Ranola
Generic Name
Ranolazine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ranola 500 mg tablet | ৳ 16.05 | ৳ 192.60 |
Description
Overview of the medicine
Ranola 500 mg Tablet contains Ranolazine, an anti-anginal medication used to treat chronic stable angina. It works by improving blood flow to the heart and reducing chest pain episodes, especially in patients who have not responded well to other anti-anginal therapies.
Uses & Indications
Dosage
Adults
Initial dose is 500 mg twice daily. Based on clinical response and tolerability, the dose may be increased to 1000 mg twice daily. The maximum recommended dose is 1000 mg twice daily.
Elderly
No specific dose adjustment is required based on age, but caution should be exercised due to potential for increased ranolazine levels with co-morbidities or concomitant medications.
Renal_impairment
Not recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). Use with caution in patients with moderate renal impairment (creatinine clearance 30-60 mL/min).
How to Take
Take Ranola 500 mg Tablet orally twice daily, with or without food. Swallow the tablet whole; do not crush, chew, or break it, as this may affect the extended-release properties.
Mechanism of Action
Ranolazine selectively inhibits the late sodium current (I_Na) in cardiac myocytes. This reduces intracellular sodium and calcium overload, which in turn decreases myocardial oxygen demand and improves coronary blood flow, thereby alleviating angina symptoms without significantly affecting heart rate or blood pressure.
Pharmacokinetics
Onset
Anti-anginal effects can be observed within hours to days of initiating therapy.
Excretion
Excreted predominantly in the urine (75%) and feces (25%) mainly as metabolites.
Half life
The elimination half-life is approximately 6-8 hours, but can be dose-dependent and vary from 2-3 hours after IV administration to 14-18 hours in some cases.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations (Cmax) are typically achieved 2-5 hours post-dose. Absolute bioavailability is approximately 30-50%.
Metabolism
Extensively metabolized in the liver and intestine primarily by CYP3A4 and to a lesser extent by CYP2D6. Multiple metabolites are formed, most of which are inactive.
Side Effects
Contraindications
- Hypersensitivity to ranolazine or any component of the formulation.
- Severe hepatic impairment.
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, nelfinavir).
- Concomitant use with strong CYP3A4 inducers (e.g., rifampin, phenobarbital, phenytoin, St. John's Wort).
Drug Interactions
CYP3A4 inducers (e.g., Rifampin, Phenytoin)
Contraindicated due to significant decrease in ranolazine plasma concentrations, leading to reduced efficacy.
P-glycoprotein inhibitors (e.g., Cyclosporine, Amiodarone)
May increase ranolazine concentrations. Caution and monitoring are advised.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Clarithromycin)
Contraindicated due to significant increase in ranolazine plasma concentrations.
Drugs prolonging QT interval (e.g., Amiodarone, Sotalol, Quinidine)
Increased risk of QTc prolongation. Use with caution and monitor ECG.
Moderate CYP3A4 inhibitors (e.g., Diltiazem, Verapamil, Erythromycin)
May increase ranolazine levels. Dose adjustment of ranolazine may be necessary, and the maximum dose should be limited to 500 mg twice daily.
Drugs metabolized by CYP2D6 (e.g., Metoprolol, Nortriptyline, Desipramine)
Ranolazine may inhibit CYP2D6, leading to increased plasma concentrations of these drugs. Dose adjustments may be needed.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include dizziness, nausea, vomiting, confusion, and potential for QTc prolongation. In case of suspected overdose, seek immediate medical attention. Management is supportive, including gastric lavage and general supportive measures. Hemodialysis is unlikely to be effective in removing ranolazine due to its high plasma protein binding.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use Ranola during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether ranolazine is excreted in human milk; caution should be exercised when Ranola is administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to ranolazine or any component of the formulation.
- Severe hepatic impairment.
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, nelfinavir).
- Concomitant use with strong CYP3A4 inducers (e.g., rifampin, phenobarbital, phenytoin, St. John's Wort).
Drug Interactions
CYP3A4 inducers (e.g., Rifampin, Phenytoin)
Contraindicated due to significant decrease in ranolazine plasma concentrations, leading to reduced efficacy.
P-glycoprotein inhibitors (e.g., Cyclosporine, Amiodarone)
May increase ranolazine concentrations. Caution and monitoring are advised.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Clarithromycin)
Contraindicated due to significant increase in ranolazine plasma concentrations.
Drugs prolonging QT interval (e.g., Amiodarone, Sotalol, Quinidine)
Increased risk of QTc prolongation. Use with caution and monitor ECG.
Moderate CYP3A4 inhibitors (e.g., Diltiazem, Verapamil, Erythromycin)
May increase ranolazine levels. Dose adjustment of ranolazine may be necessary, and the maximum dose should be limited to 500 mg twice daily.
Drugs metabolized by CYP2D6 (e.g., Metoprolol, Nortriptyline, Desipramine)
Ranolazine may inhibit CYP2D6, leading to increased plasma concentrations of these drugs. Dose adjustments may be needed.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include dizziness, nausea, vomiting, confusion, and potential for QTc prolongation. In case of suspected overdose, seek immediate medical attention. Management is supportive, including gastric lavage and general supportive measures. Hemodialysis is unlikely to be effective in removing ranolazine due to its high plasma protein binding.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use Ranola during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether ranolazine is excreted in human milk; caution should be exercised when Ranola is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the specific packaging for exact expiry date.
Availability
Pharmacies, hospitals
Approval Status
FDA approved
Patent Status
Generic versions available
Clinical Trials
Ranolazine's efficacy and safety have been established in several large-scale clinical trials, including CARISA (Combination Assessment of Ranolazine In Stable Angina) and ERICA (Effect of Ranolazine In Chronic Angina), demonstrating reductions in angina attacks and improvements in exercise duration.
Lab Monitoring
- Renal function tests (e.g., serum creatinine, BUN) before initiation and periodically during treatment.
- Liver function tests (e.g., ALT, AST) before initiation and periodically during treatment.
- ECG monitoring for QTc interval prolongation, especially during dose escalation and in patients with known QTc prolongation risk factors.
Doctor Notes
- Monitor patient's QTc interval, especially during initiation, dose titration, and if co-administered with other QTc-prolonging drugs.
- Assess renal and hepatic function before and periodically during treatment. Not recommended for severe hepatic or renal impairment.
- Counsel patients on potential dizziness and lightheadedness, particularly at treatment initiation, and advise against abrupt discontinuation.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, usually twice daily.
- Swallow the tablet whole; do not crush, chew, or break it.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements, especially strong CYP3A4 inhibitors or inducers.
- Report any severe dizziness, fainting, or prolonged palpitations to your doctor immediately.
- Do not stop taking Ranola suddenly without consulting your doctor, as this may worsen your angina.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Ranola may cause dizziness, lightheadedness, or blurred vision. If you experience these side effects, avoid driving or operating heavy machinery until you know how the medication affects you.
Lifestyle Advice
- Maintain a heart-healthy diet low in saturated fats, trans fats, and cholesterol.
- Engage in regular physical activity as advised by your doctor to improve cardiovascular health.
- Quit smoking, as it is a major risk factor for heart disease and can worsen angina.
- Manage stress effectively through relaxation techniques or other healthy coping mechanisms.
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