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TOVIAZ®Index Section (fesoterodine fumarate)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Adult Overactive Bladder

1.2 Pediatric Neurogenic Detrusor Overactivity

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients With OAB

2.2 Recommended Dosage for Pediatric Patients Aged 6 Years and Older With NDO

2.3 Recommended Dosage in Adult Patients With Renal Impairment

2.4 Recommended Dosage in Pediatric Patients With Renal Impairment

2.5 Toviaz Dosage Modifications Due to Strong CYP3A4 Inhibitors

2.6 Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

5.2 Urinary Retention in Adult Patients With Bladder Outlet Obstruction

5.3 Decreased Gastrointestinal Motility

5.4 Worsening of Narrow-Angle Glaucoma

5.5 Central Nervous System Effects

5.6 Worsening of Myasthenia Gravis Symptoms

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Antimuscarinic Drugs

7.2 CYP3A4 Inhibitors

7.3 CYP3A4 Inducers

7.4 CYP2D6 Inhibitors

7.5 Drugs Metabolized by Cytochrome P450

7.6 Oral Contraceptives

7.7 Warfarin

7.8 Drug-Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Adult Overactive Bladder

14.2 Pediatric Neurogenic Detrusor Overactivity

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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