Indicated for:

• Treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

There are no controlled trials demonstrating risk reduction with Azor.

Initial therapy with Azor is not recommended in patients ≥75 years old or hepatically impaired patients.

Do not co-administer aliskiren with Azor in patients with diabetes.

Avoid use of aliskiren with Azor in patients with renal impairment (GFR <60 ml/min).

Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy.

Azor contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.

Patients, 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 the time of dosage increase.

In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., 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.

Amlodipine. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.

If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin.

Co-administration of amlodipine with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure.

The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose.

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including AZOR.

Azor can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue Azor as soon as possible. Consider alternative antihypertensive therapy during pregnancy.

There is limited information regarding the presence of Azor in human milk, the effects on the breastfed infant, or the effects on milk production. Amlodipine is present in human milk. Olmesartan is present in rat milk.Because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with Azor.

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• Dosage greater than 10/40 mg once daily. GoToSource 

• Use in patients under the age of 18. GoToSource

• Use as initial therapy in patients 75 years and older or in hepatically impaired patients. GoToSource

• Migraine prophylaxis. GoToSource 

• Raynaud’s phenomenon. GoToSource

• Congestive heart failure. GoToSource

High-dose olmesartan associated with increased risk of death in diabetic patients treated for 6 months or longer. GoToSource

Increased risk of heart failure. GoToSource

Sprue-like enteropathy (severe, chronic diarrhea with substantial weight loss). GoToSource

Maculopapular rash (small, flat, red spots on skin). GoToSource

Peripheral edema (soft-tissue swelling) and hypotension (low blood pressure). GoToSource

Upper respiratory tract infections and urinary tract infections. GoToSource

Lawsuits filed for sprue-like enteropathy and kidney damage.