Telmisartan & Chlorthalidone Tablets
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, antihypertensive, and nephroprotective therapeutics. We provide ultra-high-purity, kinetically stabilized Telmisartan (40 mg) & Chlorthalidone (6.25 mg) Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Next-Generation 24-Hour Antihypertensive FDC” is a highly lucrative, premium export to cardiology centers, specialized hypertension clinics, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, superior intervention for essential hypertension that remains uncontrolled by ARB monotherapy.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes Telmisartan, the longest-acting Angiotensin II Receptor Blocker (ARB), with Chlorthalidone, a highly potent, exceptionally long-acting thiazide-like diuretic.
The “True 24-Hour Diuretic Synergy” Specialist:
- Mechanism 1 (The RAAS Blockade – Telmisartan 40mg): Telmisartan aggressively binds to AT1 receptors on blood vessels, preventing Angiotensin II from causing vasoconstriction. This creates massive, sustained vasodilation. Crucially, when a diuretic removes fluid from the body, the kidneys panic and release renin to raise blood pressure back up. Telmisartan completely blocks this compensatory reaction, ensuring the blood pressure stays down.
- Mechanism 2 (The Distal Tubule Diuresis – Chlorthalidone 6.25mg): Chlorthalidone inhibits the sodium-chloride symporter in the distal convoluted tubule of the kidneys, forcing the body to excrete excess sodium and water. The Chlorthalidone Advantage: Unlike standard HCTZ (which wears off after 12 hours), Chlorthalidone has a massive 40-to-60-hour half-life, providing significantly better cardiovascular outcomes and superior reduction of left ventricular hypertrophy.
- The 6.25mg Metabolic Safety Profile: High doses of diuretics cause dangerous potassium loss (hypokalemia) and elevate blood sugar. The 6.25mg micro-dose delivers almost the exact same blood pressure reduction as higher doses, but with a drastically lower risk of metabolic side effects. Furthermore, Telmisartan naturally retains potassium, perfectly counteracting the mild potassium loss caused by the diuretic.
Product Composition & Strength
We supply this product as a Precision-Blended Bilayer or Matrix Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of both the hygroscopic ARB and the micro-dosed diuretic.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Telmisartan USP/Ph.Eur. | 40 mg | Standard ARB maintenance dose for continuous 24-hour peripheral vasodilation and RAAS blockade. |
| Chlorthalidone USP/Ph.Eur. | 6.25 mg | Highly precise, long-acting thiazide-like diuresis optimized for maximum safety and efficacy. |
| Excipients | Meglumine / Sodium Hydroxide / Microcrystalline Cellulose / Sodium Starch Glycolate | Alkalizer for Telmisartan / Diluent / Superdisintegrant (Engineered for kinetic segregation and immediate dissolution) |
*Pack Sizes: 10×10 or 10×15 Alu-Alu Blisters (Optimized specifically for strict 30-day chronic cardiology adherence 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/Antihypertensives) |
| CAS Numbers | 144701-48-4 (Telmisartan) / 77-36-1 (Chlorthalidone) |
| Dosage Form | 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 formulation 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.
- Micro-Dose Geometric Blending: Delivering a highly potent 6.25 mg active ingredient alongside a bulky 40 mg ARB requires elite pharmaceutical blending. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by HPLC assay testing, to guarantee that every single tablet delivers flawless kinetic release, preventing localized toxicity or sub-therapeutic diuresis.
- Alkaline Segregation: Telmisartan requires highly alkaline stabilizers to dissolve. Our matrix formulation ensures these alkalizers do not chemically degrade the sensitive Chlorthalidone molecule during its multi-year shelf life.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of severe cardiovascular disease:
- Essential Hypertension: Treatment of high blood pressure in patients whose blood pressure is not adequately controlled on Telmisartan monotherapy, or as a direct upgrade from patients failing on Telmisartan + HCTZ regimens.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Standard Adult Dosing: One tablet taken orally once daily.
- Administration (MORNING DOSING RULE): Because of the diuretic (water pill) component, this medication MUST be taken in the morning. If taken late in the day, the resulting diuresis will cause nocturia (waking up to urinate), leading to severe 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.
- Electrolyte Imbalances: Although the 6.25mg micro-dose minimizes risks, Chlorthalidone can still cause hypokalemia (low potassium), hyponatremia (low sodium), and hypomagnesemia. Serum electrolytes should be monitored periodically, especially in elderly patients or those with severe renal impairment.
- Hyperuricemia & Gout: Thiazide-like diuretics decrease the excretion of uric acid, which can precipitate acute gout attacks in susceptible patients.
- Renal Impairment Contraindication: Chlorthalidone becomes completely ineffective, and potentially toxic, in patients with severe renal impairment (creatinine clearance < 30 mL/min) or anuria. Loop diuretics (like Torsemide) are required for these patients instead.
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.