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SILDENAFIL Citrate Tablets 20mg, Oral Suspension 10mg/mL (GREENSTONE LLC)

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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.

SILDENAFIL Citrate Tablets 20mg, Oral Suspension 10mg/mL (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

Sildenafil 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 Sildenafil Tablets and Oral Suspension

The recommended dose of sildenafil is 5 mg or 20 mg three times a day. Administer sildenafil...

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3 DOSAGE FORMS AND STRENGTHS

Sildenafil Tablets

White, film-coated, round tablets engraved with "SDF20" containing sildenafil citrate...

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4 CONTRAINDICATIONS

Sildenafil 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 sildenafil...

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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 sildenafil 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...

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11 DESCRIPTION

Sildenafil, 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...

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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

Sildenafil tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated...

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17 PATIENT COUNSELING INFORMATION

See

PATIENT INFORMATION

Sildenafil tablets

Sildenafil oral suspension

Read this Patient...

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Instructions for Use

Sildenafil oral suspension

Read this Instructions for Use for sildenafil oral suspension before you start taking and each time you get a refill. There may be new...

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

...

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