TOLTERODINE TARTRATE capsule, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mylan Institutional Inc.

INN (Διεθνής Όνομα):

TOLTERODINE TARTRATE

Σύνθεση:

TOLTERODINE TARTRATE 2 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)] . 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 tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see Warnings and Precautions (5.2), ( 5.3), ( 5.4)] . At approximately 9 to 12 times the clinical exposure to the pharmacolo

Περίληψη προϊόντος:

Tolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP. The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with MYLAN over 3402 in black ink on both the cap and body. They are available as follows: NDC 51079-197-03 – Unit dose blister packages of 30 (3 cards of 10 capsules each). The 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with MYLAN over 3404 in black ink on both the cap and body. They are available as follows: NDC 51079-198-03 – Unit dose blister packages of 30 (3 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TOLTERODINE TARTRATE- TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE
MYLAN INSTITUTIONAL INC.
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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
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:
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)
DOSAGE FORMS AND STRENGTHS
Capsules: 2 mg and 4 mg ( 3)
CONTRAINDICATIONS
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
tablets which, like tolterodine tartrate extended-release capsules,
are