Drug Catalog - Product Detail
DARIFENACIN ER TAB 15MG 90CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69097-0432-05 | CIPLA USA | 90 | 15MG | TABLET |
PACKAGE FILES
Generic Name
DARIFENACIN HYDROBROMIDE
Substance Name
DARIFENACIN HYDROBROMIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207664
Description
11 DESCRIPTION Darifenacin is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist. Chemically, darifenacin hydrobromide is (S) -2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C 28 H 30 N 2 O 2 •HBr. The structural formula is: Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5. Darifenacin is a once-a-day extended-release tablet and contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15 mg tablet also contains iron oxide red and iron oxide yellow. Image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Darifenacin extended-release tablet 7.5 mg are white to off white colored circular biconvex film coated tablet debossed with "C" on one side and "431" on the other side. Bottle of 30 ............................................................................................................... NDC 69097-431-02 Bottle of 90 ............................................................................................................... NDC 69097-431-05 Bottle of 1000 ........................................................................................................... NDC 69097-431-15 Darifenacin extended-release tablet 15 mg are light peach colored circular biconvex film coated tablet debossed with "C" on one side and "432" on the other side. Bottle of 30................................................................................................................ NDC 69097-432-02 Bottle of 90................................................................................................................ NDC 69097-432-05 Bottle of 1000 ........................................................................................................... NDC 69097-432-15 Storage Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Protect from light. Keep this and all drugs out of the reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 ) Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of darifenacin extended-release tablets is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy ( 2 ) The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg in the following patients: Patients with moderate hepatic impairment (Child-Pugh B) ( 2 , 8.6 ) Patients taking potent CYP3A4 inhibitors ( 2 , 7.1 ) Darifenacin extended-release tablets are not recommended for use in patients with severe hepatic impairment (Child-Pugh C) ( 2 , 8.6 ) Darifenacin extended-release tablets may be taken with or without food. The tablet should be swallowed whole with water and not chewed, divided or crushed. ( 2 ) The recommended starting dose of darifenacin extended-release tablet is 7.5 mg orally once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy. Darifenacin extended-release tablets should be taken orally once daily with water. Darifenacin extended-release tablets may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed. For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of darifenacin extended-release tablets should not exceed 7.5 mg. Darifenacin extended-release tablets are not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Warnings & Precautions ( 5.6 ), Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .