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Solifenacin Succinate Tablets PI 465mm (18.31”) 32mm (1.26”) HIGHLIGHTS OF PRESCRIBING • Gastrointestinal Disorders: Use with 3 DOSAGE FORMS AND STRENGTHS Table 1. Percentages of Patients With Identified Adverse Reactions, Derived From Multiple dose studies of solifenacin succinate in elderly volunteers (65 to 80 years) FDA Approved Patient Labeling FDA Approved Patient Labeling INFORMATION caution in patients with decreased Solifenacin succinate tablets are available as follows: All Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients showed that Cmax, AUC and t1/2 values were 20 to 25% higher as compared to the These highlights do not include gastrointestinal motility (5.3) 5 mg – white, round, standard, normal convex, film-coated, unscored tablets, debossed for Combined Pivotal Studies younger volunteers (18 to 55 years). Solifenacin Succinate Tablets Solifenacin Succinate Tablets all the information needed to • Central Nervous System Effects: with “TV” on one side of the tablet and with “2N” on the other side of the tablet. Placebo Solifenacin Succinate Solifenacin Succinate 8.6 Renal Impairment Read the Patient Information that comes with Read the Patient Information that comes with use SOLIFENACIN SUCCINATE Somnolence has been reported with 10 mg – light-pink to pink, round, standard, normal convex, film-coated, unscored (%) 5 mg (%) 10 mg (%) Solifenacin succinate should be used with caution in patients with renal impairment. TABLETS safely and effectively. solifenacin succinate tablets before you start solifenacin succinate tablets before you start solifenacin succinate. Advise patients not tablets, debossed with “TV” on one side of the tablet and with “3N” on the other side Number of Patients 1216 578 1233 There is a 2.1 fold increase in AUC and 1.6 fold increase in t1/2 of solifenacin in patients See full prescribing information for to drive or operate heavy machinery until of the tablet. with severe renal impairment. Doses of solifenacin succinate greater than 5 mg are taking them and each time you get a refill. There taking them and each time you get a refill. There SOLIFENACIN SUCCINATE TABLETS. GENERAL DISORDERS AND they know how solifenacin succinate affects 4 CONTRAINDICATIONS not recommended in patients with severe renal impairment (CLcr < 30 mL/min) [see may be new information. This leaflet does not may be new information. This leaflet does not SOLIFENACIN SUCCINATE tablets for them (5.4) ADMINISTRATION SITE Warnings and Precautions (5.7); Dosage and Administration (2.2)]. Solifenacin succinate tablets are contraindicated in patients with: CONDITIONS take the place of talking with your doctor about take the place of talking with your doctor about oral use • Controlled Narrow-Angle Glaucoma: • urinary retention [see Warnings and Precautions (5.2)], 8.7 Hepatic Impairment Edema Lower Limb 0.7 0.3 1.1 your medical condition or treatment. your medical condition or treatment. Initial U.S. Approval: 2004 Use with caution in patients being • gastric retention [see Warnings and Precautions (5.3)], Solifenacin succinate should be used with caution in patients with reduced hepatic treated for narrow-angle glaucoma Fatigue 1.1 1.0 2.1 function. There is a 2 fold increase in the t and 35% increase in AUC of solifenacin in What are solifenacin succinate tablets? What are solifenacin succinate tablets? INDICATIONS AND USAGE • uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5)], and 1/2 302mm (11.89”) 302mm (5.5) PSYCHIATRIC DISORDERS patients with moderate hepatic impairment. Doses of solifenacin succinate greater than 86mm (3.39”) Solifenacin succinate tablets are a Solifenacin succinate tablets are a prescription Solifenacin succinate tablets are a prescription muscarinic antagonist indicated for the • QT Prolongation: Use with caution in • in patients who have demonstrated hypersensitivity to the drug [see Adverse Reactions Depression NOS 0.8 1.2 0.8 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh medicine for adults used to treat the following medicine for adults used to treat the following treatment of overactive bladder with patients with a known history of QT (6.2)]. RESPIRATORY, THORACIC AND B). Solifenacin succinate is not recommended for patients with severe hepatic impairment symptoms of urge urinary incontinence, prolongation or patients who are taking 5 WARNINGS AND PRECAUTIONS MEDIASTINAL DISORDERS (Child-Pugh C) [see Warnings and Precautions (5.6); Dosage and Administration (2.3)]. symptoms due to a condition called overactive symptoms due to a condition called overactive urgency, and urinary frequency (1) medications known to prolong the QT 5.1 Angioedema and Anaphylactic Reactions Cough 0.2 0.2 1.1 8.8 Gender bladder: bladder: DOSAGE AND ADMINISTRATION interval (5.8) Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin. The pharmacokinetics of solifenacin is not significantly influenced by gender. • Urge urinary incontinence: a strong need to • Urge urinary incontinence: a strong need to In some cases angioedema occurred after the first dose. Cases of angioedema have VASCULAR DISORDERS • 5 mg tablet taken once daily, and if well ADVERSE REACTIONS Hypertension NOS 0.6 1.4 0.5 10 OVERDOSAGE urinate with leaking or wetting accidents urinate with leaking or wetting accidents tolerated may be increased to 10 mg The most common adverse been reported to occur hours after the first dose or after multiple doses. Angioedema Overdosage with solifenacin succinate can potentially result in severe anticholinergic associated with upper airway swelling may be life threatening. If involvement of the once daily (2.1) reactions (> 4% and > placebo) were 6.2 Postmarketing Experience effects and should be treated accordingly. The highest dose ingested in an accidental • Urgency: a strong need to urinate right away • Urgency: a strong need to urinate right away tongue, hypopharynx, or larynx occurs, solifenacin should be promptly discontinued dry mouth, and constipation at both Because these spontaneously reported events are from the worldwide postmarketing overdose of solifenacin succinate was 280 mg in a 5 hour period. This case was • Do not exceed 5 mg tablet once daily in and appropriate therapy and/or measures necessary to ensure a patent airway should be • Frequency: urinating often • Frequency: urinating often 5 mg and 10 mg doses; and urinary tract experience, the frequency of events and the role of solifenacin in their causation cannot associated with mental status changes. Some cases reported a decrease in the level patients with: promptly provided. Anaphylactic reactions have been reported rarely in patients treated severe renal impairment [Creatinine infection, and blurred vision at the 10 mg be reliably determined. of consciousness. It is not known if solifenacin succinate tablets are It is not known if solifenacin succinate tablets are o dose (6.1) with solifenacin succinate. Solifenacin succinate should not be used in patients with a Clearance] (CLcr < 30 mL/min) (2.2) known or suspected hypersensitivity to solifenacin succinate. In patients who develop The following events have been reported in association with solifenacin use in worldwide Intolerable anticholinergic side effects (fixed and dilated pupils, blurred vision, failure of safe and effective in children. safe and effective in children. o moderate hepatic impairment (Child- To report SUSPECTED anaphylactic reactions, solifenacin succinate should be discontinued and appropriate postmarketing experience: heel-to-toe exam, tremors and dry skin) occurred on day 3 in normal volunteers taking ADVERSE REACTIONS, contact 50 mg daily (5 times the maximum recommended therapeutic dose) and resolved within Who should NOT take solifenacin succinate tablets? Who should NOT take solifenacin succinate tablets? Pugh B) (2.3) therapy and/or measures should be taken. General: peripheral edema, hypersensitivity reactions, including angioedema with airway Teva Pharmaceuticals USA, Inc. at 7 days following discontinuation of drug. Do not take solifenacin succinate tablets if you: Do not take solifenacin succinate tablets if you: o concomitant use of potent CYP3A4 5.2 Urinary Retention obstruction, rash, pruritus, urticaria, and anaphylactic reaction; inhibitors (2.4) 1-888-838-2872 or FDA at 1-800-FDA-1088 or In the event of overdose with solifenacin succinate, treat with gastric lavage and www.fda.gov/medwatch. Solifenacin succinate, like other anticholinergic drugs, should be administered with Central Nervous: headache, confusion, hallucinations, delirium and somnolence; • are not able to empty your bladder (urinary retention) • are not able to empty your bladder (urinary retention) • Use of solifenacin succinate tablets caution to patients with clinically significant bladder outflow obstruction because of the appropriate supportive measures. ECG monitoring is also recommended. Cardiovascular: QT prolongation; torsade de pointes, atrial fibrillation, tachycardia, palpitations; is not recommended in patients with DRUG INTERACTIONS risk of urinary retention [see Contraindications (4)]. 11 DESCRIPTION • have delayed or slow emptying of your stomach • have delayed or slow emptying of your stomach • Inhibitors of CYP3A4 may increase the Hepatic: liver disorders mostly characterized by abnormal liver function tests, AST (aspartate severe hepatic impairment (Child-Pugh 5.3 Gastrointestinal Disorders Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin (gastric retention)
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