Soforal-LP
Generic Name
Sofosbuvir + Ledipasvir
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| soforal lp 90 mg tablet | ৳ 1,000.00 | N/A |
Description
Overview of the medicine
Soforal-LP is a combination medicine containing Sofosbuvir and Ledipasvir, used to treat chronic Hepatitis C virus (HCV) infection in adults and adolescents.
Uses & Indications
Dosage
Adults
One tablet (Sofosbuvir 400 mg/Ledipasvir 90 mg) taken orally once daily, with or without food. Duration of therapy varies from 8 to 24 weeks depending on HCV genotype, presence of cirrhosis, and prior treatment experience.
Elderly
No dosage adjustment is required for elderly patients.
Renal_impairment
No dosage adjustment is required for patients with mild or moderate renal impairment. For severe renal impairment or end-stage renal disease requiring dialysis, data are limited, and use should be considered only if the benefits outweigh the risks.
How to Take
Take the tablet orally once daily with or without food. Swallow the tablet whole; do not chew or crush it.
Mechanism of Action
Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor that prevents HCV RNA replication. Ledipasvir is an HCV NS5A inhibitor that interferes with viral replication and assembly.
Pharmacokinetics
Onset
Rapid onset of antiviral activity.
Excretion
Sofosbuvir is primarily excreted via urine (80% as metabolites). Ledipasvir is predominantly excreted unchanged in feces (87%).
Half life
Sofosbuvir: approximately 0.5 hours (major metabolite GS-331007: approximately 18 hours). Ledipasvir: approximately 28 hours.
Absorption
Sofosbuvir and Ledipasvir are rapidly absorbed after oral administration. Peak plasma concentrations are reached within 0.5-2 hours for Sofosbuvir and 1-2 hours for Ledipasvir.
Metabolism
Sofosbuvir is extensively metabolized in the liver to its pharmacologically active nucleoside triphosphate analogue. Ledipasvir undergoes minimal oxidative metabolism in vitro.
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir, Ledipasvir, or any excipients.
- Co-administration with strong P-glycoprotein (P-gp) inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital).
Drug Interactions
Amiodarone
Co-administration with amiodarone is not recommended due to risk of symptomatic bradycardia, especially in patients also taking beta-blockers.
P-gp Inducers
Strong P-gp inducers can significantly decrease plasma concentrations of Ledipasvir and Sofosbuvir, leading to reduced therapeutic effect. Avoid co-administration.
Antacids/H2 Blockers/PPIs
May decrease Ledipasvir absorption. Administer at least 4 hours apart from antacids. For H2 blockers, take at the same time or 12 hours apart. PPIs are generally not recommended or should be taken with food (same time as Soforal-LP).
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, observe for signs and symptoms of adverse reactions and initiate appropriate symptomatic treatment. Hemodialysis can remove the predominant circulating metabolite of Sofosbuvir (GS-331007) but is not effective for Ledipasvir.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Sofosbuvir or Ledipasvir are excreted in human milk; caution should be exercised when administered to a nursing mother. Advise against breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir, Ledipasvir, or any excipients.
- Co-administration with strong P-glycoprotein (P-gp) inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital).
Drug Interactions
Amiodarone
Co-administration with amiodarone is not recommended due to risk of symptomatic bradycardia, especially in patients also taking beta-blockers.
P-gp Inducers
Strong P-gp inducers can significantly decrease plasma concentrations of Ledipasvir and Sofosbuvir, leading to reduced therapeutic effect. Avoid co-administration.
Antacids/H2 Blockers/PPIs
May decrease Ledipasvir absorption. Administer at least 4 hours apart from antacids. For H2 blockers, take at the same time or 12 hours apart. PPIs are generally not recommended or should be taken with food (same time as Soforal-LP).
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, observe for signs and symptoms of adverse reactions and initiate appropriate symptomatic treatment. Hemodialysis can remove the predominant circulating metabolite of Sofosbuvir (GS-331007) but is not effective for Ledipasvir.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Sofosbuvir or Ledipasvir are excreted in human milk; caution should be exercised when administered to a nursing mother. Advise against breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals nationwide.
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA for generics)
Patent Status
Original patent held by Gilead Sciences; generic versions widely available in Bangladesh under compulsory licensing or agreements.
WHO Essential Medicine
YesClinical Trials
Extensive Phase 2 and 3 clinical trials demonstrated high rates of sustained virologic response (SVR) across various HCV genotypes, including treatment-naive and treatment-experienced patients, and those with cirrhosis.
Lab Monitoring
- HCV RNA levels (before, during, and after treatment)
- Liver function tests (ALT, AST, bilirubin) at baseline and during treatment.
- Renal function (creatinine, eGFR) at baseline.
- Hepatitis B surface antigen (HBsAg) and anti-HBc before starting treatment.
Doctor Notes
- Ensure HBV screening is performed prior to initiating therapy.
- Monitor for drug interactions, especially with amiodarone and strong P-gp inducers.
- Emphasize adherence to the full treatment course for optimal outcomes.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor for the full duration.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Report any new or worsening symptoms, especially signs of liver problems or HBV reactivation.
Missed Dose Advice
If a dose is missed within 18 hours of the scheduled time, take it as soon as possible. If more than 18 hours have passed, skip the missed dose and resume the regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Soforal-LP may cause fatigue, headache, or dizziness. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid alcohol consumption as it can worsen liver disease.
- Maintain a healthy diet and lifestyle.
- Attend all scheduled follow-up appointments and laboratory tests.
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