DRUG INTERACTIONS

Potent inhibitors of CYP1A2 should be avoided (7.1).
Potent inhibitors of CYP2D6 may increase duloxetine concentrations (7.2).
Duloxetine is a moderate inhibitor of CYP2D6 (7.9).

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data may cause fetal harm (8.1)
Nursing Mothers: Exercise caution when administered to a nursing woman (8.3)

Pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. (8)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Treatment of Major Depressive Disorder

2.2 Dosage for Treatment of Generalized Anxiety Disorder

2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain

2.5 Dosage for Treatment of Chronic Musculoskeletal Pain

2.6 Dosing in Special Populations

2.7 Discontinuing duloxetine delayed-release capsules

2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

2.9 Use of Duloxetine Delayed-Release Capsules with Other MAOIs such as Linezolid or Methylene Blue

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

5.2 Hepatotoxicity

5.3 Orthostatic Hypotension, Falls and Syncope

5.4 Serotonin Syndrome

5.5 Abnormal Bleeding

5.6 Severe Skin Reactions

5.7 Discontinuation of Treatment with Duloxetine Delayed-Release Capsules

5.8 Activation of Mania/Hypomania

5.9 Angle-Closure Glaucoma

5.10 Seizures

5.11 Effect on Blood Pressure

5.12 Clinically Important Drug Interactions

5.13 Hyponatremia

5.14 Use in Patients with Concomitant Illness

5.15 Urinary Hesitation and Retention

5.16 Laboratory Tests

6 ADVERSE REACTIONS

6.1 Clinical Trial Data Sources

6.2 Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Adult Placebo-Controlled Trials

6.3 Most Common Adult Adverse Reactions

6.4 Adverse Reactions Occurring at an Incidence of 5% or More Among Duloxetine-Treated Patients in Adult Placebo-Controlled Trials

6.5 Adverse Reactions Occurring at an Incidence of 2% or More Among Duloxetine-Treated Patients in Adult Placebo-Controlled Trials

6.6 Effects on Male and Female Sexual Function in Adults

6.7 Vital Sign Changes in Adults

6.8 Laboratory Changes in Adults

6.9 Electrocardiogram Changes in Adults

6.10 Other Adverse Reactions Observed During the Premarketing and Postmarketing Clinical Trial eva luation of Duloxetine in Adults

6.11 Adverse Reactions Observed in Children and Adolescent Placebo-Controlled Clinical Trials

6.12 Postmarketing Spontaneous Reports

7 DRUG INTERACTIONS

7.1 Inhibitors of CYP1A2

7.2 Inhibitors of CYP2D6

7.3 Dual Inhibition of CYP1A2 and CYP2D6