SILDENAFIL tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Amneal Pharmaceuticals LLC

INN (International Adı):

SILDENAFIL CITRATE

Kompozisyon:

SILDENAFIL 20 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. New Dosing Regimen in Adults with Pulmonary Arterial Hypertension (PAH) and treatment of PAH in Pediatric Patients (Ages 1 to 17) information are approved for Viatris Specialty LLC’s Revatio (Sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with these information. 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 (5.1)] . - Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - Known hypersensitivity to sildenafil or any component of the tablet.

Ürün özeti:

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: Bottles of 90:                                   NDC 65162-351-09 Bottles of 1000:                               NDC 65162-351-11 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].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SILDENAFIL- SILDENAFIL TABLET
AMNEAL PHARMACEUTICALS LLC
----------
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) 01/2023
Dosage and Administration (2.1) 01/2023
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)
DOSAGE AND ADMINISTRATION
Adults: 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
Vasodilation effects may be more common in patients with hypotension
or on antihypertensive
therapy. (5.1)
Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary
edema and is not
recommended. (5.2)
Hearing or visual impairment: Seek medical attention if sudden
decrease or loss of vision or hearing
occurs. (5.4, 5.5)
Pulmonary hypertension (PH) secondary to sickle cell disease:
Sildenafil citrate may cause serious
vaso-occlusive crises. (5.8)
ADVERSE REACTIONS
Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back
pain and diarrhea. (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
Use with strong CYP3A inhibitors: Not recommended. (7, 12.3)
Concomitant PDE-5 inhibitors: Avoid use with Viagra or other PDE-5
inhibitors. (5.6)
_New Dosing Regimen in Adults with Pulmonary Arterial Hypertension
(PAH) and treatment of PAH in_
_Pediatric Patients (Ages 1 to 17) information are approved for
Vi