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CARDIOVASCULAR SYSTEM › AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM › ACE INHIBITORS, COMBINATIONS › ACE inhibitors, other combinations
ramipril, amlodipine and hydrochlorothiazide
C09BX03
Forms & Strengths
- Capsule: ramipril 2.5 mg / amlodipine 5 mg / hydrochlorothiazide 12.5 mg
- Capsule: ramipril 5 mg / amlodipine 5 mg / hydrochlorothiazide 12.5 mg
- Capsule: ramipril 5 mg / amlodipine 5 mg / hydrochlorothiazide 25 mg
- Capsule: ramipril 5 mg / amlodipine 10 mg / hydrochlorothiazide 25 mg
- Capsule: ramipril 10 mg / amlodipine 10 mg / hydrochlorothiazide 25 mg
Adult Dosing
- Hypertension: 1 capsule once daily, selected based on individual component titration
- Max dose: 10 mg ramipril, 10 mg amlodipine, 25 mg hydrochlorothiazide daily
- Renal impairment (CrCl < 60 mL/min): Not recommended for initial therapy; use individual components
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
- Use is generally not recommended in children and adolescents
Indications
- Treatment of essential hypertension as substitution therapy in patients adequately controlled with the individual components given concurrently at the same dose level
Mechanism of Action
- Ramipril: ACE inhibitor preventing conversion of Ang I to Ang II, reducing vasoconstriction and aldosterone secretion
- Amlodipine: Dihydropyridine calcium channel blocker inhibiting transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle
- Hydrochlorothiazide: Thiazide diuretic inhibiting NaCl reabsorption in the distal convoluted tubules, increasing excretion of sodium, chloride, and water
Contraindications
- Hypersensitivity to ramipril, amlodipine, hydrochlorothiazide, other ACE inhibitors, dihydropyridines, or sulfonamide-derived drugs
- History of angioedema (hereditary, idiopathic, or due to previous ACE inhibitor therapy)
- Anuria or severe renal impairment (CrCl < 30 mL/min)
- Severe hepatic impairment or hepatic coma
- Refractory hypokalemia, hyponatremia, or hypercalcemia
- Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min)
- Significant aortic stenosis or cardiogenic shock (due to amlodipine component)
- Pregnancy (second and third trimesters)
Adverse Reactions
- Dizziness, headache, fatigue, somnolence
- Peripheral edema, flushing, palpitations
- Persistent dry cough (ACE inhibitor class effect)
- Hypotension, orthostatic hypotension
- Electrolyte disturbances (hypokalemia, hyponatremia, hyperuricemia, hyperglycemia)
- Renal function impairment, hyperkalemia
- Nausea, abdominal pain, diarrhea
Drug Interactions
- Dual blockade of the renin-angiotensin system (ARB, ACEi, or aliskiren) increases risk of hypotension, hyperkalemia, and renal impairment
- Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium increase risk of severe hyperkalemia
- NSAIDs may reduce antihypertensive efficacy and increase risk of worsening renal function
- Lithium: decreased renal clearance, leading to potential lithium toxicity
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase plasma concentrations of amlodipine
- Antidiabetic agents (insulin and oral agents): thiazides may antagonize hypoglycemic effects
- Other antihypertensive agents may produce additive hypotensive effects
Curated Content: Needs Vetting Before Put to Clinical Use