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Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor
Therapeutic class: Antihypertensive
Pregnancy risk category D
FDA Box Warning
Drugs that act directly on the renin-angiotensin system can cause injury to or death of a developing fetus. Discontinue drug as soon as possible when pregnancy is detected.
Inhibits conversion of angiotensin I to the potent vasoconstrictor angiotensin II, promoting vasodilation. Also increases plasma renin and stimulates aldosterone secretion, inducing diuresis.
Tablets: 1 mg, 2 mg, 4 mg
⊘Indications and dosages
Adults: For patients not receiving diuretics, 1 mg/day P.O. in nonblack patients or 2 mg/day P.O. in black patients. If response inadequate, may increase at weekly intervals up to 4 mg/day. For patients receiving diuretics, start with 0.5 mg/day P.O.
➣ Heart failure or left ventricular dysfunction after myocardial infarction
Adults: Initially, 1 mg P.O. daily. Titrate up to 4 mg daily, if tolerated.
• Renal impairment (creatinine clearance less than 30 ml/minute)
• Hepatic cirrhosis
• Hypersensitivity to drug or other ACE inhibitors
• Hereditary/idiopathic angioedema and angioedema with previous ACE inhibitor use
• Patients with diabetes mellitus taking insulin or oral hypoglycemics
Use cautiously in:
• renal or hepatic impairment, hypovolemia, hyponatremia, aortic stenosis or hypertrophic cardiomyopathy, cerebrovascular or cardiac insufficiency, surgery and anesthesia, risk factors for hyperkalemia (including renal insufficiency, diabetes mellitus, concurrent use of potassium supplements or potassium-containing salt substitutes)
• family history of angioedema
• concurrent diuretic therapy or drugs that cause increased serum potassium level
• black patients with hypertension
• elderly patients
• pregnant patients
• breastfeeding patients (avoid use)
• children (safety not established).
• Give once or twice daily as prescribed, with or without food.
CNS: insomnia, paresthesia, dizziness, drowsiness, asthenia, syncope, cerebrovascular accident
CV: chest pain, palpitations, intermittent claudication, bradycardia, first-degree atrioventricular block, cardiogenic shock
EENT: epistaxis, sinusitis, throat inflammation
GI: vomiting, diarrhea, constipation, abdominal pain or distention, gastritis, dyspepsia, intestinal angioedema, pancreatitis
GU: urinary tract infection, erectile dysfunction, decreased libido
Hematologic: agranulocytosis, neutropenia
Hepatic: syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death (rare)
Metabolic: hypocalcemia, gout, increased creatinine, hyperkalemia
Musculoskeletal: muscle cramps, myalgia, extremity pain
Respiratory: cough, dyspnea, upper respiratory infection
Skin: rash, flushing, pruritus
Other: edema, angioedema (face, extremities, lips, tongue, glottis, and larynx)
Drug-drug. Diuretics, general anesthetics, other antihypertensives: increased risk of hypotension
Hypoglycemics (insulin, oral agents): increased risk of blood glucose-lowering effect with greater risk of hypoglycemia
Lithium: increased lithium blood level, greater risk of toxicity
Nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors: increased risk of renal impairment, including acute renal failure in elderly patients, volume-depleted patients, or those with compromised renal function; loss of trandodolapril antihypertensive effect
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium: additive hyperkalemia
Sodium aurothiomalate (gold): increased risk of nitritoid reactions (including facial flushing, nausea, vomiting, and hypotension)
Drug-diagnostic tests. Creatinine, potassium: increased level
Neutrophils, platelets: decreased counts
Drug-food. Salt substitutes containing potassium: hyperkalemia
• Monitor vital signs, especially for hypotension and bradycardia when therapy begins.
• Assess CBC with white cell differential. Watch for signs and symptoms of bleeding and infection.
• Monitor electrolyte levels, especially potassium. Stay alert for hyperkalemia.
• Assess renal function tests and fluid intake and output.
Stay alert for signs and symptoms of hypersensitivity reactions (including angioedema). Discontinue drug immediately if laryngeal stridor or angioedema of face, tongue, or glottis occurs, treat appropriately, and closely observe patient until swelling disappears.
Be aware that rarely ACE inhibitors have been associated with a syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death. If patient develops jaundice, discontinue drug and provide appropriate followup care.
• Tell patient drug may cause bleeding tendency or increase his infection risk. Teach him which warning signs to report.
Teach patient to recognize and report signs or symptoms of hyperkalemia, infection, angioedema (including intestinal angioedema that may present as abdominal pain with or without nausea), and syndrome of cholestatic jaundice.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure drop.
• Caution patient not to exercise vigorously in hot environments.
• Advise patient not to use salt substitutes containing potassium. Tell him to avoid high-potassium foods.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.