Fluoxetine

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

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