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REVATIO®(sildenafil)

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REVATIO® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was...

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2 DOSAGE AND ADMINISTRATION

2.1 REVATIO Tablets and Oral Suspension

The recommended dose of REVATIO is 5 mg or 20 mg three times a day. Administer REVATIO doses 4...

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3 DOSAGE FORMS AND STRENGTHS

REVATIO Tablets

White, film-coated, round tablets engraved with "RVT20" containing sildenafil citrate equivalent...

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4 CONTRAINDICATIONS

REVATIO is contraindicated in patients with:

  • Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension...
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5 WARNINGS AND PRECAUTIONS

5.1 Mortality with Pediatric Use

In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing...

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6 ADVERSE REACTIONS

The following serious adverse events are discussed elsewhere in the labeling:

  • Mortality with pediatric use [see

    6.1 Clinical Trials Experience

    ...
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7 DRUG INTERACTIONS

Nitrates

Concomitant use of REVATIO with nitrates in any form is contraindicated [see...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited published data...

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10 OVERDOSAGE

In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.

In cases of overdose, standard supportive...

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11 DESCRIPTION

REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sildenafil is an inhibitor of cGMP specific phosphodiesterase type-5 (PDE-5) in the smooth muscle of the pulmonary...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Sildenafil was not carcinogenic when administered to rats for up to 24 months at...

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14 CLINICAL STUDIES

Studies of Adults with Pulmonary Arterial Hypertension

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

...
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17 PATIENT COUNSELING INFORMATION

See

PATIENT INFORMATION

REVATIO® (re-VAH-tee-oh)
(sildenafil) tablets

REVATIO® (re-VAH-tee-oh)...

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Instructions for Use

REVATIO® (re-VAH-tee-oh)
(sildenafil) oral suspension

Read this Instructions for Use for REVATIO oral suspension before you start taking and...

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

...

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Resources

REVATIO Savings Card
For questions regarding the REVATIO Savings Card, please call (866) 732-4468
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