Solifenacin Succinate

SOLIFENACIN SUCCINATE- solifenacin succinate tablet, film coated
Amneal Pharmaceuticals NY LLC

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 are 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 (CLcr < 30 mL/min/1.73 m2) [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

Solifenacin Succinate Tablets, 5 mg are light yellow, round shaped film-coated tablet debossed with “AC” and “07” on one side and plain on other side.

Solifenacin Succinate Tablets, 10 mg are light pink, round shaped film-coated tablet debossed with “AC” and “09” on one side and plain on other side.

4 CONTRAINDICATIONS

Solifenacin succinate tablets are contraindicated in patients:

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 and provide appropriate therapy and/or measures necessary to ensure a patent airway.

5.2 Urinary Retention

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

5.4 Central Nervous System Effects

Solifenacin succinate is 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 affects them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation.

5.5 Controlled Narrow-Angle Glaucoma

Solifenacin succinate 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 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.

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 1,811 adult patients in four randomized, placebo-controlled trials (Studies 1 to 4) [see Clinical Studies (14)]. 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 10 mg dose group 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 was 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 in Study 5 [see Clinical Studies (14)].

The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, in the four randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with solifenacin succinate tablets 5 mg or 10 mg once daily for up to 12 weeks.

Table 1: Adverse Reactions Reported by ≥ 1% of Patients and Exceeding Placebo in Studies 1, 2, 3 and 4

Placebo (%)

Solifenacin Succinate 5 mg (%)

Solifenacin Succinate 10 mg (%)

Number of Patients

1,216

578

1,233

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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