Metoprolol & Amlodipine Bilayer Tablets (25mg/5mg & 50mg/5mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-hypertensive, and anti-anginal therapeutics. We provide ultra-high-purity, kinetically synchronized Metoprolol (as Succinate ER/Tartrate) & Amlodipine (as Besylate) Film-Coated Bilayer Tablets (25mg/5mg & 50mg/5mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Dual-Action Hemodynamic Synergy” is a massive-volume, highly lucrative export to cardiology centers, internal medicine clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for severe Essential Hypertension and Chronic Stable Angina Pectoris.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes an elite, cardioselective beta-blocker with the world’s most potent dihydropyridine calcium channel blocker. Together, they form a flawless, self-correcting antihypertensive loop that massively drops blood pressure without triggering the adverse compensatory mechanisms seen in single-drug therapy.
The “Rate-Control & Vasodilatory” Specialist:
- Mechanism 1 (The Vasodilatory Driver – Amlodipine): Amlodipine aggressively blocks the influx of calcium ions into the smooth muscle cells lining the peripheral arteries. Without calcium, the arteries cannot physically contract. This forces them to dramatically widen (vasodilation), which plummets the systemic vascular resistance and radically lowers blood pressure.
- Mechanism 2 (The Cardiac Shield – Metoprolol): While Amlodipine drops the pressure in the body, Metoprolol targets the Beta-1 receptors in the heart. It shields the myocardium from adrenaline spikes, significantly slowing the resting heart rate and decreasing the mechanical force of each heartbeat, thereby drastically reducing the heart’s oxygen demand.
- The Flawless Hemodynamic Synergy: When used alone, Amlodipine drops blood pressure so fast that the body panics and triggers a “reflex tachycardia” (a racing heart). Metoprolol completely neutralizes this side effect by capping the heart rate. Conversely, Metoprolol alone can cause cold extremities due to peripheral vasoconstriction; Amlodipine perfectly neutralizes this by forcing the vessels open. This synergistic pairing delivers profound, side-effect-free blood pressure control and absolute angina prevention.
Product Composition & Strength
We supply this product as a Precision-Engineered, API-Segregated Bilayer Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or high-density PVC/PVDC blister strips to ensure the absolute chemical stability of the combined molecules.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Metoprolol (as Tartrate/Succinate ER) Ph.Eur./USP | 25 mg / 50 mg | Cardioselective Base: Reduces heart rate, cardiac workload, and neutralizes CCB-induced reflex tachycardia. |
| Amlodipine (as Besylate) Ph.Eur./USP | 5 mg | Calcium Channel Blocker (CCB): Forces profound peripheral arterial vasodilation, dropping severe blood pressure and relieving coronary spasms. |
| Excipients | Microcrystalline Cellulose / Dibasic Calcium Phosphate / Crospovidone / Magnesium Stearate / Premium Opadry Film / Iron Oxide Colors | Diluent / Stabilizing Buffer / Superdisintegrant / Lubricant (Engineered specifically using bilayer press technology to physically separate the slightly acidic Metoprolol salt from the basic Amlodipine, preventing destructive chemical cross-talk) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict 30-day 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/Antihypertensive FDC) |
| CAS Numbers | 56392-17-7 (Metoprolol Succinate) / 111470-99-6 (Amlodipine Besylate) |
| Dosage Form | Film-Coated Bilayer Tablet |
| Packaging | High-Density PVC/PVDC or Alu-Alu Blisters. Protects the formulation from environmental humidity, preventing the degradation of the besylate salt across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Alkaline/Acidic Bilayer Segregation Engineering (CRITICAL COMPLIANCE): Combining Amlodipine (a basic compound) with Metoprolol (an acidic salt) in a single homogeneous layer often leads to rapid API degradation, discoloration, and loss of potency over time. Our facilities utilize advanced, climate-controlled Bilayer Rotary Presses. We physically separate the two APIs into distinct layers within the same tablet, incorporating specific pH-buffering excipients. This guarantees absolute chemical isolation during shelf-life and flawless, synchronized dissolution in the gastrointestinal tract.
Therapeutic Indications (Human Use)
Indicated for the comprehensive, step-up management of severe cardiovascular disease:
- Essential Hypertension: Treatment of high blood pressure as substitution therapy in patients whose blood pressure is not adequately controlled on Metoprolol or Amlodipine monotherapy.
- Chronic Stable Angina & Vasospastic Angina: Prevention of severe chest pain and ischemic episodes by simultaneously dilating coronary arteries and reducing the heart’s oxygen demand.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Standard Adult Dosing: One tablet taken orally once daily, usually in the morning.
- Administration: Can be taken with or without food. Tablets must be swallowed completely whole with water.
- Abrupt Cessation Warning: Because this FDC contains a beta-blocker, therapy MUST NOT be stopped abruptly. Sudden discontinuation can trigger severe rebound tachycardia, exacerbated angina, or a fatal myocardial infarction. The dose must be tapered over 1 to 2 weeks.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Severe Bradycardia & Heart Block: Metoprolol significantly slows the heart. It is strictly contraindicated in patients with severe bradycardia (< 45 bpm), second or third-degree heart block, sick sinus syndrome, or uncompensated heart failure.
- Peripheral Edema (Swelling): Amlodipine frequently causes dose-dependent fluid retention and severe swelling in the ankles and lower legs. While the Metoprolol component helps mitigate this slightly, patients must be monitored for severe edema.
- Severe Hepatic Impairment: Both APIs are extensively metabolized by the liver. The half-life of Amlodipine is massively prolonged in patients with severe liver disease, requiring extreme caution and potentially lower initial dosing.
- Asthma / Bronchospastic Disease: While Metoprolol is cardio-selective, high doses can spill over and block Beta-2 receptors in the lungs, triggering fatal bronchospasms in severe asthmatics.
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 Bilayer FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for hypertension clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.