Fluoxetine HCl

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

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

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