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Drugs reference index «Amlodipine/Olmesartan Medoxomil»

Amlodipine / Olmesartan Medoxomil

Pronunciation: (am-LOE-di-peen/OL-me-SAR-tan me-DOX-oh-mil)Class: Antihypertensive combination

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

Pharmacology

Amlodipine

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

Olmesartan

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

Indications and Usage

Treatment of hypertension.

Contraindications

Standard considerations.

Dosage and Administration

Add-On TherapyAdults

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.

Replacement TherapyAdults

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).

General Advice

  • 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.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Conivaptan, diltiazem, potassium-sparing diuretics, protease inhibitors (eg, ritonavir)

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.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Amlodipine

Palpitation (5%).

CNS

Amlodipine

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

Olmesartan

Dizziness (3%); asthenia (postmarketing).

Dermatologic

Amlodipine

Flushing (3%).

Olmesartan

Alopecia, pruritus, urticaria (postmarketing).

GI

Olmesartan

Vomiting (postmarketing).

Genitourinary

Olmesartan

Acute renal failure (postmarketing).

Hepatic

Amlodipine

Hepatic enzyme elevations, jaundice (postmarketing).

Musculoskeletal

Olmesartan

Rhabdomyolysis (postmarketing).

Miscellaneous

Amlodipine

Edema (11%).

Olmesartan

Angioedema (postmarketing).

Precautions

Warnings

Pregnancy

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

Pregnancy

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

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

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.

Renal Function

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.

Hepatic Function

Use with caution in patients with severe hepatic function impairment.

Angina or MI

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

CHF

Use with caution in patients with history of CHF.

Hypotension

Amlodipine

Acute hypotension may occur.

Olmesartan

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

Overdosage

Symptoms

Amlodipine

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

Olmesartan

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

Patient Information

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

Copyright © 2009 Wolters Kluwer Health.

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