SILDENACAP

What it is

Sildenacap contains sildenafil citrate. Sildenacap 25 mg capsules are clear hard gelatin capsules, and Sildenacap 50 mg capsules are yellow opaque hard gelatin capsules.

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 patients with severe renal impairment, a 25 mg starting dose should be considered. In patients with hepatic impairment, a 25 mg starting dose should be considered. In elderly patients, a first dose of 25 mg should be considered.

Key safety warnings

Sildenacap has vasodilator properties, resulting in mild and transient decreases in blood pressure and potentiates the hypotensive effect of nitrates. Patients should stop use of Sildenacap 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. Sildenacap should be used with caution in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's disease, or in patients with conditions that may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, has been reported in a small number of cases; patients should stop taking Sildenacap and consult a physician promptly if this occurs. Prolonged erections greater than four hours and priapism have been reported; in the event of an erection persisting longer than 4 hours, the patient should seek immediate medical assistance, as untreated priapism may result in penile tissue damage and permanent loss of potency.

Contraindications

Sildenacap is contraindicated in patients with known hypersensitivity to any component of the capsule. Nitrates and Sildenacap must not be used concomitantly, as Sildenacap potentiates the hypotensive effects of both acute and chronic nitrate administration. Sildenacap is contraindicated with guanylate cyclase stimulators, such as riociguat, as it may potentially lead to symptomatic hypotension. Sildenacap 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. Sildenacap is contraindicated in 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

Sildenacap 25 mg and 50 mg capsules were first listed on the ARTG on 31 July 2018.