SILDENAFIL tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)

Διαθέσιμο από:

Camber Pharmaceuticals, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Sildenafil tablets are 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 tablets were 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 tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component

Περίληψη προϊόντος:

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '113' on the other side. They are available as follows: Bottles of 30 tablets   NDC 31722-965-30 Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '114 'on the other side. They are available as follows: Bottles of 30 tablets   NDC 31722-966-30 Bottles of 100 tablets NDC 31722-966-01 Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and  '115' on the other side. They are available as follows: Bottles of 30 tablets   NDC 31722-967-30 Bottles of 100 tablets NDC 31722-967-01 Recommended Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SILDENAFIL - SILDENAFIL TABLET, FILM COATED
CAMBER 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
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on the Eye (5.3) 08/2017
INDICATIONS AND USAGE
Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated
for the treatment of erectile dysfunction (ED) (1)
DOSAGE AND ADMINISTRATION
•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)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
•Administration of sildenafil tablets to patients using nitric oxide
donors, such as organic nitrates or organic nitrites in any
form. Sildenafil tablets were 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)
WARNINGS AND PRECAUTIONS
•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)
•Patients should stop sildenafil tablets and seek medical care if a
sudden loss of vision occurs in one or both eyes, which
could be a sign of non arteritic anterior ischemic optic neuropathy
(NAION). Sildenafil tablets should be used with caution,
and only when the anticipated benefits outweigh th