TOLTERODINE TARTRATE- 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:

Teva Pharmaceuticals USA 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) ]. 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 did not produce adverse deve

Product summary:

Tolterodine tartrate extended-release capsules are supplied as follows: Store at 20°–25°C (68°–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TOLTERODINE TARTRATE- TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE
TEVA PHARMACEUTICALS USA 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
C APSULE S.
TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES
FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: DECEMBER 2000
INDICATIONS AND USAGE
Tolterodine tartrate extended-release capsules is 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 with the first or
subsequent doses of tolterodine