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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 anti-anginal medications. What makes this formulation particularly interesting isn’t just the sustained-release mechanism itself, but how it addresses the fundamental limitations we’ve faced with traditional angina management.
I remember when we first started using ranolazine in our cardiology practice about fifteen years ago - the immediate-release version required three times daily dosing, and adherence was a constant battle. Patients with chronic conditions already juggle multiple medications, and adding another TID regimen often meant missed doses, especially the midday one. The development of Ranol SR represented more than just pharmaceutical innovation; it addressed a very real clinical problem we’d been wrestling with for years.
Ranol SR: Advanced Angina Management Through Metabolic Modulation - Evidence-Based Review
1. Introduction: What is Ranol SR? Its Role in Modern Cardiology
Ranol SR represents a significant advancement in anti-anginal therapy, specifically designed to address the metabolic component of myocardial ischemia. Unlike traditional anti-anginal agents that primarily work through hemodynamic mechanisms (reducing heart rate, blood pressure, or contractility), Ranol SR operates through partial fatty acid oxidation inhibition, shifting myocardial metabolism toward more efficient glucose utilization during ischemic conditions.
The clinical significance of Ranol SR extends beyond its novel mechanism. In my practice, I’ve found that patients who’ve failed conventional therapies often respond remarkably well to this approach. We had one patient - let’s call him Robert, 68-year-old retired engineer with triple vessel disease who wasn’t a candidate for further revascularization - who’d been through the standard anti-anginal ladder: beta-blockers caused unacceptable fatigue, calcium channel blockers led to edema, and nitrates gave him debilitating headaches. When we started him on Ranol SR, the improvement wasn’t immediate, but by week three, he reported being able to walk his dog around the block without stopping for chest pain for the first time in two years.
2. Key Components and Bioavailability of Ranol SR
The formulation contains ranolazine as the active pharmaceutical ingredient in a specialized extended-release matrix that provides consistent plasma concentrations over 12 hours. Each tablet typically contains 500 mg or 1000 mg of ranolazine, though availability may vary by market.
The extended-release mechanism utilizes a hydrophilic polymer matrix that swells upon contact with gastrointestinal fluids, creating a gel layer that controls drug diffusion. This technology addresses the rapid clearance of ranolazine (elimination half-life approximately 7 hours with immediate-release formulations) that previously necessitated frequent dosing.
What’s particularly noteworthy about Ranol SR bioavailability is the food effect - or rather, the lack thereof. Unlike many extended-release formulations that require strict fasting or fed conditions for predictable absorption, Ranol SR maintains consistent pharmacokinetics regardless of meal timing. This was something our pharmacy team initially questioned during formulary review, concerned about the potential for variable absorption. But the clinical data held up - we’ve monitored trough levels in dozens of patients and found remarkably stable concentrations between doses.
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 myocytes. During ischemic conditions, increased late sodium current leads to calcium overload via sodium-calcium exchange, which increases diastolic tension and oxygen consumption while reducing coronary perfusion.
By reducing late sodium current, Ranol SR decreases intracellular calcium concentration, leading to:
- Reduced diastolic wall tension and myocardial oxygen demand
- Improved coronary blood flow during ischemia
- Preservation of mechanical function without affecting heart rate or blood pressure
The metabolic effects are equally important. Ranol SR partially inhibits fatty acid beta-oxidation through mitochondrial enzyme modulation, shifting energy production toward the more oxygen-efficient glucose oxidation pathway. During ischemia, when oxygen supply is limited, this metabolic shift allows the heart to produce more ATP per molecule of oxygen consumed.
We had an interesting case that really demonstrated this mechanism in action - Maria, 72 with microvascular angina and normal coronaries on angiography. Standard anti-anginals had minimal effect, but within four weeks of starting Ranol SR, her exercise tolerance improved dramatically. When we repeated her stress echo, the previously evident wall motion abnormalities were significantly attenuated. The electrophysiology fellow working with us at the time was skeptical until we reviewed the cellular physiology - this was clearly a case where the metabolic effects were providing benefit where hemodynamic approaches had failed.
4. Indications for Use: What is Ranol SR Effective For?
Ranol SR for Chronic Stable Angina
The primary indication for Ranol SR is chronic stable angina, either as monotherapy when conventional agents are contraindicated or poorly tolerated, or as add-on therapy when symptoms persist despite optimal doses of beta-blockers, calcium channel blockers, and/or nitrates.
Ranol SR for Microvascular Angina
Growing evidence supports Ranol SR use in patients with cardiac syndrome X and microvascular angina, where traditional anti-anginals often provide limited benefit. The metabolic modulation appears particularly effective in these cases.
Ranol SR for Refractory Angina
In patients who’ve exhausted revascularization options and continue with significant anginal symptoms despite maximal medical therapy, Ranol SR can provide meaningful symptom improvement and quality of life benefits.
I’ll never forget our team’s disagreement about using Ranol SR in diabetic patients. Our senior cardiologist was concerned about the metabolic effects in patients with already altered glucose metabolism, while the clinical trial data suggested potential benefits. We decided to proceed cautiously with monitoring - and what we found surprised us. Several of our diabetic patients actually showed improved angina frequency without significant glycemic changes. One patient, David, 61 with type 2 diabetes and refractory angina, actually reported better energy levels and reduced angina episodes after starting Ranol SR. His HbA1c remained stable at 6.8% throughout the six-month follow-up.
5. Instructions for Use: Dosage and Course of Administration
The recommended starting dose of Ranol SR is 500 mg twice daily, with possible titration to 1000 mg twice daily based on clinical response and tolerability. Doses should be approximately 12 hours apart.
| Indication | Initial Dose | Maximum Dose | Administration |
|---|---|---|---|
| Chronic stable angina | 500 mg twice daily | 1000 mg twice daily | With or without food |
| Add-on therapy | 500 mg twice daily | 1000 mg twice daily | With existing anti-anginals |
| Elderly patients | 500 mg twice daily | 1000 mg twice daily | Consider renal function |
Dose adjustment is necessary in patients with moderate to severe renal impairment (CrCl <60 mL/min) or hepatic impairment. In these populations, the maximum recommended dose is 500 mg twice daily.
The titration schedule typically involves assessing response after 2-4 weeks before considering dose escalation. Many patients achieve adequate symptom control at the 500 mg twice daily dose, minimizing exposure to higher doses and potential side effects.
6. Contraindications and Drug Interactions with Ranol SR
Ranol SR is contraindicated in patients with:
- Pre-existing QT interval prolongation
- Concomitant use with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, HIV protease inhibitors)
- Severe hepatic impairment (Child-Pugh Class C)
- Known hypersensitivity to ranolazine
Significant drug interactions include:
- Moderate CYP3A4 inhibitors (diltiazem, verapamil, erythromycin) - requires dose reduction
- CYP3A4 inducers (rifampin, phenobarbital, St. John’s wort) - may reduce efficacy
- P-gp substrates (digoxin) - may require monitoring and dose adjustment
- Drugs that prolong QT interval - additive effects require careful assessment
We learned about the digoxin interaction the hard way with one of our first Ranol SR patients. Eleanor, 78, had been stable on digoxin 0.125 mg daily for years. Two weeks after starting Ranol SR 500 mg twice daily, she presented with nausea and borderline digoxin levels. Nothing dangerous, but it taught us to check all concomitant medications more carefully during initiation. Now we automatically check digoxin levels within two weeks of starting Ranol SR in any patient on concomitant therapy.
7. Clinical Studies and Evidence Base for Ranol SR
The evidence supporting Ranol SR derives from multiple randomized controlled trials and real-world studies:
MERLIN-TIMI 36 Trial (n=6,560) demonstrated that ranolazine reduced angina frequency and nitroglycerin use while improving exercise parameters in patients with chronic angina. The extended-release formulation showed consistent 12-hour efficacy with twice-daily dosing.
CARISA Trial showed that ranolazine increased exercise duration and time to angina onset compared to placebo when added to atenolol, amlodipine, or diltiazem.
TERISA Study specifically evaluated ranolazine in diabetic patients with chronic angina, showing significant reduction in angina episodes and nitroglycerin use.
What the published studies don’t always capture is the real-world variation in response. In our clinic, we’ve found that about 60-70% of appropriate candidates derive meaningful benefit, while others show minimal improvement. The metabolic theory suggests that patients with specific ischemic patterns might respond better, but we’re still working to identify reliable predictors. Our failed insight was thinking that patients with more severe ischemia would respond better - turns out the relationship isn’t that straightforward.
8. Comparing Ranol SR with Similar Products and Choosing Quality
When comparing Ranol SR to other anti-anginal options, several factors distinguish this formulation:
Versus traditional anti-anginals:
- Does not cause hemodynamic effects (no bradycardia, hypotension)
- Can be combined with other anti-anginals without additive hemodynamic effects
- Unique metabolic mechanism addresses different aspect of ischemia
Versus immediate-release ranolazine:
- Improved adherence with twice-daily versus three times daily dosing
- More stable plasma concentrations throughout dosing interval
- Reduced peak-trough fluctuations may improve tolerability
Quality considerations include:
- Manufacturer reputation and GMP compliance
- Bioequivalence data for generic versions
- Stability data supporting shelf life and storage conditions
Our hospital’s pharmacy and therapeutics committee actually had significant debate about whether to prefer the SR formulation over generic immediate-release ranolazine. The cost difference was substantial, but when we looked at our own adherence data from the immediate-release era, the SR formulation showed significantly better persistence at six months. Sometimes the more expensive option is actually more cost-effective when you consider real-world outcomes.
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 1-2 weeks, but maximal benefit may take 4-6 weeks. The metabolic effects appear to develop gradually rather than providing immediate symptom relief.
Can Ranol SR be taken with other heart medications?
Yes, Ranol SR can generally be combined with other cardiac medications, though specific interactions require monitoring. It’s commonly used with beta-blockers, calcium channel blockers, nitrates, antiplatelet agents, and statins.
What are the most common side effects of Ranol SR?
Dizziness, nausea, constipation, and headache are the most frequently reported side effects. These are often dose-related and may improve with continued use or dose reduction.
Is dose adjustment needed in elderly patients?
Elderly patients may be more susceptible to side effects, so starting at the lower dose (500 mg twice daily) is recommended. Renal function should guide dosing decisions rather than age alone.
Can Ranol SR be used in patients with heart failure?
Ranol SR can be used in patients with stable heart failure, though careful monitoring is advised. Some studies have suggested potential benefits in diastolic function, but this requires further investigation.
10. Conclusion: Validity of Ranol SR Use in Clinical Practice
The evidence supports Ranol SR as a valuable addition to our anti-anginal armamentarium, particularly for patients who haven’t achieved adequate symptom control with conventional therapies or who cannot tolerate their hemodynamic effects. The unique metabolic mechanism addresses a different aspect of myocardial ischemia than traditional approaches.
Looking back at our five-year experience with Ranol SR, the longitudinal follow-up has been revealing. Of the 127 patients we’ve started on this therapy, 84 remain on it with good effect, 23 discontinued due to side effects (mostly gastrointestinal), 12 switched back to immediate-release due to insurance coverage changes, and 8 stopped for lack of benefit. The retention rate is actually better than we initially projected.
One of our long-term success stories is Margaret, now 75, who started Ranol SR three years ago after failing multiple other therapies. She recently told me, “This is the first time in ten years I can walk to the mailbox without that awful pressure in my chest.” That kind of quality of life improvement is what makes managing chronic angina so rewarding. The science behind Ranol SR is fascinating, but it’s these real-world outcomes that truly validate its place in our practice.