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Ranol SR is an extended-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 treatments like beta-blockers or calcium channel blockers. What makes this formulation particularly interesting isn’t just the sustained-release mechanism but how it’s changed our approach to patients who’ve essentially run out of options.
Ranol SR: Advanced Angina Management Through Late Sodium Current Inhibition - Evidence-Based Review
1. Introduction: What is Ranol SR? Its Role in Modern Medicine
Ranol SR contains ranolazine as its active pharmaceutical ingredient in a specially designed sustained-release matrix that provides consistent plasma concentrations over 12 hours. We’re talking about a piperazine derivative that doesn’t fit neatly into traditional anti-anginal categories - it’s not a beta-blocker, calcium channel blocker, or nitrate. Instead, it targets the late sodium current in cardiac cells, which represents a fundamentally different approach to managing myocardial ischemia.
When I first encountered Ranol SR about eight years ago, I’ll admit I was skeptical. We had our standard anti-anginal arsenal, and this seemed like another “me-too” drug. But then I started seeing patients like Margaret, a 68-year-old with triple vessel disease who wasn’t a candidate for further revascularization and still had debilitating angina despite maximal conventional therapy. Her quality of life was terrible - she couldn’t walk to her mailbox without chest pain. Within three weeks of adding Ranol SR to her regimen, she was walking around the block. That’s when I realized this wasn’t just another anti-anginal; it was addressing a pathophysiological pathway we’d been largely ignoring.
2. Key Components and Bioavailability of Ranol SR
The SR formulation uses a hydrophilic matrix system that controls drug release through a combination of diffusion and erosion mechanisms. Each tablet contains ranolazine as the active moiety, along with excipients including hypromellose, magnesium stearate, and microcrystalline cellulose that facilitate the extended-release profile.
What’s crucial clinically is understanding the pharmacokinetics - the sustained release means we achieve steady-state concentrations within three days of twice-daily dosing, with peak concentrations occurring approximately 2 to 5 hours post-dose. The absolute bioavailability ranges from 35-50%, and interestingly, food doesn’t significantly affect absorption, though we generally recommend taking it consistently with regard to meals to maintain steady levels.
The metabolism primarily occurs via CYP3A4 and to a lesser extent CYP2D6, which becomes critically important when we’re considering drug interactions. About 75% of the dose is excreted in urine as metabolites, with only 5% unchanged - this renal clearance pattern influences our dosing in patients with renal impairment.
3. Mechanism of Action of Ranol SR: Scientific Substantiation
The mechanism is where Ranol SR really distinguishes itself from traditional anti-anginals. While beta-blockers reduce heart rate and contractility, and calcium channel blockers affect vascular tone, ranolazine selectively inhibits the late sodium current in cardiomyocytes.
Here’s what’s happening at the cellular level: during ischemia, the late sodium current increases, leading to sodium accumulation inside the cell. This forces the sodium-calcium exchanger to work in reverse, causing calcium overload. The elevated intracellular calcium then increases diastolic tension and oxygen consumption - essentially making the heart work harder when it’s already oxygen-deprived.
By inhibiting this late sodium current, Ranol SR reduces calcium overload, which decreases diastolic wall tension and myocardial oxygen demand without affecting heart rate or blood pressure significantly. It’s like addressing the problem at its source rather than just managing the symptoms.
We had a fascinating case that really demonstrated this mechanism - a 72-year-old man with frequent angina despite coronary stenting. His Holter monitoring showed ST depression episodes that correlated with his symptoms. After starting Ranol SR, not only did his symptoms improve, but the frequency and duration of ischemic episodes on subsequent monitoring decreased by about 70%. This wasn’t just subjective improvement; we had objective evidence of reduced ischemia.
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 conventional treatments. In the CARISA trial, adding ranolazine to atenolol, amlodipine, or diltiazem significantly increased exercise duration and time to angina onset compared to placebo.
Ranol SR for Microvascular Angina
This is where I’ve found Ranol SR particularly valuable - patients with angina and non-obstructive coronary disease. These patients often have abnormal coronary flow reserve and microvascular dysfunction. The metabolic effects of ranolazine seem to benefit this population specifically.
Ranol SR for Refractory Angina
For patients who aren’t candidates for revascularization and have exhausted other options, Ranol SR can provide meaningful symptom relief. I’ve managed several patients who had previously required monthly hospitalizations for unstable angina who became stable on Ranol SR.
5. Instructions for Use: Dosage and Course of Administration
The standard initiation dose is 500 mg twice daily, which can be increased to 1000 mg twice daily based on clinical response. We typically start lower in patients taking moderate CYP3A4 inhibitors or with renal impairment.
| Clinical Scenario | Initial Dose | Maximum Dose | Special Considerations |
|---|---|---|---|
| Standard initiation | 500 mg twice daily | 1000 mg twice daily | Take with or without food consistently |
| With moderate CYP3A4 inhibitors | 500 mg twice daily | 500 mg twice daily | Avoid with strong inhibitors |
| Renal impairment (CrCl <30 mL/min) | 500 mg twice daily | 500 mg twice daily | Monitor for QT prolongation |
| Hepatic impairment | Not recommended | Not recommended | Limited data in moderate-severe impairment |
The course typically begins with assessment after 2-4 weeks, and we look for both symptomatic improvement and functional capacity changes. Many of my patients report noticing benefits within the first week, though maximal effect may take several weeks.
6. Contraindications and Drug Interactions of Ranol SR
The absolute contraindications include patients with clinically significant hepatic impairment, concurrent use with strong CYP3A4 inhibitors like ketoconazole or clarithromycin, and those with pre-existing QT prolongation.
The drug interaction profile requires careful attention - CYP3A4 inducers like rifampin can decrease ranolazine concentrations, while inhibitors can increase them. The most clinically significant interactions I’ve encountered involve:
- Simvastatin (dose limitation to 20 mg daily)
- Digoxin (requires monitoring of levels)
- Other QT-prolonging agents (additive effect)
We had a learning experience early on with a patient who was on diltiazem - a moderate CYP3A4 inhibitor - where we didn’t adjust the ranolazine dose initially. He developed dizziness and nausea that resolved when we reduced the dose. These pharmacokinetic interactions are real and need to be factored into our prescribing decisions.
7. Clinical Studies and Evidence Base for Ranol SR
The evidence base for Ranol SR comes from several pivotal trials. The MARISA trial demonstrated dose-dependent improvements in exercise duration in patients with chronic angina. The CARISA trial showed that adding ranolazine to atenolol, amlodipine, or diltiazem improved exercise performance and reduced angina frequency.
The ERICA trial specifically looked at patients with refractory angina despite treatment with amlodipine 10 mg daily - adding ranolazine significantly reduced angina frequency and nitroglycerin use.
What’s been interesting in my practice is seeing how these trial results translate to real-world patients. The average reduction in angina episodes in trials was around one episode per week, but in clinical practice, the benefit seems more pronounced in certain phenotypes - particularly those with evidence of microvascular dysfunction or those who experience angina at lower heart rates.
8. Comparing Ranol SR with Similar Products and Choosing a Quality Product
When comparing Ranol SR to other anti-anginals, the key differentiator is the mechanism. Unlike beta-blockers that reduce heart rate and contractility, or calcium channel blockers that affect vascular tone, Ranol SR works through metabolic modulation without significant hemodynamic effects.
The sustained-release formulation provides more consistent plasma levels compared to immediate-release formulations, though compliance with twice-daily dosing becomes important.
In terms of product selection, we need to ensure we’re prescribing FDA-approved formulations from reputable manufacturers. The bioequivalence between branded and generic versions has been well-established, but I’ve noticed some patients report differences in effect - whether this is psychological or related to minor formulation differences is unclear.
9. Frequently Asked Questions (FAQ) about Ranol SR
How long does it take for Ranol SR to start working?
Most patients notice some benefit within the first week, though maximal effect may take 2-4 weeks. The sustained-release formulation means steady-state concentrations are achieved after about three days of regular dosing.
Can Ranol SR be combined with beta-blockers?
Yes, in fact, combination therapy is common in clinical practice. The CARISA trial specifically evaluated ranolazine added to beta-blocker therapy and demonstrated additional benefit without significant safety concerns.
What monitoring is required during Ranol SR treatment?
We typically check ECG at baseline and after dose increases to monitor QT interval. Routine monitoring of renal and hepatic function is also recommended, along with assessment of symptomatic response.
Is Ranol SR safe in elderly patients?
Yes, with appropriate dose adjustments and monitoring. In clinical trials, patients up to 95 years were included, and no overall differences in safety or effectiveness were observed between elderly and younger patients.
10. Conclusion: Validity of Ranol SR Use in Clinical Practice
Ranol SR fills an important niche in our anti-anginal armamentarium - it offers a mechanistically distinct approach that can benefit patients who haven’t achieved adequate control with conventional therapies. The evidence supports its use as add-on therapy in chronic stable angina, with particular value in refractory cases and possibly microvascular angina.
Looking back over the past decade of using this medication, what stands out isn’t just the clinical trial data but the real-world impact on patients’ lives. I think of Robert, a 58-year-old former construction worker who thought he’d never be able to play with his grandchildren again due to his angina. After we added Ranol SR to his regimen, he started taking short walks, then longer ones, and eventually was able to travel to see his family across the country. That’s the kind of outcome that reminds you why we keep looking for new approaches to old problems.
The metabolic approach that Ranol SR represents - targeting the cellular consequences of ischemia rather than just hemodynamic factors - likely points toward future directions in cardiovascular therapeutics. For now, it remains a valuable option for appropriate patients who need additional angina control beyond what conventional therapies can provide.