Solifenacin Succinate 10 mg/1
Solifenacin Succinate · TABLET, COATED · Alembic Pharmaceuticals Limited
Solifenacin Succinate is a tablet, coated containing solifenacin succinate at 10 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.
Key Facts
- Brand Name
- Solifenacin Succinate
- Generic Name
- Solifenacin Succinate
- NDC Code (Product)
46708-193- Manufacturer
- Alembic Pharmaceuticals Limited
- Strength
- 10 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205575
- Marketing Start
- 05/20/2019
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
CIPLA
CGMP Deviations
Breckenridge Pharmaceutical, Inc
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Aidapak Services, LLC
Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree: W003754, EXP: 6/26/2014.
Breckenridge Pharmaceutical, Inc
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency ( 1 ).
Dosage & Administration
2 DOSAGE AND 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 are 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 impai…
Contraindications
4 CONTRAINDICATIONS Solifenacin succinate tablets are contraindicated in patients: • With urinary retention [ see Warnings and Precautions ( 5.2 ) ], • With gastric retention [ see Warnings and Precautions ( 5.3 ) ], • With uncontrolled narrow-angle glaucoma [ see Warnings and Precautions ( 5.5 ) ], and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema [ see Adverse Reactions ( 6.2 ) ]. • Urinary retention ( 4 , 5.2 ). • Gastric retention ( 4 , 5.3 ). • Uncontrolled narrow-angle glaucoma ( 4 , 5.5 ). • Hypersensitivity to this product or any of its components ( 4 , 5.1 , 6.2 ).
Drug Interactions
7 DRUG INTERACTIONS CYP3A4 Inhibitors : Do not exceed the 5 mg dose of solifenacin succinate with concomitant use of strong CYP3A4 inhibitors ( 7.1 ). 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [ see Clinical Pharmacology ( 12.3 ) ]. The dosage of solifenacin succinate greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [ see Dosage and Administration ( 2.4 ) ].
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Solifenacin succinate has been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1 to 4) [see Clinical Studies ( 14 )] . Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with solifenacin succinate was higher in the 10 mg dose group compared to the 5 m…
Frequently Asked Questions
What is Solifenacin Succinate used for?
Solifenacin Succinate contains Solifenacin Succinate. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Solifenacin Succinate a controlled substance?
Solifenacin Succinate is not classified as a controlled substance by the DEA.
What is the generic name for Solifenacin Succinate?
The generic name for Solifenacin Succinate is Solifenacin Succinate. There are 7 other brand versions of Solifenacin Succinate.
What is the NDC code for Solifenacin Succinate 10 mg/1?
The NDC (National Drug Code) for Solifenacin Succinate 10 mg/1 is 46708-193, listed by Alembic Pharmaceuticals Limited.