SILDENAFIL CITRATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Major Pharmaceuticals

INN (Kansainvälinen yleisnimi):

SILDENAFIL CITRATE

Koostumus:

SILDENAFIL 20 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 citrate is contraindicated in patients with: Risk Summary Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear associati

Tuoteyhteenveto:

Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6671-04 Carton of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6671-06 Recommended Storage for Sildenafil Tablets USP: 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].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SILDENAFIL CITRATE- SILDENAFIL CITRATE TABLET
MAJOR PHARMACEUTICALS
----------
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) 07/2017
INDICATIONS AND USAGE
Sildenafil citrate 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) (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not
result in any beneficial effect on exercise
capacity. (1, 14) (1)
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENTPHARMA INC. AT
1-800-912-9561
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
•
•
•
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
or on antihypertensive
therapy. (5.2)
Use in pulmonary veno-occlusive disease may cause pulmonary edema and
is not