BENICAR

AbsorptionOlmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. Benicar tablets and the suspension formulation prepared from Benicar tablets are bioequivalent [see Dosage and Administration (2.2) ] . The absolute bioavailability of olmesartan is approximately 26%. After oral administration, the peak plasma concentration (C max ) of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavai...

14.1 Adult Hypertension The antihypertensive effects of Benicar have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. A total of 2693 patients (2145 Benicar; 548 placebo) with essential hypertension were studied. Benicar once daily lowered diastolic and systolic blood pressure. The response was dose related, as shown in the following graph. A Benicar dose of 20 mg daily produces a trough sitting blood pressure (BP) reduction over placebo of about 10...

The most common adverse reaction in adults was dizziness (3%) ( 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...

Do not co-administer aliskiren with Benicar in patients with diabetes [see Drug Interactions (7.3) ]. Do not co-administer aliskiren with Benicar in patients with diabetes ( 4 ).

Avoid fetal ( in utero ) exposure ( 5.1 ). Use of Benicar in children <1 year of age is not recommended ( 5.2 ). Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation ( 5.3 ). Monitor for worsening renal function in patients with renal impairment ( 5.4 ). Sprue-like enteropathy has been reported. Consider alternative antihypertensive therapy in cases where no other etiology is found ( 5.5 ). 5.1 Fetal Toxicity Benicar can cause fetal harm wh...

7 DRUG INTERACTIONS Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ). NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ). Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ). Lithium: Increases in serum lithium concentrations and lithium toxicit...