trandolapril: clinical use

Prescribing considerations

• Assess volume and sodium depletion, concurrent diuretics, hypotension risk, renal or hepatic impairment and renovascular disease before initiation.
• Use additional caution in heart failure, ischaemic heart or cerebrovascular disease, haemodynamically significant valve disease and recent kidney transplantation.
• Review medicines that increase potassium, impair renal function, lower blood pressure or increase angioedema risk.
• Consider white-cell monitoring where renal impairment, collagen vascular disease or immunosuppressive treatment increases the risk of neutropenia.

Contraindications and cautions

• Hypersensitivity to trandolapril, another ACE inhibitor or an excipient.
• Previous ACE-inhibitor-associated angioedema, or hereditary or idiopathic angioedema.
• Second or third trimester of pregnancy.
• Concurrent sacubitril/valsartan.
• Aliskiren-containing treatment in patients with diabetes or specified renal impairment.

Monitoring

• Check baseline blood pressure, renal function, sodium and potassium.
• Repeat blood pressure, renal function and electrolytes after initiation, treatment changes and intercurrent illness that may compromise renal function.
• Investigate clinically significant creatinine or potassium changes and review contributing medicines, dehydration or renovascular disease.
• Monitor glucose more closely when used with insulin or oral glucose-lowering treatment.

Clinical pharmacology

Trandolapril is an orally absorbed prodrug hydrolysed to the active ACE inhibitor trandolaprilat. Food does not materially affect absorption or formation of the active metabolite. Trandolaprilat is highly protein-bound and its exposure increases in significant renal impairment; severe hepatic impairment also reduces metabolic clearance.

Formulation and product differences

• The selected product is a hard capsule containing lactose monohydrate.
• The capsule shell contains gelatin, titanium dioxide, erythrosine and iron oxide colourings.
• The capsule should be swallowed whole; the product information does not provide an authorised liquid formulation.

Capsule

Route: Oral

Strengths: 0.5 mg, 1 mg, 2 mg, 4 mg