Country: United States
Language: English
Source: NLM (National Library of Medicine)
TOLTERODINE TARTRATE (UNII: 5T619TQR3R) (TOLTERODINE - UNII:WHE7A56U7K)
Major Pharmaceuticals
TOLTERODINE TARTRATE
TOLTERODINE TARTRATE 2 mg
ORAL
PRESCRIPTION DRUG
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
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. Carton of 30 capsules (10 capsules each blister pack x 3), NDC 0904-6592-04 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. Carton of 30 capsules (10 capsules each blister pack x 3), NDC 0904-6593-04 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.
Abbreviated New Drug Application
TOLTERODINE TARTRATE- TOLTERODINE CAPSULE, EXTENDED RELEASE MAJOR PHARMACEUTICALS ---------- 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 • • • • 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 • • • • • • • 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) Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with Read the complete document