Fluoxetine (Brand Names in India: Prodep, Flunil, Fludac, Floxet, Fluoxee, Flutex)

1. Generic Name

Fluoxetine Hydrochloride

2. Brand Names

• Prodep (Sun Pharmaceutical)
• Flunil (Intas Pharmaceuticals)
• Fludac (Torrent Pharmaceuticals)
• Floxet (Cadila Healthcare)
• Fluoxee (Alkem Laboratories)
• Flutex (Cipla Limited)

3. Pharmaceutical Formulation

• Capsules: 10 mg, 20 mg
• Tablets: 10 mg, 20 mg
• Oral Solution: 20 mg/5 mL

4. Therapeutic Classification

Selective Serotonin Reuptake Inhibitor (SSRI)

5. Indications

Fluoxetine is indicated for:

• Major Depressive Disorder (MDD): Adults and children ≥8 years.
• Obsessive-Compulsive Disorder (OCD): Adults and children ≥7 years.
• Bulimia Nervosa: Adults as part of a comprehensive treatment plan.
• Panic Disorder: With or without agoraphobia.
• Premenstrual Dysphoric Disorder (PMDD): Cyclic treatment during the luteal phase or continuous use.

6. Mechanism of Action

Fluoxetine selectively inhibits the reuptake of serotonin (5-HT) in the central nervous system, enhancing serotonergic activity. This leads to mood stabilization and reduction in anxiety and compulsive behaviors.

7. Dosage and Administration

Adults:

• MDD and OCD: Initial dose 20 mg/day, maximum dose 60 mg/day.
• Bulimia Nervosa: 60 mg/day.
• Panic Disorder: Start with 10 mg/day, increase to 20 mg/day.
• PMDD: 20 mg/day during the luteal phase or continuous dosing.

Pediatric:

• MDD (≥8 years) and OCD (≥7 years): Start with 10 mg/day, titrate to 20 mg/day after 1-2 weeks.

Elderly or Hepatic Impairment:
Lower starting doses or alternate-day dosing is recommended.

8. Onset of Action

Important Note:
Fluoxetine and other SSRIs typically take 2 to 4 weeks to show noticeable improvement in symptoms. In some cases, it may take up to 6 to 8 weeks for full therapeutic effects. Patients should be counseled to continue medication as prescribed and report any concerns to their healthcare provider.

9. Contraindications

• Hypersensitivity to fluoxetine or any excipients.
• Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation.
• Concurrent use with pimozide or thioridazine due to QT prolongation risk.

10. Warnings and Precautions

• Suicidality: Monitor for increased risk of suicidal ideation, especially in younger patients.
• Serotonin Syndrome: Risk when combined with other serotonergic drugs.
• QT Prolongation: Use cautiously in patients with electrolyte imbalance or cardiac conditions.
• Seizures: Use with caution in patients with a history of seizures.
• Hepatic/Renal Impairment: Dose adjustment may be required.

11. Side Effects

Common:

• Nausea, diarrhea, dry mouth
• Insomnia, somnolence, nervousness
• Anorexia, weight changes
• Sexual dysfunction

Serious:

• Serotonin syndrome
• QT prolongation
• Hyponatremia (SIADH)
• Stevens-Johnson Syndrome (rare)

12. Drug Interactions

• MAOIs and Linezolid: Risk of serotonin syndrome.
• Anticoagulants (Warfarin): Increased bleeding risk.
• CYP2D6 Substrates: May increase plasma levels of tricyclic antidepressants, antipsychotics.
• NSAIDs/Aspirin: Increased risk of gastrointestinal bleeding.

13. Overdose Management

Symptoms: Nausea, vomiting, seizures, cardiac arrhythmias, agitation, serotonin syndrome.
Treatment: Symptomatic and supportive care. Gastric lavage if recent ingestion. No specific antidote.

14. Pharmacokinetics

• Absorption: Well absorbed; peak plasma levels within 6-8 hours.
• Distribution: Highly protein-bound (~95%).
• Metabolism: Extensive hepatic metabolism; major active metabolite is norfluoxetine.
• Elimination: Long half-life (~4-6 days); norfluoxetine (~9 days).

15. Storage and Handling

Store at a temperature below 30°C, protected from light and moisture. Keep out of reach of children.

16. Packaging

Available in blister packs of 10, 20, or 30 capsules/tablets.

17. Manufacturer Information

• Prodep: Sun Pharmaceutical
• Flunil: Intas Pharmaceuticals
• Fludac: Torrent Pharmaceuticals
• Floxet: Cadila Healthcare
• Fluoxee: Alkem Laboratories
• Flutex: Cipla Limited