Home About

FLUOXETINE HCL

FLUOXETINE HCL

Manufacturer: Strides Pharma Science Limited

Score: 144.0

Quick Summary

Fluoxetine HCl is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Bulimia Nervosa, and Panic Disorder. It works by increasing the levels of serotonin in the brain, helping to improve mood and reduce symptoms of these conditions. The drug has various adverse reactions, including suicidal thoughts and behaviors, serotonin syndrome, and allergic reactions, and has important safety information and contraindications, such as the risk of postpartum hemorrhage and the potential for interaction with other medications. Dosing recommendations vary depending on the condition being treated and the patient population, with initial dosing and titration details provided for adults and pediatric patients. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of Major Depressive Disorder (MDD)
  • Treatment of Obsessive Compulsive Disorder (OCD)
  • Treatment of Bulimia Nervosa
  • Treatment of Panic Disorder

Important Safety Information

Warning

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

Contraindications

  • Monoamine Oxidase Inhibitors (MAOIs)
  • Pimozide
  • Thioridazine
  • Known hypersensitivity to fluoxetine products

Adverse Reactions

  • Suicidal thoughts and behaviors
  • Serotonin syndrome
  • Allergic 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

General Guidance

Use a lower or less frequent dosage in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications

MDD

Adult Dose

20 mg/day in morning (initial dose), 20-80 mg/day (target dose)

Pediatric Dose

10-20 mg/day (initial dose), 10-60 mg/day (target dose)

OCD

Adult Dose

20 mg/day in morning (initial dose), 20-60 mg/day (target dose)

Pediatric Dose

10 mg/day (initial dose), 10-60 mg/day (target dose)

Bulimia Nervosa

Adult Dose

60 mg/day in morning

Pediatric Dose

Not established

Panic Disorder

Adult Dose

10 mg/day (initial dose), 20-60 mg/day (target dose)

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use of fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage
  • Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

  • Caution should be exercised when fluoxetine is administered to a nursing woman

Pediatric Use

  • The safety and effectiveness of fluoxetine in pediatric patients < 8 years of age with MDD and < 7 years of age with OCD have not been established
  • Fluoxetine is approved for use in pediatric patients with MDD and OCD

Geriatric Use

  • US 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