MICARDIS

What it is

MICARDIS PLUS is a combination medicine containing telmisartan and hydrochlorothiazide. It is available in three tablet strengths: MICARDIS PLUS 40/12.5 containing telmisartan 40 mg and hydrochlorothiazide 12.5 mg; MICARDIS PLUS 80/12.5 containing telmisartan 80 mg and hydrochlorothiazide 12.5 mg; and MICARDIS PLUS 80/25 containing telmisartan 80 mg and hydrochlorothiazide 25 mg. MICARDIS PLUS is a combination of an angiotensin II receptor blocker, telmisartan, and a thiazide diuretic, hydrochlorothiazide.

Approved indications

— Hypertension

Dosing overview

The recommended dose is one tablet once daily. MICARDIS PLUS 40/12.5 may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 40 mg or hydrochlorothiazide. MICARDIS PLUS 80/12.5 may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 80 mg or by MICARDIS PLUS 40/12.5. MICARDIS PLUS 80/25 may be administered in patients whose blood pressure is not adequately controlled by MICARDIS PLUS 80/12.5 or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately. The maximum antihypertensive effect with MICARDIS PLUS is generally attained 4 to 8 weeks after the start of treatment.

Key safety warnings

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. An increased risk of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) with increasing cumulative dose of hydrochlorothiazide exposure has been observed in epidemiological studies. Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for this risk. Patients taking hydrochlorothiazide should be informed of the risk and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised. Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) have been reported after taking hydrochlorothiazide. Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, MICARDIS PLUS should be withdrawn and appropriate treatment given. Exploratory post-hoc analyses of two placebo-controlled 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 either coronary heart disease or myocardial infarction. Treatment with MICARDIS PLUS may further reduce coronary perfusion in these patients. For this reason, patients with diabetes mellitus should undergo specific diagnostics and be treated accordingly before initiating therapy with MICARDIS PLUS.

Contraindications

MICARDIS PLUS is contraindicated in patients with hypersensitivity to any of the components of the product or sulphonamide-derived substances; pregnancy; lactation; cholestasis and biliary obstructive disorders; severe hepatic impairment, coma hepaticum, or hepatic precoma; severe renal impairment (creatinine clearance less than 30 mL/min or serum creatinine greater than 160 μmol/L), anuria, or acute glomerulonephritis; refractory hypokalaemia or hypercalcaemia; therapy-refractory hyponatraemia; hypovolaemia; and symptomatic hyperuricaemia or gout. The concomitant use of MICARDIS PLUS with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR less than 60 mL/min/1.73 m²).

PBS listing

MICARDIS PLUS 80/25 is listed on the PBS. The ex-manufacturer price is A$13.30.

Regulatory history

MICARDIS telmisartan 40 mg and 80 mg tablets were first registered on the Australian Register of Therapeutic Goods on 27 August 1999. MICARDIS PLUS 40/12.5 and 80/12.5 tablets were first registered on 12 September 2002. MICARDIS PLUS 80/25 tablets were first registered on 22 September 2008.