trandolapril


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trandolapril

 [tran-do´lah-pril″]
an angiotensin-converting enzyme inhibitor used in treatment of hypertension and post–myocardial infarction congestive heart failure or left ventricular dysfunction; administered orally.

trandolapril

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.

Action

Inhibits conversion of angiotensin I to the potent vasoconstrictor angiotensin II, promoting vasodilation. Also increases plasma renin and stimulates aldosterone secretion, inducing diuresis.

Availability

Tablets: 1 mg, 2 mg, 4 mg

Indications and dosages

Hypertension

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.

Dosage adjustment

• Renal impairment (creatinine clearance less than 30 ml/minute)
• Hepatic cirrhosis

Contraindications

• 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

Precautions

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).

Administration

• Give once or twice daily as prescribed, with or without food.

Adverse reactions

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)

Interactions

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

Patient monitoring

• 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.

Patient teaching

• 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.

trandolapril

/tran·do·la·pril/ (tran-do´lah-pril″) an angiotensin-converting enzyme inhibitor used in the treatment of hypertension and post–myocardial infarction congestive heart failure or left ventricular dysfunction.

trandolapril

an antihypertensive. Its prototype is enalapril.
indications It is used to treat hypertension, heart failure, and postmyocardial infarction/left ventricular dysfunction.
contraindications Factors that prohibit its use include known hypersensitivity, a history of angioedema, and second- or third-trimester pregnancy.
adverse effects Life-threatening effects include myocardial infarction, stroke, agranulocytosis, neutropenia, leukopenia, anemia, proteinuria, and renal failure. Other adverse effects include palpitations, angina, transient ischemic attacks, bradycardia, arrhythmias, paresthesias, headache, fatigue, drowsiness, depression, sleep disturbances, nausea, vomiting, cramps, diarrhea, constipation, ileus, pancreatitis, hepatitis, rash, purpura, dyspnea, hyperkalemia, hyponatremia, and impotence. Common side effects include hypotension, dizziness, dyspepsia, cough, and myalgia.

trandolapril

Mavik® An ACE inhibitor indicated as maintenance of Pts with post-MI left ventricular dysfunction, post-MI heart failure. See TRACE.

trandolapril

An ANGIOTENSIN-CONVERTING ENZYME inhibitor drug used to treat high blood pressure (HYPERTENSION) and weak function of the left ventricle following a heart attack. Brand names are Gopten and Odrik.
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Widely used ACE inhibitors include captopril (Capoten[R]), enalapril (Vasotec[R]), lisinopril (Prinivil[R], Zestril[R]), benazepril (Lotensin[R]), quinapril (Acupril[R]), trandolapril (Mavik[R]), ramipril (Altace[R]), moexipril (Univasc[R]), and fosinopril (Monopril[R]).
In 3717 patients who were randomized to trandolapril or placebo as part of the Prevention of Events with Angiotensin Converting Enzyme (PEACE) trial, increased concentrations of MR-proANP were independently associated with the risk of cardiovascular death or heart failure (HR per 1 SD, 1.
Earlier this year, Glenmark launched the market's first generic version of trandolapril and verapamil HCl extended release tablets.