Amlodipine/Olmesartan

DEA Class; Rx

Common Brand Names; Azor

• ARBs

Amlodipine, a calcium channel blocker, and olmesartan, an angiotensin II receptor antagonist, are combined in 1 tablet to treat hypertension.

Indicated for the treatment of hypertension, either alone or in combination with other antihypertensive agents.

Hypersensitivity to olmesartan, amlodipine or excipients

Coadministration with aliskiren in patients with diabetes mellitus

• Peripheral edema (11%)
• Palpitation
• Nocturia
• Urinary frequency
• Orthostatic hypotension
• Pruritus
• Rash
• Acute renal failure
• Anaphylactic reactions
• Angioedema
• Diarrhea
• Hepatic enzyme elevations
• Jaundice
• Rhabdomyolysis
• Extrapyramidal disorder
• Increased blood creatinine levels

Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren is associated with increased risk for hyperkalemia and renal function changes (including acute renal failure) compared to monotherapy; monitor electrolytes periodically

Changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system; in patients whose renal function may depend upon activity of renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death; similar effects may occur in patients treated with the drug combination because of the olmesartan medoxomil component

Increased angina or myocardial infarction reported, particularly those with severe obstructive coronary artery disease, may develop increased frequency duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at time of dosage increase; the mechanism of this effect has not been elucidated

Intestinal problems (eg, sprue-like enteropathy) reported with olmesartan months to years after initiation; symptoms may include severe, chronic diarrhea with substantial weight loss; intestinal biopsies have demonstrated villous atrophy; if patient develops these symptoms during treatment exclude other etiologies; discontinue therapy if no other etiology identified

Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy

Pregnancy

Therapy can cause fetal harm in pregnant women; use of drugs that act on renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

Lactation

There is limited information regarding the presence of drug in human milk, effects on breastfed infant, or on milk production