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VIAGRA®(sildenafil citrate)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

VIAGRA® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

VIAGRA is indicated for the treatment of erectile dysfunction.

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2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity....

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3 DOSAGE FORMS AND STRENGTHS

VIAGRA is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with PFIZER on one...

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4 CONTRAINDICATIONS

4.1 Nitrates

Consistent with its known effects on the nitric oxide/cGMP pathway [see

4.2 Hypersensitivity Reactions...

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5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease....

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6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

  • Cardiovascular [see

    6.1 Clinical Trials Experience

    ...

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7 DRUG INTERACTIONS

7.1 Nitrates

Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated....

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

VIAGRA is not indicated...

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10 OVERDOSAGE

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,...

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11 DESCRIPTION

VIAGRA (sildenafil citrate), an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

In clinical studies, VIAGRA was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and...

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16 HOW SUPPLIED/STORAGE AND HANDLING

VIAGRA (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Nitrates...

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