TADALACCORD

What it is

Tadalaccord contains tadalafil in 5 mg and 20 mg film-coated tablet formulations. The 20 mg tablets are yellow, capsule shaped, biconvex, bevel-edged tablets debossed with "T 20", while the 5 mg tablets are light yellow with the same shape and finish, debossed with "T 5".

Approved indications Tadalaccord 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 and maximum dosing frequency of 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), once-daily dosing with 5 mg is recommended at approximately the same time each day, and the dose must not exceed 5 mg daily. 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 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

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 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 of an alpha-blocker and tadalafil for the treatment of benign prostatic hyperplasia has not been adequately studied and is therefore not recommended. Physicians should advise patients to stop taking 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 use, and most cases resolved spontaneously after stopping the medicine; physicians should advise patients to stop use and seek medical attention in the event of a sudden visual defect, visual acuity impairment, visual distortion or loss of vision. Priapism has been reported with tadalafil, and 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

Nitrates and tadalafil must not be used concomitantly; co-administration of tadalafil with nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is contraindicated, and administration of tadalafil to patients 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 (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 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

The 20 mg tablet is listed on the PBS as one item with authority required restriction, with an ex-manufacturer price of A$86.27.

Regulatory history

Tadalaccord tadalafil 5 mg and 20 mg film-coated tablets were first registered on the Australian Register of Therapeutic Goods on 15 January 2018 in licence category RE.