CIALIS

What it is

CIALIS contains tadalafil in strengths of 2.5 mg, 5 mg, 10 mg and 20 mg tablets. The tablets are film-coated, almond-shaped tablets for oral administration.

Approved indications CIALIS is indicated for the treatment of:

— Erectile dysfunction (ED) in adult males — Moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) 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 and maximum dosing frequency of once per day. CIALIS 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 with 5 mg taken at approximately the same time of day is recommended, with a maximum dose of 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. In clinical studies, tadalafil was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration, thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Patients should stop taking CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing, which may be accompanied by tinnitus and has been reported in association with the use of PDE5 inhibitors. Visual defects including central serous chorioretinopathy (CSCR) have been reported in connection with tadalafil intake, with most cases resolving spontaneously after stopping the medicine. Non-arteritic anterior ischaemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of PDE5 inhibitors. Priapism has been reported with PDE5 inhibitors including tadalafil; patients who experience erections lasting 4 hours or more should seek immediate medical assistance, as failure to treat priapism immediately may result in penile tissue damage and permanent loss of potency. Tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure; physicians should carefully consider whether patients with underlying cardiovascular disease could be affected adversely by these vasodilatory effects.

Contraindications

Nitrates and tadalafil must not be used concomitantly. Tadalafil is contraindicated in men for whom sexual intercourse is inadvisable due to unstable cardiovascular disease (for example, 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 (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. The following groups of patients with cardiovascular disease are 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 (less than 90/50 mm Hg), or uncontrolled hypertension; and patients with a stroke within the last 6 months. Tadalafil should not be used in patients with a known hypersensitivity to tadalafil or to any ingredient of the tablet. The combination of tadalafil and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension.

Regulatory history

CIALIS tadalafil 20 mg and 10 mg tablets were first listed on the ARTG on 23 October 2002. The 5 mg and 2.5 mg tablet strengths were first listed on 14 February 2008. On 16 May 2013, the TGA approved the application to extend the indications for CIALIS to include moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH) in adult males, in addition to its existing indication for erectile dysfunction.