OLMESARTAN MEDOXOMIL

AbsorptionOlmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil tablets and the suspension formulation prepared from olmesartan medoxomil tablets are bioequivalent [see Dosage and Administration ( 2.2 )] . The absolute bioavailability of olmesartan is approximately 26%. After oral administration, the peak plasma concentration (Cmax) of olmesartan is reached after 1 to 2 hours. Food do...

14.1 Adult Hypertension The antihypertensive effects of olmesartan medoxomil tablets 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 olmesartan medoxomil tablets; 548 placebo) with essential hypertension were studied. Olmesartan medoxomil tablets once daily lowered diastolic and systolic blood pressure. The response was dose related, as shown in the following graph. A olmesartan medoxomil tablets dose of 20 mg da...

The most common adverse reaction in adults was dizziness (3%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 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 ...

Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions ( 7.3 ) ]. Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes.

· Avoid fetal (in utero) exposure ( 5.1 ). · Use of olmesartan medoxomil tablets in children less than 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 To...

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...