SILDENAFIL CITRATE- sildenafil tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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 citrate, 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 is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets, 25

Dettagli prodotto:

Sildenafil 100 mg tablets USP are blue, round biconvex, film coated tablets debossed with 88 on one side and plain on other side. NDC 68071-4744-3 BOTTLES OF 30 Recommended Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

SILDENAFIL CITRATE- SILDENAFIL TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
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
INITIAL U.S. APPROVAL:1998
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on the Eye (5.3) 08/2017
INDICATIONS AND USAGE
Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated
for the treatment of erectile
dysfunction (ED) (1) (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 and 100 mg (3) (3)
. (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Patients should not use sildenafil citrate if sexual activity is
inadvisable due to cardiovascular status
(5.1)
Patients should seek emergency treatment if an erection lasts >4
hours. Use sildenafil citrate 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 the
risks, in patients with a history of