ranol sr
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Ranol SR is a sustained-release formulation of ranolazine, a late sodium current inhibitor used primarily as anti-anginal therapy in patients with chronic stable angina who haven’t achieved adequate symptom control with conventional anti-anginal medications. What makes this formulation particularly interesting from a clinical perspective isn’t just the mechanism - which we’ll get into - but how the sustained-release delivery system actually changes the practical management of these often complex cardiac patients.
I remember when we first started using the immediate-release formulation back in the mid-2000s, we were constantly battling peak-trough fluctuations that left patients either over-sedated or experiencing breakthrough angina. The SR version fundamentally changed that dynamic.
Ranol SR: Advanced Angina Management Through Late Sodium Current Inhibition - Evidence-Based Review
1. Introduction: What is Ranol SR? Its Role in Modern Cardiology
Ranol SR contains ranolazine as its active pharmaceutical ingredient in a specially designed sustained-release matrix that provides consistent plasma concentrations over 12 hours. Unlike traditional anti-anginal medications that primarily work through hemodynamic mechanisms (reducing heart rate, blood pressure, or contractility), Ranol SR operates through metabolic modulation by selectively inhibiting the late sodium current in cardiac myocytes.
The clinical significance of Ranol SR lies in its ability to provide symptomatic relief without the hemodynamic compromises associated with beta-blockers, calcium channel blockers, or nitrates. This makes it particularly valuable for patients who cannot tolerate standard therapies due to bradycardia, hypotension, or heart failure.
From my experience managing the cardiology service at University Hospital, we’ve found that approximately 30-40% of chronic angina patients continue experiencing symptoms despite maximal conventional therapy. Before Ranol SR became available, our options were quite limited - we’d either accept suboptimal control or consider more invasive approaches like enhanced external counterpulsation or coronary revascularization in borderline candidates.
2. Key Components and Bioavailability of Ranol SR
The formulation contains ranolazine hydrochloride in concentrations of 500 mg or 1000 mg per extended-release tablet. The sustained-release mechanism utilizes a hydrophilic matrix system that controls drug release through gradual hydration and erosion, maintaining therapeutic plasma concentrations between 2-6 μmol/L throughout the dosing interval.
The bioavailability of Ranol SR is approximately 35-50% under fasting conditions and increases to 60-70% with food, particularly high-fat meals. This food effect is clinically relevant - we always instruct patients to take it with their morning and evening meals to ensure consistent absorption. The time to peak concentration (Tmax) ranges from 4-6 hours, and the elimination half-life is approximately 7 hours, which supports the twice-daily dosing schedule.
The development team actually struggled significantly with achieving the right release profile. Early prototypes either released too quickly, causing the same side effect issues as immediate-release formulations, or too slowly, failing to reach therapeutic levels. It took nearly 18 months of formulation adjustments to get the hydrophilic matrix composition just right.
3. Mechanism of Action of Ranol SR: Scientific Substantiation
Ranol SR’s primary mechanism involves selective inhibition of the late sodium current (INaL) in cardiac cells. During ischemic conditions, the late sodium current becomes exaggerated, leading to sodium accumulation within myocytes. This increased intracellular sodium then drives calcium overload via the sodium-calcium exchanger, resulting in mechanical dysfunction (diastolic tension), electrical instability, and increased oxygen consumption.
By reducing the late sodium current, Ranol SR decreases intracellular sodium and calcium loading, which improves diastolic function and reduces myocardial oxygen demand without affecting heart rate or blood pressure. Think of it as addressing the metabolic consequences of ischemia rather than just the hemodynamic aspects.
The research team initially thought the drug worked primarily through fatty acid oxidation inhibition, but subsequent studies revealed the late sodium current inhibition was the dominant mechanism. This was one of those unexpected findings that completely changed our understanding of how the drug worked. We had several heated debates in our journal club about whether the metabolic effects were primary or secondary - turns out they were mostly downstream consequences of the sodium channel modulation.
4. Indications for Use: What is Ranol SR Effective For?
Ranol SR for Chronic Stable Angina
The primary indication is chronic stable angina as add-on therapy when symptoms persist despite maximally tolerated doses of conventional anti-anginal drugs. In the CARISA trial, Ranol SR reduced angina frequency by approximately 30% compared to placebo and increased exercise duration by about 115 seconds.
Ranol SR for Microvascular Angina
Emerging evidence supports use in patients with cardiac syndrome X and microvascular angina where traditional anti-anginals often prove ineffective. The mechanism of action specifically addresses the metabolic abnormalities in these conditions.
Ranol SR for Refractory Angina
Patients who aren’t candidates for revascularization and continue experiencing symptoms despite multiple anti-anginal medications represent another important population. The MERLIN-TIMI 36 trial provided valuable safety data in this higher-risk group.
I had a patient, Margaret, 68-year-old with extensive coronary disease who’d already had CABG and multiple PCIs but kept having daily angina. Beta-blockers made her too fatigued to function, calcium channel blockers caused edema, and nitrates gave her intolerable headaches. We started Ranol SR 500 mg twice daily and within two weeks, her angina frequency dropped from daily to maybe once or twice weekly. More importantly, she could walk her dog around the block without stopping - something she hadn’t been able to do for years.
5. Instructions for Use: Dosage and Course of Administration
The initial recommended dosage is 500 mg twice daily, which can be increased to 1000 mg twice daily based on clinical response and tolerability. Dose adjustments should occur at intervals of 2-4 weeks to allow for steady-state concentrations and proper assessment of effectiveness.
| Clinical Scenario | Initial Dose | Maximum Dose | Administration Instructions |
|---|---|---|---|
| New initiation | 500 mg | 1000 mg | Twice daily with meals |
| Elderly patients | 500 mg | 1000 mg | Consider starting with 500 mg once daily |
| Hepatic impairment | Avoid or 500 mg once daily | 500 mg once daily | Monitor closely |
| Concomitant CYP3A4 inhibitors | 500 mg twice daily | 500 mg twice daily | Avoid strong inhibitors |
We typically start most patients on the 500 mg twice daily regimen and reassess at one month. If they’re responding well but still having breakthrough symptoms, we’ll increase to 1000 mg twice daily. About 20% of our patients need the higher dose to achieve adequate symptom control.
6. Contraindications and Drug Interactions of Ranol SR
Ranol SR is contraindicated in patients with clinically significant hepatic impairment (Child-Pugh Class C or acute liver failure) due to substantially increased exposure. Pre-existing QT interval prolongation and concomitant use of other QT-prolonging drugs represent relative contraindications requiring careful risk-benefit assessment.
The most significant drug interactions involve CYP3A4 inhibitors:
- Strong inhibitors (ketoconazole, clarithromycin, ritonavir): Contraindicated due to 3-4 fold increase in ranolazine exposure
- Moderate inhibitors (diltiazem, verapamil, erythromycin): Maximum dose should not exceed 500 mg twice daily
- P-gp inhibitors: May increase ranolazine concentrations
Common side effects include dizziness (6%), constipation (5%), and nausea (4%), which are usually mild to moderate and often resolve with continued use. The QT prolongation effect is dose-dependent, with average increases of 6 ms at 1000 mg twice daily.
We had a close call early on with a patient who was started on clarithromycin for pneumonia while taking Ranol SR 1000 mg twice daily. He presented with significant dizziness and was found to have a QT interval of 520 ms. Fortunately, holding both medications resolved the issue, but it reinforced the importance of thorough medication reconciliation and patient education about potential interactions.
7. Clinical Studies and Evidence Base for Ranol SR
The evidence base for Ranol SR includes several pivotal randomized controlled trials:
CARISA Trial (Combination Assessment of Ranolazine In Stable Angina): This multicenter trial demonstrated that ranolazine increased exercise duration and reduced angina frequency as add-on therapy to atenolol, amlodipine, or diltiazem. The improvement was maintained throughout the 12-week study period.
ERICA Trial (Efficacy of Ranolazine in Chronic Angina): Specifically examined patients who remained symptomatic despite maximum amlodipine dose (10 mg daily). Ranol SR significantly reduced nitroglycerin consumption and angina attacks compared to placebo.
MERLIN-TIMI 36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes): While the primary endpoint wasn’t met, the trial provided extensive safety data and showed significant reduction in recurrent ischemia in the NSTE-ACS population.
What’s interesting is that the clinical benefits appear to extend beyond just symptom reduction. Several substudies have suggested potential anti-arrhythmic effects, particularly for suppressing atrial and ventricular arrhythmias, though these remain investigational uses.
8. Comparing Ranol SR with Similar Products and Choosing Quality Formulations
When comparing Ranol SR to other anti-anginal options, the key differentiator is its hemodynamically neutral profile. Unlike beta-blockers that reduce heart rate and contractility, or calcium channel blockers and nitrates that lower blood pressure, Ranol SR provides symptomatic relief without these effects.
Available formulations include:
- Branded Ranol SR: Consistently demonstrated bioavailability and release profile
- Generic sustained-release ranolazine: Must demonstrate bioequivalence
- Immediate-release formulations: Not equivalent and not recommended for twice-daily dosing
Quality considerations focus on consistent release characteristics and manufacturing standards. We recommend sticking with manufacturers who have established quality control processes and can provide dissolution profile data.
The pharmacy committee at our hospital actually debated whether to allow automatic therapeutic substitution to generic versions. I argued against it initially because some early generic formulations had different release profiles, but the current FDA standards have largely addressed those concerns. Still, we monitor patients closely when switching between manufacturers.
9. Frequently Asked Questions (FAQ) about Ranol SR
How long does it take for Ranol SR to start working?
Most patients notice some improvement within the first 1-2 weeks, but maximal benefit typically occurs after 4-6 weeks of consistent dosing. The sustained-release formulation requires time to reach steady-state concentrations and for the metabolic effects to fully manifest.
Can Ranol SR be combined with other anti-anginal medications?
Yes, Ranol SR is specifically indicated as add-on therapy to conventional anti-anginal medications. In clinical trials, it was safely combined with beta-blockers, calcium channel blockers, and nitrates. The combination often provides synergistic benefits through complementary mechanisms.
What monitoring is required during Ranol SR therapy?
Baseline ECG to assess QT interval is recommended, with follow-up ECGs after dose increases. Routine monitoring of liver function tests is advised, particularly during the first 6 months of therapy. No specific hemodynamic monitoring is required given the neutral effects on heart rate and blood pressure.
Is dose adjustment necessary in elderly patients?
Elderly patients may be more susceptible to adverse effects, particularly dizziness and constipation. Starting with the lower dose (500 mg twice daily) and increasing cautiously is recommended. Renal function rather than age per se should guide dosing decisions.
10. Conclusion: Validity of Ranol SR Use in Clinical Practice
Ranol SR represents an important therapeutic option for patients with chronic angina who remain symptomatic despite conventional therapy. The unique mechanism of late sodium current inhibition provides symptomatic relief without compromising hemodynamics, filling a significant gap in our anti-anginal armamentarium.
The evidence from multiple randomized trials supports its efficacy and safety when used appropriately, with particular attention to drug interactions and contraindications. For selected patients, Ranol SR can meaningfully improve quality of life and functional capacity.
Looking back over the past decade of using this medication, I’ve been consistently impressed with how it’s helped some of our most challenging angina patients. There was David, the 72-year-old retired engineer with recurrent angina after multiple stents who meticulously tracked his symptoms - he showed me his spreadsheet demonstrating a 70% reduction in angina episodes after starting Ranol SR. Or Maria, the 65-year-old with microvascular angina who’d failed every other therapy but could finally return to her water aerobics class.
The development wasn’t straightforward - we had plenty of debates about whether the metabolic effects were clinically relevant, concerns about the QT prolongation, and frustration with the drug interaction profile. But seeing patients regain their ability to perform daily activities without angina has convinced me of its value in our toolkit. We recently completed a 5-year follow-up of our first 50 patients started on Ranol SR, and the sustained benefit and safety profile have held up remarkably well in real-world practice.