TOLTERODINE TARTRATE EXTENDED RELEASE- tolterodine tartrate capsule, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Greenstone LLC

INN (nume internaţional):

TOLTERODINE TARTRATE

Compoziție:

TOLTERODINE TARTRATE 2 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Tolterodine tartrate extended- release capsules are supplied as follows: Bottles of 30 Bottles of 500 Bottles of 90 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.

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

TOLTERODINE TARTRATE EXTENDED RELEASE- TOLTERODINE TARTRATE CAPSULE,
EXTENDED
RELEASE
GREENSTONE LLC
----------
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 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 with the first or
subsequent doses of tolterod