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2. Summary
Depreban® is a branded formulation of fluoxetine, a selective serotonin reuptake inhibitor (SSRI) antidepressant. Fluoxetine is a first-line agent in the treatment of major depressive disorder and several anxiety-related psychiatric conditions. It is distinguished pharmacologically by its long elimination half-life and the presence of an active metabolite (norfluoxetine), which significantly influence dosing strategies, drug interactions, and washout requirements.
3. Brand Name
Depreban®
4. Category
- Psychiatric Agents – Antidepressants
- Selective Serotonin Reuptake Inhibitor (SSRI)
- ATC Code: N06AB03
5. Active Ingredient
Fluoxetine (as fluoxetine hydrochloride)
6. Pharmaceutical Form & Strength
- Pharmaceutical Form: Hard gelatin capsules (oral use)
- Strength: 20 mg fluoxetine (as hydrochloride) per capsule
7. Manufacturer & Marketing Authorization Holder
Amriya Pharmaceutical Industries, Egypt
Marketing authorization status may vary by country and should be verified with the local regulatory authority.
8. Mechanism of Action
Fluoxetine selectively inhibits the presynaptic reuptake of serotonin (5-hydroxytryptamine, 5-HT) in the central nervous system. This results in increased serotonergic neurotransmission by elevating serotonin concentrations in the synaptic cleft.
Fluoxetine has minimal affinity for muscarinic, histaminergic, or α-adrenergic receptors, explaining its lower anticholinergic, sedative, and cardiovascular adverse effects compared with tricyclic antidepressants.
9. Spectrum of Activity
Not applicable.
(Fluoxetine is a non-antimicrobial agent.)
10. Pharmacokinetics
- Absorption: Well absorbed after oral administration; bioavailability approximately 70–90%. Food does not significantly affect absorption.
- Distribution: Widely distributed; highly protein bound (~94–95%).
- Metabolism: Extensive hepatic metabolism, primarily via CYP2D6, to the active metabolite norfluoxetine (desmethylfluoxetine).
- Elimination Half-Life:
- Fluoxetine: ~1–4 days (single dose), up to 4–6 days with chronic dosing
- Norfluoxetine: ~7–16 days
- Excretion: Predominantly renal excretion as metabolites; minimal unchanged drug.
The prolonged half-life reduces discontinuation symptoms but increases the duration of drug interactions and washout periods.
11. Indications
Approved and evidence-based indications include:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Bulimia Nervosa
- Panic Disorder (with or without agoraphobia)
- Premenstrual Dysphoric Disorder (PMDD)
- Treatment-resistant depression (in combination with olanzapine)
Local labeling should be consulted for country-specific approvals.
12. Administration
- Route: Oral
- Usual Adult Starting Dose: 20 mg once daily (preferably morning)
- Typical Therapeutic Range: 20–60 mg/day
- Maximum Dose: 80 mg/day (depending on indication)
- Capsules should be swallowed whole, with or without food.
13. Method of Preparation
Not applicable.
(The product is a ready-to-use oral capsule and requires no reconstitution.)
14. Contraindications
- Hypersensitivity to fluoxetine or any excipient
- Concomitant use with monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping an MAOI
- Concomitant use with linezolid or intravenous methylene blue
- Concomitant use with pimozide or thioridazine
- Use of thioridazine within 5 weeks after discontinuation of fluoxetine
15. Warnings & Precautions
- Suicidality: Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults, particularly during initiation or dose changes
- Serotonin Syndrome: Risk increases with other serotonergic agents
- Activation of Mania/Hypomania: Screen for bipolar disorder
- Seizures: Use with caution in patients with epilepsy
- Hyponatremia/SIADH: Particularly in elderly or volume-depleted patients
- Abnormal Bleeding: Increased risk when combined with NSAIDs, antiplatelets, or anticoagulants
- Angle-closure glaucoma: Mydriasis may occur
- Hepatic impairment: Dose reduction or extended dosing interval recommended
- Alcohol: Concomitant use is discouraged
- Driving and machinery: May impair alertness, especially early in therapy
16. Drug Interactions
- MAO inhibitors, linezolid, methylene blue (contraindicated)
- Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol, triptans, St. John’s wort)
- CYP2D6 substrates (e.g., TCAs, antipsychotics, beta-blockers, tamoxifen)
- Anticoagulants and antiplatelet agents (increased bleeding risk)
- Alcohol (enhanced CNS effects)
17. Side Effects
Common:
- Nausea, diarrhea, dyspepsia
- Headache, insomnia, anxiety, tremor
- Sweating
- Decreased appetite and weight loss
- Sexual dysfunction
Less Common but Serious:
- Hyponatremia
- Serotonin syndrome
- Manic episodes
- Seizures
- QT prolongation (rare)
- Severe allergic reactions
18. Use in Special Populations
- Pediatrics: Approved for MDD (≥8 years) and OCD (≥7 years) with strict monitoring for suicidality
- Elderly: Increased sensitivity; lower starting doses recommended
- Pregnancy: Use only if benefits outweigh risks; neonatal adaptation syndrome reported with late-pregnancy exposure
- Lactation: Excreted in breast milk; monitor infant for adverse effects
- Hepatic Impairment: Dose reduction or alternate-day dosing recommended
- Renal Impairment: No routine dose adjustment required; caution in severe impairment
19. Storage Conditions
- Store below 30°C
- Protect from light and moisture
- Keep out of reach of children
20. Additional Sections
- Fluoxetine does not cause physical dependence
- Long half-life reduces discontinuation syndrome compared with other SSRIs
- Requires extended washout period before initiating MAOIs or certain antipsychotics
21. Frequently Asked Questions (FAQ)
Q1: How long does Depreban take to work?
A: Clinical improvement typically begins after 2–4 weeks; full effect may take 6–8 weeks.
Q2: Can Depreban be stopped abruptly?
A: Abrupt discontinuation is less problematic than with shorter-acting SSRIs, but gradual tapering is still recommended.
Q3: Is Depreban addictive?
A: No physical dependence has been demonstrated.
Q4: Is Depreban the same as Prozac®?
A: Yes. Both contain fluoxetine; Depreban® is a branded generic.
22. References
- FDA Prescribing Information – Fluoxetine Hydrochloride (updated 2023)
- European Medicines Agency (EMA) – Prozac® Summary of Product Characteristics (2024)
- British National Formulary (BNF)
- Goodman & Gilman’s The Pharmacological Basis of Therapeutics
- WHO Model Formulary
