VESIcare

VESICARE- solifenacin succinate tablet, film coated
Astellas Pharma Technologies, Inc.

1 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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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 (5.7); Use in Specific Populations (8.6)].

2.3 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 (5.6); Use in Specific Populations (8.7)].

2.4 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 (7.1)].

3 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.

4 CONTRAINDICATIONS

VESIcare is contraindicated in patients with:

urinary retention [see Warnings and Precautions (5.2)],
gastric retention [see Warnings and Precautions (5.3)],
uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5)], and
in patients who have demonstrated hypersensitivity to the drug [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Angioedema and Anaphylactic Reactions

Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin. In some cases angioedema occurred after the first dose. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, solifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Anaphylactic reactions have been reported rarely in patients treated with solifenacin succinate. Solifenacin succinate should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

5.2 Urinary Retention

VESIcare, like other anticholinergic drugs, should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4)].

5.3 Gastrointestinal Disorders

VESIcare, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility [see Contraindications (4)].

5.4 Central Nervous System Effects

VESIcare is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2)]. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how VESIcare affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.5 Controlled Narrow-Angle Glaucoma

VESIcare should be used with caution in patients being treated for narrow-angle glaucoma [see Contraindications (4)].

5.6 Hepatic Impairment

VESIcare should be used with caution in patients with hepatic impairment. Doses of VESIcare greater than 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh B). VESIcare is not recommended for patients with severe hepatic impairment (Child-Pugh C) [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)].

5.7 Renal Impairment

VESIcare should be used with caution in patients with renal impairment. Doses of VESIcare greater than 5 mg are not recommended in patients with severe renal impairment (CLcr < 30 mL/min) [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

5.8 Patients with Congenital or Acquired QT Prolongation

In a study of the effect of solifenacin on the QT interval in 76 healthy women [see Clinical Pharmacology (12.2)] the QT prolonging effect appeared less with solifenacin 10 mg than with 30 mg (three times the maximum recommended dose), and the effect of solifenacin 30 mg did not appear as large as that of the positive control moxifloxacin at its therapeutic dose. This observation should be considered in clinical decisions to prescribe VESIcare for patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

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