SILDENAFIL CITRATE- sildenafil tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

A-S Medication Solutions

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Product: 50090-5906 NDC: 50090-5906-0 10 TABLET, FILM COATED in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SILDENAFIL CITRATE - SILDENAFIL TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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
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 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 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 the risks, in
patients with a history of NAION. Patients with a “crowded” optic
disc may also be at a