Prestalia 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 (1).
• As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).
DOSAGE AND ADMINISTRATION

• Anaphylactoid reactions, including angioedema (head, neck, or intestinal) (5.2).
• Myocardial infarction: 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 (5.3).
• Assess for hypotension and hyperkalemia (5.4, 5.5).
• Monitor renal function during therapy (5.7).

The most common adverse reactions were edema (7.2%), cough (3.2%), headache (2.5%), and dizziness (2.5%) (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact SYMPLMED LLC at 1-888-552-9769 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Potassium supplements and potassium-sparing diuretics: risk of hyperkalemia (7).
• Lithium: increased serum lithium levels; toxicity symptoms (7).
• Injectable gold: flushing, nausea, vomiting, or hypotension (7).
• Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, and hyperkalemia (7).
• Do not exceed doses greater than 20 mg daily of simvastatin (7).
• NSAIDs: risk of renal impairment and loss of antihypertensive effect (7).
• Diuretics: increased risk of hypotension, consider dose reduction (7).
• CYP3A inhibitors: risk of hypotension and edema (7).

• Nursing Mothers: Discontinue nursing or PRESTALIA (