VIAGRA (sildenafil citrate) is a prescription medicine used to treat erectile dysfunction (ED). VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the
treatment of erectile dysfunction (ED) (1). You will not get an
erection just by taking this medicine. VIAGRA helps a man with erectile dysfunction get and
keep an erection only when he is sexually excited (stimulated).
VIAGRA is not for use in women or children.
It is not known if VIAGRA is safe and effective in women or children under 18 years of age.
For most patients, the recommended dose is 50 mg taken, as needed,
approximately 1 hour before sexual activity. However, VIAGRA may be
taken anywhere from 30 minutes to 4 hours before sexual activity (2.1)
• Based on effectiveness and toleration, may increase to a maximum of
100 mg or decrease to 25 mg (2.1)
• Maximum recommended dosing frequency is once per day (2.1)
Tablets: 25 mg, 50 mg, 100 mg (3)
Take VIAGRA exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much VIAGRA to take and when to take it.
• Your healthcare provider may change your dose if needed.
• Take VIAGRA about 1 hour before sexual activity. You may take VIAGRA between 30
minutes to 4 hours before sexual activity if needed.
• VIAGRA can be taken with or without food. If you take VIAGRA after a high fat meal (such
as a cheeseburger and french fries), VIAGRA may take a little longer to start working
• Do not take VIAGRA more than 1 time a day.
• If you accidentally take too much VIAGRA, call your doctor or go to the nearest hospital
emergency room right away.
headache
• flushing
• upset stomach
• abnormal vision, such as changes in color vision (such as having a blue color tinge) and
blurred vision
• stuffy or runny nose
• back pain
• muscle pain
• nausea
• dizziness
• rash
In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men
taking VIAGRA. Most, but not all, of these men had heart problems before taking VIAGRA. It is
not known if VIAGRA caused these problems.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of VIAGRA. For more information, ask your healthcare
provider or pharmacist.
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled
Room Temperature].
VIAGRA can potentiate the hypotensive effects of nitrates, alpha blockers,
and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2)
• With concomitant use of alpha blockers, initiate VIAGRA at 25 mg dose
(2.3)
• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole,
erythromycin): Increase VIAGRA exposure (2.4, 7.4, 12.3)
? Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48
hour period (2.4, 5.6)
? Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole,
itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4,
7.4)
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.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not
expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the
urine.