"The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired d"...
DOSAGE AND ADMINISTRATION
The recommended dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. VESIcare should be taken with water and swallowed whole. VESIcare can be administered with or without food.
Dose Adjustment in Patients with Renal Impairment
Dose Adjustment in Patients with Hepatic Impairment
For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of VESIcare greater than 5 mg is not recommended. Use of VESIcare in patients with severe hepatic impairment (Child-Pugh C) is not recommended [see WARNINGS AND PRECAUTIONS; Use in Specific Populations].
Dose Adjustment in Patients Taking CYP3A4 Inhibitors
When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of VESIcare greater than 5 mg is not recommended [see DRUG INTERACTIONS].
Dosage Forms And Strengths
The 5 mg tablets are round, light yellow, debossed with 150.
The 10 mg tablets are round, light pink, debossed with 151.
Storage And Handling
VESIcare is supplied as round, film-coated tablets, available in bottles and unit dose blister packages as follows:
Each 5 mg tablet is light yellow and debossed with a logo and “150” and is available as follows:
Bottle of 30 NDC 51248-150-01
Bottle of 90 NDC 51248-150-03
Unit Dose Pack of 100 NDC 51248-150-52
Each 10 mg tablet is light pink and debossed with a logo and “151” and is available as follows:
Bottle of 30 NDC 51248-151-01
Bottle of 90 NDC 51248-151-03
Unit Dose Pack of 100 NDC 51248-151-52
Store at 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F-86°F) [see USP Controlled Room Temperature].
Manufactured by: Astellas Pharma Technologies, Inc., Norman, Oklahoma 73072. Marketed and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062. Revised: October 2013
Last reviewed on RxList: 11/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional VESIcare Information
VESIcare - User Reviews
VESIcare User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.