💊 Fluoxetine (Fluoxetine)

🏷️ Brand names & manufacturers

Fluoxetine🏭 Modavar Pharmaceuticals LLCDailyMed

Fluoxetine🏭 Teva Pharmaceuticals USA, Inc.DailyMed

Fluoxetine🏭 Aurobindo Pharma LimitedDailyMed

✅ What it is used for

• Treatment of major depressive disorder (MDD) in adults and in pediatric patients 8 to 18 years of age
• Treatment of obsessions and compulsions in obsessive compulsive disorder (OCD) in adults and in pediatric patients 7 to 17 years of age
• Treatment of binge-eating and vomiting behaviors in moderate to severe bulimia nervosa (adults)
• Treatment of panic disorder, with or without agoraphobia (adults)

🧪 Active ingredient

The active ingredient is fluoxetine hydrochloride, a selective serotonin reuptake inhibitor. Its effect is presumed to be linked to inhibition of CNS neuronal uptake of serotonin, although the exact mechanism is unknown.

🌿 Benefits

• Improves symptoms of major depressive disorder in adults and children aged 8 and older
• Reduces obsessions and compulsions in OCD
• Reduces binge-eating and vomiting in bulimia nervosa
• Treats panic disorder in adults

📝 How to use

• Take by mouth; the dose and duration are set by your doctor or pharmacist.
• This product is available only as a 60 mg tablet; a 30 mg dose may be achieved with one-half of the scored tablet. Initial titration and doses of 10 to 20 mg/day require another fluoxetine product.
• It can be taken with or without food; food does not appear to affect absorption significantly.
• In depression, the full effect may be delayed until 4 weeks of treatment or longer.
• Do not stop the medicine or change the dose without consulting your doctor.

💊 Dosage forms

• 60 mg tablets (fluoxetine base equivalent): white to off-white, film-coated, capsule-shaped, functionally scored

🔄 Drug interactions

• MAOIs (including linezolid and IV methylene blue): contraindicated due to risk of serotonin syndrome
• Pimozide and thioridazine: contraindicated; both prolong QT and their levels may rise through fluoxetine's CYP2D6 inhibition
• Other serotonergic drugs (other SSRIs/SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort): increased risk of serotonin syndrome
• Tricyclic antidepressants: TCA dose may need reduction and plasma levels monitoring
• Benzodiazepines: increased half-life of diazepam; alprazolam levels increase with further psychomotor impairment
• Antipsychotics: potential elevation of haloperidol and clozapine levels
• Anticonvulsants: potential elevation of phenytoin and carbamazepine levels with clinical anticonvulsant toxicity
• Drugs affecting hemostasis (NSAIDs, aspirin, warfarin): may increase bleeding risk
• Other QT-prolonging drugs: use with caution
• Other CNS-acting drugs: use caution, consider lower initial doses and conservative titration with clinical monitoring

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👨‍⚕️ For healthcare professionals

Mechanism of action

Effect presumed linked to inhibition of CNS neuronal serotonin uptake; blocks serotonin uptake into human platelets and is a much more potent inhibitor of serotonin than norepinephrine uptake. Binds muscarinic, histaminergic and α1-adrenergic receptors much less potently than tricyclics. Racemic (50/50) R-/S-fluoxetine; ~94.5% protein bound in vitro. After a single oral 60 mg tablet: Cmax 49.6 ± 10.0 ng/mL, Tmax 7.20 ± 1.41 h. Food may delay absorption by 1–2 h without clinical significance. Potent CYP2D6 inhibitor.

Labeled dosing

MDD (adult): start 20 mg/day in the morning; consider increase after several weeks; doses above 20 mg/day may be given once daily in the morning or twice daily (morning and noon); maximum 80 mg/day. OCD (adult): start 20 mg/day in the morning; target 20–60 mg/day. Bulimia nervosa: 60 mg/day in the morning. Panic disorder: initial 10 mg/day, target 20 mg/day, maximum studied 60 mg/day. No additional benefit seen above 20 mg/day in MDD. This product is 60 mg only (30 mg via half scored tablet) and requires initial titration with another fluoxetine product. Final dosing is determined by the prescriber/pharmacist.

• Use a lower or less frequent dosage in hepatic impairment, the elderly, and patients with concurrent disease or multiple concomitant medications.
• When switching to/from a TCA, the TCA dose may need to be reduced and plasma TCA concentrations monitored.
• Full antidepressant effect may be delayed 4 weeks or longer; periodically reassess need for maintenance treatment.
• Due to the long half-life, dose changes are not fully reflected in plasma for several weeks.
• Report suspected adverse reactions: Par Pharmaceutical 1-800-828-9393 or FDA 1-800-FDA-1088.

🎓 Key points for students

• Class: selective serotonin reuptake inhibitor (SSRI).
• Indications: MDD, OCD, bulimia nervosa, panic disorder.
• Potent CYP2D6 inhibitor, raising levels of TCAs, pimozide, thioridazine and others.
• Key contraindications: MAOIs (5-week and 14-day washouts), pimozide, thioridazine, hypersensitivity.
• Boxed warning: suicidal thoughts and behaviors in children, adolescents and young adults.
• Warnings: serotonin syndrome, mania, seizures, bleeding, angle-closure glaucoma, hyponatremia, QT prolongation.
• Long half-life means slow reflection of dose changes and importance of washout periods.
• Common adverse effects: nausea, diarrhea, insomnia, somnolence, sexual dysfunction, tremor, sweating.