SILCAP

What it is

SILCAP is sildenafil citrate, indicated for the treatment of erectile dysfunction in adult males. The product is supplied as hard gelatin capsules available in 25 mg and 50 mg strengths.

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. In elderly patients, a first dose of 25 mg should be considered, with the dose increased to 50 mg and 100 mg based on efficacy and toleration. In patients with severe renal impairment (Clcr <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. In patients with hepatic impairment, a 25 mg starting dose should be considered, with the dose increased to 50 mg and 100 mg based on efficacy and toleration.

Key safety warnings

Nitrates and SILCAP must not be used concomitantly, as sildenafil potentiates the hypotensive effects of both acute and chronic nitrate administration. Co-administration of SILCAP with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension. Patients should stop use of SILCAP 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 PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence, and PDE5 inhibitors are 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 post-marketing and clinical trial cases with the use of PDE5 inhibitors. In case of sudden decrease or loss of hearing, patients should be advised to stop taking SILCAP and consult a physician promptly. Caution is advised when SILCAP is administered to patients taking an alpha-blocker, as co-administration may lead to symptomatic hypotension in a few susceptible individuals. To minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating SILCAP treatment, and initiation at lower doses should be considered. Prolonged erections greater than four hours and priapism (painful erections greater than six hours) have been reported infrequently. In the event of an erection that persists longer than four 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

SILCAP is contraindicated in patients with known hypersensitivity to any component of the capsule. SILCAP must not be used concomitantly with nitrates and related compounds, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil and organic nitrates in any form. Co-administration with guanylate cyclase stimulators such as riociguat is contraindicated. SILCAP is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors, such as patients with severe cardiovascular disease, established cardiac failure and unstable angina pectoris. SILCAP use is contraindicated in patients with severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), hypertension (blood pressure >170/110 mmHg), recent history of stroke or myocardial infarction, and known hereditary degenerative retinal disorders such as retinitis pigmentosa.

Regulatory history

SILCAP 25 mg and 50 mg capsules were first registered on the ARTG on 31 July 2018.