WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Prestalia as soon as possible
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
INDICATIONS AND USAGE
PRESTALIA® (perindopril arginine and amlodipine) is a combination of perindopril, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension to lower blood pressure:
- In patients not adequately controlled with monotherapy.
- As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
PRESTALIA is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous angiotensin converting enzyme (ACE) inhibitor treatment, and in patients who are hypersensitive to perindopril, to ACE inhibitors, or to amlodipine. Rare cases of angioedema, including intestinal angioedema, have been reported in patients treated with ACE inhibitors. Do not co-administer aliskiren with ACE inhibitors, including PRESTALIA, in patients with diabetes.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of PRESTALIA, particularly in patients with severe obstructive coronary artery disease. In patients at risk of excessive hypotension, start PRESTALIA therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of PRESTALIA is increased or a diuretic is added or its dose increased. Monitor renal function periodically in patients treated with PRESTALIA. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.
The most common adverse events associated with PRESTALIA include peripheral edema, cough, headache, and dizziness.