Solifenacin Succinate

SOLIFENACIN SUCCINATE- solifenacin succinate tablet, film coated
Proficient Rx LP

1 INDICATIONS AND USAGE

Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended oral dose of Solifenacin Succinate Tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.

Solifenacin Succinate Tablets should be taken with water and swallowed whole. Solifenacin Succinate Tablets can be administered with or without food.

2.2 Dosing Recommendations in Patients with Renal Impairment

Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr < 30 mL/min/1.73 m 2) [see Use in Specific Populations ( 8.6)] .

2.3 Dosing Recommendations in Patients with Hepatic Impairment

Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use Solifenacin Succinate Tablets in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7)] .

2.4 Dosing Recommendations in Patients Taking CYP3A4 Inhibitors

Do not exceed 5 mg once daily when Solifenacin Succinate Tablets are administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions ( 7.1)] .

3 DOSAGE FORMS AND STRENGTHS

Tablets:

•5 mg: round, light yellow, debossed with 23

•10 mg: round, light pink, debossed with 24

4 CONTRAINDICATIONS

Solifenacin Succinate Tablets are contraindicated in patients:

•With urinary retention [see Warnings and Precautions ( 5.2)] ,

•With gastric retention [see Warnings and Precautions ( 5.3)] ,

•With uncontrolled narrow-angle glaucoma [see Warnings and Precautions ( 5.5)] , and

•Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in Solifenacin Succinate Tablets. Reported adverse reactions have included anaphylaxis and angioedema [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 succinate. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate. Angioedema associated with upper airway swelling and anaphylactic reactions may be life-threatening.

Solifenacin Succinate Tablets are contraindicated in patients with a known or suspected hypersensitivity to solifenacin succinate [see Contraindications ( 4)] . If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue Solifenacin Succinate Tablets and provide appropriate therapy and/or measures necessary to ensure a patent airway.

5.2 Urinary Retention

The use of Solifenacin Succinate Tablets, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction including patients with urinary retention, may result in further urinary retention and kidney injury. The use of Solifenacin Succinate Tablets is not recommended in patients with clinically significant bladder outlet obstruction and is contraindicated in patients with urinary retention [see Contraindications ( 4)] .

5.3 Gastrointestinal Disorders

The use of Solifenacin Succinate Tablets, like other antimuscarinic drugs, in patients with conditions associated with decreased gastrointestinal motility may result in further decreased gastrointestinal motility. Solifenacin Succinate Tablets are contraindicated in patients with gastric retention [see Contraindications ( 4)] . The use of Solifenacin Succinate Tablets is not recommended in patients with conditions associated with decreased gastrointestinal motility.

5.4 Central Nervous System Effects

Solifenacin Succinate Tablets are associated with antimuscarinic central nervous system (CNS) adverse reactions [see Adverse Reactions ( 6.2)] . A variety of CNS antimuscarinic adverse reactions have been reported, including headache, confusion, hallucinations, and somnolence. Monitor patients for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Solifenacin Succinate Tablets affect them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation.

5.5 Controlled Narrow-Angle Glaucoma

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

5.6 QT Prolongation in Patients at High Risk of QT Prolongation

In a study of the effect of solifenacin succinate on the QT interval conducted in 76 healthy women [see Clinical Pharmacology ( 12.2)] , solifenacin succinate 30 mg (three times the largest maximum recommended dose in adult patients) was associated with a mean increase in the Fridericia-corrected QT interval of 8 msec (90% CI, 4, 13). The QT prolonging effect appeared less with solifenacin succinate 10 mg than with solifenacin succinate 30 mg, and the effect of solifenacin succinate 30 mg did not appear as large as that of the positive control moxifloxacin at its therapeutic dose.

The use of Solifenacin Succinate Tablets is not recommended in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients who are taking medications known to prolong the QT interval.

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