SILDENAFIL tablet, film coated SILDENAFIL powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

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: 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 outcomes when sildenafil is used d

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: Bottle of 90 Tablets 20 mg 59762-0033-1 SDF20 Bottle of 300 Tablets 20 mg 59762-0033-3 SDF20 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]. Sildenafil powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Powder for oral suspension – bottle 10 mg/mL (when reconstituted) 59762-2058-1 Recommended storage for sildenafil for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Reconstituted Oral Suspension Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36° F – 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

SILDENAFIL- SILDENAFIL TABLET, FILM COATED
SILDENAFIL- SILDENAFIL POWDER, FOR SUSPENSION
GREENSTONE LLC
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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)
DOSAGE FORMS AND STRENGTHS
_Tablets:_ 20 mg (3)
_For Oral Suspension:_ 10 mg/mL (when reconstituted) (3)
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