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Uses

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.

Heart Failure or Left Ventricular Dysfunction after AMI

Reduction of the risk of mortality (mainly cardiovascular mortality) and risk of heart failure-associated hospitalization following MI in hemodynamically stable patients who have evidence of left ventricular systolic dysfunction or who have demonstrated clinical signs of CHF within a few days following AMI.

CHF

Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.

Dosage and Administration

General

Hypertension

• Trandolapril/verapamil fixed combination should not be used for initial treatment of hypertension.

Administration

Oral Administration

Administer orally once or twice daily.

Administer trandolapril/verapamil fixed combination with food; manufacturer makes no specific recommendation regarding administration of trandolapril with meals.

Dosage

Adults

Hypertension

Oral

Initially, 2 mg once daily in black patients and 1 mg once daily in patients of other races as monotherapy. Adjust dosage at intervals of ≥1 week.

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating trandolapril. May cautiously resume diuretic therapy if BP not controlled adequately with trandolapril alone. If diuretic cannot be discontinued, initiate therapy at 0.5 mg daily under close medical supervision for several hours until BP has stabilized.

Usual dosage: 2–4 mg once daily.

If 4 mg once daily does not adequately control BP, consider administering drug in 2 divided doses. If trandolapril monotherapy does not adequately control BP, consider adding a diuretic.

Limited clinical experience with dosages >8 mg daily.

Trandolapril/Verapamil Combination Therapy

Oral

Adjust dosage by first administering each drug separately. For patients receiving verapamil (up to 240 mg) and trandolapril (up to 8 mg) in separate tablets once daily, replacement with the fixed combination can be attempted using tablets containing the same component doses.

Heart Failure or Left Ventricular Dysfunction after AMI

Oral

Initially, 1 mg once daily; therapy may be initiated about 3–5 days after AMI.

Titrate dosage as tolerated to a target dosage of 4 mg once daily; if 4 mg daily is not tolerated, may continue therapy at the highest tolerated dosage.

Prescribing Limits

Adults

Hypertension

Oral

Limited clinical experience with dosages >8 mg daily.

Special Populations

Dosage in Hepatic Impairment

Hypertension

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with hepatic cirrhosis; titrate subsequent dosage according to BP response.

Heart Failure or Left Ventricular Dysfunction after AMI

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with hepatic cirrhosis; titrate subsequent dosage as tolerated according to response.

Dosage in Renal Impairment

Hypertension

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with severe renal impairment (Cl_cr <30 mL/minute); titrate subsequent dosage according to BP response.

Heart Failure or Left Ventricular Dysfunction after AMI

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with severe renal impairment (Cl_cr <30 mL/minute); titrate subsequent dosage as tolerated according to response.