Fluoxetine

FLUOXETINE

Manufacturer: Alembic Pharmaceuticals Limited

Score: 148.0

Quick Summary

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat various conditions, including major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder. It works by increasing the levels of serotonin in the brain. The recommended initial dose for adults is 20 mg/day, and for pediatric patients, it is 10 mg/day. Fluoxetine has several important safety considerations, including a boxed warning for suicidal thoughts and behaviors in children, adolescents, and young adults, and contraindications for use with monoamine oxidase inhibitors (MAOIs) and certain other medications. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Major depressive disorder
Obsessive-compulsive disorder
Bulimia nervosa
Panic disorder

Important Safety Information

Warning

Suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

Monoamine oxidase inhibitors (MAOIs)
Pimozide
Thioridazine

Adverse Reactions

Abnormal dreams
Abnormal ejaculation
Anorexia
Anxiety
Asthenia
Diarrhea
Dry mouth
Dyspepsia
Flu syndrome
Impotence
Insomnia
Libido decreased
Nausea
Nervousness
Pharyngitis
Rash
Sinusitis
Somnolence
Sweating
Tremor
Vasodilatation
Yawn

Dosing Recommendations

Nursing Mothers

Fluoxetine is excreted in human milk, and nursing while on fluoxetine is not recommended.
Infants exposed to fluoxetine via breast milk have developed adverse reactions such as crying, sleep disturbance, vomiting, and watery stools.

Pediatric Use

The safety and effectiveness of fluoxetine in pediatric patients < 8 years of age have not been established.
Fluoxetine has been associated with decreased weight gain and decreased alkaline phosphatase levels in pediatric patients.

Geriatric Use

U.S. fluoxetine clinical trials included 687 patients ≥ 65 years of age and 93 patients ≥ 75 years of age.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects.