HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES, USP.
DULOXETINE delayed-release capsules USP, for oral use.
Initial U.S. Approval: 2004
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS  See full prescribing information for complete boxed warning.  Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants (5.1)
Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1)

RECENT MAJOR CHANGES

Warning and precautions:

Serotonin Syndrome (5.4)                                   01/2017                        

INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: (1)
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsule once daily, with or without food. Swallow duloxetine delayed-release capsule whole; do not crush or chew, do not open capsule. Take a missed dose as soon as it is remembered. Do not take two doses of duloxetine delayed-release capsules at the same time. (2)
Indication
 Starting Dose
 Target Dose
 Maximum Dose
 
MDD (2.1)
 40 mg/day to 60 mg/day
 Acute Treatment:
40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day
 120 mg/day
 
GAD (2.2)
Adults
 60 mg/day
 60 mg/day
(once daily)
 120 mg/day
 
DPNP (2.3)
 60 mg/day
 60 mg/day (once daily)
 60 mg/day
 
Chronic Musculoskeletal Pain (2.5)
 30 mg/day
 60 mg/day (once daily)
 60 mg/day
 
Some patients may benefit from starting at 30 mg once daily (2)
There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent (2)
Discontinuing duloxetine delayed-release capsules: Gragually reduce dosage to avoid discontinuation symptoms (2.7, 5.7)
Hepatic Impairment: Avoid use in patients with chronic liver disease or cirrhosis (5.14)
Renal Impairment: Avoid use in patients with severe renal impairment, GFR <30 mL/min (5.14)

DOSAGE FORMS AND STRENGTHS

20 mg, 30 mg, and 60 mg delayed-release capsules (3) (3)
CONTRAINDICATIONS

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules. Do not use duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start duloxetin