SILDENAFIL CITRATE- sildenafil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sildenafil citrate (UNII: BW9B0ZE037) (sildenafil - UNII:3M7OB98Y7H)

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sildenafil citrate is indicated for the treatment of erectile dysfunction. Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2) ], sildenafil citrate was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2) ]. Sildenafil citrate is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the

Product summary:

Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides with 100 and SC in Child Resistant containers of: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL CITRATE- SILDENAFIL TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILDENAFIL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SILDENAFIL TABLETS.
SILDENAFIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated
for the treatment of erectile
dysfunction (ED) (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 AJANTA PHARMA USA INC.
AT 855-664-
7744 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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For most patients, the recommended dose is 50 mg taken, as needed,
approximately 1 hour before
sexual activity. However, sildenafil tablets 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)
Administration of sildenafil tablets to patients using nitric oxide
donors, such as organic nitrates or
organic nitrites in any form. Sildenafil citrate 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)
Patients should not use sildenafil tablets if sexual activity is
inadvisable due to cardiovascular status
(5.1)
Patients should seek emergency treatment if an erection lasts >4
hours. Use sildenafil tablets with
caution in patients predisposed to priapism (5.2)
P