Velpacee
Generic Name
Sofosbuvir
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| velpacee 400 mg tablet | ৳ 930.00 | ৳ 6,510.00 |
Description
Overview of the medicine
Velpacee 400 mg Tablet contains Sofosbuvir, an antiviral medication used in combination with other drugs to treat chronic Hepatitis C virus (HCV) infection in adults and children aged 3 years and older. It works by stopping the virus from multiplying, thereby reducing the viral load in the body.
Uses & Indications
Dosage
Adults
One 400 mg tablet once daily with or without food, in combination with other antivirals as determined by genotype and liver disease status.
Elderly
No dose adjustment required for elderly patients.
Renal_impairment
No dose adjustment needed for mild or moderate renal impairment. Not recommended for severe renal impairment (eGFR <30 mL/min/1.73 m2) or End-Stage Renal Disease (ESRD) requiring dialysis, due to insufficient data.
How to Take
Oral administration. Take one tablet once daily with or without food. Swallow the tablet whole; do not chew, crush, or break it.
Mechanism of Action
Sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor. It is a prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203). This active metabolite acts as a chain terminator for RNA synthesis by the HCV NS5B RNA-dependent RNA polymerase, thereby inhibiting HCV replication.
Pharmacokinetics
Onset
Within hours for antiviral effect, but sustained virologic response (SVR) is assessed after weeks of therapy.
Excretion
Primarily renal (approximately 80% as GS-331007), with fecal excretion accounting for about 14%.
Half life
Sofosbuvir: 0.5 hours; GS-331007 (main metabolite): 27 hours.
Absorption
Rapidly absorbed, peak plasma concentration reached within 0.5-2 hours. Absolute bioavailability is approximately 64%.
Metabolism
Sofosbuvir is a prodrug and is extensively metabolized intracellularly in the liver to form the pharmacologically active nucleoside triphosphate analogue (GS-461203). Hydrolysis of the carboxyl ester group by cathepsin A or carboxylesterase 1 and sequential phosphorylation steps are involved. The main circulating metabolite, GS-331007, is formed by hydrolytic cleavage.
Side Effects
Contraindications
- •Hypersensitivity to Sofosbuvir or any excipients in the formulation.
- •Monotherapy with Sofosbuvir is not recommended; it must be used in combination with other direct-acting antivirals.
Drug Interactions
Digoxin
May increase digoxin concentrations, monitor digoxin levels.
Amiodarone
Concomitant use with sofosbuvir-containing regimens and amiodarone may lead to symptomatic bradycardia. Co-administration is not recommended. If unavoidable, monitor heart rate.
P-gp Inducers (e.g., Rifampin, St. John's Wort, Carbamazepine, Phenytoin)
May significantly decrease sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Co-administration is not recommended.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote is available. In case of overdose, monitor the patient for any signs or symptoms of toxicity. Sofosbuvir and its main metabolite (GS-331007) are not efficiently removed by hemodialysis. Treatment of overdose should consist of general supportive measures.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if sofosbuvir or its metabolites are excreted in human milk; caution should be exercised when administered to a nursing woman. If co-administered with Ribavirin, the contraindications and warnings for Ribavirin regarding pregnancy apply.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, depending on manufacturer.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA
Patent Status
Patent protected (original manufacturer), Generics available
WHO Essential Medicine
YesAlternative Medicines in Bangladesh
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Global Brand Names
International brand names for this medicine
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