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warnings and cautions
5 WARNINGS AND PRECAUTIONS Angioedema and anaphylactic reactions: Reports of angioedema of the face, lips and/or larynx, in some cases occurring after the first dose, have been described. Anaphylactic reactions have been reported rarely ( 5.1 ) Urinary Retention: Administer with caution to patients with clinically significant bladder outflow obstruction ( 5.2 ) Gastrointestinal Disorders: Use with caution in patients with decreased gastrointestinal motility ( 5.3 ) Central Nervous System Effects: Somnolence has been reported with Solifenacin Succinate Tablets. Advise patients not to drive or operate heavy machinery until they know how Solifenacin Succinate Tablets affects them ( 5.4 ) Controlled Narrow-Angle Glaucoma: Use with caution in patients being treated for narrow-angle glaucoma ( 5.5 ) QT Prolongation: Use with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval ( 5.8 ) 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 Solifenacin Succinate Tablets, 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 Solifenacin Succinate Tablets, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility [ see Contraindications (4) ]. 5.4 Central Nervous System Effects Solifenacin Succinate Tablets are 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 Solifenacin Succinate Tablets affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. 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 Hepatic Impairment Solifenacin Succinate Tablets should be used with caution in patients with hepatic impairment. Doses of Solifenacin Succinate Tablets greater than 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Solifenacin Succinate Tablets are 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 Solifenacin Succinate Tablets should be used with caution in patients with renal impairment. Doses of Solifenacin Succinate Tablets greater than 5 mg are not recommended in patients with severe renal impairment (CL cr <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 Solifenacin Succinate Tablets for patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.
6 ADVERSE REACTIONS The most common adverse reactions (> 4% and > placebo) were dry mouth, and constipation at both 5 mg and 10 mg doses; and urinary tract infection, and blurred vision at the 10 mg dose ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical Inc at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Solifenacin Succinate Tablets have been evaluated for safety in 1811 patients in randomized, placebo- controlled trials. Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with Solifenacin Succinate Tablets was higher in the 10 mg compared to the 5 mg dose group. In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the Solifenacin Succinate Tablets 10 mg group. Angioneurotic edema has been reported in one patient taking Solifenacin Succinate Tablets 5 mg. Compared to 12 weeks of treatment with Solifenacin Succinate Tablets, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months. The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events, in randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with Solifenacin Succinate Tablets 5 or 10 mg once daily for up to 12 weeks. Table 1. Percentages of Patients with Identified Adverse Reactions, Derived from All Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients for Combined Pivotal Studies Placebo (%) Solifenacin Succinate Tablets 5 mg (%) Solifenacin Succinate Tablets 10 mg (%) Number of Patients 1216 578 1233 GASTROINTESTINAL DISORDERS Dry Mouth 4.2 10.9 27.6 Constipation 2.9 5.4 13.4 Nausea 2.0 1.7 3.3 Dyspepsia 1.0 1.4 3.9 Abdominal Pain Upper 1.0 1.9 1.2 Vomiting NOS 0.9 0.2 1.1 INFECTIONS AND INFESTATIONS Urinary Tract Infection NOS 2.8 2.8 4.8 Influenza 1.3 2.2 0.9 Pharyngitis NOS 1.0 0.3 1.1 NERVOUS SYSTEM DISORDERS Dizziness 1.8 1.9 1.8 EYE DISORDERS Vision Blurred 1.8 3.8 4.8 Dry Eyes NOS 0.6 0.3 1.6 RENAL AND URINARY DISORDERS Urinary Retention 0.6 0 1.4 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Edema Lower Limb 0.7 0.3 1.1 Fatigue 1.1 1.0 2.1 PSYCHIATRIC DISORDERS Depression NOS 0.8 1.2 0.8 RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Cough 0.2 0.2 1.1 VASCULAR DISORDERS Hypertension NOS 0.6 1.4 0.5 6.2 Post-Marketing Experience Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined. The following events have been reported in association with solifenacin use in worldwide postmarketing experience: General : peripheral edema, hypersensitivity reactions, including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction; Central Nervous : headache, confusion, hallucinations, delirium, and somnolence; Cardiovascular : QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, and palpitations; Hepatic : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), and GGT (gamma-glutamyl transferase); Renal : renal impairment; Metabolism and nutrition disorders : decreased appetite and hyperkalemia; Dermatologic : exfoliative dermatitis, erythema multiforme, and dry skin; Eye disorders : glaucoma; Gastrointestinal disorders : gastroesophageal reflux disease, ileus, abdominal pain, and dysgeusia; Respiratory, thoracic and mediastinal disorders : dysphonia and nasal dryness; Musculoskeletal and connective tissue disorders : muscular weakness.