VIAGRA- sildenafil citrate tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

PD-Rx Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 100 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

VIAGRA 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) ], VIAGRA 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 VIAGRA, 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) ]. VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, in

Descriptif du produit:

VIAGRA (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 100mg of sildenafil and debossed on the obverse with VGR 100 and reverse side with Pfizer: Bottles of 10 (NDC 55289-524-10). Recommended Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

VIAGRA- SILDENAFIL CITRATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIAGRA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIAGRA.
VIAGRA® (SILDENAFIL CITRATE) 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
VIAGRA 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, VIAGRA 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 VIAGRA to patients using nitric oxide donors, such
as organic nitrates or organic nitrites in any form.
VIAGRA 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)
WARNINGS AND PRECAUTIONS
Patients should not use VIAGRA if sexual activity is inadvisable due
to cardiovascular status ( 5.1)
Patients should seek emergency treatment if an erection lasts >4
hours. Use VIAGRA with caution in patients
predisposed to priapism ( 5.2)
Patients should stop VIAGRA 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).
VIAGRA should be used with caution, and only
when the anticipated benefits outweigh the risks, in patients with a
history of NAION. Patients with a "crowded" optic
disc may also be at an increased risk