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VIAGRA (sildenafil citrate) Contraindications

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Contraindications

VIAGRA (sildenafil citrate) has been shown to potentiate the hypotensive effects of nitrates in healthy volunteers and in patients, and is therefore contraindicated in patients who are taking any type of nitrate drug therapy, or who utilize short-acting nitrate-containing medications, due to the risk of developing potentially life-threatening hypotension. The use of organic nitrates, either regularly and/or intermittently, in any form (e.g. oral, sublingual, transdermal, by inhalation) is absolutely contraindicated (see ACTION AND CLINICAL PHARMACOLOGY, DOSAGE AND ADMINISTRATION).

After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Plasma levels of sildenafil at 24 hours post-dose are much lower (2 ng/mL) than at peak concentration (440 ng/mL). In the following patients: age >65, hepatic impairment (e.g. cirrhosis), severe renal impairment (e.g. CLcr <30 mL/min), and concomitant use of potent cytochrome P-450 3A4 inhibitors (erythromycin), plasma levels of sildenafil at 24 hours post-dose have been found to be 3 to 8 times higher than those seen in healthy volunteers. Although plasma levels of sildenafil at 24 hours post-dose are much lower than at peak concentration, it is unknown whether nitrates can be safely coadministered at this time point (see DETAILED PHARMACOLOGY, Pharmacodynamic Studies).

Treatments for erectile dysfunction should not be generally used in men for whom sexual activity is inadvisable (see also WARNINGS AND PRECAUTIONS).

VIAGRA is contraindicated in patients with a known hypersensitivity to any component of the tablet (see PHARMACEUTICAL INFORMATION).

VIAGRA is contraindicated in patients with erectile dysfunction with previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see WARNINGS AND PRECAUTIONS).

The co-administration of PDE5 inhibitors, including VIAGRA®, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to potentially life-threatening episodes of symptomatic hypotension or syncope.