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VIAGRA® (sildenafil citrate) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA.

VIAGRA® (sildenafil citrate) tablets, for oral use
Initial U.S. Approval: 1998

RECENT MAJOR CHANGES

Warnings and Precautions, Effects on the Eye (5.3)08/2017

INDICATIONS AND USAGE

VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)

DOSAGE AND ADMINISTRATION

  • 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)

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg, 50 mg, 100 mg (3)

CONTRAINDICATIONS

  • Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VIAGRA was shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2)
  • Known hypersensitivity to sildenafil or any component of tablet (4.2)
  • Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3)

WARNINGS AND PRECAUTIONS

  • Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status (5.1)
  • Patients should seek emergency treatment if an erection lasts >4 hours. Use VIAGRA with caution in patients predisposed to priapism (5.2)
  • Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. (5.3)
  • Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4)
  • Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5)
  • Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in VIAGRA dosage is recommended (2.4, 5.6)

ADVERSE REACTIONS

Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • 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)

USE IN SPECIFIC POPULATIONS

  • Geriatric use: Consider a starting dose of 25 mg (2.5, 8.5)
  • Severe renal impairment: Consider a starting dose of 25 mg (2.5, 8.6)
  • Hepatic impairment: Consider a starting dose of 25 mg (2.5, 8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2017

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