ADIRAMED

What it is

ADIRAMED contains tadalafil 2.5 mg, 5 mg, 10 mg or 20 mg per tablet. The 20 mg and 10 mg tablets are yellow, film coated, oval shaped, biconvex tablets for oral administration.

Approved indications —

Erectile dysfunction in adult males — Moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia in adult males

Dosing overview

ADIRAMED has been proven effective up to 36 hours after dosing and in some patients as early as 16 minutes after dosing.

Key safety warnings

ADIRAMED must not be used with nitrates or nitric oxide donors in any form. Co-administration with glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates is contraindicated. If nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours in most patients and 4–5 days in the elderly should have elapsed after the last dose of ADIRAMED before nitrate administration, and nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring. ADIRAMED has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure. Physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by vasodilatory effects. Caution should be exercised when prescribing ADIRAMED to patients taking alpha-blockers such as doxazosin, as simultaneous administration may lead to symptomatic hypotension. The efficacy of co-administration of an alpha-blocker and ADIRAMED for the treatment of BPH has not been adequately studied and is therefore not recommended. Physicians should advise patients to stop taking ADIRAMED and seek prompt medical attention in the event of sudden decrease or loss of hearing, which may be accompanied by tinnitus. Visual defects including central serous chorioretinopathy have been reported in connection with ADIRAMED. Most cases resolved spontaneously after stopping ADIRAMED. Patients should stop use and seek medical attention in the event of a sudden visual defect, visual acuity impairment, visual distortion and/or loss of vision in one or both eyes. Priapism has been reported with ADIRAMED. Patients who experience erections lasting 4 hours or more should seek immediate medical assistance, as untreated priapism may result in penile tissue damage and permanent loss of potency.

Contraindications

ADIRAMED is contraindicated in men for whom sexual intercourse is inadvisable due to unstable cardiovascular disease such as patients with unstable angina and severe congestive heart failure. ADIRAMED is contraindicated in patients with a myocardial infarction within the last 90 days; unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months; uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension; or a stroke within the last 6 months. ADIRAMED is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy, regardless of whether this episode was in connection with previous PDE5 inhibitor exposure. ADIRAMED should not be used in patients with known hypersensitivity to tadalafil or to any ingredient of the tablet. The combination of ADIRAMED and guanylate cyclase stimulators such as riociguat is contraindicated because it may lead to symptomatic hypotension.

PBS listing

The available source documents do not contain information regarding PBS listing status, item numbers, restriction type, or pricing for ADIRAMED.

Regulatory history

ADIRAMED tadalafil 20 mg and 10 mg film-coated tablets were first listed on the ARTG on 12 May 2020.