Description
Nicorandil Tablets (5 mg / 10 mg / 20 mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-anginal, and vasodilatory therapeutics. We provide ultra-high-purity, kinetically stabilized Nicorandil Uncoated / Film-Coated Tablets (5 mg / 10 mg / 20 mg), manufactured in WHO–GMP certified, ultra-low humidity oral solid dosage facilities. This “Dual-Pathway Potassium-Channel Opener” is a massive-volume, highly lucrative export to cardiology centers, specialized ischemia clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-efficacy intervention for the prevention and long-term treatment of refractory Angina Pectoris.
Product Overview
This highly advanced formulation utilizes a unique, dual-action chemical structure (a nicotinamide ester) to forcefully open up the blood vessels, delivering a massive flood of oxygen to a starving, ischemic heart while simultaneously dropping the mechanical workload required to pump blood.
The “Preload & Afterload Reduction” Specialist:
- Mechanism 1 (The K-ATP Channel Opener – Afterload Reduction): Nicorandil actively opens ATP-sensitive potassium (K-ATP) channels in the smooth muscle cells lining the arteries. This causes potassium to rush out of the cells (hyperpolarization), physically preventing the arteries from contracting. As the peripheral arteries forcefully relax and widen, the resistance the heart must pump against (afterload) plummets, drastically reducing the heart’s oxygen demand.
- Mechanism 2 (The Nitric Oxide Donor – Preload Reduction): Simultaneously, the molecule acts like a classic nitrate, releasing Nitric Oxide (NO) into the venous system. This causes the large veins returning blood to the heart to dilate and pool blood. By reducing the volume of blood rushing into the heart chambers (preload), the physical stretching and strain on the heart muscle are profoundly alleviated.
- The Refractory Angina Rescue: For patients suffering from severe, chronic stable angina who cannot tolerate beta-blockers (due to asthma) or who have maxed out their calcium channel blocker dosages, Nicorandil provides a completely independent, life-saving pharmacological pathway to stop excruciating chest pain and prevent myocardial infarction.
Product Composition & Strength
We supply this product as a Precision-Blended, Moisture-Shielded Tablet, packed exclusively in highly secure, heavy-gauge Alu-Alu blister strips to ensure the absolute chemical stability of the highly volatile active ingredient.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Nicorandil Ph.Eur./BP | 5 mg | Initiation / Titration Standard: Base therapeutic unit for the mandatory slow-titration protocol required to build patient tolerance and prevent severe “nitrate headaches.” |
| Nicorandil Ph.Eur./BP | 10 mg / 20 mg | Global Cardiology Standard: High-dose adult maintenance therapy for severe, refractory stable angina pectoris. |
| Excipients | Maize Starch / Croscarmellose Sodium / Stearic Acid / Mannitol | Low-Moisture Diluent / Superdisintegrant / Lubricant (Engineered specifically without hygroscopic binders to guarantee the tablet remains perfectly dry and structurally intact throughout its shelf life) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict chronic cardiology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Cardiovascular/Anti-anginals) |
| CAS Number | 65141-46-0 (Nicorandil) |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | Heavy-Gauge Alu-Alu Blisters (STRICTLY MANDATORY). Nicorandil undergoes rapid, violent hydrolytic degradation when exposed to atmospheric humidity. Standard PVC is strictly prohibited. Heavy-gauge Alu-Alu barrier packaging (often with integrated blister desiccants) guarantees absolute chemical stability across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture. Blisters must be kept in the outer carton. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Ultra-Low Humidity Dry-Blending Engineering (CRITICAL COMPLIANCE): Manufacturing Nicorandil is a severe test of a facility’s HVAC and environmental control capabilities. Wet granulation cannot be used. Our facilities utilize strictly controlled, ultra-low humidity suites (RH < 25%) and advanced direct-compression dry-blending techniques. This absolutely prevents premature hydrolysis of the nitrate ester group on the factory floor, ensuring the patient receives 100% of the active vasodilatory payload.
Therapeutic Indications (Human Use)
Indicated for the comprehensive, multi-pathway management of severe ischemic heart disease:
- Stable Angina Pectoris: Second-line treatment for the symptomatic relief of chronic stable angina in adults who are inadequately controlled by, or have a contraindication or intolerance to, first-line anti-anginal therapies (such as beta-blockers and calcium channel antagonists).
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Initial Dosing: 10 mg twice daily. A lower starting dose of 5 mg twice daily is mandatory for patients particularly susceptible to headaches.
- Maintenance Dosing: The dose is slowly titrated upward based on clinical response, typically up to 20 mg twice daily.
- Administration: Can be taken with or without food. Tablets must be swallowed completely whole with water.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Fatal Hypotension with PDE5 Inhibitors (BLACK BOX EQUIVALENT): Nicorandil massively amplifies the blood-pressure-lowering effects of PDE5 inhibitors used for erectile dysfunction (e.g., Sildenafil/Viagra, Tadalafil, Vardenafil). Co-administration is strictly contraindicated as it can cause sudden, fatal cardiovascular collapse.
- Severe Mucosal Ulceration (NICORANDIL-SPECIFIC ALERT): This drug has a rare but notorious side effect: it can cause severe, refractory ulcerations anywhere in the gastrointestinal tract, including the mouth, stomach, intestines, and perianal region. If a patient develops unexplained ulcers or anal fissures, the drug must be withdrawn immediately. Surgery will not heal the ulcers while the patient is still taking the medication.
- Severe Vasodilatory Headaches: Like all nitrate-like drugs, Nicorandil frequently causes intense, throbbing headaches during the first few weeks of therapy as the cerebral blood vessels dilate.
- Hypovolemia & Acute Pulmonary Edema: Must be used with extreme caution in volume-depleted patients or those with low systolic blood pressure, as it can cause acute syncopal (fainting) episodes.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Cardiology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular and Moisture-Sensitive Formulations. Whether you are looking for a reliable Government Tender Supplier for ischemia clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.
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