Duloxetine hydrochloride

DULOXETIN HYDROCHLORIDE

Manufacturer: Torrent Pharmaceuticals Limited

Score: 144.0

Quick Summary

Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) used for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), chronic musculoskeletal pain, and fibromyalgia. The drug has a boxed warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Important safety information includes contraindications with monoamine oxidase inhibitors (MAOIs), potential for serotonin syndrome, and increased risk of bleeding. The recommended dosage varies by condition, with initial dosing and titration ranging from 30 mg to 60 mg per day. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific warnings and precautions for each group.

Key Clinical Findings and Indications

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

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

Monoamine oxidase inhibitors (MAOIs)
Linezolid and intravenous methylene blue

Adverse Reactions

Nausea
Dry mouth
Somnolence
Constipation
Decreased appetite
Hyperhidrosis

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with hepatic or renal impairment

MDD

Adult Dose

40 mg/day to 60 mg/day

Pediatric Dose

Not established

GAD

Adult Dose

60 mg/day

Pediatric Dose

Not established

DPNP

Adult Dose

60 mg/day

Pediatric Dose

Not established

Chronic musculoskeletal pain

Adult Dose

30 mg/day to 60 mg/day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy only if potential benefit justifies potential risk to fetus
No adequate and well-controlled studies in pregnant women

Nursing Mothers

Nursing while on duloxetine is not recommended
Duloxetine is excreted into breast milk

Pediatric Use

Safety and effectiveness not established in pediatric population
Decreased appetite and weight loss have been observed in association with SSRIs and SNRIs

Geriatric Use

No overall differences in safety or effectiveness observed between elderly and younger patients
Greater sensitivity of some older individuals cannot be ruled out