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SILDENAFIL Citrate Tablets 25mg, 50mg, 100mg (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 25mg, 50mg, 100mg (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

SILDENAFIL CITRATE TABLETS 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

SILDENAFIL CITRATE TABLETS are supplied as white to off-white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil....

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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. Therefore...

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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

    Because...

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7 DRUG INTERACTIONS

7.1 Nitrates

Administration of SILDENAFIL CITRATE TABLETS with nitric oxide donors such as organic nitrates or organic nitrites in any form is...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

SILDENAFIL CITRATE...

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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

SILDENAFIL CITRATE TABLETS (sildenafil citrate), an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific...

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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, sildenafil citrate 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...

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16 HOW SUPPLIED/STORAGE AND HANDLING

SILDENAFIL CITRATE TABLETS (sildenafil citrate) are supplied as white to off-white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally...

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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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