Solifenacin Succinate 5 Mg

SOLIFENACIN SUCCINATE 5 MG- solifenacin succinate tablet, film coated
SOLIFENACIN SUCCINATE 10 MG- solifenacin succinate tablet, film coated
Strides Pharma Inc.

1 INDICATIONS AND USAGE

Solifenacin succinate tablets, 5 mg and 10 mg are 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 Solifenacin succinate tablet 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 tablet should be taken with water and swallowed whole. Solifenacin succinate tablet 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 Solifenacin succinate tablet 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 Solifenacin succinate tablet greater than 5 mg is not recommended. Use of Solifenacin succinate tablets 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 Solifenacin succinate tablet greater than 5 mg is not recommended [see Drug Interactions (7.1) ].

3 DOSAGE FORMS AND STRENGTHS

The 5 mg tablets are Yellow colored, round, biconvex, film coated tablets with emboss44-(i) debossed on one side and logo-(i) on the other side.

The 10 mg tablets are Pink colored, round, biconvex, film coated tablets with emboss45-(i) debossed on one side and logo-(ii) on the other side.

4 CONTRAINDICATIONS

Solifenacin succinate tablets are 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

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 affects 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 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 (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 Solifenacin succinate for patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

6 ADVERSE REACTIONS

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 has 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 was higher in the 10mg 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 10 mg group. Angioneurotic edema has been reported in one patient taking Solifenacin succinate 5 mg. Compared to 12 weeks of treatment with Solifenacin succinate, 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

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