Viagra®
Brand Name: Viagra®
Active Ingredient:
sildenafil citrate
Strength(s): 25
mg, 50mg & 100mg
Dosage Form(s):
Oral tablet
Company Name:
Pfizer Inc.
Availability:
Prescription only
Date Approved by
FDA: March 27, 1998
What is Viagra used for?
Viagra is used to treat
impotence in men. Viagra increases the body’s ability to achieve and maintain an
erection during
sexual stimulation. Viagra does not protect you from getting
sexually transmitted diseases, including
HIV.
Who should not take Viagra?
Men who are currently using medicines that contain
nitrates, such as
nitroglycerin should not use Viagra because taken together they can lower the
blood pressure too much. Viagra should not be used by women or children.
Reports of Patients’ Experiences Since Viagra Became Available:
In patients taking Viagra, several
heart-related side effects have been reported, including
heart attack,
sudden death,
irregular heart rhythm,
stroke,
chest pain, and
increased blood pressure. It is not possible to determine whether these events are directly related to Viagra, to
sexual activity, to the patient’s heart
condition, to a combination of these factors, or to other factors.
The following factors are associated with increased blood levels of Viagra:
age greater than 65 years
liver problems (such as
cirrhosis)
severe
kidney problems
taking certain medications at the same time (e.g.,
ketoconazole,
itraconazole,
erythromycin and
saquinavir).
In these patients, the recommended starting dose of Viagra is 25 mg.
Special Warnings:
Viagra was not studied in patients who have a history of the following conditions:
Heart attack,
stroke, or
life-threatening irregular
heart rhythm within the last 6 months
Very low and very high blood pressure
Heart failure or unstable
chest pain
Certain
eye disorders
Viagra can cause a rare but serious condition of
prolonged erection (
priapism). It is important to contact your health care provider immediately if your erection lasts longer than 4 hours.
Possible side effects:
Headache
Flushing
Upset stomach
Stuffy nose
Urinary tract infection
Visual changes such as mild and temporary changes in blue/green colors or increased
sensitivity to light.
Diarrhea
More information can be found at www.fda.gov/cder/ or on the
package insert.