SILDENAFIL tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Proficient Rx LP

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 birth defects, miscarriage, or adverse maternal or fetal outcom

Prehľad produktov:

Sildenafil Tablets USP, 20 mg are supplied as white, film-coated, unscored, round biconvex tablets, debossed with “TEVA” on one side of the tablet and “5517” on the other side, in bottles of 30 (NDC 71205-509-30), 60 (NDC 71205-509-60), and 90 (NDC 71205-509-90). Recommended Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

SILDENAFIL- 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
INDICATIONS AND USAGE
Sildenafil is a 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
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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 TEVA PHARMACEUTICALS
USA, INC. AT 1-888-838-2872 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: 11/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Sildenafil Tablets
Tablet: 20 mg three times a day, 4 to 6 hours apart (2.1)
_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
recommended for use in pediatric patients. (5.1)
Vasodilation effects may be more common in patients with hypotension