TARKA

What it is

TARKA is a film coated tablet containing trandolapril and verapamil hydrochloride as active ingredients. Two strengths are available: TARKA 2/180, containing trandolapril 2 mg and verapamil 180 mg modified release, and TARKA 4/240, containing trandolapril 4 mg and verapamil 240 mg modified release.

Approved indications

— Treatment of hypertension.

Dosing overview

The usual dosage for adults is one tablet daily, with a maximum dose of TARKA 4/240 mg once daily. The product should be swallowed whole with water ideally in the morning with or after food.

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. Angioedema associated with laryngeal oedema is potentially life-threatening and requires immediate subcutaneous administration of adrenaline (epinephrine) solution (1:1000) along with other therapeutic measures. 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 or those treated with potassium-sparing diuretics or potassium supplements. Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction properties; however, in clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary oedema.

Contraindications

TARKA is contraindicated in patients hypersensitive to trandolapril or any ACE inhibitor or to verapamil hydrochloride or any inactive ingredients; in children and adolescents under 18 years; in patients concomitantly treated with intravenous beta-adrenoreceptor antagonists; during pregnancy and lactation; in severe renal impairment (creatinine clearance less than 30 mL/min); during dialysis; with concomitant use of aliskiren in patients with diabetes mellitus or renal impairment (GFR less than 60 mL/min/1.73 m²); 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 with concomitant use of neprilysin inhibitors such as sacubitril and racecadotril. Because of the verapamil component, TARKA is contraindicated in severe left ventricular dysfunction; hypotension (less than 90 mmHg systolic pressure) or cardiogenic shock; sick sinus syndrome except in patients with a functioning artificial ventricular pacemaker; and second- or third-degree atrioventricular block except in patients with a functioning artificial ventricular pacemaker. TARKA is also contraindicated in heart failure with reduced ejection fraction of less than 35%, and/or pulmonary wedge pressure above 20 mmHg.

Regulatory history

TARKA 2/180 and TARKA 4/240 were first registered on the Australian Register of Therapeutic Goods on 24 October 2005.