TADACIP

What it is

TADACIP is a medicine containing tadalafil 2.5 mg, 5 mg, 10 mg or 20 mg per tablet. The tablets are yellow film-coated, oval-shaped, biconvex tablets for oral administration.

Approved indications TADACIP is indicated for the treatment of:

— 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 of tadalafil (at least twice weekly), the recommended once-daily dose is 5 mg taken at approximately the same time of day, with a maximum 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. For men with both 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

Nitrates and tadalafil must not be used concomitantly, as co-administration with nitric oxide donors, organic nitrates or organic nitrites in any form is contraindicated. 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 on the nitric oxide/cGMP pathway. Tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure, and physicians should carefully consider whether patients with underlying cardiovascular disease could be affected adversely by these vasodilatory effects. Caution should be exercised when prescribing tadalafil to patients taking alpha-blockers such as doxazosin, as simultaneous administration may lead to symptomatic hypotension, and the efficacy of co-administration for benign prostatic hyperplasia treatment has not been adequately studied. Physicians should advise patients to stop taking PDE5 inhibitors, including tadalafil, 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 tadalafil and other PDE5 inhibitors, with most cases resolving spontaneously after stopping tadalafil. Priapism has been reported with PDE5 inhibitors including tadalafil; patients experiencing 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

Nitrates and tadalafil must not be used concomitantly, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. 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. The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is 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 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. Tadalafil should not be used in patients with 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.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

TADACIP 10 mg, 20 mg and 5 mg film-coated tablets were first listed on the ARTG on 27 March 2017.