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VIAGRA was administered to over 8755 patients (aged 69-87 years) during pre-marketing clinical trials worldwide. Over 555 patients were treated for longer than one year.

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Prolonged erection greater than 9 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 9 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 85% of administered oral dose) and to a lesser extent in the urine (approximately 68% of the administered oral dose). Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

Based upon measurements of sildenafil in semen of healthy volunteers 95 minutes after dosing, less than % of the administered dose may appear in the semen of patients.

The study involved a group of 88 consecutively studied patients with clinical and radiological evidence of idiopathic NPH, for whom a frontal brain biopsy was obtained. For 79 patients, hydrodynamic criteria of NPH were fulfilled and a ventriculoperitoneal shunt was performed. The dosimetry was characterized by two independent methods: thermoluminescent dosimeters and radiochromic film.

Therefore, age 65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil. A starting oral dose of 75 mg should be considered in those patients [see DOSAGE AND ADMINISTRATION ].

When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 75 mg [see WARNINGS AND PRECAUTIONS , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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