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Duloxetine

DULOXETINE HYDROCHLORIDE

Manufacturer: Quallent Pharmaceuticals Health, LLC

Score: 144.0

Quick Summary

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain. It is available in delayed-release capsules and should be taken once daily with or without food. The recommended dosage varies by condition, with a typical starting dose of 40-60 mg/day for MDD and GAD, and 60 mg/day for DPNP, fibromyalgia, and chronic musculoskeletal pain. Duloxetine has several important safety considerations, including a boxed warning for increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, and contraindications for use with monoamine oxidase inhibitors (MAOIs) and in patients with uncontrolled narrow-angle glaucoma. Common adverse reactions include nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.

Key Clinical Findings and Indications

  • Major depressive disorder (MDD)
  • Generalized anxiety disorder (GAD)
  • Diabetic peripheral neuropathic pain (DPNP)
  • Fibromyalgia
  • Chronic musculoskeletal pain

Important Safety Information

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

Dosing Recommendations

General Guidance

Gradually reduce dosage to avoid discontinuation symptoms

MDD

Adult Dose

40-60 mg/day

Pediatric Dose

Not established

GAD

Adult Dose

60 mg/day

Pediatric Dose

30-60 mg/day (7-17 years old)

DPNP

Adult Dose

60 mg/day

Pediatric Dose

Not established

Fibromyalgia

Adult Dose

60 mg/day

Pediatric Dose

Not established

Chronic musculoskeletal pain

Adult Dose

60 mg/day

Pediatric Dose

Not established

Special Population Considerations

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

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