TRANALPHA

What it is

TRANALPHA is a registered Australian medicine containing trandolapril, available in capsule strengths of 0.5 mg, 1 mg, 2 mg, and 4 mg.

Approved indications

— Treatment of hypertension.

Dosing overview

The usual dosage for adults is one tablet daily. The maximum dose is 4 mg once daily.

Key safety warnings

Severe life-threatening angioedema has been reported with most ACE inhibitors, with an overall incidence of approximately 0.1% to 0.2%. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with ACE inhibitors, and the product should be discontinued promptly if such symptoms occur. A persistent dry, non-productive irritating cough has been reported with most ACE inhibitors, with incidence varying between 2% to 15% depending on the drug, dosage and duration of use. The cough is most likely due to stimulation of the pulmonary cough reflex by kinins and/or prostaglandins that accumulate because of ACE inhibition. Serum potassium concentrations exceeding 5.5 mEq/L may occur because ACE inhibitors decrease the formation of Angiotensin II and subsequent production of aldosterone, with hyperkalaemia more likely in patients with renal impairment or those treated with potassium-sparing diuretics or potassium supplements.

Contraindications

TRANALPHA is contraindicated in patients who are hypersensitive to trandolapril or any other ACE inhibitor or to any of the inactive ingredients, in children and adolescents under 18 years of age, and in patients concomitantly treated with intravenous beta-adrenoreceptor antagonists. Because of the trandolapril component, TRANALPHA is contraindicated in pregnancy, lactation, severe renal impairment with creatinine clearance less than 30 mL/min, dialysis, concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment, liver cirrhosis with ascites, patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous treatment with an ACE inhibitor, and concomitant use with neprilysin inhibitors such as sacubitril and racecadotril.

Regulatory history

TRANALPHA trandolapril capsules in strengths of 0.5 mg, 1 mg, 2 mg, and 4 mg were first listed on the ARTG on 28 August 2012, sponsored by Alphapharm.