First FDA-approved, single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate
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 to or death of the developing fetus.
Prestalia® contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may also be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.
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.
Please read the full prescribing information.
Prestalia Available through bpCareConnect
Prestalia is available to physicians and patients through bpCareConnect, a hypertension management program offered by Symplmed. Powered by Symplmed’s DyrctAxess™ technology, bpCareConnect is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships directly to the patient. To enroll in bpCareConnect, visit www.bpcareconnect.com.
Symplmed’s development partner Servier, a leading French private pharmaceutical research company, currently markets this single-pill FDC combination treatment as Coveram® in 84 countries outside the United States.Learn more about our patient support programs.