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boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Azor as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 , 8.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Azor as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
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warnings and cautions
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. 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 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Azor as soon as possible [ see Use in S pecific Populations ( 8.1 ) ] . 5.2 Hypotension in Volume- or Salt-Depleted Patients Olmesartan medoxomil. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil. Initiate treatment with Azor under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.3 Increased Angina or Myocardial Infarction 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. The mechanism of this effect has not been elucidated. 5.4 Impaired Renal Function Changes in renal function may be anticipated in susceptible individuals treated with olmesartan...
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adverse reactions
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. 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 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 Azor was similar to that seen with corresponding doses of the individual components of Azor, and to placebo. The reported adverse reactions were generally mild and seldom led to discontinuation of treatment (2.6% for Azor and 6.8% for placebo). Edema Edema is a known, dose-dependent adverse effect of amlodipine but not of olmesartan medoxomil. The placebo-subtracted incidence of edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy. The incidence was significantly reduced when 20 mg or 40 mg of olmesartan medoxomil was added to the 10 mg amlodipine dose. Placebo-Subtracted Incidence of Edema During the Double-Blind Treatment Period Olmesartan Medoxomil Placebo 20 mg 40 mg Amlodipine Placebo － * -2.4% 6.2% 5 mg 0.7% 5.7% 6.2% 10 mg 24.5% 13.3% 11.2% * 12.3% = actual placebo incidence Across all treatment groups, the frequency of edema was generally higher in women than men, as has been observed in previous studies of amlodipine. There was a greater decrease in hemoglobin and hematocrit in patients treated with Azor as compared to patients receiving either component. Adverse reactions seen at lower rates during the double-blind period also occurred in the patients treated with Azor at about the same or greater incidence as in patients receiving placebo. T...