TOLTERODINE TARTRATE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

TOLTERODINE TARTRATE

Composition:

TOLTERODINE TARTRATE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . There are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. In animal reproduction studies, oral administration of to

Product summary:

Tolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP. The 2 mg capsules are hard-shell gelatin capsules with a green opaque cap and green opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 3402 in black ink on the cap and body. They are available as follows: NDC 60429-825-30 bottles of 30 capsules NDC 60429-825-90 bottles of 90 capsules NDC 60429-825-05 bottles of 500 capsules The 4 mg capsules are hard-shell gelatin capsules with a powder blue opaque cap and powder blue opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 3404 in black ink on the cap and body. They are available as follows: NDC 60429-826-30 bottles of 30 capsules NDC 60429-826-90 bottles of 90 capsules NDC 60429-826-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. 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

TOLTERODINE TARTRATE- TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES
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
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) 10-30 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 metabolized to 5-hydroxymethyl tolterodine. ( 4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and angioedema requiring hospitalization and emergency
medical treatment have occurred