SILDENAFIL- sildenafil citrate tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Aphena Pharma Solutions - Tennessee, LLC

INN (Διεθνής Όνομα):

SILDENAFIL CITRATE

Σύνθεση:

SILDENAFIL 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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), 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 Warnings and Precautions (5.2)] . - Concomitant use of riociguat, a guanylate cyclase stimulator. PDE5 inhibitors, including silde

Περίληψη προϊόντος:

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].

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Αρχείο Π.Χ.Π.

SILDENAFIL- SILDENAFIL CITRATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, 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
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
CONTRAINDICATIONS (4)
5/2015
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–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: 20 mg three times a day, 4–6 hours apart (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 (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 were epistaxis, headache,
dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinit