AZOR

The pharmacokinetics of amlodipine and olmesartan medoxomil from Azor are equivalent to the pharmacokinetics of amlodipine and olmesartan medoxomil when administered separately. The bioavailability of both components is well below 100%, but neither component is affected by food. The effective half-lives of amlodipine (45±11 hours) and olmesartan (7±1 hours) result in a 2- to 3- fold accumulation for amlodipine and negligible accumulation for olmesartan with once-daily dosing. A mlodipine . After...

6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Azor The data described below reflect exposure to Azor in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Azor was studied in one placebo-controlled factorial trial [s ee Clinical Trials ( 14.1 ) ] . The population had a mean age of ...

Most common adverse reaction (incidence ≥3%) is edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in prac...

Do not co-administer aliskiren with Azor in patients with diabetes [see Drug Interactions ( 7.2 )] . Do not co-administer aliskiren with Azor in patients with diabetes ( 4 ).

Anticipate hypotension in volume- or salt-depleted patients with treatment initiation. Start treatment under close supervision ( 5.2 ). Increased angina or myocardial infarction may occur upon dosage initiation or increase ( 5.3 ). Impaired renal function: changes in renal function may occur ( 5.4 ). Sprue-like enteropathy has been reported. Consider discontinuation of Azor in cases where no other etiology is found ( 5.6 ). 5.1 Fetal Toxicity Azor can cause fetal harm when administered to a preg...

7 DRUG INTERACTIONS Amlodipine ( 7.1 ): If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. Increased exposure of amlodipine when coadministered with CYP3A inhibitors. Olmesartan medoxomil ( 7.2 ): Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antih...