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AZOR Important patient safety information

USE IN PREGNANCY

When pregnancy is detected, discontinue AZOR as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. See WARNINGS AND PRECAUTIONS, Fetal/Neonatal
Morbidity and Mortality.

What is AZOR?

AZOR is a prescription drug used for the treatment of hypertension or high blood pressure. AZOR contains two different active ingredients in one tablet, namely amlodipine and olmesartan medoxomil.

AZOR may be used either alone or in combination with other drugs to treat high blood pressure.

AZOR is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Initial therapy with AZOR is not recommended in patients 75 years of age and older or in hepatically impaired patients.

AZOR should not be used during pregnancy.

What should I tell my healthcare provider?

Be sure to tell your healthcare provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

It is particularly important to tell your healthcare provider if you are currently taking diuretics (water pills) because starting AZOR therapy in some patients taking diuretics or who may have low salt or fluid levels may increase the possibility of hypotension (low blood pressure) that may require treatment.

Tell your healthcare provider if you have any heart problems, such as severe aortic stenosis (narrowing of the aortic valve), coronary artery disease, or congestive heart failure.

Tell your healthcare provider if you have kidney or liver problems. While no initial dosage adjustments for AZOR are usually necessary for patients with kidney or liver problems, nor in those who are elderly, your healthcare provider may want to monitor you more closely. Initial therapy with AZOR is not recommended in patients 75 years and older or in hepatically impaired patients.

If you are taking any other prescription or nonprescription medicines, including vitamins and herbal supplements, tell your healthcare provider. This information can help your healthcare provider avoid possible interactions with AZOR. If you decide to stop taking AZOR for any reason, you should notify your healthcare provider as soon as possible.

What are some possible side effects of AZOR?

The most common side effect with AZOR was edema.

In a clinical study, only edema occurred in greater than or equal to 3% of patients treated with AZOR and more frequently than placebo. The placebo-subtracted incidence was 5.7% with AZOR 5/20 mg, 6.2% with AZOR 5/40 mg, 13.3% with AZOR 10/20 mg, and 11.2% with AZOR 10/40 mg. The edema incidence for placebo was 12.3%. A placebo is an inactive, nondrug substance, such as a sugar pill, that is given in a drug study to compare the effect of a treatment including the drug being studied with the effect of the same treatment without the drug. Placebo-subtracted incidence means subtracting the percent of patients who took placebo and had edema from the total percent of patients who had edema for each other dose.

Other side effects occurred less often than edema but at about the same or greater frequency as in patients receiving placebo. These side effects included low blood pressure, low blood pressure after standing up too quickly, rash, itching, heart palpitation, urinating more often, and excessive urination throughout the night.

In separate clinical studies of the individual components of AZOR, other common side effects included headache, dizziness, and flushing. Call your healthcare provider if you experience any unpleasant effects while taking AZOR.

Please see full product information for AZOR.

The photos on this site depict models, not actual patients or healthcare professionals.

This information is intended for U.S. residents only.
AZOR is promoted by Daiichi Sankyo, Inc.
© 2009 Daiichi Sankyo, Inc.