Sildenafil-WGR

What it is

Sildenafil-WGR is indicated for the treatment of erectile dysfunction in adult males. It 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. Sildenafil is a potent and selective inhibitor of cGMP PDE5 which is responsible for degradation of cGMP in the corpus cavernosum.

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, with increases 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. In patients with hepatic impairment, a 25 mg starting dose should be considered, with increases based on efficacy and toleration.

Key safety warnings

Patients should stop use of all PDE5 inhibitors, including Sildenafil-WGR, and seek immediate medical attention in the event of a 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. 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. Sildenafil-WGR has vasodilator properties, resulting in mild and transient decreases in blood pressure and potentiates the hypotensive effect of nitrates. Caution is advised when Sildenafil-WGR is administered to patients taking an alpha-blocker, as co-administration may lead to symptomatic hypotension in a few susceptible individuals, and patients should be haemodynamically stable on alpha-blocker therapy prior to initiating treatment. Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, has been reported in a small number of cases, though most patients had risk factors for sudden decrease or loss of hearing, and no causal relationship has been made between the use of PDE5 inhibitors and sudden decrease or loss of hearing. Prolonged erections greater than four hours in duration and priapism 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

Use of Sildenafil-WGR is contraindicated in patients with known hypersensitivity to any component of the capsule. Nitrates and Sildenafil-WGR must not be used concomitantly, as Sildenafil-WGR was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration. The co-administration of PDE5 inhibitors, including Sildenafil-WGR, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension. Sildenafil-WGR is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors, for example patients with severe cardiovascular disease such as established cardiac failure and unstable angina pectoris. The safety of Sildenafil-WGR has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: 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

Sildenafil-WGR was first registered on the ARTG on 8 February 2024 in three strengths: 25 mg, 50 mg and 100 mg tablet blister packs.