SILDENAFIL- sildinafil 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:

Mylan Pharmaceuticals Inc.

INN (International Name):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)] . Pediatric Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)] . Sildenafil tablets are contraindicated in patients with: Click here to enter Use in Specific Populations 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 mo

Product summary:

Sildenafil Tablets, USP are available containing sildenafil citrate, USP equivalent to 20 mg of sildenafil. The 20 mg tablets are blue, film-coated, oval, unscored tablets debossed with M on one side of the tablet and SL  20 on the other side. They are available as follows: NDC 0378-1657-77 bottles of 90 tablets Recommended Storage for Sildenafil Tablets: 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 using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL- SILDINAFIL TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
Indications and Usage (1) 1/2023
Dosage and Administration (2.1, 2.2) 1/2023
INDICATIONS AND USAGE
Adults
Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor
indicated for the treatment of pulmonary
arterial hypertension (PAH) (World Health Organization [WHO] Group I)
in adults to improve exercise ability
and delay clinical worsening. (1)
Pediatric Patients (1 to 17 years old)
Sildenafil tablets are indicated in pediatric patients 1 to 17 years
old for the treatment of pulmonary
arterial hypertension (PAH) (WHO Group I) to improve exercise ability
and, in pediatric patients too young
to perform standard exercise testing, pulmonary hemodynamics thought
to underly improvements in
exercise (1, 14)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back
pain and diarrhea. (6.1, 6.2)
Children: Priapism. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT
1-877-446-3679 (1-877-4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Adults: 20 mg three times a day. Dose may be increased based on
symptoms and tolerability. (2.1)
Pediatric patients (2.2)
o
o
o
≤20 kg: 10 mg three times a day
20 kg to 45 kg: 20 mg three times a day
>45 kg: 20 mg three times a day. Dose may be increased based on
symptoms and tolerability.
Tablets: 20 mg (3)
Use with organic nitrates or riociguat. (4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet. (4)
Vasodilation effects may be more common in patients with hypotension
or on antihypert