Indications and Dosage

Major Depression

• By Mouth (Adults):

• • Initial Dose: 20 mg daily.
  • Adjustments: If necessary, the dose can be increased after 3–4 weeks and at appropriate intervals thereafter.
  • Maximum Dose: 60 mg per day, administered as a single or divided dose.

• By Mouth (Elderly):

• • Initial Dose: 20 mg daily.
  • Usual Maximum Dose: 40 mg daily, but doses up to 60 mg daily can be used.

Bulimia Nervosa

• By Mouth (Adults):

• • Standard Dose: 60 mg daily, administered as a single or divided dose.

• By Mouth (Elderly):

• • Usual Dose: Up to 40 mg daily, administered as a single or divided dose.
  • Maximum Dose: 40 mg daily, but doses up to 60 mg daily can be used.

Obsessive-Compulsive Disorder

• By Mouth (Adults):

• • Initial Dose: 20 mg daily.
  • Adjustments: Increase if necessary up to 60 mg daily, administered as a single or divided dose. Gradually increase the dose.
  • Review: Treatment should be reviewed if there is an inadequate response after 10 weeks.
  • Maximum Dose: 60 mg per day.

• By Mouth (Elderly):

• • Initial Dose: 20 mg daily.
  • Adjustments: Increase if necessary up to 40 mg daily, administered as a single or divided dose. Gradually increase the dose.
  • Review: Treatment should be reviewed if there is an inadequate response after 10 weeks.
  • Usual Maximum Dose: 40 mg daily, but doses up to 60 mg daily can be used.

Menopausal Symptoms in Women with Breast Cancer

• By Mouth (Adults):

• • Dose: 20 mg once daily. Not recommended for those taking tamoxifen due to potential drug interactions.

Pharmacokinetics

• Note: Consider the long half-life of fluoxetine when adjusting the dosage or managing overdosage.

Unlicensed Use

• Menopausal Symptoms: Fluoxetine is used to manage menopausal symptoms, but it is important to note that this is not a licensed indication for the drug.

Side Effects

• Common/Very Common:

• • Chills, feeling abnormal, postmenopausal hemorrhage, uterine disorders, vasodilation, blurred vision.

• Uncommon:

• • Cold sweat, dysphagia (difficulty swallowing), dyspnea (difficulty breathing), hypotension (low blood pressure), altered mood, muscle twitching, self-injurious behavior, altered temperature sensation, abnormal thinking.

• Rare/Very Rare:

• • Buccoglossal syndrome, leucopenia (low white blood cell count), neutropenia (low neutrophil count), esophageal pain, pharyngitis, respiratory disorders, serum sickness, speech disorder, vasculitis.

• Frequency Not Known:

• • Bone fracture.

Special Considerations

Breastfeeding:

• • Fluoxetine is present in breast milk. It is recommended to avoid use during breastfeeding due to potential risks to the infant.

Hepatic Impairment:

• • Dose adjustments are advised. Manufacturer suggests dose reduction or an increase in dose interval for patients with liver impairment.

Administration:

• • Dispersible tablets can be dispersed in water for easier administration or swallowed whole with plenty of water.

Patient and Carer Advice

• Tablet Administration: Patients and carers should be informed on how to properly administer dispersible tablets.
• Driving and Skilled Tasks: Patients should be counseled on the potential effects of fluoxetine on driving and performing skilled tasks, as it may impair these abilities.

Medicinal Forms

Tablets

• Fluoxetine Tablets (Non-proprietary):

• • Available as Fluoxetine hydrochloride in a 10 mg dosage.

Dispersible Tablets

• Olena (Advanz Pharma):

• • Fluoxetine hydrochloride 20 mg dispersible tablets, sugar-free.

Oral Solutions

• Fluoxetine Oral Solutions (Non-proprietary):

• • Fluoxetine hydrochloride 4 mg per 1 ml available in:

• • • 20 mg/5 ml oral solution.
    • 20 mg/5 ml oral solution, sugar-free.

• Prozep (Rosemont Pharmaceuticals Ltd):

• • Fluoxetine hydrochloride 4 mg per 1 ml in a 20 mg/5 ml oral solution, sugar-free.

Capsules

• Fluoxetine Capsules (Non-proprietary):

• • Fluoxetine hydrochloride capsules available in multiple strengths:

• • • 10 mg
    • 20 mg
    • 30 mg
    • 40 mg
    • 60 mg