Drug Catalog - Product Detail
TOLTERODINE TARTRATE ER CP 2MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-3402-93 | MYLAN | 30 | 2MG | CAPSULE |
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Description
11 DESCRIPTION Tolterodine tartrate extended-release capsules contain 2 mg or 4 mg of tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (+)-( R )-2-[I-[2-(Diisopropylamino)ethyl]benzyl]- p -cresol L-tartrate (1:1) (salt). The molecular formula of tolterodine tartrate is C 26 H 37 NO 7 . Its structure is: Tolterodine tartrate, USP is a white to off-white colored solid with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each capsule contains 2 mg or 4 mg of tolterodine tartrate with the following inactive ingredients: ethylcellulose, FD&C Blue No. 2, gelatin, hypromellose, sodium lauryl sulfate, sugar spheres (corn starch and sucrose), talc and titanium dioxide. The 2 mg capsules also contain yellow iron oxide. The imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol and shellac. Tolterodine Tartrate Strcutural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
Indications & Usage
1 INDICATIONS AND USAGE 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 an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 )
Dosage and Administration
2 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 ) 2.1 Dosing Information The recommended dose of tolterodine tartrate extended-release capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for tolterodine tartrate extended-release capsules 2 mg [see Clinical Studies (14) ] . 2.2 Dosage Adjustment in Specific Populations For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10-30 mL/min), the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily. Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr < 10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see Warnings and Precautions (5.6) , Use in Specific Populations (8.6 , 8.7) ]. 2.3 Dosage Adjustment in Presence of Concomitant Drugs For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g., ketoconazole, clarithromycin, ritonavir], the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [see Drug Interactions (7.2) ] .