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T he FDA has approved Symplmed's Prestalia (perindo- pril arginine and amlodipine besylate) tablets for the treatment of hypertension to lower blood pressure in patients who are not adequately controlled with mono- therapy or as initial therapy in patients likely to need multiple medications to achieve their blood pressure (BP) goals. 1 An estimated 1 in 3 Americans have hypertension, about half of whom have it controlled. 2 Lowering BP reduces the risk of fatal and nonfatal car- diovascular events, pri- marily strokes and myo- cardial infarctions (MIs). Although this effect has been seen in controlled trials of antihypertensive medications, includ- ing amlodipine and angiotensin-converting enzyme (ACE) inhibitors, there are no controlled trials that demonstrate this benefit with Prestalia. 1,3 Pharmacology and Pharmacokinetics Perindopril is an ACE inhibitor. Amlodipine is a dihydropyridine calcium channel blocker. Prestalia should not be used in patients with renal impairment (creatinine clear- ance <60 mL/min), hepatic impair- ment, or heart failure. 1 Dosage and Administration Prestalia is available as a fixed-dose tablet of perindopril arginine and amlodipine in 3.5/2.5 mg, 7/5 mg, and 14/10 mg. Treatment should begin with 3.5/2.5 mg once daily. The dose should be adjusted at 1- to 2-week intervals, as needed, for BP control, with a maximum dose of 14/10 mg once daily. 1 Clinical Trials The maximum daily dose of Prestalia (14/10 mg) was studied in a double-blind, active-controlled study of 837 patients with hyper- tension. Study participants received Prestalia 14/10 mg, perindopril erbumine 16 mg, or amlodipine 10 mg once daily. At week 6, the patients using Prestalia demon- strated a statistically significant reduction in BP compared with the patients in the other groups. The minimum daily dose of Prestalia (3.5/2.5 mg) was evalu- ated in a study of 1581 patients with hyperten- sion. Patients received either Prestalia 3.5/2.5 mg, perindopril argi- nine 3.5 mg, perin- dopril arginine 5 mg, amlodipine 2.5 mg, amlodipine 5 mg, or placebo. At week 8, the Prestalia group had a statistically significant reduction in BP com- pared with the groups using perindopril argi- nine 3.5 mg or amlodipine 2.5 mg. 1 Contraindications, Warnings, and Precautions Prestalia carries a black box warning regarding the risk for fetal toxic- ity. Agents that act directly on the renin-angiotensin system can cause injury and death to a developing fetus. If pregnancy is confirmed in a patient using Prestalia, the medica- tion should be discontinued as soon as possible. Prestalia is contraindicated in patients with a history of angioede- ma or hypersensitivity to any ACE inhibitor or amlodipine. Aliskiren should not be used concomitantly with Prestalia in patients with dia- betes. Anaphylactoid reactions, such as angioedema of the head and neck or intestines, may occur. Worsening angina and an acute MI can develop after starting or increas- ing the dose of Prestalia, especially in patients with severe obstructive coronary artery disease. Patients using Prestalia should be monitored for hypotension and hyperkalemia. Renal function should be monitored throughout treatment. A persistent nonproductive cough has been reported with all ACE inhibitors. Concurrent use of potassium supplements and potassium-sparing diuretics may increase the risk of hyperkalemia. Concurrent use with lithium may lead to increased serum lithium levels and toxicity symp- toms. When used with injectable gold, flushing, nausea, or hypoten- sion may occur. Use of Prestalia with another inhibitor of the renin- angiotensin system may increase the risk of renal impairment, hypotension, and hyperkalemia. When used with simvastatin, the daily simvastatin dose should not exceed 20 mg. Concurrent use with nonsteroidal anti-inflammatory drugs may increase the risk of renal impairment and loss of antihyper- tensive effect. Use with diuretics may increase risk of hypotension. Use with CYP3A4 inhibitors may increase risk of hypotension and edema. Prestalia should not be used dur- ing breast-feeding. Its safety and effectiveness have not been studied in pediatric patients. Because there are currently no data to guide dos- ing in patients older than 65 years, Prestalia should not be used in these patients. The most common adverse reac- tions are edema, cough, headache, and dizziness. 1 n NEWS Prestalia Monica Holmberg, PharmD, BCPS Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona. NEW FDA ACTIONS RX FOCUS MORE @ PHARMACY TIMES.COM For references, go to PharmacyTimes.com/ publications/issue. 48 PharmacyTimes.com December 2015 An estimated 1 in 3 Americans have hyperten- sion, about half of whom have it con- trolled. 2