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:

Mylan Pharmaceuticals 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 tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis did not produce adverse developmental outco

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 0378-3402-93 bottles of 30 capsules NDC 0378-3402-05 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 0378-3404-93 bottles of 30 capsules NDC 0378-3404-05 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
MYLAN PHARMACEUTICALS 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
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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ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 4% and > placebo)
were dry mouth, headache, constipation, and
abdominal pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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:
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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)
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 th