Fluoxetine

DEA Class;  Rx

Common Brand Names; Prozac, Prozac Weekly (DSC), Sarafem (DSC)

  • Antidepressants, SSRIs

Oral selective serotonin reuptake inhibitor (SSRI) antidepressant
Indicated for depression, obsessive-compulsive disorder (OCD), panic disorder, bulimia nervosa, and premenstrual dysphoric disorder in adults; used for depression and OCD in pediatric patients
Increased risk of suicidality in pediatrics and young adults during treatment initiation

Indicated for acute and maintenance treatment of major depressive disorder (MDD)

Indicated in combination with olanzapine for treatment of resistant depression (MMD in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode)

Indicated in combination with olanzapine for treatment of acute depressive episodes associated with bipolar I disorder

Indicated for acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD)

Indicted for acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa

Indicated for acute treatment of panic disorder, with or without agoraphobia

Indicated for treatment of premenstrual dysphoric disorder

Off-label Uses

  • Fibromyalgia
  • Generalized anxiety disorder
  • Posttraumatic stress disorder
  • Social anxiety disorder

Hypersensitivity

Concomitant pimozide or thioridazine (within 5 weeks of administering fluoxetine)

Breastfeeding

  • Insomnia (10-33%)
  • Nausea (12-29%)
  • Headache (20-25%)
  • Weakness (7-21%)
  • Diarrhea (8-18%)
  • Somnolence (5-17%)
  • Anorexia (4-17%)
  • Asthenia (10-15%)
  • Anxiety (6-15%)
  • Nervousness (8-14%)
  • Tremor (3-13%)
  • Dry mouth (6-10%)
  • Dyspepsia (6-10%)
  • Chills (1-10%)
  • Flu syndrome (1-10%)
  • Palpitation (1-10%)
  • Dizziness (9%)
  • Sweating (2-8%)
  • Impotence (2-7%)
  • Rash (4-6%)
  • Constipation (5%)
  • Abnormal dreams (1-5%)
  • Decreased libido (1-5%)
  • Flatulence (3%)
  • Vomiting (3%)
  • Abnormal vision (2%)
  • Fever (2%)
  • Urinary frequency (2%)
  • Dysglycemia in patients with DM
  • Risk of seizure with concomitant electroconvulsive therapy (rare)
  • Hypertension
  • Galactorrhea

Clinical worsening and suicidal ideation may occur despite medication in adolescents and young adults (aged 18-24 years)

Development of potentially life-threatening serotonin syndrome reported with SNRIs and SSRIs alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. Johns Wart) if concomitant use with these types of drugs is clinically warranted, inform patients of potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (see Contraindications and Drug Interactions)

Risk of bleeding (GI and other) when used in combination with NSAIDs, aspirin, or drugs affecting coagulation; may impair platelet aggregation

Activation of mania/hypomania (screen for bipolar disorder)

Fluoxetine therapy has been associated with occurrence of rash and allergic reaction, including vasculitis; discontinue if they occur

Bone fractures have been associated with antidepressant therapy; consider possibility of bone fracture when patient presents with bone pain

May cause or exacerbate sexual dysfunction

Use caution in patients with risk for QT prolongation, including congenital long QT syndrome, history of prolonged QT, or history of prolonged QT; QT prolongation and ventricular arrhythmia, including torsade de pointes

Hyponatremia reported with use; consider discontinuation if symptomatic hyponatremia occurs

Use caution in patients with history of seizure disorders

May prolong QT interval and cause ventricular arrhythmia, including torsade de pointes

May cause nervousness, anxiety, insomnia, or anorexia

Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomical narrow angles without a patent iridectomy

Hypoglycemia reported; may alter glycemic control in patients with diabetes

Conflicting evidence reported regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn, or PPHN (see Pregnancy)

Risk of complications in neonates exposed to SNRIs/SSRIs late in third trimester (eg, feeding difficulties, irritability, and respiratory problems)

A pregnancy exposure registry monitors pregnancy outcome in women exposed to antidepressants during pregnancy

Data from published literature report the presence of fluoxetine and norfluoxetine in human milk

Adults

80 mg/day PO (immediate-release daily dose forms); 90 mg/week PO for once weekly formulation.

Geriatric

80 mg/day PO (immediate-release daily dose forms); 90 mg/week PO for once weekly formulation.

Adolescents

60 mg/day PO of conventional oral dosage forms; safety and efficacy not established for the once-weekly dosage form.

Children

7 to 12 years: 60 mg/day PO. Do not use the once-weekly dosage form.
4 to 6 years: Safety and efficacy have not been established. Doses up to 0.6 mg/kg/day PO (Max: 60 mg/day) have been used off-label in children with selective mutism. Do not use the once-weekly dosage form.
2 to 3 years: Safety and efficacy have not been established. Doses up to 0.5 mg/kg/day PO (Max: 40 mg/day) have been used off-label in children with autism. Do not use the once-weekly dosage form.
1 year: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Fluoxetine hydrochloride

capsule (Prozac, generic)

  • 10mg
  • 20mg
  • 40mg

capsule, delayed-release (generic)

  • 90mg

tablet (generic)

  • 10mg
  • 20mg
  • 60mg

oral solution

  • 20mg/5mL (generic)

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