Description
Telmisartan, Amlodipine & Hydrochlorothiazide Tablets
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, antihypertensive, and nephroprotective therapeutics. We provide ultra-high-purity, kinetically segregated Telmisartan (40 mg) + Amlodipine (5 mg) + Hydrochlorothiazide (12.5 mg) Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Triple-Pathway Hemodynamic FDC” is a massive-volume, premium export to cardiology centers, intensive care step-down units, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, definitive intervention for severe, refractory essential hypertension.
Product Overview
This highly advanced Triple-FDC masterfully synchronizes an Angiotensin II Receptor Blocker (ARB), a Calcium Channel Blocker (CCB), and a Thiazide Diuretic into a single, perfectly balanced cardioprotective shield.
The “Refractory Hypertension & Synergistic Defense” Specialist:
- Mechanism 1 (The RAAS Blockade – Telmisartan 40mg): Telmisartan aggressively binds to AT1 receptors, preventing Angiotensin II from causing vasoconstriction. This drops systemic resistance and blocks the release of aldosterone. Crucially, Telmisartan’s mechanism naturally forces the body to retain potassium, which perfectly counters the potassium loss caused by the diuretic component.
- Mechanism 2 (The Arterial Relaxer – Amlodipine 5mg): Amlodipine physically blocks L-type calcium channels in the smooth muscle cells of the blood vessels. Without calcium, the blood vessels cannot contract. They remain wide open, drastically lowering blood pressure and increasing oxygen supply to the heart. While Amlodipine frequently causes swelling in the ankles (peripheral edema), this side effect is powerfully neutralized by the third ingredient.
- Mechanism 3 (The Volume Reducer – Hydrochlorothiazide 12.5mg): HCTZ inhibits the sodium-chloride symporter in the kidneys, forcing the body to excrete excess sodium and water. This reduces total blood volume, further lowering blood pressure and actively flushing out the ankle edema caused by the Amlodipine.
- The Compliance Miracle: Patients with severe hypertension often abandon therapy because they are forced to take three or four different pills daily. Fusing these three synergistically perfect molecules into a single, once-daily tablet guarantees unparalleled patient compliance and massive reductions in cardiovascular mortality.
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/Antihypertensives) |
| CAS Numbers | 144701-48-4 (Telmisartan) / 111470-99-6 (Amlodipine Besylate) / 58-93-5 (HCTZ) |
| Dosage Form | Multi-Layer Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Telmisartan is extremely hygroscopic. Heavy-gauge Alu-Alu packaging guarantees absolute stability and protects the sensitive micro-dose formulations from humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Triple-Matrix Segregation Engineering: Combining three vastly different APIs into one stable tablet is an elite manufacturing challenge. Telmisartan requires highly alkaline stabilizers (like Meglumine) to dissolve. If this alkaline environment touches Amlodipine, it causes rapid chemical degradation and therapeutic failure. Our facilities utilize advanced Multi-Layer Tablet Pressing Technology or specialized Micro-Encapsulation to physically separate the three active ingredients, guaranteeing 100% therapeutic potency and a multi-year shelf life.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of severe cardiovascular disease:
- Severe/Refractory Essential Hypertension: Treatment of high blood pressure in patients whose blood pressure is not adequately controlled on dual therapy (e.g., Telmisartan + Amlodipine or Telmisartan + HCTZ), or as highly convenient substitution therapy for patients already taking all three individual components.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Standard Adult Dosing: One tablet taken orally once daily.
- Administration (MORNING DOSING RULE): Because this formulation contains a diuretic (water pill) component, it MUST be taken in the morning. Taking it late in the afternoon or evening will cause severe nocturia (frequently waking up to urinate), leading to debilitating insomnia. Can be taken with or without food.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Fetal Toxicity): The Telmisartan component can cause catastrophic injury and death to the developing fetus. Strictly contraindicated in pregnancy.
- Severe Hypotension: Combining three powerful blood pressure agents can cause an excessive, symptomatic drop in blood pressure (hypotension), especially in volume-depleted patients. Dosage must be initiated carefully under medical supervision.
- Electrolyte Imbalances: While Telmisartan and HCTZ balance each other’s potassium effects, patients can still experience hypokalemia, hyponatremia, or hyperuricemia (which can trigger gout). Periodic monitoring of serum electrolytes is required.
- Renal Impairment Contraindication: Thiazide diuretics become ineffective and potentially toxic in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of 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 FDCs, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for national hypertension programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.








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