ADIRA

What it is

ADIRA is tadalafil, available in 2.5 mg, 5 mg, 10 mg or 20 mg tablets. The tablets are film-coated, oval-shaped, and biconvex 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

For erectile dysfunction using on-demand dosing, the recommended dose is either 10 mg or 20 mg taken prior to anticipated sexual activity, with a maximum recommended dose of 20 mg. The maximum recommended dosing frequency is once per day. Tadalafil has been proven effective up to 36 hours after dosing and, in some patients, as early as 16 minutes after dosing. For patients anticipating frequent use (at least twice weekly), a once-daily regimen is available with a recommended dose of 5 mg taken once a day at approximately the same time, not exceeding 5 mg daily. The dose may be decreased to 2.5 mg once a day based on individual tolerability. For lower urinary tract symptoms associated with benign prostatic hyperplasia, the recommended dose is 5 mg, taken at approximately the same time every day.

Key safety warnings

Nitrates and tadalafil must not be used concomitantly, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. 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 tadalafil before nitrate administration is considered. Tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure, and physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely. Caution should be exercised when prescribing tadalafil to patients taking alpha-blockers such as doxazosin, as simultaneous administration may lead to symptomatic hypotension in some patients. Patients should stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing, which may be accompanied by tinnitus. Patients should 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. Patients who experience erections lasting 4 hours or more should seek immediate medical assistance.

Contraindications

Administration of tadalafil to patients who are using any form of organic nitrate is contraindicated. Tadalafil 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. Tadalafil 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 phosphodiesterase type 5 inhibitor exposure. The following groups of patients with cardiovascular disease are contraindicated: patients with myocardial infarction within the last 90 days; patients with unstable angina or angina occurring during sexual intercourse; patients with New York Heart Association Class 2 or greater heart failure in the last 6 months; patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension; and patients with stroke within the last 6 months. The combination of tadalafil and guanylate cyclase stimulators such as riociguat is contraindicated because it may lead to symptomatic hypotension.

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

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