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VESIcare

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VESIcare

Indications
Dosage
How Supplied

INDICATIONS

VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

DOSAGE AND ADMINISTRATION

Dosing Information

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

For patients with severe renal impairment (CLcr < 30 mL/min), a daily dose of VESIcare greater than 5 mg is not recommended [see WARNINGS AND PRECAUTIONS; Use in Specific Populations].

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].

HOW SUPPLIED

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.

Indications
Dosage
How Supplied
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VESIcare - User Reviews

VESIcare User Reviews

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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.


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