VEDAFIL

What it is

VEDAFIL contains sildenafil as citrate. It is supplied as hard gelatin capsules available in 25 mg and 50 mg strengths. Sildenafil is an oral therapy for erectile dysfunction, which restores impaired erectile function by increasing blood flow to the penis, resulting in a natural response to sexual stimulation.

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, with a maximum recommended dose of 100 mg. The maximum recommended dosing frequency is once per day. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), a 25 mg starting dose should be considered. For patients with hepatic impairment such as cirrhosis, a 25 mg starting dose should be considered. For elderly patients, a first dose of 25 mg should be considered.

Key safety warnings

Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure and potentiates the hypotensive effect of nitrates. Patients should stop use of all PDE5 inhibitors and seek immediate medical attention in the event of a sudden loss of vision in one or both eyes, as this may be a sign of non-arteritic anterior ischaemic optic neuropathy (NAION), which has been reported rarely post marketing in temporal association with the use of all PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence, and PDE5 inhibitors are not recommended in patients with male erectile dysfunction with a previous episode of NAION. Prolonged erections greater than four hours and priapism (painful erections greater than 6 hours) have been reported infrequently; if an erection persists longer than 4 hours, the patient should seek immediate medical assistance, as priapism if not treated immediately may result in penile tissue damage and permanent loss of potency. Sudden decrease or loss of hearing has been reported in a small number of post marketing and clinical trial cases; in case of sudden decrease or loss of hearing, patients should be advised to stop taking sildenafil and consult a physician promptly.

Contraindications

Use of sildenafil is contraindicated in patients with known hypersensitivity to any component of the capsule. Nitrates and sildenafil must not be used concomitantly; drugs which must not be used concomitantly include glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. Co-administration of PDE5 inhibitors with guanylate cyclase stimulators such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension. Sildenafil is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors, including patients with severe cardiovascular disease such as established cardiac failure and unstable angina pectoris. The safety of sildenafil has not been studied 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, and its use is therefore contraindicated until further information is available.

PBS listing

No information regarding PBS listing is contained in the provided source documents.

Regulatory history

VEDAFIL sildenafil citrate 25 mg, 50 mg and 100 mg film-coated tablets were first listed on the ARTG on 20 May 2013.