SILDENAFIL tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Sildenafil Tablets USP, 20 mg are supplied as white, film-coated, unscored, round biconvex tablets, debossed with “TEVA” on one side of the tablet and “5517” on the other side, in bottles of 90 (NDC 0093-5517-98). Recommended Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

SILDENAFIL- SILDENAFIL TABLET, FILM COATED
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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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
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 to 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, flushing, insomnia, erythema, dyspnea, and rhinitis. ( 6.1,
6.2)
TO REP