Drug Catalog - Product Detail
SOLIFENACIN SUCCINATE 5MG TB 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67877-0527-30 | ASCEND LABORATORIES | 30 | 5MG | TABLET |
PACKAGE FILES
Generic Name
SOLIFENACIN SUCCINATE
Substance Name
SOLIFENACIN SUCCINATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA210224
Description
11 DESCRIPTION Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate. The coating material contains hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet). solifenacin-st
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Solifenacin succinate tablets are supplied as round, film-coated tablets, available in bottles and unit-dose blister packages as follows: 5 mg tablets: Light yellow, round shaped, film coated tablets debossed with “S5” on one side and plain on other side. Tablets are provided as follows: Bottle of 30: NDC 67877-527-30 Bottle of 90: NDC 67877-527-90 Carton of 100 (10 x10 Unit-Dose) Tablets : NDC 67877-527-38 10 mg tablets: Light pink, round shaped, film coated tablets debossed with "S10" on one side and plain on other side. Tablets are provided as follows: Bottle of 30: NDC 67877-528-30 Bottle of 90: NDC 67877-528-90 Carton of 100 (10 x10 Unit-Dose) Tablets: NDC 67877-528-38 Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS & USAGE Solifenacin succinate tablets is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )
Dosage and Administration
2 DOSAGE & ADMINISTRATION 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. ( 2.1 ) Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with: Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2 . ( 2.2 , 8.6 ) Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets is not recommended in patients with severe hepatic impairment (Child- Pugh C). ( 2.3 , 8.7 ) Concomitant use of strong CYP3A4 inhibitors. ( 2.4 , 7.1 ) 2.1 Dosing Information The recommended oral dose of solifenacin succinate tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin succinate tablets should be taken with water and swallowed whole. Solifenacin succinate tablets can be administered with or without food. 2.2 Dosing Recommendations in Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr < 30 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.6 ) ] . 2.3 Dosing Recommendations in Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use solifenacin succinate tablets in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 )] . 2.4 Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when solifenacin succinate tablets is administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions ( 7.1 ) ] .