Duloxetine Delayed-Release

Warning

Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients

Contraindications

• Use with monoamine oxidase inhibitors (MAOIs)
• Uncontrolled narrow-angle glaucoma

Adverse Reactions

• Nausea
• Dry mouth
• Somnolence
• Constipation
• Decreased appetite
• Hyperhidrosis

General Guidance

Gradually reduce dosage to avoid discontinuation symptoms

Pregnancy

• Use during pregnancy may be associated with increased risk of postpartum hemorrhage
• Data from published literature and postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes

Nursing Mothers

• Duloxetine is present in human milk
• Monitor infants for sedation, poor feeding, and poor weight gain

Pediatric Use

• Safety and effectiveness established for GAD in patients 7-17 years old
• Not established for MDD, DPNP, fibromyalgia, or chronic musculoskeletal pain in pediatric patients

Geriatric Use

• No overall differences in safety or effectiveness observed between geriatric and younger adult patients
• Greater sensitivity of some older patients cannot be ruled out
• Increased risk of hyponatremia and falls in geriatric patients