APO-Tadalafil

What it is

APO-Tadalafil is available in strengths of 2.5 mg, 5 mg, 10 mg or 20 mg tadalafil per tablet. The 20 mg, 10 mg, 5 mg and 2.5 mg tablets are yellow film-coated, oval-shaped, biconvex tablets for oral administration. The tablets contain lactose as an ingredient with known effects.

Approved indications APO-Tadalafil 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 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, in some patients, as early as 16 minutes after dosing. For frequent use (at least twice weekly), the recommended dose is 5 mg taken once daily at approximately the same time of day, with a maximum of 5 mg daily. The dose may be decreased to 2.5 mg once 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.

Key safety warnings

Nitrates and tadalafil must not be used concomitantly. Co-administration of tadalafil with nitric oxide donors, organic nitrates or organic nitrites in any form is contraindicated, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite and nicorandil. Tadalafil potentiates the hypotensive effects of both acute and chronic nitrate administration through combined effects on the nitric oxide/cGMP pathway. Patients should be advised to stop taking APO-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, although most cases resolved spontaneously after stopping the medicine. Priapism has been reported with tadalafil. 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. Tadalafil should be used with caution in patients with conditions predisposing them to priapism, such as sickle cell anaemia, multiple myeloma or leukaemia, or in patients with anatomical deformation of the penis. Caution should be exercised when prescribing APO-Tadalafil to patients taking alpha-blockers such as doxazosin, as simultaneous administration may lead to symptomatic hypotension. The efficacy of co-administration of an alpha-blocker and tadalafil for benign prostatic hyperplasia has not been adequately studied and is not recommended.

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. The following groups of patients with cardiovascular disease were not included in clinical trials and 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 (<90/50 mm Hg), or uncontrolled hypertension; and patients with 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 any ingredient of the tablet. The combination of tadalafil and guanylate cyclase stimulators such as riociguat is contraindicated as it may lead to symptomatic hypotension.

PBS listing

The provided documents do not contain information regarding PBS listing status, strengths listed, item numbers, restriction types or ex-manufacturer prices for APO-Tadalafil.

Regulatory history

APO-Tadalafil 5 mg, 10 mg and 20 mg film-coated tablets were first listed on the ARTG on 15 January 2018 under licence category RE.