Perindopril/​Amlodipine

DEA Class; Rx

Common Brand Names; Prestalia

• ACEI/CCB Combos

Combination dihydropyridine calcium-channel blocker (amlodipine) and ACE inhibitor (perindopril)
Used for hypertension
Black box warning for use during pregnancy

Indicated for the treatment of hypertension in patients likely to need multiple drugs to achieve their blood pressure goals or in patients not adequately controlled with monotherapy.

History of hereditary or acquired angioedema associated with previous ACE inhibitor treatment

Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan

Coadministration with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)

Peripheral edema (7.2%)

Cough (3.2%)

Headache (2.5%)

Dizziness (2.5%)

Dermatologic: Rash

Digestive: Nausea, diarrhea

Perindopril

• Cardiac arrest
• Eosinophilic pneumonitis
• Acute renal failure, nephritis
• Falls
• Hepatic failure, jaundice (hepatocellular or cholestatic), acute pancreatitis
• Symptomatic bullous pemphigoid, pemphigus
• Exfoliative dermatitis, psoriasis, and a syndrome that may include arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations
• Positive antinuclear antibody (ANA), symptomatic hyponatremia, thrombocytopenia, neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), leukocytosis, eosinophilia, or an elevated erythrocyte sedimentation rate (ESR)

Amlodipine

• Palpitations
• Gynecomastia
• Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), some requiring hospitalization

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Pregnancy)

Worsening angina and acute MI can develop after starting or increasing the dose, particularly in patients with severe obstructive CAD

Hyperkalemia reported; monitor serum potassium levels

Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema

Persistent cough reported with all ACE inhibitors, presumably because of the inhibition of the degradation of endogenous bradykinin; generally resolves after discontinuing

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death; patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up

Pregnancy Category: D

Discontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death

Lactation: Unknown if distributed in human breast milk; because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug