VIAGRA

What it is

VIAGRA is indicated for the treatment of erectile dysfunction in adult males. VIAGRA is available in 25 mg, 50 mg and 100 mg tablets containing sildenafil citrate as the active ingredient. The tablets are blue, rounded diamond shaped film coated tablets.

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. The maximum recommended dose is 100 mg and the maximum recommended dosing frequency is once per day. For elderly patients, a first dose of 25 mg should be considered since sildenafil clearance is reduced in elderly patients, and the dose may be increased to 50 mg and 100 mg based on efficacy and toleration. For patients with severe renal impairment, a 25 mg starting dose should be considered, with possible increases to 50 mg and 100 mg based on efficacy and toleration. Similarly, for patients with hepatic impairment, a 25 mg starting dose should be considered with possible increases based on efficacy and toleration.

Key safety warnings

VIAGRA was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration, and co-administration with nitrates in any form is contraindicated, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside and amyl nitrite. VIAGRA 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. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, including those with recent onset angina, since there is a degree of cardiovascular risk associated with sexual intercourse. Non-arteritic anterior ischaemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post marketing in temporal association with the use of all PDE5 inhibitors. Physicians should advise patients to stop use of all PDE5 inhibitors, including VIAGRA, and seek immediate medical attention in the event of sudden visual defect, visual acuity impairment, visual distortion and/or loss of vision in one or both eyes. 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 trials cases with the use of all PDE5 inhibitors, including sildenafil, though no causal relationship has been made. In case of sudden decrease or loss of hearing patients should be advised to stop taking sildenafil and consult a physician promptly. Prolonged erections greater than four hours in duration 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 VIAGRA is contraindicated in patients with known hypersensitivity to any component of the tablet. Nitrates and VIAGRA must not be used concomitantly. The co-administration of PDE5 inhibitors, including VIAGRA, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension. The safety of sildenafil 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

VIAGRA sildenafil citrate tablets in 25 mg, 50 mg and 100 mg strengths were first listed on the ARTG on 4 September 1998.