Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 practice.
Amlodipine besylate and olmesartan medoxomil The data described below reflect exposure to amlodipine besylate and olmesartan medoxomil in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year.
Amlodipine besylate and olmesartan medoxomil was studied in one placebo-controlled factorial trial [s ee Clinical Trials ( 14.1 ) ] .
The population had a mean age of 54 years and included approximately 55% males.
Seventy-one percent were Caucasian and 25% were Black.
Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily.
The overall incidence of adverse reactions on therapy with amlodipine besylate and olmesartan medoxomil was similar to that seen with corresponding doses of the individual components of amlodipine besylate and olmesartan medoxomil, and to placebo.
5 WARNINGS AND PRECAUTIONS 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.
Like all medications, Amlodipine Besylate And Olmesartan Medoxomil can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: