VESICARE- solifenacin succinate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U)

Available from:

Cardinal Health

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VESIcare® is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. VESIcare is contraindicated in patients with: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in mice, rats and rabbits. After oral administration of 14 C-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. No embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the MRHD, during the major period of organ development resulted in reduced fetal body weights. Administration of 7.9 times (250 mg/kg/day) the MRHD to pregnant mice resulted in an increased incidence of cleft palate. In

Product summary:

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 in bottles of 3240 tablets, NDC 55154-3877-2. Each 10 mg tablet is light pink and debossed with a logo and “151” and is available in bottles of 4590 tablets, NDC 55154-3878-8. Distributed By: Cardinal Health Dublin, OH 43017 Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

VESICARE- SOLIFENACIN SUCCINATE TABLET, FILM COATED
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VESICARE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VESICARE.
VESICARE (SOLIFENACIN SUCCINATE) TABLETS
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
VESIcare is a muscarinic antagonist indicated for the treatment of
overactive bladder with symptoms of urge urinary
incontinence, urgency, and urinary frequency (1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
THE MOST COMMON ADVERSE REACTIONS (> 4% AND > PLACEBO) 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 ASTELLAS PHARMA US, INC AT 1-800-727-7003
OR FDA AT 1-800-FDA-1088 OR
HTTP://WWW.FDA.G O V/M E DWATC H.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
_Pregnancy and Nursing Mothers_: VESIcare should be used during
pregnancy only if the potential benefit for the mother
justifies the potential risk to the fetus. VESIcare should not be
administered during nursing (8.1, 8.3).
_Pediatric Use_: The safety and effectiveness of VESIcare in pediatric
patients have not been established (8.4).
®
5 mg tablet taken once daily, and if well tolerated may be increased
to 10 mg once daily (2.1).
Do not exceed 5 mg tablet once daily in patients with:
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severe renal impairment [Creatinine Clearance] (CL < 30 mL/min) (2.2).
cr
moderate hepatic impairment (Child-Pugh B) (2.3).
concomitant use of potent CYP3A4 inhibitors (2.4).
Use of VESIcare is not recommended in patients with severe hepatic
impairment (Child-Pugh C) (2.3).
Urinary retention (4, 5.2).
Gastric retention (4, 5.3).
Uncontrolled narrow-angle glaucoma (4, 5.5).
In patients who have demonstrated hypersensitivity to the