MIZART

What it is

MIZART is a telmisartan tablet available in strengths of 40 mg or 80 mg. Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II, and does not exhibit any partial agonist activity at the AT1 receptor or reveal relevant affinity for other receptors.

Approved indications

— Treatment of hypertension in adults. — Prevention of cardiovascular morbidity and mortality in adults 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage.

Dosing overview

The maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. MIZART may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel blockers such as amlodipine, which have been shown to have an additive blood pressure lowering effect. No dose adjustment is necessary for elderly patients or patients with renal impairment. In patients with mild to moderate hepatic impairment, MIZART should be administered with caution, and the dosage should not exceed 40 mg once daily.

Key safety warnings

Exploratory post-hoc analyses of telmisartan trials suggested an increased risk of fatal myocardial infarction and unexpected cardiovascular death in patients with diabetes mellitus who have no documented medical history of coronary heart disease or myocardial infarction; because coronary heart disease may be asymptomatic in diabetic patients, treatment with telmisartan may further reduce coronary perfusion, and patients with diabetes mellitus should undergo specific diagnostics and be treated accordingly before initiating therapy. During treatment with MIZART, hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure, and monitoring of serum potassium levels in patients at risk is recommended. Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting; such conditions should be corrected before administration of MIZART. Special caution is indicated in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in myocardial infarction or stroke. There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with MIZART.

Contraindications

MIZART is contraindicated in patients with hypersensitivity to any of its components, pregnancy, lactation, biliary obstructive disorders, or severe hepatic impairment, and in patients with concomitant use of aliskiren in the setting of diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).

PBS listing

Information on PBS listing for MIZART is not available in the provided documents.

Regulatory history

MIZART telmisartan 40 mg tablets and 80 mg tablets were first listed on the Australian Register of Therapeutic Goods on 13 August 2015. The date of first approval was 4 August 2015.