SILDENAFIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 to 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: - Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)] . - Concomitant use of riociguat, a guanylate cyclase stim

Product summary:

Sildenafil Tablets USP, 20 mg are white colored, round shape, biconvex, film-coated  tablets, debossed with ‘T’ on one side and ‘27’ on other side. Recommended Storage for Sildenafil Tablets USP: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL- SILDENAFIL TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
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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 20 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
CONTRAINDICATIONS (4) 4/2015
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 to 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
Tablet and oral suspension: 5 mg or 20 mg three times a day, 4 to 6
hours apart (2.1)
Injection: 10 mg three times a day administered as an intravenous
bolus injection (2.2)
DOSAGE FORMS AND STRENGTHS
_Tablets_: 20 mg (3)
CONTRAINDICATIONS
Use with organic nitrates or riociguat (4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet, injection, or oral suspension (4)
WARNINGS AND PRECAUTIONS
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 recommended. (5.3)
Hearing or visual impairment: Seek medical attention if sudden
decrease or loss of vision or hearing occurs. (5.5, 5.6)
Pulmonary hypertension secondary to sickle cell disease: Sildenafil
may cause serious vaso-occlusive crises. (5.9)
ADVERSE REACTIONS
Most common adverse reac