TOLTERODINE TARTRATE capsule, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aphena Pharma Solutions - Tennessee, LLC

INN (Kansainvälinen yleisnimi):

TOLTERODINE TARTRATE

Koostumus:

TOLTERODINE TARTRATE 4 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 pharmacologically active components of tolterodine tartrate extended-release capsules, no anomalies or malformations were observed in mice (based on the AUC of tolterodine and its 5-HMT metabolite at a dose of 20 mg/kg/day). At 14 to 18 times

Tuoteyhteenveto:

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 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 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 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. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

TOLTERODINE TARTRATE- TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 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)
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 the drug or
its ingredients, or to fesoterodine fuma