HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use REVATIO safely and effectively. See full prescribing information for REVATIO.
REVATIO (sildenafil) tablets, for oral use
REVATIO (sildenafil) for oral suspension
REVATIO (sildenafil) injection, for intravenous use
Initial U.S. Approval: 1998
RECENT MAJOR CHANGES
Indication and Use (1) 08/2012
Dosage and Administration (2.3) 08/2012
Contraindications (4) 08/2012
Warnings and Precautions (5) 08/2012
INDICATIONS AND USAGE
REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II–III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: The efficacy of REVATIO has not been adequately eva luated in patients taking bosentan concurrently. (1)
DOSAGE AND ADMINISTRATION
Tablet and oral suspension: 20 mg three times a day, 4–6 hours apart (2.1)
Injection: 10 mg (12.5 mL) three times a day administered as an intravenous bolus injection (2.2)
DOSAGE FORMS AND STRENGTHS
■Tablets: 20 mg (3)
■Injection: 10 mg (12.5 mL) single use vial (3)
■For Oral Suspension: 10 mg/mL (3)
CONTRAINDICATIONS
■Use with organic nitrates (4)
■History of hypersensitivity reaction to sildenafil or any component of the tablet, injection, or oral suspension (4)
WARNINGS AND PRECAUTIONS
■Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients. (5.1)
■Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. (5.2)
■Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. (5.3)
■Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.5, 5.6)
■Pulmonary hypertension secondary to sickle cell disease: REVATIO may cause serious vaso-occlusive crises. (5.9)
ADVERSE REACTIONS
Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. (6.1, 6.2)
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
■Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects. (7)
■Use with ritonavir and other potent CYP3A inhibitors: Not recommended. (7, 12.3)
■Concomitant PDE-5 inhibitors: Avoid use with Viagra or other PDE-5 inhibitors. (5.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 08/2012
 FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 REVATIO Tablets and Oral Suspension
2.2 REVATIO Injection
2.3 Reconstitution of the Powder for Oral Suspension
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Mortality with Pediatric Use
5.2 Hypotension
5.3 Worsening Pulmonary Vascular Occlusive Disease
5.4 Epistaxis
5.5 Visual Loss
5.6 Hearing Loss
5.7 Combination with other PDE-5 inhibitors
5.8 Priapism
5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients with Hepatic Impairment
8.7 Patients with Rena