Ranol SR: Advanced Angina Management with Sustained-Release Protection
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Ranol SR is a sustained-release formulation of Ranolazine, a clinically proven antianginal agent specifically designed for the chronic management of chronic stable angina pectoris. It functions as a late sodium current inhibitor, offering a unique mechanism of action that complements traditional antianginal therapies. This medication is indicated for use in patients who have not achieved adequate symptom control with other antianginal agents, providing an additional therapeutic option to reduce angina frequency and improve exercise tolerance. Its sustained-release delivery system ensures stable plasma concentrations, supporting consistent efficacy and simplified dosing regimens for long-term cardiovascular care.
Features
- Active ingredient: Ranolazine 500 mg or 1000 mg per extended-release tablet
- Pharmacologic class: Late sodium current inhibitor
- Formulation: Film-coated, sustained-release tablets for oral administration
- Mechanism: Selectively inhibits the late sodium current in cardiac cells, reducing calcium overload and improving myocardial oxygen supply-demand balance
- FDA-approved for chronic angina management
- Bioavailability: Approximately 76% under fasting conditions
- Half-life: Approximately 7 hours
- Peak plasma concentration: Achieved within 2–5 hours post-dose
- Metabolism: Primarily hepatic via CYP3A4 and secondarily via CYP2D6
- Excretion: Approximately 75% renal, 25% fecal
Benefits
- Reduces frequency of angina episodes and nitroglycerin rescue use
- Improves exercise tolerance and time to onset of angina during physical activity
- Provides 24-hour angina protection through sustained plasma concentrations
- Compatible with standard antianginal regimens (beta-blockers, calcium channel blockers, nitrates)
- Does not significantly affect heart rate or blood pressure
- Offers therapeutic option for patients with contraindications to traditional antianginal agents
Common use
Ranol SR is primarily prescribed for the treatment of chronic stable angina pectoris in patients who have remained symptomatic despite standard antianginal therapy. It is particularly valuable in cases where beta-blockers are contraindicated, poorly tolerated, or insufficiently effective. The medication is commonly used as add-on therapy to existing antianginal regimens, though it may be used as monotherapy in specific clinical scenarios. Clinical studies demonstrate its efficacy across various patient populations, including those with comorbid conditions such as diabetes mellitus and peripheral arterial disease.
Dosage and direction
The recommended initial dosage of Ranol SR is 500 mg twice daily, with or without food. Based on clinical response and tolerability, the dosage may be increased to 1000 mg twice daily. Tablets should be swallowed whole and must not be crushed, chewed, or divided, as this would compromise the sustained-release properties and potentially lead to rapid drug release. Dosage adjustment is required in patients with moderate to severe renal impairment (creatinine clearance <30 mL/min) and in those taking moderate CYP3A4 inhibitors. The maximum recommended dose is 1000 mg twice daily.
Precautions
Patients should be monitored for QT interval prolongation, although Ranol SR’s effect on QT interval is modest and dose-dependent. Regular assessment of renal function is recommended, particularly in elderly patients or those with pre-existing renal impairment. Hepatic function should be evaluated before initiation and periodically during treatment. Caution is advised in patients with congenital long QT syndrome or those taking other medications that prolong the QT interval. Patients should be advised that Ranol SR may cause dizziness or lightheadedness, potentially affecting the ability to operate machinery or drive.
Contraindications
Ranol SR is contraindicated in patients with known hypersensitivity to Ranolazine or any component of the formulation. It is contraindicated in patients with clinically significant hepatic impairment (Child-Pugh Class B and C). Concomitant use with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir) is contraindicated. The medication is contraindicated with CYP3A4 inducers (rifampin, phenobarbital, phenytoin, carbamazepine, St. John’s wort). Use is contraindicated in patients with pre-existing QT interval prolongation or those taking other drugs that prolong the QT interval.
Possible side effects
Common adverse reactions (≥2% and more frequent than placebo) include dizziness (6.2%), nausea (4.5%), constipation (4.5%), and headache (3.9%). Other reported side effects include dry mouth, abdominal pain, vomiting, dyspepsia, asthenia, and peripheral edema. Serious but rare adverse effects include QT interval prolongation, syncope, hallucinations, confusion, and visual disturbances. Laboratory abnormalities may include increased serum creatinine, BUN, and transaminases. Most adverse reactions are mild to moderate in severity and often diminish with continued therapy.
Drug interaction
Ranol SR is primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6, resulting in significant interaction potential. Strong CYP3A4 inhibitors increase Ranolazine exposure approximately 3-fold and are contraindicated. Moderate CYP3A4 inhibitors (diltiazem, verapamil, erythromycin) require dose reduction. CYP3A4 inducers significantly decrease Ranolazine concentrations. Digoxin levels may increase by approximately 1.5-fold when co-administered with Ranol SR. Simvastatin exposure increases approximately 2-fold with concomitant use. Metoprolol (CYP2D6 substrate) concentrations may increase. Careful monitoring and dose adjustments are necessary when administering with these medications.
Missed dose
If a dose of Ranol SR 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. Patients should not double the dose to make up for a missed dose. Consistent adherence to the prescribed twice-daily regimen is important for maintaining therapeutic plasma concentrations and optimal antianginal efficacy.
Overdose
Cases of Ranolazine overdose have been reported with doses up to 9000 mg. Symptoms may include nausea, vomiting, drowsiness, dizziness, paresthesia, and syncope. QT interval prolongation and hypotension may occur in significant overdose. There is no specific antidote for Ranolazine overdose. Management should include supportive care with continuous ECG monitoring for at least 12 hours. Gastric lavage may be considered if performed soon after ingestion. Hemodialysis is unlikely to be effective due to Ranolazine’s high protein binding and extensive tissue distribution.
Storage
Store Ranol SR tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly discard any unused medication through medication take-back programs or according to local regulations.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Ranol SR is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Patients should not initiate, discontinue, or change dosage without consulting their physician. The complete prescribing information should be consulted before administration. Individual patient responses may vary, and not all side effects or interactions are listed here.
Reviews
Clinical trials demonstrate that Ranol SR significantly reduces weekly angina frequency (mean reduction of approximately 1.5 attacks per week compared to placebo) and decreases nitroglycerin use. Exercise tolerance testing shows consistent improvement in exercise duration and time to angina onset. Post-marketing surveillance data indicate sustained efficacy and acceptable safety profile in real-world populations. Patient-reported outcomes show improvements in quality of life measures and treatment satisfaction scores. Long-term extension studies support maintained efficacy over 12 months of treatment with no new safety concerns emerging with extended use.