Tadalafil-WGR

What it is

Tadalafil-WGR is available as film-coated tablets containing 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil. The tablets contain lactose as an ingredient with known effects. The 20 mg, 10 mg, 5 mg and 2.5 mg tablets are yellow or light yellow, film-coated, oval-shaped, biconvex tablets for oral administration, with identifying markings on one side.

Approved indications Tadalafil-WGR is indicated for the treatment of:

— <cite index="1-8">Erectile dysfunction in adult males — Moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia in adult males </cite>

Dosing overview

For erectile dysfunction with 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 as early as 16 minutes after dosing. For patients anticipating frequent use (at least twice weekly), a once-daily regimen is available, with the recommended dose being 5 mg taken once daily at approximately the same time each day, not exceeding 5 mg daily, and potentially decreased to 2.5 mg daily 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 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, including all forms of organic nitrates, nitric oxide donors and organic nitrites such as glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite and nicorandil. In a life-threatening situation where nitrate administration is deemed medically necessary, at least 48 hours should have elapsed after the last dose of tadalafil in most patients and 4–5 days in elderly patients before nitrate administration is considered. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease, as tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure. 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 benign prostatic hyperplasia has not been adequately studied and is 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, with most cases resolving spontaneously after stopping treatment, and patients should stop use and seek medical attention in the event of sudden visual defect, visual acuity impairment, visual distortion or loss of vision. Priapism has been reported with tadalafil, and patients experiencing erections lasting 4 hours or more should seek immediate medical assistance, as untreated priapism may result in permanent loss of potency.

Contraindications

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.

Regulatory history

Tadalafil-WGR was first registered on the Australian Register of Therapeutic Goods on 26 May 2017, with registrations for 2.5 mg, 5 mg, 10 mg and 20 mg film-coated tablet strengths (ARTG numbers 277541, 277545, 277564 and 277544 respectively).