensated cirrhosis
- With decompensated cirrhosis for use in combination with ribavirin
Therapeutic Class: Hepatic viral infections (Hepatitis C)
Pharmacology
It 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.
Dosage & Administration
The recommended dosage is one tablet (400 mg of Sofosbuvir and 100 mg of Velpatasvir) taken orally once daily. Recommended treatment regimen:
- Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A): one tablet once daily for 12 weeks
- Patients with decompensated cirrhosis (Child-Pugh B or C): one tablet once daily and Ribavirin for 12 weeks. The recommended dosage of Ribavirin is based on bodyweight (1000 mg/day for patients < 75 kg and 1200 mg/day for ≥ 75 kg, in two divided dose/day)
Interaction
Drugs may decrease the concentrations of Sofosvel: Antacids, H2-receptor antagonists, Proton-pump inhibitors etc.
Coadministration is not recommended with: topotecan, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, efavirenz, Tipranavir, Ritonavir, Hypericum perforatum.
Coadministration of Sofosbuvir and Velpatasvir combination, with Rosuvastatin, Atorvastatin may significantly increase the concentration of Rosuvastatin, Atorvastatin.
Contraindications: Sofosbuvir, Velpatasvir and Ribavirin combination regimen is contraindicated in patients for whom Ribavirin is contraindicated.
Side Effects
The most common side effects of drugs combination include headache and tiredness. Treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (a medicine use to treat certain heart problems).
Pregnancy & Lactation
No adequate human data are available to establish whether or not Capsule combination poses a risk to pregnancy outcomes. If Tablets combination administered with Ribavirin, the combination regimen contraindicate in pregnant women and in men whose female partner is pregnant or going to be pregnant in next six months.
Precautions & Warnings
Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with Sofosbuvir and Velpatasvir combination not to recommend. In patients without alternative viable treatment options, cardiac monitoring recommend.
Use in Special Populations
Renal impairment patient: No dosage recommendation give for patients with severe renal impairment (eGFR ≤30 mL/min/1.73 m2) or with ESRD, due to higher exposures of the predominant sofosbuvir metabolite.
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