7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)

7.5 Lorazepam

7.6 Temazepam

7.7 Drugs that Affect Gastric Acidity

7.8 Drugs Metabolized by CYP1A2

7.9 Drugs Metabolized by CYP2D6

7.10 Drugs Metabolized by CYP2C9

7.11 Drugs Metabolized by CYP3A

7.12 Drugs Metabolized by CYP2C19

7.13 Monoamine Oxidase Inhibitors (MAOIs)

7.14 Serotonergic Drugs

7.15 Alcohol

7.16 CNS Drugs

7.17 Drugs Highly Bound to Plasma Protein

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Gender

8.7 Smoking Status

8.8 Race

8.9 Hepatic Impairment

8.10 Severe Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

10.1 Signs and Symptoms

10.2 Management of Overdose

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 Major Depressive Disorder

14.2 Generalized Anxiety Disorder

14.3 Diabetic Peripheral Neuropathic Pain

14.5 Chronic Musculoskeletal Pain

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are indicated for the treatment of:
Major Depressive Disorder[see Clinical Studies 14.1]
Generalized Anxiety Disorder[see Clinical Studies 14.2]
Diabetic Peripheral Neuropathy[see Clinical Studies 14.3]
Chronic Musculoskeletal Pain[see Clinical Studies 14.5]

2 DOSAGE AND ADMINISTRATION

Swallow duloxetine delayed-release capsules whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.

2.1 Dosage for Treatment of Major Depressive Disorder

Administer duloxetine delayed-release capsules at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately eva luated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].

2.2 Dosage for Treatment of Generalized Anxiety Disorder
 
Adults — For most patients, initiate duloxetine delayed-release capsules 60 mg once daily. For some patients, it may be desirable to start at 30 mg once dail