Drugplain

VESIcare LS 1 mg/mL

solifenacin succinate · SUSPENSION · Astellas Pharma US, Inc.

No Recall History
Plain English

Vesicare LS (solifenacin succinate) is a liquid medication taken by mouth used to treat overactive bladder symptoms such as frequent urination, urgency, and incontinence. It works by relaxing the bladder muscle to help improve bladder control.

Key Facts

Brand Name
VESIcare LS
Generic Name
solifenacin succinate
NDC Code (Product)
51248-250
Manufacturer
Astellas Pharma US, Inc.
Strength
1 mg/mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
NDA209529
Marketing Start
05/26/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,610 reports
constipation1,622 reports
dry mouth1,620 reports
fatigue1,287 reports
off label use1,247 reports
fall1,231 reports
dizziness1,041 reports
nausea903 reports
headache865 reports
vision blurred789 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VESIcare LS ® is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older. VESIcare LS is a muscarinic antagonist indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • The recommended once daily dose of VESIcare LS is based on patient weight, refer to Table 1. Dosing should be initiated at the recommended starting dose. Dosage may be titrated to the lowest effective dose but should not exceed the maximum recommended dose. ( 2.1 ) • Instruct patients or their caregivers that patients should take VESIcare LS orally followed by liquid (e.g., water or milk). • Do not exceed the recommended starting dose of VESIcare LS 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). VESIcare LS 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 Dosing Information in Pediatric Patients Aged 2 Years and Older The recommended starting and maximum VESIcare LS oral suspension doses are shown in mL in Table 1 . VESIcare LS oral suspension has a concentration of 1 mg/1 mL. The recommended doses are weight-based and are administered once daily. After administration of the recommended starting dose, the dose may be increased t…

Contraindications

4 CONTRAINDICATIONS VESIcare LS is contraindicated in patients: • 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 VESIcare LS oral suspension. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions ( 6.2 )] . • 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 recommended starting dose of VESIcare LS 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 VESIcare LS greater than the starting dose is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] .

Adverse Reactions

6 ADVERSE REACTIONS • Angioedema and Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.3 )] • Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] • QT Prolongation in Patients at High Risk of QT Prolongation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (> 2%) were constipation, dry mouth and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or 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. The safety of VESIcare LS oral suspension was evaluated in two open-label trials (Studies 1 and 2) [see Clinical Studies ( 14 )] . The two studies included 95 pediatric patients aged 2 to 17 years with neurogenic detrusor overactivity (NDO) who were 53% fema…

Frequently Asked Questions

What is VESIcare LS used for?

Vesicare LS (solifenacin succinate) is a liquid medication taken by mouth used to treat overactive bladder symptoms such as frequent urination, urgency, and incontinence. It works by relaxing the bladder muscle to help improve bladder control.

Is VESIcare LS a controlled substance?

VESIcare LS is not classified as a controlled substance by the DEA.

What is the generic name for VESIcare LS?

The generic name for VESIcare LS is solifenacin succinate. There are 12 other brand versions of solifenacin succinate.

What is the NDC code for VESIcare LS 1 mg/mL?

The NDC (National Drug Code) for VESIcare LS 1 mg/mL is 51248-250, listed by Astellas Pharma US, Inc..

Product NDC

51248-250

Package NDC

51248-250-99

Other Solifenacin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)