Olmesartan, Amlodipine & Hydrochlorothiazide Tablets (20mg/5mg/12.5mg & 40mg/10mg/25mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-hypertensive, and severe metabolic therapeutics. We provide ultra-high-purity, kinetically synchronized Olmesartan Medoxomil, Amlodipine Besylate & Hydrochlorothiazide (HCTZ) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision multi-particulate oral solid dosage facilities. This “Triple-Mechanism Antihypertensive Synergy” is an ultra-high-value, massive-volume export to cardiology centers, tertiary care hospitals, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for severe, treatment-resistant Essential Hypertension.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes three entirely different classes of blood-pressure-lowering medications into a single, highly compliant daily dose, attacking severe hypertension from three completely distinct physiological angles simultaneously.
The “Triple-Pathway Hemodynamic” Specialist:
- Mechanism 1 (The RAAS Blockade – Olmesartan): Olmesartan Medoxomil is a potent Angiotensin II Receptor Blocker (ARB). It directly stops Angiotensin II from binding to receptors on the blood vessels, physically preventing the arteries from constricting and profoundly reducing the workload on the heart.
- Mechanism 2 (The Peripheral Vasodilator – Amlodipine): Amlodipine Besylate is a long-acting Calcium Channel Blocker (CCB). It physically blocks calcium ions from entering the smooth muscle cells of the arterial walls. Without calcium, the arteries cannot maintain their rigidity; they forcefully relax and dilate, allowing blood to flow with minimal resistance.
- Mechanism 3 (The Volume Reducer – Hydrochlorothiazide): HCTZ is a thiazide diuretic. It acts directly on the kidneys, forcing them to excrete excess sodium and water. This physically reduces the total volume of fluid circulating in the cardiovascular system, lowering the pressure against the vessel walls. Crucially, HCTZ prevents the fluid retention (edema) that is often caused by Amlodipine, while Olmesartan prevents the potassium loss (hypokalemia) caused by HCTZ, creating a perfect, self-balancing safety profile.
- The “Pill Burden” Compliance Rescue: Patients with severe hypertension typically fail treatment because they forget or refuse to swallow three to four different pills every morning. By condensing the entire triple-therapy protocol into a single, easy-to-swallow tablet, clinical compliance skyrockets, directly preventing fatal strokes and myocardial infarctions.
Product Composition & Strength
We supply this product as a Precision-Engineered, API-Segregated Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of all three active ingredients across their entire shelf life.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Olmesartan Medoxomil Ph.Eur./USP | 20 mg / 40 mg | ARB Base: Blocks the renin-angiotensin-aldosterone system (RAAS) and provides critical diabetic renoprotection. |
| Amlodipine (as Besylate) Ph.Eur./USP | 5 mg / 10 mg | CCB Vasodilator: Forces profound, sustained peripheral arterial relaxation. |
| Hydrochlorothiazide (HCTZ) Ph.Eur./USP | 12.5 mg / 25 mg | Diuretic Volume Controller: Flushes excess sodium/water and massively amplifies the efficacy of the ARB component. |
| Excipients | Silicified Microcrystalline Cellulose / Pregelatinized Starch / Croscarmellose Sodium / Magnesium Stearate / Opadry Protective Film | Moisture-Scavenging Diluent / Binder / Superdisintegrant / Premium Film-Coating (Engineered specifically to physically isolate the highly sensitive Olmesartan ester from the alkaline Amlodipine salt to prevent cross-degradation) |
*Pack Sizes: 10×10 Alu-Alu Blisters or 3×10 Unit-Dose 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 | 144689-63-4 (Olmesartan) / 111470-99-6 (Amlodipine Besylate) / 58-93-5 (HCTZ) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Olmesartan Medoxomil undergoes violent hydrolytic degradation if exposed to humidity. Heavy-gauge Alu-Alu barrier packaging guarantees absolute chemical stability and full triple-potency across Zone IVb tropical climates. |
| Storage | Store strictly below 25°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.
- Tri-Active Segregation & Dry-Granulation Engineering: Combining an ester prodrug (Olmesartan), a highly light-sensitive basic salt (Amlodipine), and a diuretic (HCTZ) is a severe pharmaceutical challenge. If mixed improperly, the Amlodipine will chemically attack and destroy the Olmesartan. Our facilities utilize advanced dry-granulation and specialized physical barrier excipients (like Silicified MCC). By creating distinct micro-environments within the tablet matrix, we ensure all three APIs remain 100% chemically isolated until the tablet dissolves in the patient’s stomach, guaranteeing a flawless, multi-year shelf life.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of severe, complex cardiovascular dysfunction:
- Treatment-Resistant Essential Hypertension: Indicated as a substitution therapy for adult patients whose blood pressure is already adequately controlled on the combination of Olmesartan, Amlodipine, and HCTZ taken as separate tablets, or as add-on therapy when dual combinations have clinically failed.
- Note: This potent combination is not indicated for initial therapy (first-line) of hypertension.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Standard Adult Dosing: One tablet taken orally once daily.
- Administration: Can be administered with or without food. Tablets must be swallowed completely whole with water.
- Hydration Rule: Because HCTZ is a potent diuretic, patients must maintain adequate fluid intake to prevent severe dehydration and sudden orthostatic hypotension (fainting upon standing).
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Fetal Toxicity): Like all drugs acting directly on the renin-angiotensin system, this FDC must be discontinued immediately upon detection of pregnancy, as it can cause profound injury and death to the developing fetus.
- Severe Hypotension & Syncope: Combining three potent blood-pressure-lowering agents drastically increases the risk of severe, sudden hypotension, particularly in volume-depleted or elderly patients.
- Electrolyte Imbalance (The Tug-of-War): HCTZ forces potassium out of the body (hypokalemia), while Olmesartan forces the body to retain it (hyperkalemia). While they generally balance each other out, severe imbalances can still occur. Serum electrolytes and renal function (Creatinine/BUN) must be monitored closely.
- Sprue-Like Enteropathy (Olmesartan Specific): Can cause severe, chronic diarrhea with substantial weight loss. If this occurs, the drug must be discontinued immediately.
- Peripheral Edema: Amlodipine frequently causes swelling in the ankles and feet. (The addition of Olmesartan and HCTZ significantly mitigates this, but it may still occur).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular Triple-FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for cardiology 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.