Adult Dosing

Overactive bladder

• Start 5 mg PO qd; if well tolerated, increase the dose to 10 mg PO qd
• When used concomitantly with potent CYP3A4 inhibitors, solifenacin dose should not exceed 5 mg/day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

• Hypersensitivity to any of the ingredients of the product
• Urinary retention
• Gastric retention
• Uncontrolled narrow-angle glaucoma
• Severe hepatic impairment

• N/A

Renal Dose Adjustment (Based on CrCl)

• Severe renal impairment (CrCL <30 mL/min): 5 mg PO qd, caution advised

Hepatic Dose Adjustment

• Child-Pugh B (moderate hepatic impairment): 5 mg PO qd, caution advised
• Child-Pugh C (severe hepatic impairment): Contraindicated

See Supplemental Patient Information

• Incidences of angioedema involving the face, lips, tongue, and/or larynx have occurred during therapy; some events associated with upper airway swelling may be life threatening. Promptly discontinue therapy and initiate appropriate medical treatment if such events occur
• Use cautiously in patients with a history of QT prolongation and in patients receiving medicines known to prolong the QT interval
• Therapy may cause heat prostration; advise patients to use cautiously in hot weather
• CNS anticholinergic effects including headache, confusion, hallucinations and somnolence have been reported with therapy. Monitor for signs of anticholinergic CNS effects, especially after initiating treatment or increasing the dose

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Bladder outflow obstruction
• Decreased GI motility
• Controlled narrow-angle glaucoma
• Elderly patients

Supplemental Patient Information

• Instruct patients to seek medical attention if they experience severe abdominal pain and constipation for more than 3 days
• Advise patients not to engage in potentially dangerous tasks such as driving or operating machinery until the drug's effect on the patient's vision has been determined

Vesicare interacts with :

	Aricept
	Aricept ODT
	Donepezil
	Exelon
	Galantamine
	Razadyne
	Razadyne ER
	Rivastigmine

Pregnancy Category:C

Breastfeeding: An alternate drug may be preferred, especially while nursing a newborn or preterm infant because solifenacin has a long half-life (55 hrs) and less published data. Prolonged use may reduce milk production. Monitor infant for signs of decreased milk production such as insatiety, poor weight gain and for anticholinergic symptoms including constipation, urinary retention, UTI, and dry mouth. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 May 2011. As per manufacturer's data, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CNS: Dizziness, depression
• GI: Dry mouth, constipation, nausea, colonic obstruction, severe fecal impaction, intestinal obstruction, dyspepsia, upper abdominal pain, vomiting
• CV: Hypertension, QT prolongation, torsades de pointes
• RESP: Cough
• EENT: Blurred vision, dry eyes
• GU: Urinary retention, UTI
• HYPERSENSITIVITY: Angioneurotic edema
• DERM: Exfoliative dermatitis, erythema multiforme
• MISC: Influenza, pharyngitis, edema, fatigue, heat stroke

• Competitive muscarinic acetylcholine receptor antagonist; contracts urinary bladder smooth muscle and stimulates salivary secretion
• Metabolized in liver, active metabolite 4R-hydroxy solifenacin; CYP450: 3A4 substrate
• Excreted renally (69.2%), feces (22.5%)
• Half-life: 45-68 hrs

US Trade Name(s)

• Vesicare

US Availability

solifenacin (generic)

• TABS: 5, 10 mg

Vesicare

• TABS: 5, 10 mg

Canadian Trade Name(s)

• Vesicare

Canadian Availability

Vesicare

• TABS: 5, 10 mg

UK Trade Name(s)

• Vesicare

UK Availability

Vesicare

• TABS: 5, 10 mg

Australian Trade Name(s)

• Vesicare

Australian Availability

Vesicare

• TABS: 5, 10 mg

[Outline]

Urologic

Antispasmodics; Urinary

Anticholinergics

Pricing data from www.DrugStore.com in U.S.A.

• VESIcare 5 MG TABS [Bottle] (ASTELLAS)
  30 mg = $184
  90 mg = $526.99
• VESIcare 10 MG TABS [Bottle] (ASTELLAS)
  30 mg = $170.09
  90 mg = $481.91

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: VESIcare 10 MG Oral Tablet

Ingredient(s): Solifenacin

Imprint: 151

Color(s): Pink

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Astellas Pharma Technologies, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: VESIcare 5 MG Oral Tablet

Ingredient(s): Solifenacin

Imprint: 150

Color(s): Yellow

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Astellas Pharma Technologies, Inc.

DEA Schedule:
Non-Scheduled