SILDENAFIL tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

BluePoint Laboratories

INN (Међународно име):

SILDENAFIL CITRATE

Састав:

SILDENAFIL 20 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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: 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 during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Con

Резиме производа:

Sildenafil tablets, USP, 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. They are available as follows: Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

SILDENAFIL- SILDENAFIL TABLET
BLUEPOINT LABORATORIES
----------
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
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
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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 REACTIONS, CONTACT AMNEAL PHARMACEUTICALS
AT 1-877-835-5472 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2018
Warnings and Precautions, Visual Loss (5.5) 07/2017
_Tablets:_ 20 mg (3)
Use with organic nitrates or riociguat (4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet (4)
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 atte