TOLTERODINE TARTRATE- tolterodine 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:

American Health Packaging

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) ]. Risk Summary 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 tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis di

Product summary:

Tolterodine tartrate extended-release capsules are supplied as follows: 2 mg capsules are size "4", hard gelatin capsules having a green cap and green body, imprinted "1189" on the cap with white ink, containing off-white to brownish colored pellets. Unit dose packages of 30 (3×10) NDC 60687-319-21 4 mg capsules are size "3", hard gelatin capsules having a blue cap and blue body, imprinted "1190" on the cap with white ink, containing off-white to brownish colored pellets. Unit dose packages of 30 (3×10) NDC 60687-330-21 Store tolterodine tartrate extended-release capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOLTERODINE TARTRATE- TOLTERODINE CAPSULE, EXTENDED RELEASE
AMERICAN HEALTH PACKAGING
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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 ADMINISTRATION
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 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 metabolized to 5-hydroxymethyl tolterodine. ( 4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and angioedema requiring hospitalization and emergency
medical treatment have
occurred with the first or subsequent doses of tolter