A triple-drug, fixed-dose combination (FDC) antihypertensive therapy containing an angiotensin II receptor blocker (ARB), a dihydropyridine calcium channel blocker (CCB), and a thiazide diuretic. It is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on any two of the following drug classes: ARBs, CCBs, and thiazide diuretics. This combination provides synergistic action, improved compliance, and is a cost-effective strategy for hypertension management in the Indian population.
Adult: One tablet (Telmisartan 80mg/Amlodipine 5mg/Hydrochlorothiazide 12.5mg) orally once daily. Dose may be titrated after 4-6 weeks based on response. Not for initial therapy.
Note: Can be taken with or without food, preferably at the same time each day. Swallow whole with a glass of water. Do not crush or chew. Morning administration is preferred to avoid nocturia from HCTZ.
This combination exerts a multi-faceted antihypertensive effect: 1) Telmisartan selectively and competitively blocks the binding of angiotensin II to the AT1 receptor, inhibiting vasoconstriction and aldosterone secretion. 2) Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing peripheral arterial vasodilation. 3) Hydrochlorothiazide inhibits sodium reabsorption in the distal convoluted tubule, increasing excretion of sodium, chloride, and water, reducing plasma volume.
Pregnancy: CONTRANDICATED in second and third trimesters (FDA Category D). Drugs that act directly on the RAAS can cause injury and death to the developing fetus, including oligohydramnios, renal failure, skull hypoplasia, and death. Discontinue as soon as pregnancy is detected.
Driving: Caution required, especially during initiation and dose adjustment. Dizziness, fatigue, or vertigo may occur, affecting ability to drive or operate machinery.
| Other Antihypertensives (e.g., Beta-blockers, ACEi) | Additive hypotensive effect. Risk of first-dose hypotension. | Major |
| Potassium supplements / Potassium-sparing diuretics (Spironolactone, Amiloride) / Salt substitutes | Increased risk of hyperkalemia due to Telmisartan. | Major |
| NSAIDs (e.g., Ibuprofen, Diclofenac) | Reduced antihypertensive effect; risk of acute renal failure and hyperkalemia. | Major |
| Lithium | HCTZ reduces renal clearance of Lithium, leading to toxicity. | Major |
| Digoxin | Hypokalemia from HCTZ can potentiate Digoxin toxicity. | Moderate |
| Corticosteroids, ACTH | Intensified electrolyte depletion, particularly hypokalemia. | Moderate |
| Cholestyramine, Colestipol | Reduced absorption of HCTZ. Separate administration by 4 hours. | Moderate |
| Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir) | Increased Amlodipine plasma levels, risk of hypotension and edema. | Moderate |
| Allopurinol | Increased risk of hypersensitivity reactions when combined with HCTZ. | Moderate |
| Antidiabetic drugs (Insulin, Sulfonylureas) | HCTZ may decrease glucose tolerance, requiring dose adjustment. | Moderate |
Same composition (Telmisartan (80mg) + Amlodipine (5mg) + Hydrochlorothiazide (12.5mg)), different brands: