SILDENAFIL CITRATE- sildenafil tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Proficient Rx LP

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. Sildenafil tablets are contraindicated in patients with: Risk Summary Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major

Produktbesonderheiten:

Sildenafil Tablets, USP 20 mg are supplied as white round, biconvex film coated tablets debossed with "R" on one side and "20" on the other side, containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Package Configuration Strength NDC Debossing on Tablet Bottle of 10 Tablets 20 mg 71205-305-10 R on one side and 20 on other Bottle of 20 Tablets 20 mg 71205-305-20 R on one side and 20 on other Bottle of 30 Tablets 20 mg 71205-305-30 R on one side and 20 on other Bottle of 60 Tablets 20 mg 71205-305-60 R on one side and 20 on other Bottle of 90 Tablets 20 mg 71205-305-90 R on one side and 20 on other Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20°C -25°C (68°F -77°F); excursions permitted to 15°C -30°C (59°F -86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

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.
SILDENAFIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Loss ( 5.5) 7/2017
INDICATIONS AND USAGE
Sildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated
for the treatment of pulmonary arterial hypertension
(PAH) (WHO Group I) in adults to improve exercise ability and delay
clinical worsening. Studies establishing effectiveness
were short-term (12 to 16 weeks), and included predominately patients
with NYHA Functional Class II-III symptoms.
Etiologies were idiopathic (71%) or associated with connective tissue
disease (25%). ( 1)
Limitation of Use: Adding sildenafil to bosentan therapy does not
result in any beneficial effect on exercise capacity. ( 1, 14)
DOSAGE AND ADMINISTRATION
Tablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions greater than or equal to 3% and more
frequent than placebo were epistaxis, headache,
dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. ( 6.1,
6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TRUPHARMA LLC AT
1-800-541-5504. OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Sildenafil Tablets
3. DOSAGE FORMS AND STRENGTHS
_Tablets_ : 20 mg ( 3)
Use with organic nitrates or riociguat ( 4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet ( 4)
Increased mortality with increasing doses in pediatric patients. Not
recomme