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:

Proficient Rx LP

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 mg, 50 mg and 100 mg and sild

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.                      Bottles of 20                    NDC 71205-231-20 Bottles of 30                    NDC 71205-231-30 Bottles of 60                    NDC 71205-231-60 Bottles of 90                    NDC 71205-231-90 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
PROFICIENT RX LP
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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
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
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg (3) (3)
. (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). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-800-912-9561
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6)
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 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
c