Amlodipine + Losartan

Amlodipine, a dihydropyridine calcium channel blocker, inhibits the influx of calcium ions into vascular smooth muscle and myocardial cells, causing peripheral arterial vasodilation and reduced peripheral vascular resistance. Losartan, an angiotensin II receptor blocker (ARB), selectively blocks the binding of angiotensin II to the AT1 receptor, preventing vasoconstriction and aldosterone secretion. The combination provides complementary blood pressure lowering effects by targeting different pathways, leading to more effective and sustained blood pressure control. Combination rationale: The combination of amlodipine and losartan offers a rational approach to hypertension management. Amlodipine, a calcium channel blocker, provides vasodilation, while losartan, an ARB, blocks the renin-angiotensin system, a key mechanism in blood pressure regulation. This dual mechanism often leads to superior blood pressure control compared to monotherapy, reduces the dose-dependent side effects of individual drugs, and improves patient compliance due to simplified dosing.

Adult

Typically initiated with Amlodipine 5 mg + Losartan 50 mg orally once daily. Dosing can be adjusted based on clinical response and tolerability, up to a maximum of Amlodipine 10 mg + Losartan 100 mg orally once daily. Common strengths available in India include Amlodipine 5 mg + Losartan 25 mg, Amlodipine 5 mg + Losartan 50 mg, and Amlodipine 10 mg + Losartan 50 mg.

Pediatric

Safety and efficacy in pediatric patients have not been established; therefore, not recommended for use in this population.

Renal adjustment

No initial dosage adjustment is generally required for amlodipine in renal impairment. For losartan, no initial adjustment is needed for mild to moderate renal impairment, but caution is advised. In severe renal impairment (creatinine clearance < 30 mL/min) or patients on dialysis, a lower starting dose of losartan (e.g., 25 mg once daily) should be considered.…

Hepatic adjustment

Use with caution in patients with mild to moderate hepatic impairment. Amlodipine dosage reduction may be required. Losartan dosage should be reduced in patients with hepatic impairment (e.g., start with 25 mg once daily). This FDC may be contraindicated in severe hepatic impairment.

Geriatric

Initiate with lower doses (e.g., Amlodipine 2.5 mg + Losartan 25 mg or Amlodipine 5 mg + Losartan 25 mg once daily) and titrate carefully, considering potential age-related decrease in renal or hepatic function and increased sensitivity to adverse effects.

Max dose

Maximum recommended daily dose is Amlodipine 10 mg + Losartan 100 mg.

• Hypersensitivity to amlodipine, losartan, or any excipients. Pregnancy (second and third trimesters) and lactation. Severe hepatic impairment. Bilateral renal artery stenosis or severe unilateral renal artery stenosis in a single functioning kidney. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m2).