VIAGRA™
INFORMATION FOR PATIENTS
The use of viagra offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the human immunodeficiency virus (hiv/aids) should be considered. Precautions against unwanted pregnancy should be taken.
Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of organic nitrates.
Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician.
Physicians should warn patients that prolonged erections greater than 4 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 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Pregnancy and Lactation
VIAGRA is not indicated for use in women.
No teratogenic effects, impairment of fertility or adverse effects on peri/postnatal development were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
There was no effect on sperm motility or morphology after single 100 mg oral doses of VIAGRA in healthy volunteers.
Effects on Ability to Drive and Use Machines
As dizziness and altered vision were reported in clinical trials with VIAGRA, patients should be aware how they react to VIAGRA and exercise caution before driving, operating hazardous machinery or performing hazardous tasks.
DOSAGE AND DIRECTIONS FOR USE
VIAGRA tablets are for oral administration.
Use in Adults
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. The maximum recommended dosing frequency is once per day.
Use in the Elderly and in Patients with Impaired Renal or Hepatic Function
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil. Therefore the following factors are associated with increased plasma levels of sildenafil:
Age >65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 80%), severe renal impairment (creatinine clearance <30 mL/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, 200%).
Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.
VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.
Use in Children
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