Ranol SR

Ranol SR is a specialized sustained-release formulation of isosorbide mononitrate, designed for the prophylactic management of chronic stable angina pectoris. This advanced pharmaceutical product offers a predictable pharmacokinetic profile, ensuring consistent therapeutic plasma levels over an extended duration. Its development focuses on enhancing patient adherence through simplified dosing while minimizing the peaks and troughs associated with immediate-release formulations. Clinicians favor Ranol SR for its ability to provide reliable coronary vasodilation and reduce cardiac preload and afterload, thereby decreasing myocardial oxygen demand. This makes it a cornerstone therapy in long-term angina management strategies for appropriate patient populations.

Features

• Active ingredient: Isosorbide mononitrate 60mg
• Pharmaceutical form: Sustained-release tablet
• Mechanism: Organic nitrate vasodilator
• Release profile: Modified-release matrix system
• Duration: Provides 12-hour therapeutic coverage
• Packaging: Blister packs of 28 tablets
• Excipients: Hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate
• Bioavailability: Approximately 100% relative to solution
• Half-life: 4-6 hours (sustained-release profile)

Benefits

• Provides continuous prophylactic protection against angina attacks through maintained vasodilation
• Reduces frequency and severity of anginal episodes, improving exercise tolerance
• Simplified twice-daily dosing enhances treatment adherence compared to multiple daily dosing regimens
• Minimizes development of nitrate tolerance through consistent plasma levels
• Decreases myocardial oxygen demand through reduction in preload and afterload
• Offers predictable pharmacokinetics with reduced peak-trough fluctuations

Common use

Ranol SR is indicated for the prophylactic management of patients with chronic stable angina pectoris who remain symptomatic despite adequate doses of beta-blockers and/or calcium channel blockers, or for those intolerant to these agents. It is particularly suitable for patients requiring long-term nitrate therapy who would benefit from reduced dosing frequency. The medication is commonly prescribed as part of comprehensive anti-anginal therapy, often in combination with other anti-ischemic medications. Clinical use typically involves patients with documented coronary artery disease who experience exertional angina, with the goal of improving functional capacity and quality of life.

Dosage and direction

The recommended dosage of Ranol SR is one 60mg tablet taken orally twice daily, approximately 12 hours apart (typically morning and evening). Tablets should be swallowed whole with a glass of water and should not be crushed, chewed, or divided. Administration should occur on an empty stomach, either one hour before or two hours after meals, to ensure consistent absorption. The initial dose should be titrated based on individual patient response and tolerance, particularly regarding headache and hypotension. For patients transitioning from immediate-release isosorbide mononitrate, appropriate dose conversion should be calculated based on previous total daily dosage. Elderly patients or those with hepatic impairment may require dose adjustment, though specific guidelines are limited due to the drug’s extensive metabolism.

Precautions

Patients should be advised that Ranol SR treatment requires a gradual dose reduction when discontinuing therapy to avoid potential rebound angina. Concomitant use with phosphodiesterase-5 inhibitors (sildenafil, tadalafil, vardenafil) is absolutely contraindicated due to risk of severe hypotension. Caution is warranted in patients with hypovolemia, hypotension, or hypertrophic cardiomyopathy. Headache is a common initial side effect that typically diminishes with continued therapy; patients should be counseled accordingly. Alcohol consumption may enhance the vasodilatory effects and should be avoided or limited. Patients should be monitored for signs of nitrate tolerance, which may develop with continuous therapy without a nitrate-free interval, though the sustained-release formulation is designed to mitigate this concern.

Contraindications

Ranol SR is contraindicated in patients with known hypersensitivity to organic nitrates or any component of the formulation. Additional absolute contraindications include use in patients with severe anemia, increased intracranial pressure, or closed-angle glaucoma. The medication must not be administered to patients with cardiogenic shock, extreme hypotension (systolic blood pressure <90 mmHg), or marked bradycardia (<50 beats per minute). Concurrent administration with phosphodiesterase-5 inhibitors is strictly prohibited. The product is contraindicated in patients with acute myocardial infarction with low filling pressures and in those with circulatory failure and peripheral edema.

Possible side effects

The most frequently reported adverse reaction is headache (occurring in approximately 30% of patients), which is often dose-related and tends to diminish with continued therapy. Other common side effects include dizziness (10-15%), orthostatic hypotension (5-8%), and reflex tachycardia (3-5%). Gastrointestinal disturbances such as nausea and vomiting may occur in approximately 5% of patients. Less frequently reported effects include flushing, weakness, and syncope (particularly with initial doses or dose increases). Cutaneous vasodilation with flushing may occur in sensitive individuals. Rare cases of methemoglobinemia have been reported with high doses of organic nitrates, though this is exceptionally uncommon at therapeutic doses.

Drug interaction

Concomitant use with antihypertensive agents, beta-blockers, calcium channel blockers, phenothiazines, or other vasodilators may potentiate the hypotensive effects of Ranol SR. Alcohol consumption may enhance the vasodilatory and hypotensive effects. Concurrent administration with dihydroergotamine may increase ergotamine bioavailability and toxicity. Aspirin may increase nitrate serum concentrations due to competition for clearance pathways. Heparin’s anticoagulant effect may be reduced when administered with nitrates. Most significantly, phosphodiesterase-5 inhibitors (sildenafil, tadalafil, vardenafil) can cause profound hypotension and are absolutely contraindicated.

Missed dose

If a dose of Ranol SR is missed, the patient 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 never double the dose to make up for a missed administration. Consistent timing is important for maintaining therapeutic plasma levels, but occasional missed doses are unlikely to cause significant clinical deterioration in stable angina patients. However, patients should be advised to maintain regular dosing as prescribed for optimal prophylactic effect.

Overdose

Symptoms of Ranol SR overdose primarily involve vasodilation resulting in severe hypotension, reflex tachycardia, headache, dizziness, syncope, and flushing. Methemoglobinemia may occur with massive overdosage, presenting as cyanosis, anemia, fatigue, and dyspnea. Management involves placing the patient in a supine position with legs elevated to maximize venous return. Administration of intravenous fluids and alpha-adrenergic agonists may be necessary for hypotension correction. Methylene blue (1-2 mg/kg intravenously over 5 minutes) is indicated for methemoglobinemia exceeding 30%. Hemodialysis is not effective due to extensive protein binding and tissue distribution.

Storage

Ranol SR tablets should be stored in their original packaging at room temperature (15-30°C/59-86°F), protected from light and moisture. The product should be kept in a tightly closed container to prevent degradation from atmospheric conditions. Tablets should not be removed from blister packs until immediately before administration. Patients should be advised to check expiration dates and properly dispose of any expired medication. The product should be kept out of reach of children and pets. Storage in bathrooms or other humid environments should be avoided to maintain stability.

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, modify, or discontinue therapy without consulting their physician. The prescribing information provided here may not be comprehensive; healthcare providers should consult the full prescribing information before administration. Individual patient responses may vary, and therapeutic decisions should be based on clinical judgment and patient-specific factors.

Reviews

Clinical studies demonstrate that Ranol SR effectively reduces angina attack frequency by 60-70% compared to placebo in stable angina patients. Long-term observational data indicate improved exercise tolerance and quality of life measures in approximately 80% of appropriately selected patients. Cardiology specialists note the formulation’s advantage in maintaining consistent therapeutic levels with reduced dosing frequency. Some patients report initial headache as a challenging side effect, though most describe improvement within the first week of therapy. The twice-daily regimen receives positive feedback for convenience compared to more frequent dosing schedules of immediate-release formulations.