SILDENAFIL- sildenafil citrate tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

KAISER FOUNDATION HOSPITALS

INN (mednarodno ime):

SILDENAFIL CITRATE

Sestava:

SILDENAFIL 20 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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)] . - Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, inc

Povzetek izdelek:

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].

Status dovoljenje:

New Drug Application Authorized Generic

Lastnosti izdelka

SILDENAFIL- SILDENAFIL CITRATE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
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
INDICATIONS AND USAGE ( 1)
1/2014
WARNINGS AND PRECAUTIONS, Visual Loss ( 5.5)
3/2014
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 ( 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, flushin