SILDENAFIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Sildenafil tablets are contraindicated in patients with: Teratogenic Effects : Pregnancy Category B There are no adequate and well-controlled studies of sildenafil in pregnant women. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2  basis, 32- and 68-times, respectively, the recommended hum

Product summary:

Sildenafil tablets are supplied as white to off white colored, round shaped, biconvex, film coated tablets debossed with 'J' on one side and '95' on the other side. The tablets are available as follows Bottle of 10's                                                                                  NDC 63187-619-10 Bottle of 30's                                                                                  NDC 63187-619-30 Bottle of 60's                                                                                  NDC 63187-619-60 Bottle of 90's                                                                                  NDC 63187-619-90 Recommended Storage for Sildenafil Tablets: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL- SILDENAFIL TABLET, FILM COATED
PROFICIENT RX LP
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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
INDICATIONS AND USAGE (1)01/2014
WARNINGS AND PRECAUTIONS, Visual Loss (5.5) 03/2014
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 to III symptoms. Etiologies were
idiopathic (71%) or associated with
connective tissue disease (25%). (1)
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•Use with organic nitrates (4)
•History of hypersensitivity reaction to sildenafil or any component
of the tablet (4)
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 HETERO LABS LIMITED AT
866-495-1995
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.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2022
Tablet: 20 mg three times a day, 4 to 6 hours apart (2.1)
_Tablets:_ 20 mg (3)
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