Amlodipine / Olmesartan Medoxomil

Trade Names:
Azor
- Tablets 5/20 mg
- Tablets 10/20 mg
- Tablets 5/40 mg
- Tablets 10/40 mg

Causes peripheral artery vasodilation by inhibiting the transmembrane influx of calcium ions into vascular smooth muscle.

Blocks vasoconstrictor effects of angiotensin II by selectively blocking its binding to the AT 1 receptor in vascular smooth muscle.

Treatment of hypertension.

Standard considerations.

PO Add-on therapy for patients not adequately controlled on amlodipine or olmesartan medoxomil. Maximum daily dose is amlodipine 10 mg/olmesartan medoxomil 40 mg.

PO May be substituted for individually titrated components. When substituting for individual components, the dose of one or both components can be increased if BP control is not satisfactory (max, amlodipine 10 mg/olmesartan medoxomil 40 mg).

• Max antihypertensive effects are attained within 2 wk after a dose change. Dose may be increased after 2 wk.
• May be taken with or without food.
• May be administered with other antihypertensive agents.

Store at 59° to 86°F.

Amlodipine plasma concentrations may be elevated, increasing the pharmacologic effects and adverse reactions. Coadministration of olmesartan and potassium-sparing diuretics may cause elevated serum potassium concentrations.

None well documented.

Palpitation (5%).

Dizziness (3%); somnolence (2%).

Dizziness (3%); asthenia (postmarketing).

Flushing (3%).

Alopecia, pruritus, urticaria (postmarketing).

Vomiting (postmarketing).

Acute renal failure (postmarketing).

Hepatic enzyme elevations, jaundice (postmarketing).

Rhabdomyolysis (postmarketing).

Edema (11%).

Angioedema (postmarketing).

Olmesartan can cause injury and death to the developing fetus when used during the second and third trimester of pregnancy.

Category C (first trimester) and Category D (second and third trimesters).

Undetermined.

Safety and efficacy not established.

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

In patients whose renal function may depend on activity of the renin-angiotensin-aldosterone system (eg, patients with severe CHF), olmesartan treatment may be associated with oliguria and progressive azotemia, which may rarely result in acute renal failure and death.

Use with caution in patients with severe hepatic function impairment.

Increased frequency, duration, or severity of angina or acute MI may occur.

Use with caution in patients with history of CHF.

Acute hypotension may occur.

Symptomatic hypotension may occur after initiation of treatment, especially in patients with an activated renin-angiotensin system (eg, volume- and/or salt-depleted patients)

Excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia is expected to occur.

Hypotension, tachycardia, and bradycardia (from parasympathetic stimulation) are expected to occur.

• Inform female patients of childbearing age to report pregnancy to health care provider as soon as possible.

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