Ranol SR is a next-generation sustained-release formulation of ranolazine, specifically engineered to provide long-lasting antianginal and cardioprotective effects. As a selective late sodium current inhibitor, it uniquely addresses the underlying metabolic and ionic imbalances in ischemic myocardium without significantly affecting hemodynamic parameters. This makes it an indispensable option for patients with chronic angina pectoris who remain symptomatic despite conventional therapy. Its optimized pharmacokinetic profile ensures stable plasma concentrations, enhancing both efficacy and tolerability in diverse clinical populations.

Features

• Sustained-release formulation for consistent 12-hour therapeutic coverage
• Selective inhibition of the late sodium current in cardiac myocytes
• Minimal impact on heart rate and blood pressure
• Bioavailability of approximately 76% under fed conditions
• Metabolized primarily via CYP3A4 and CYP2D6 pathways
• White, capsule-shaped, biconvex tablets with functional scoring

Benefits

• Reduces frequency of angina episodes and nitroglycerin rescue use
• Improves exercise tolerance and time to ST-segment depression
• Provides cardioprotective effects through metabolic modulation
• Suitable for combination therapy with beta-blockers, calcium channel blockers, or nitrates
• Enhances quality of life through sustained symptom control
• Offers favorable safety profile in elderly and comorbid patients

Common use

Ranol SR is primarily indicated for the management of chronic angina pectoris in patients who have not achieved adequate response with first-line antianginal agents. It is particularly valuable in cases where beta-blockers are contraindicated, poorly tolerated, or insufficiently effective. The medication demonstrates special utility in microvascular angina and in patients with diabetes mellitus, where its metabolic effects provide additional therapeutic advantages. Off-label uses include atrial fibrillation management and cardioprotection during perioperative periods, though these applications require further clinical validation.

Dosage and direction

Initiate treatment with 500 mg twice daily, with or without food. Tablets should be swallowed whole and must not be crushed, chewed, or divided. Based on therapeutic response and tolerability, the dosage may be increased to a maximum of 1000 mg twice daily. Dose titration should occur at intervals of no less than two weeks. For patients with moderate hepatic impairment (Child-Pugh Class B), the maximum recommended dose is 500 mg twice daily. Use in severe hepatic impairment (Child-Pugh Class C) is contraindicated. Administration with grapefruit juice or strong CYP3A4 inhibitors must be avoided.

Precautions

Electrocardiographic monitoring is recommended upon initiation and dose escalation due to possible QT interval prolongation. Renal function should be assessed periodically, particularly in elderly patients or those with pre-existing renal impairment. Caution is advised in patients with congenital long QT syndrome or those taking other QT-prolonging medications. Patients should be advised about potential dizziness and advised against operating machinery until they understand how the medication affects them. Regular assessment of hepatic enzymes is recommended during long-term therapy.

Contraindications

Hypersensitivity to ranolazine or any component of the formulation; severe hepatic impairment (Child-Pugh Class C); concomitant use with strong CYP3A4 inhibitors (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir); concomitant use with CYP3A4 inducers (such as rifampin, phenobarbital, phenytoin, carbamazepine, St. John’s wort); pre-existing QT interval prolongation or history of torsades de pointes.

Possible side effects

Common adverse reactions (≥4% incidence) include dizziness, nausea, constipation, and headache. Less frequent effects (1-4%) comprise peripheral edema, abdominal pain, dry mouth, vomiting, and asthenia. Serious but rare adverse events (<1%) include syncope, palpitations, blurred vision, tinnitus, hypotension, urinary retention, and dyspnea. QT interval prolongation dose-dependently occurs but rarely leads to clinical consequences when properly monitored. Laboratory abnormalities may include elevated serum creatinine, BUN, and mild transaminase elevations.

Drug interaction

Strong CYP3A4 inhibitors increase ranolazine exposure approximately 3-fold and are contraindicated. Moderate CYP3A4 inhibitors (diltiazem, verapamil, erythromycin) require dose reduction and careful monitoring. CYP3A4 inducers significantly decrease ranolazine concentrations and should be avoided. Ranolazine moderately inhibits CYP2D6, potentially increasing concentrations of metoprolol, tricyclic antidepressants, and antipsychotics. It may slightly digoxin levels requiring monitoring. Concurrent use with other QT-prolonging agents warrants enhanced ECG surveillance.

Missed dose

If a dose is missed, patients should take it as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Doubling of doses is not recommended. Consistent twice-daily administration is crucial for maintaining therapeutic plasma concentrations. Patients should be educated about the importance of adherence and provided with strategies such as pill organizers or alarm reminders.

Overdose

Cases of accidental overdose have reported intensified adverse effects including nausea, vomiting, dizziness, syncope, and QT prolongation. There is no specific antidote. Management consists of immediate gastric lavage if presented early, followed by activated charcoal administration. Continuous ECG monitoring for at least 24 hours is essential. Supportive care should include correction of electrolyte abnormalities and management of arrhythmias if they occur. Hemodialysis is unlikely to be effective due to high protein binding and extensive metabolism.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) in the original container. Protect from moisture and light. Keep tightly closed and away from excessive heat. Do not store in bathroom cabinets where humidity fluctuations occur. Keep out of reach of children and pets. Discard any medication that appears discolored, damaged, or beyond the expiration date printed on the packaging.

Disclaimer

This information is intended for healthcare professionals and should not replace comprehensive clinical judgment. Prescribing decisions must be based on individual patient assessment, official prescribing information, and current treatment guidelines. The manufacturer provides complete prescribing information with detailed pharmacokinetic data, clinical trial results, and additional safety information. Patients should be fully informed about benefits and risks before initiation of therapy.

Reviews

Clinical trials demonstrate consistent efficacy with 65-72% of patients experiencing reduced angina frequency and improved exercise tolerance. Long-term extension studies show maintained effectiveness over 12-24 months with stable safety profile. Real-world evidence confirms these findings while noting particular benefit in elderly populations and those with multiple comorbidities. Some studies suggest potential benefits beyond angina management, including antiarrhythmic effects and metabolic improvements, though these require further investigation. Overall satisfaction rates among both clinicians and patients remain high, particularly regarding the medication’s unique mechanism and favorable hemodynamic profile.