SILDENAFIL-ISPL

What it is

Sildenafil citrate (brand name SILDENAFIL-ISPL) is indicated for the treatment of erectile dysfunction in adult males. It is available as clear hard gelatin capsules containing 25 mg sildenafil, and yellow opaque hard gelatin capsules containing 50 mg sildenafil. Sildenafil capsules are for oral administration.

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, a 25 mg starting dose should be considered. For patients with hepatic impairment, a 25 mg starting dose should be considered. For elderly patients, a first dose of 25 mg should be considered. For patients receiving potent CYP 3A4 inhibitors, a starting dose of 25 mg should be considered. For patients receiving concomitant therapy with ritonavir, it is recommended not to exceed a maximum single dose of 25 mg in a 48 hour period.

Key safety warnings

Nitrates and sildenafil must not be used together, as sildenafil potentiates the hypotensive effects of both acute and chronic nitrate administration. The co-administration of sildenafil with guanylate cyclase stimulators such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension. Patients should stop use of sildenafil 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), which has been reported rarely post marketing in temporal association with the use of phosphodiesterase type 5 (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 cases with the use of all PDE5 inhibitors. In case of sudden decrease or loss of hearing, patients should stop taking sildenafil and consult a physician promptly. Prior to prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by vasodilatory effects, especially in combination with sexual activity, including those with left ventricular outflow obstruction or the rare syndrome of multiple system atrophy. Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis or conditions which may predispose them to priapism. Prolonged erections greater than four hours and priapism have been reported infrequently since market approval. In the event of an erection that persists 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 is contraindicated in patients with known hypersensitivity to any component of the capsule. Nitrates and sildenafil must not be used concomitantly. The co-administration of sildenafil 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, such as patients with severe cardiovascular disease, established cardiac failure and unstable angina pectoris. Sildenafil 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

SILDENAFIL-ISPL was first registered on the ARTG on 31 July 2018, with two strengths listed: 25 mg and 50 mg capsules.