SILDENAFIL- sildenafil tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

REMEDYREPACK INC.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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-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 guanylat

Produkt oppsummering:

Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Dispense in tight containers (USP).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SILDENAFIL- SILDENAFIL TABLET, FILM COATED
REMEDYREPACK INC.
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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, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Loss ( 5.5) 07/2017
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
Tablet: 20 mg three times a day, 4-6 hours apart ( 2.1)
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, flush