DOLAPRIL

What it is

DOLAPRIL is a capsule containing trandolapril as the active ingredient, available in strengths of 0.5 mg, 1 mg, 2 mg or 4 mg. DOLAPRIL is an orally active angiotensin converting enzyme (ACE) inhibitor administered as a pro-drug (trandolapril) which is rapidly converted to its biologically active metabolite trandolaprilat. DOLAPRIL has a duration of action of greater than 24 hours and should not be administered at intervals of less than 24 hours.

Approved indications

— Treatment of hypertension. — Treatment of patients with left ventricular dysfunction post myocardial infarction (ejection fraction 35% or Wall Motion Index 1.2).

Dosing overview

Since there is no clinically significant effect of food on the absorption of DOLAPRIL, the capsules may be taken before, during, or after a meal.

Key safety warnings

Severe life-threatening angioedema has been reported with most ACE inhibitors since 1984, 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; angioedema involving the tongue, glottis or larynx requires immediate subcutaneous administration of 0.3–0.5 mL of adrenaline (epinephrine) solution (1:1000). Concomitant inhibition of ACE and neprilysin (neutral endopeptidase, NEP) may increase the risk of angioedema, and co-administration of ACE inhibitors and NEP inhibitors (such as sacubitril and racecadotril) is contraindicated. Hypotension may occur in patients commencing treatment with ACE inhibitors, though excessive hypotension is rarely seen in patients with uncomplicated hypertension but can develop in patients with impaired renal function, those that are salt/volume depleted, and in patients undergoing dialysis. In patients with severe congestive heart failure, with or without associated renal insufficiency, excessive hypotension has been observed, which may be associated with syncope, neurological deficits, oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death. A dry and non-productive cough may occur during treatment with an ACE inhibitor, which disappears after discontinuation; a persistent dry (non-productive) irritating cough has been reported with most ACE inhibitors. Because ACE inhibitors decrease the formation of Angiotensin II and the subsequent production of aldosterone, serum potassium concentrations exceeding 5.5 mEq/L may occur, and hyperkalemia is more likely in patients with some degree of renal impairment, those treated with potassium-sparing diuretics or potassium supplements, and in those patients taking other active substances associated with increases in serum potassium.

Contraindications

DOLAPRIL is contraindicated in patients who are hypersensitive to DOLAPRIL or any other ACE inhibitor or to any of the excipients; patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous treatment with an angiotensin converting enzyme inhibitor; pregnancy; lactation; children; concomitant use with neprilysin (neutral endopeptidase, NEP) inhibitors such as sacubitril and racecadotril; and haemodialysis and other extracorporeal treatments. DOLAPRIL is contraindicated in patients haemodialysed using high-flux polyacrylonitrile ('AN69') membranes or patients undergoing low-density lipoprotein apheresis with dextran sulfate, who are highly likely to experience anaphylactoid reactions. DOLAPRIL is contraindicated in combination with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73m²) and in liver cirrhosis with ascites.

PBS listing

No information on PBS listing is available in the provided sources.

Regulatory history

DOLAPRIL (sponsored by Arrotex Pharmaceuticals) was first listed on the ARTG on 10 July 2007 with four registered variants: DOLAPRIL 0.5 mg (ARTG 125432), DOLAPRIL 1 mg (ARTG 125433), DOLAPRIL 2 mg (ARTG 125434), and DOLAPRIL 4 mg (ARTG 125435), all as trandolapril capsules in blister packs under licence category RE.