TOLTERODINE TARTRATE capsule extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

TOLTERODINE TARTRATE (UNII: 5T619TQR3R) (TOLTERODINE - UNII:WHE7A56U7K)

זמין מ:

Avera McKennan Hospital

INN (שם בינלאומי):

TOLTERODINE TARTRATE

הרכב:

TOLTERODINE TARTRATE 4 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TOLTERODINE TARTRATE- TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOLTERODINE TARTRATE EXTENDED-
RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TOLTERODINE TARTRATE
EXTENDED-RELEASE CAPSULES.
TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: DECEMBER 2000
RECENT MAJOR CHANGES
Contraindications: Hypersensitivity to fesoterodine fumarate (4)
09/2011
Warnings and Precautions: Angioedema (5.1) 09/2011
Warnings and Precautions: Central Nervous System Effects (5.5) 08/2012
INDICATIONS AND USAGE
Tolterodine tartrate extended-release capsules are an antimuscarinic
indicated for the treatment of overactive bladder with
symptoms of urge urinary incontinence, urgency, and frequency. (1)
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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4 mg capsules taken orally once daily with water and swallowed whole.
(2.1)
2 mg capsules taken orally once daily with water and swallowed whole
in the presence of:
o
o
o
mild to moderate hepatic impairment (Child-Pugh Class A or B) (2.2)
severe renal impairment [Creatinine Clearance (CCr) 10 mL/min to 30
mL/min] (2.2)
drugs that are potent CYP3A4 inhibitors. (2.2)
Tolterodine tartrate extended-release capsules are not recommended for
use in patients with CCr < 10 mL/min. (2.2)
Tolterodine tartrate extended-release capsules are not recommended for
use in patients with severe hepatic
impairment (Child-Pugh Class C). (2.2)
Capsules: 2 mg and 4 mg (3)
Tolterodine tartrate extended-release capsules are contraindicated in
patients with urinary retention, gastric
retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate
extended-release capsules are also
contraindicated in patients with known hypersensitivity to the drug or
its ingredients, or to fesoterodine fumarate
extended-release t