SILDENAFIL- sildenafil tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

NuCare Pharmaceuticals, Inc.

INN (Mezinárodní Name):

SILDENAFIL CITRATE

Složení:

SILDENAFIL 20 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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%). 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)] . - Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use

Přehled produktů:

Sildenafil tablets, 20 mg, are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. NDC 68071-3329-4 Bottle of 4 NDC 68071-3329- 8 Bottle of 8 NDC 68071-3329-1 Bottle of 10 NDC 68071-3329-5 Botte of 20 NDC 68071-3329-2 Bottle of 28 NDC 68071-3329-3 Bottle of 30 Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SILDENAFIL- SILDENAFIL TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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
Indication and Use (1) 01/2014
Dosage and Administration (2.1) 01/2014
Warnings and Precautions, Visual Loss (5.5) 02/2014
INDICATIONS AND USAGE
Sildenafil tablets are 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)
DOSAGE AND ADMINISTRATION
Tablet: 20 mg three times a day, 4 to 6 hours apart (2.1)
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
citrate 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 rhinitis.
(6.1,6.2)
TO REPORT SUSPECTED ADVERSE REACT