TADALIS

What it is

TADALIS contains tadalafil 2.5 mg, 5 mg, 10 mg or 20 mg per tablet. The tablets are yellow, film coated, oval shaped, and biconvex for oral administration. Tadalafil is a reversible inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5) in the smooth muscle of the corpus cavernosum, the prostate, the bladder and their vascular supply.

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 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), the recommended once-daily dose is 5 mg taken at approximately the same time of day, and the dose must not exceed 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. For adult men with erectile dysfunction and 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

Tadalafil 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 TADALIS to patients taking alpha-1 blockers, such as doxazosin, as simultaneous administration may lead to symptomatic hypotension in some patients. Physicians should advise patients to stop taking TADALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing. This may be accompanied by tinnitus. Visual defects including central serous chorioretinopathy have been reported in connection with the intake of TADALIS. Most cases resolved spontaneously after stopping TADALIS. Non-arteritic anterior ischaemic optic neuropathy, a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors. Priapism has been reported with PDE5 inhibitors. Patients who experience erections lasting 4 hours or more should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Contraindications

Nitrates and TADALIS must not be used concomitantly. Co-administration of TADALIS with nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is contraindicated. TADALIS is contraindicated in men for whom sexual intercourse is inadvisable due to unstable cardiovascular disease (e.g. patients with unstable angina and severe congestive heart failure). TADALIS 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 or not with previous PDE5 inhibitor exposure. The following groups of patients with cardiovascular disease were not included in clinical trials and the use of TADALIS is therefore contraindicated: patients with a 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 a stroke within the last 6 months. TADALIS should not be used in patients with a known hypersensitivity to tadalafil or to any ingredient of the tablet. The combination of TADALIS and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension.

PBS listing

TADALIS 20 mg tablets are listed on the PBS with 4 items. Authority required restriction applies. The ex-manufacturer price is A$509.51.

Regulatory history

TADALIS 20 mg film-coated tablets were first listed on the ARTG on 27 March 2017.