A fixed-dose combination (FDC) antihypertensive medication containing an angiotensin II receptor blocker (ARB), Telmisartan, and a dihydropyridine calcium channel blocker (CCB), Amlodipine. This combination provides synergistic blood pressure control by blocking the renin-angiotensin-aldosterone system (RAAS) and inhibiting calcium influx into vascular smooth muscle, leading to potent vasodilation. It is a first-line therapy for essential hypertension, especially in patients requiring more than one drug to achieve target BP, and is widely used in the Indian population due to its efficacy, tolerability, and once-daily dosing.
Adult: One tablet (Telmisartan 40mg + Amlodipine 5mg) orally once daily. Dose may be titrated to Telmisartan 80mg + Amlodipine 5mg or 10mg after 2-4 weeks based on response. Maximum: Telmisartan 80mg + Amlodipine 10mg daily.
Note: Can be taken with or without food, at the same time each day, preferably in the morning. Tablet should be swallowed whole with a glass of water. Do not crush or chew. Dose is not influenced by food.
The combination exerts a dual mechanism: 1) Telmisartan selectively and competitively blocks the binding of angiotensin II to the AT1 receptor subtype, inhibiting its vasoconstrictor and aldosterone-secreting effects. 2) Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing peripheral arterial vasodilation and reduced peripheral vascular resistance. The combined effect leads to a more pronounced and sustained reduction in blood pressure with potential mitigation of CCB-induced peripheral edema.
Pregnancy: CONTRANDICATED in second and third trimesters (Pregnancy Category D). Drug exposure during these trimesters can cause injury and death to the developing fetus (oligohydramnios, renal failure, skull hypoplasia, hypotension). Discontinue as soon as pregnancy is detected. First trimester use should be avoided unless no alternative exists.
Driving: May cause dizziness, somnolence, fatigue, or vertigo, especially at initiation of therapy or dose increase. Patients should not drive or operate machinery until they know how the medication affects them.
| Other Antihypertensives (Diuretics, Beta-blockers, ACEi) | Additive hypotensive effect; risk of severe hypotension. | Major |
| Potassium supplements / Potassium-sparing diuretics (Spironolactone, Amiloride) | Increased risk of hyperkalemia. | Major |
| NSAIDs (e.g., Ibuprofen, Diclofenac) | May reduce antihypertensive effect and increase risk of renal impairment and hyperkalemia. | Major |
| Lithium | Increased serum lithium levels and toxicity (with Telmisartan). | Major |
| Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin) | Increased plasma concentration of Amlodipine, risk of hypotension and edema. | Moderate |
| Simvastatin | Increased exposure to Simvastatin; limit simvastatin dose to 20mg daily. | Moderate |
| Digoxin | Possible increase in digoxin concentration (monitor levels). | Moderate |
| Sildenafil, Tadalafil | Additive hypotensive effect. | Moderate |
Same composition (Telmisartan (40mg) + Amlodipine (5mg)), different brands: