Ralozine-SR
Generic Name
Ranolazine extended-release 500 mg tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ralozine sr 500 mg tablet | ৳ 16.00 | ৳ 160.00 |
Description
Overview of the medicine
Ralozine-SR 500 mg Tablet contains Ranolazine, an antianginal medication used to treat chronic stable angina (chest pain). It helps reduce the frequency of angina attacks and improves exercise tolerance without significantly affecting heart rate or blood pressure.
Uses & Indications
Dosage
Adults
The recommended starting dose is 500 mg orally twice daily. The dose may be titrated to 1000 mg orally twice daily based on clinical response and tolerability.
Elderly
No specific dose adjustment is required, but caution is advised due to potential age-related decrease in renal function and increased susceptibility to adverse effects.
Renal_impairment
No dose adjustment is needed for mild to moderate renal impairment. For severe renal impairment (CrCl < 30 mL/min), use with caution; close monitoring is recommended. Contraindicated in end-stage renal disease (ESRD) patients on dialysis.
How to Take
Take Ralozine-SR tablets orally twice daily, with or without food. Swallow the tablet whole; do not crush, break, or chew it. For optimal effect, try to take doses at the same time each day.
Mechanism of Action
Ranolazine selectively inhibits the late sodium current (I_Na) in cardiac myocytes, which reduces intracellular sodium and subsequent calcium overload during myocardial ischemia. This in turn reduces myocardial oxygen demand and improves coronary blood flow, leading to antianginal effects.
Pharmacokinetics
Onset
Steady-state plasma concentrations are achieved within 3 days with twice-daily dosing.
Excretion
Approximately 75% eliminated via urine and 25% via feces.
Half life
Approximately 7 hours (terminal half-life for extended-release).
Absorption
Well absorbed after oral administration, with peak plasma concentrations occurring 2-5 hours post-dose for the extended-release formulation. Absolute bioavailability is approximately 35-50%.
Metabolism
Extensively metabolized primarily by CYP3A4 and to a lesser extent by CYP2D6 in the liver.
Side Effects
Contraindications
- Hypersensitivity to ranolazine or any component of the formulation
- Severe hepatic impairment (Child-Pugh Class C)
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Drug Interactions
Strong CYP3A4 inhibitors
Concurrent use is contraindicated as it significantly increases ranolazine concentrations, increasing risk of QT prolongation and other adverse effects.
P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine)
May increase ranolazine levels; use with caution.
Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil)
Limit ranolazine dose to 500 mg twice daily; monitor for adverse effects.
Drugs that prolong the QT interval (e.g., antiarrhythmics, antipsychotics)
Increased risk of additive QT prolongation; use with caution and monitor ECG.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptoms may include dizziness, nausea, vomiting, and QT prolongation. Treatment should be symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Continuous ECG monitoring is recommended.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ranolazine is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to ranolazine or any component of the formulation
- Severe hepatic impairment (Child-Pugh Class C)
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Drug Interactions
Strong CYP3A4 inhibitors
Concurrent use is contraindicated as it significantly increases ranolazine concentrations, increasing risk of QT prolongation and other adverse effects.
P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine)
May increase ranolazine levels; use with caution.
Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil)
Limit ranolazine dose to 500 mg twice daily; monitor for adverse effects.
Drugs that prolong the QT interval (e.g., antiarrhythmics, antipsychotics)
Increased risk of additive QT prolongation; use with caution and monitor ECG.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptoms may include dizziness, nausea, vomiting, and QT prolongation. Treatment should be symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Continuous ECG monitoring is recommended.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ranolazine is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Original patent expired, generic versions available
Clinical Trials
Key clinical trials include CARISA (Combination Assessment of Ranolazine In Stable Angina), ERICA (Effect of Ranolazine in Chronic Angina), and MERLIN-TIMI 36 (Metabolic EfficiencY With Ranolazine for Less Ischemia in Non–ST Elevation Acute Coronary Syndromes).
Lab Monitoring
- Baseline and periodic ECG monitoring, especially in patients at risk of QT prolongation.
- Renal function (e.g., serum creatinine, eGFR) periodically.
- Liver function tests (LFTs) in patients with moderate hepatic impairment.
Doctor Notes
- Monitor ECG for QT interval prolongation, particularly during initiation or dose titration, and in patients with risk factors.
- Counsel patients on potential drug interactions, especially with strong and moderate CYP3A4 inhibitors.
- Contraindicated in severe hepatic impairment and co-administration with strong CYP3A4 inhibitors.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not crush, chew, or break the tablet. Swallow it whole.
- Inform your doctor about all other medicines you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, lightheadedness, or blurred vision. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet low in saturated fats and cholesterol.
- Engage in regular physical activity as advised by your doctor.
- Avoid smoking and limit alcohol consumption.
- Manage stress effectively.
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