ZEDACE

What it is

ZEDACE is captopril, a highly specific competitive inhibitor of angiotensin I converting enzyme, the enzyme responsible for the conversion of angiotensin I to angiotensin II. ZEDACE tablets are available in 25 mg and 50 mg strengths.

Approved indications

— Treatment of hypertension. — Treatment to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, manifested as an ejection fraction ≤ 40%, and to decrease the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure. — Treatment of heart failure. — Treatment of diabetic nephropathy in patients with Type 1 insulin-dependent diabetes mellitus.

Dosing overview

Dosing varies by indication. For hypertension, a starting dose of 12.5 mg may be used, increasing to 25 mg twice a day, and if needed after two to four weeks, to 50 mg twice a day. The usual effective dose in mild to moderate hypertension does not exceed 50 mg twice a day. For myocardial infarction, after an initial dose of 6.25 mg, therapy should be increased as tolerated to 25 mg three times a day during the next several days and to a final target dose of 50 mg three times a day over the next several weeks. For heart failure, the maintenance dose is usually in the range of 25 to 75 mg twice a day. For diabetic nephropathy, the recommended dose is 75 to 100 mg daily, in divided doses.

Key safety warnings

Severe life-threatening angioedema has been reported rarely with ACE inhibitors, with an overall incidence of approximately 0.1% to 0.2%. In the majority of reported cases, symptoms occurred during the first week of therapy, although onset may be delayed for weeks to months. Angioedema associated with laryngeal oedema is potentially life-threatening. Neutropenia has occurred in some patients taking captopril, limited chiefly to those with pre-existing impaired renal function, immunosuppressant therapy, collagen vascular disease, or a combination of these factors. For patients with significantly impaired renal function, collagen vascular disease, or those being treated with immunosuppressant drugs and for patients with pre-existing neutropenia, white blood cell and differential counts should be performed before commencement of captopril treatment and at regular intervals thereafter. Hypotension may occur occasionally in patients starting treatment with ACE inhibitors, and excessive hypotension can develop in patients with impaired renal function, those who are salt or volume depleted due to renovascular disease, vomiting or diarrhoea, diuretic treatment, and in dialysis patients. A persistent, dry non-productive cough has been reported with all ACE inhibitors, appearing to be a class effect, with incidence varying between 2 and 15% depending upon the drug, dosage and duration of use.

Contraindications

History of previous hypersensitivity to captopril or any of the excipients. Pregnancy. History of hereditary and/or idiopathic angioedema or angioedema associated with previous ACE inhibitor therapy. Concomitant use with sacubitril/valsartan therapy.

PBS listing

No source document provides PBS listing information for ZEDACE.

Regulatory history

ZEDACE Captopril 25 mg and 50 mg tablets were first registered on the Australian Register of Therapeutic Goods on 10 October 1996.