APX-SILDENAFIL

What it is

APX-SILDENAFIL is sildenafil citrate, indicated for the treatment of erectile dysfunction in adult males. The medicine is available as hard gelatin capsules in two strengths: 25 mg capsules (clear/clear) and 50 mg capsules (yellow opaque/yellow opaque).

Approved indications

— Treatment of erectile dysfunction in adult males

Dosing overview

The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg, with a maximum dosing frequency of once per day. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), a 25 mg starting dose should be considered, with the dose increased to 50 mg and 100 mg based on efficacy and toleration. Similarly, for patients with hepatic impairment such as cirrhosis, a 25 mg starting dose should be considered, with doses increased to 50 mg and 100 mg based on efficacy and toleration. For elderly patients, a first dose of 25 mg should be considered, with doses increased to 50 mg and 100 mg based on efficacy and toleration. When using concomitant potent CYP3A4 inhibitors, a starting dose of 25 mg should be considered. With ritonavir therapy, the maximum single dose should not exceed 25 mg in a 48-hour period.

Key safety warnings

APX-SILDENAFIL is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors, such as patients with severe cardiovascular disease including established cardiac failure and unstable angina pectoris. Prior to initiating treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, including those with recent onset angina, since there is a degree of cardiovascular risk associated with sexual intercourse. Patients should be advised to stop use of APX-SILDENAFIL and seek immediate medical attention in the event of sudden loss of vision in one or both eyes, which may be a sign of non-arteritic anterior ischaemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision that has been reported rarely with PDE5 inhibitor use. APX-SILDENAFIL is not recommended in patients with a previous episode of NAION. Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, has been reported in a small number of cases with PDE5 inhibitor use. In case of sudden hearing loss, patients should be advised to stop taking APX-SILDENAFIL and consult a physician promptly. Prolonged erections greater than four hours in duration and priapism have been reported infrequently. In the event of an erection persisting longer than four hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Contraindications

Use of APX-SILDENAFIL is contraindicated in patients with known hypersensitivity to any component of the capsule. Nitrates and APX-SILDENAFIL must not be used concomitantly, as sildenafil potentiates the hypotensive effects of both acute and chronic nitrate administration. Drugs which must not be used concomitantly include glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil and organic nitrates in any form. The co-administration of APX-SILDENAFIL with guanylate cyclase stimulators such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension. APX-SILDENAFIL is contraindicated in severe hepatic impairment, hypotension (blood pressure less than 90/50 mmHg), hypertension (blood pressure greater than 170/110 mmHg), recent history of stroke or myocardial infarction, and known hereditary degenerative retinal disorders such as retinitis pigmentosa, pending further safety information.

Regulatory history

APX-SILDENAFIL was first listed on the ARTG on 24 September 2012, with three registered strengths: 25 mg, 50 mg and 100 mg film-coated tablets.