Tenormin (atenolol)

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Indications

Hypertension (High Blood Pressure)

Zestril is a prescription medicine that belongs to a group of medicines called “ACE inhibitors.” Zestril is used, alone or in combination with other medicines, to treat high blood pressure (hypertension) in patients 6 years of age and older.

Heart failure

Zestril is used to reduce signs and symptoms of systolic heart failure, a type of heart failure due to the heart failing to pump with enough force.

Reduction of Mortality in Acute Myocardial Infarcation (Heart Attack)

Zestril is used to reduce the risk of death in patients that have had a heart attack (acute myocardial infarction) within 24 hours and otherwise have no sign of difficulty with blood circulation. Patients should receive, as appropriate, other standard recommended treatments.

Important Safety Information

Do not take Zestril if you have a history of a medical condition known as angioedema, the rapid swelling of the area beneath the skin. Do not take Zestril if you have had an allergic reaction to previous treatment with other ACE inhibitors. If you have diabetes, do not take Zestril with a drug called aliskiren.

Angioedema of the head, neck and intestine, including some fatal reactions with angioedema of the head and neck, have occurred in patients taking Zestril. Patients with involvement of the tongue, and other close organs may experience a blocking of the airway, especially those with a history of airway surgery. Patients with a history of angioedema unrelated to ACE inhibitors may be at increased risk. ACE inhibitors have been associated with a higher rate of angioedema in black patients.

Severe, life-threatening allergic reactions have occurred in patients taking ACE inhibitors.

Changes in kidney function, including kidney failure, can be caused by ACE inhibitors such as Zestril. Certain patients may be at greater risk of kidney failure depending on their kidney function. Patients taking Zestril that experience a decrease in kidney function may need to discontinue treatment.

Zestril can cause low blood pressure, sometimes complicated by issues with kidney function, acute kidney failure or death.

Zestril should not be used in patients who have difficulty with blood circulation after a heart attack.

Tell your doctor if you are scheduled to have major surgery or undergo anesthesia.

ACE inhibitors have been associated with liver problems. Patients taking Zestril should discontinue treatment if they develop signs of liver problems.

The most common side effects with Zestril in clinical trials for patients with high blood pressure were headache, dizziness and cough. In patients with heart failure, the most common side effects were low blood pressure and chest pain. In patients that had a heart attack, the most common side effects were low blood pressure and kidney dysfunction.

To avoid a serious or potentially life-threatening condition, tell your doctor about all the drugs you are taking as Zestril may cause problematic drug interactions.

These are not all of the side effects associated with Zestril. Please see full prescribing information for additional safety information on Zestril.com

You are encouraged to report negative side effects of prescription drugs to TWi Pharmaceuticals, Inc. at 1-844-518-298 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.