GOPTEN

What it is

GOPTEN is a trandolapril medicine registered on the Australian Register of Therapeutic Goods (ARTG) . It is supplied as capsules in blister packs .

Approved indications GOPTEN is indicated for the treatment of hypertension .

Dosing overview

GOPTEN is available in strengths of 0.5 mg, 1 mg, 2 mg, and 4 mg . The product should be swallowed whole with water ideally in the morning with or after food, and the usual dosage is one capsule 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 in such cases, the product should be discontinued promptly and the patient observed carefully until the swelling disappears . A persistent dry irritating cough has been reported with most ACE inhibitors, with an incidence varying between 2% to 15% depending upon the drug, dosage and duration of use . Because ACE inhibitors decrease the formation of Angiotensin II and subsequent production of aldosterone, serum potassium concentrations exceeding 5.5 mEq/L may occur, particularly in patients with some degree of renal impairment, those treated with potassium-sparing diuretics or potassium supplements .

Contraindications

GOPTEN is contraindicated in patients hypersensitive to trandolapril or any other ACE inhibitor or to any inactive ingredients; in children and adolescents under 18 years; in pregnancy; in lactation; in severe renal impairment with creatinine clearance less than 30 mL/min; in patients undergoing dialysis; in liver cirrhosis with ascites; in patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous ACE inhibitor treatment; and in concomitant use with neprilysin inhibitors such as sacubitril and racecadotril .

PBS listing

GOPTEN capsules 0.5 mg, 1 mg, 2 mg and 4 mg are PBS listed with restriction types that include both restricted and unrestricted items, with ex-manufacturer prices of A$5.76, A$6.95, A$4.45 and A$8.36 respectively .

Regulatory history

GOPTEN trandolapril 0.5 mg capsule was first registered on the ARTG on 27 January 1994 . GOPTEN trandolapril 1 mg capsule was first registered on 24 January 1994 . GOPTEN trandolapril 2 mg capsule was first registered on 27 January 1994 . GOPTEN trandolapril 4 mg capsule was first registered on 17 June 2004 .