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There have been postmarketing reports of bleeding events in patients who have taken VIAGRA. In humans, VIAGRA has no effect on bleeding time when taken alone or with aspirin. Prolonged erection greater than 4 hours and priapism have been reported infrequently since market approval of VIAGRA. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking VIAGRA with and without anti-hypertensive medication.

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  • If you are taking sildenafil for erectile dysfunction, do not take any more doses of sildenafil or similar medications such as tadalafil or vardenafil until you talk to your doctor.
  • Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil.
  • If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately.
  • If you are taking sildenafil for PAH, do not stop taking your medication until you talk to your doctor.
  • If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately.

This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. 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 25 mg . VIAGRA , an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate -specific phosphodiesterase type 5 . Patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment. The 3 dosages of VIAGRA—25 mg, 50 mg, and 100 mg—are the only dosages of sildenafil citrate that are FDA approved for the treatment of ED. Sildenafil is available as a generic drug in the United States, labelled for pulmonary arterial hypertension.

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In the first study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 2-period crossover design to 4 generally healthy males with benign prostatic hyperplasia . Following a review of the data from these first 4 subjects , the VIAGRA dose was reduced to 25 mg. In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased. Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively . There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC.

The major product of metabolisation by these enzymes is N-desmethylated sildenafil, which is metabolised further. This metabolite also has an affinity for the PDE receptors, about 40% of that of sildenafil. Sildenafil is excreted as metabolites predominantly in the feces (about 80% of administered oral dose) and to a lesser extent in the urine (around 13% of the administered oral dose).

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Both sildenafil and the metabolite have terminal half lives of about 4 hours. There was no effect on sperm motility or morphology after single 100 mg oral doses of VIAGRA in healthy volunteers. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. Subjects in the study reported this finding as difficulties in discriminating blue/green. Single oral doses of sildenafil up to 100 mg produced no clinically relevant changes in the ECGs of normal male volunteers. In the second study, a single oral dose of VIAGRA 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH.

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If taken with a high-fat meal, absorption is reduced; the time taken to reach the maximum plasma concentration increases by around one hour, and the maximum concentration itself is decreased by nearly one-third. Tentative evidence suggests that sildenafil may help men who experience antidepressant-induced erectile dysfunction. Sildenafil acts by blocking phosphodiesterase 5 , an enzyme that promotes breakdown of cGMP, which regulates blood flow in the penis.

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