SILDENAFIL- sildenafil citrate 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sildenafil is 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 was 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 is contraindicated in patients with: - Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Wa

Product summary:

Sildenafil tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets: 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].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

SILDENAFIL- SILDENAFIL CITRATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILDENAFIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SILDENAFIL.
SILDENAFIL TABLETS, FOR ORAL USE
SILDENAFIL FOR ORAL SUSPENSION
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
Tablets and oral suspension: 5 mg or 20 mg three times a day, 4–6
hours apart; see full prescribing
information for reconstitution instructions for the Powder for Oral
Suspension ( 2.1, 2.2)
CONTRAINDICATIONS
Use with organic nitrates or riociguat. ( 4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet 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 reactions greater than or equal to 3% and more
frequent than placebo