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CARDIOVASCULAR SYSTEM › AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM › ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS › Angiotensin II receptor blockers (ARBs), other combinations
irbesartan, amlodipine and hydrochlorothiazide
C09DX07
Forms & Strengths
- Irbesartan/Amlodipine/HCTZ 150/5/12.5 mg oral tablets
- Irbesartan/Amlodipine/HCTZ 300/5/12.5 mg oral tablets
- Irbesartan/Amlodipine/HCTZ 300/5/25 mg oral tablets
- Irbesartan/Amlodipine/HCTZ 300/10/12.5 mg oral tablets
- Irbesartan/Amlodipine/HCTZ 300/10/25 mg oral tablets
Adult Dosing
- One tablet daily, taken with or without food
- Titrate individual components prior to switching to combination product
- Maximum recommended dose: Irbesartan 300 mg, amlodipine 10 mg, HCTZ 25 mg once daily
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
- Use in patients under 18 years of age is not recommended
Indications
- Treatment of hypertension to lower blood pressure
- Indicated in patients not adequately controlled on dual-therapy or as initial therapy in patients likely to need multiple drugs to reach blood pressure goals
Mechanism of Action
- Irbesartan: Selective angiotensin II receptor blocker (ARB) at the AT1 receptor subtype, preventing vasoconstriction and aldosterone secretion
- Amlodipine: Dihydropyridine calcium channel blocker (CCB) inhibiting the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle
- Hydrochlorothiazide (HCTZ): Thiazide diuretic inhibiting sodium and chloride reabsorption in the distal convoluted tubules, increasing excretion of sodium, water, potassium, and hydrogen ions
Contraindications
- Hypersensitivity to irbesartan, amlodipine, sulfonamide-derived drugs, or any component of the formulation
- Anuria or severe renal impairment (CrCl <30 mL/min)
- Concomitant use with aliskiren in patients with diabetes mellitus
- Second and third trimesters of pregnancy due to risk of fetal injury and death
Adverse Reactions
- Dizziness, lightheadedness, and orthostatic hypotension
- Peripheral edema, flushing, and palpitations (amlodipine-related)
- Fatigue, asthenia, and headache
- Electrolyte disturbances (hypokalemia, hyponatremia, hypercalcemia, hyperuricemia)
- Increased serum creatinine and blood urea nitrogen
Drug Interactions
- Lithium: Increased risk of lithium toxicity due to reduced renal clearance by HCTZ and ARBs
- Nonsteroidal anti-inflammatory drugs (NSAIDs): May decrease antihypertensive efficacy and increase risk of renal impairment
- Potassium-sparing diuretics, potassium supplements, or salt substitutes: Increased risk of hyperkalemia with irbesartan
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase systemic exposure and hypotensive effects of amlodipine
- Dual blockade of the renin-angiotensin system (e.g., ACE inhibitors, ARBs, or aliskiren): Increased risk of hypotension, hyperkalemia, and renal changes
Curated Content: Needs Vetting Before Put to Clinical Use