Solifenacin

Brands

DEA Class;  Rx

Common Brand Names; VESIcare, VESIcare LS

  • Anticholinergics, Genitourinary

Oral competitive selective M3 antimuscarinic agent
Used for overactive bladder (OAB) in adult or pediatric patients 2 years and older; in adults may be used in combination with a beta-3 adrenoreceptor agonist
Common side effects include dry mouth or constipation; monitor for urinary retention

Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency.

For the treatment of neurogenic detrusor overactivity (neurogenic bladder).

Hypersensitivity

Gastric retention

Uncontrolled narrow-angle glaucoma

tablets only

  • Urinary retention

Tablets

  • Blurred vision (3.8-4.8%)
  • Dry mouth (10.6-27.6%)
  • Constipation (5.4-13.4%)
  • Urinary tract infection NOS (2.8-4.8%)
  • Dyspepsia (1.4-3.9%)
  • Nausea (1.7-3.3%)
  • Influenza (0.9-2.2%)
  • Fatigue (1-2.1%)
  • Dizziness (1.8-1.9%)
  • Upper abdominal pain (1.2-1.9%)
  • Dry eyes NOS (0.3-1.6%)
  • Urinary retention (1.4%)
  • Hypertension NOS (0.5-1.4%)
  • Depression NOS (0.8-1.2%)
  • Edema lower limb (0.3-1.1%)
  • Vomiting (0.2-1.1%)
  • Cough (0.2-1.1%)

Oral suspension

  • Constipation (7.4%)
  • Dry mouth (3.2%)
  • Urinary tract infection (2.1%)
  • Abdominal pain (1.1%)
  • Positive urinalysis bacterial test (1.1%)
  • Somnolence (1.1%)

Reports of angioedema of face, lips and/or larynx, in some cases occurring after the first dose, described; anaphylactic reactions reported rarely

Administer with caution with clinically significant bladder outflow obstruction

Caution with decreased gastrointestinal motility

Somnolence reported; advise patients not to drive or operate heavy machinery until they know how therapy affects them

Caution in patients being treated for narrow-angle glaucoma

Caution with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval

Associated with antimuscarinic CNS adverse reactions; monitor for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose

There are no studies on use in pregnant females

Adults

10 mg/day PO.

Geriatric

10 mg/day PO.

Adolescents

weighing more than 60 kg: 10 mg/day PO.
weighing 46 to 60 kg: 8 mg/day PO.
weighing 31 to 45 kg: 6 mg/day PO.
weighing 16 to 30 kg: 5 mg/day PO.
weighing 9 to 15 kg: 4 mg/day PO.

Children

2 to 12 years:
weighing more than 60 kg: 10 mg/day PO.
weighing 46 to 60 kg: 8 mg/day PO.
weighing 31 to 45 kg: 6 mg/day PO.
weighing 16 to 30 kg: 5 mg/day PO.
weighing 9 to 15 kg: 4 mg/day PO.
1 year: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Solifenacin succinate

tablet

  • 5mg (VESIcare)
  • 10mg (VESIcare)

VESIcare Oral Susp: 1mg, 1mL

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