FESOTERODINE FUMARATE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227)

Available from:

Golden State Medical Supply, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.’s TOVIAZ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following, - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [s ee Clinical Pharmacology ( 12.1) ]. - Reactions have included angioedema [ see Warnings and Precautions ( 5.1) ]. - urinary retention [ see Warnings and Precautions ( 5

Product summary:

Fesoterodine fumarate extended-release tablets, 4 mg are light blue colored, oval shaped, biconvex, film-coated, debossed with ‘ ’ on one side and 'FS' on the other side and are supplied in bottles of 30's. Bottles of 30 NDC 51407-661-30 Fesoterodine fumarate extended-release tablets, 8 mg are blue colored, oval shaped, biconvex, film-coated, debossed with ‘ ’ on one side and ‘FT’ on the other side and are supplied in bottles of 30's. Bottles of 30 NDC 51407-662-30 Store fesoterodine fumarate extended-release tablets, at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FESOTERODINE FUMARATE- FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FESOTERODINE FUMARATE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FESOTERODINE
FUMARATE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS.
FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage ( 1.1) 06/2021
Dosage and Administration ( 2.1, 2.3, 2.5, 2.6) 06/2021
Contraindications ( 4) 06/2021
Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4, 5.6) 06/2021
INDICATIONS AND USAGE
Fesoterodine fumarate is indicated for the treatment of:
• Overactive bladder(OAB) in adults with symptoms of urge urinary
incontinence, urgency, and frequency.
( 1.1)
DOSAGE AND ADMINISTRATION
• OAB in Adults:The recommended starting dosage is 4 mg orally once
daily. Based upon individual
response and tolerability, increase the maximum dosage of 8 mg once
daily. ( 2.1)
• Adult Patients with Renal or Hepatic Impairment: Refer to the full
prescribing information for
recommended dosage. ( 2.3)
• Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the
full prescribing information for
recommended dosage. ( 2.5)
• Administration: Swallow whole with liquid. Do not chew, divide, or
crush. Take with or without food. ( 2.6)
CONTRAINDICATIONS
• Known or suspected hypersensitivity to fesoterodine fumarate
extended-release tablets or any of its
ingredients or to tolterodine tartrate tablets or tolterodine tartrate
extended-release capsules. ( 4)
• Urinary retention ( 4)
• Gastric retention ( 4)
• Uncontrolled narrow-angle glaucoma. ( 4)
WARNINGS AND PRECAUTIONS
Angioedema: Promptly discontinue fesoterodine fumarate
extended-release tablets and provide
appropriate therapy. ( 5.1).
Urinary Retention: Fesoterodine fumarate extended-release tablets are
not recommended in patients
with clinically signi