VASAFIL

What it is

Vasafil contains sildenafil, indicated for the treatment of erectile dysfunction in adult males. The medicine is available as sildenafil citrate in capsule form. Vasafil 25 mg capsules are clear hard gelatin capsules, and Vasafil 50 mg capsules are yellow opaque hard gelatin capsules.

Approved indications

— 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. In elderly patients, a first dose of 25 mg should be considered due to reduced sildenafil clearance. In patients with severe renal impairment (creatinine clearance less than 30 mL/min), a 25 mg starting dose should be considered. In patients with hepatic impairment such as cirrhosis, a 25 mg starting dose should be considered.

Key safety warnings

Vasafil 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. Physicians should consider the cardiovascular status of their patients prior to initiating treatment, including those with recent onset angina, since there is a degree of cardiovascular risk associated with sexual activity. Patients should stop use of Vasafil and seek immediate medical attention in the event of sudden loss of vision in one or both eyes, as this 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 inhibitors. 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 inhibitors including sildenafil; in case of sudden decrease or loss of hearing patients should stop taking Vasafil and consult a physician promptly. Prolonged erections greater than four hours and priapism (painful erections greater than 6 hours) have been reported infrequently; in the event of an erection persisting longer than 4 hours, the patient should seek immediate medical assistance, as if priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Contraindications

Vasafil is contraindicated in patients with known hypersensitivity to any component of the capsule. Nitrates and Vasafil must not be used together, 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 or organic nitrates in any form. The co-administration of Vasafil with guanylate cyclase stimulators such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension. Vasafil is contraindicated in patients with 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.

PBS listing

Vasafil is listed on the PBS in three strengths: 25 mg, 50 mg, and 100 mg tablets, each as a single item with authority required restriction. The ex-manufacturer prices are A$40.88 for 25 mg, A$52.04 for 50 mg, and A$56.29 for 100 mg.

Regulatory history

Vasafil 25 mg, 50 mg, and 100 mg tablets were first listed on the ARTG on 22 June 2011 under licence category RE.