Fluoxetine 60mg Tablets

Fluoxetine 60mg Tablets, also available as capsules, are a prescription-only generic equivalent of Prozac® 60mg, containing fluoxetine hydrochloride equivalent to fluoxetine 60mg per unit. Fluoxetine belongs to the selective serotonin reuptake inhibitor (SSRI) class of antidepressants. The 60mg strength is the highest approved fluoxetine dose, representing the maximum dose recommended in approved labeling across major markets. It is the only FDA-approved dose of fluoxetine specifically indicated for bulimia nervosa, and is also used in higher-dose OCD management and treatment-resistant depression. Generic fluoxetine 60mg tablets and capsules are marketed internationally across the USA, UK, Australia, UAE, Germany, France, Russia, South Korea and worldwide.

Product Information

Generic Manufacturers — Fluoxetine 60mg

• Teva Pharmaceuticals (USA, UK, EU)
• Sandoz / Novartis (USA, UK, EU, AU)
• Mylan / Viatris (USA, UK, EU)
• Aurobindo Pharma (USA, UK, EU)
• Dr. Reddy's Laboratories (USA, UK, EU)
• Accord Healthcare (UK, EU)
• Hikma Pharmaceuticals (USA, UK)
• Sun Pharmaceutical (USA, UK, EU)

Note: The 60mg strength is less widely stocked than 20mg and 40mg. Confirm availability with your pharmacy or supplier. Some markets supply 60mg as two x 30mg units or by combining lower strengths under prescriber direction.

Fluoxetine 60mg is the maximum approved dose and is indicated for the following conditions, subject to market-specific labeling:

Bulimia Nervosa — Approved Therapeutic Dose Fluoxetine 60mg once daily is the only FDA-approved pharmacological dose specifically indicated for bulimia nervosa. Clinical trials demonstrated that 60mg/day — not 20mg or 40mg — produces clinically meaningful reductions in binge eating and purging episodes. Fluoxetine 60mg for bulimia is approved in the USA (FDA), UK (MHRA), EU (EMA) and other major markets. It is the first-line pharmacological treatment for bulimia nervosa in multiple national guidelines.

Obsessive-Compulsive Disorder (OCD) — Higher-Dose Management OCD commonly requires higher fluoxetine doses than depression. The approved dose range for OCD is 20–60mg/day. Fluoxetine 60mg is used where lower doses (20mg or 40mg) have not produced adequate symptom control after an adequate treatment trial of 6–10 weeks.

Treatment-Resistant Depression In patients with major depressive disorder who have not responded to standard doses of 20mg or 40mg, fluoxetine 60mg is explored as a maximum-dose strategy before switching or augmenting with another agent. This approach is supported by evidence from treatment-resistant depression protocols in multiple markets.

Major Depressive Disorder — Maximum Dose 60mg represents the upper dose limit for fluoxetine in major depressive disorder across all major approved labeling. It is used only when lower doses have been inadequate.

United States: Fluoxetine 60mg is available as capsules from multiple FDA-approved generic manufacturers. The 60mg dose is specifically FDA-approved for bulimia nervosa. It is also used for OCD and treatment-resistant depression at the maximum approved dose. Carries an FDA Black Box Warning for increased suicidal thinking and behaviour in children, adolescents and young adults during early treatment and dose escalation.

United Kingdom / EU: Fluoxetine 60mg is indicated in the UK for bulimia nervosa and is used for OCD and treatment-resistant depression per BNF and NICE guidance. MHRA-approved generic products available. PIL and SPC available for all authorised products. In the EU, EMA-aligned labeling covers bulimia nervosa at 60mg as the approved dose.

Australia: Fluoxetine 60mg Australia products are listed on the Australian Register of Therapeutic Goods (ARTG). The 60mg dose is used for bulimia nervosa and higher-dose OCD. PBS subsidisation subject to indication and patient eligibility. Consult your prescriber regarding PBS authority requirements.

UAE / Gulf: Fluoxetine 60mg is available in the UAE from MOHAP-registered pharmacies on valid prescription. Prescription-only (POM) across all GCC states. Availability of the specific 60mg strength varies by registered product and emirate. Consult a UAE-licensed physician.

Germany: Fluoxetin 60mg is available in Germany as tablets and capsules. Prescription-only (rezeptpflichtig). Used for bulimia nervosa (Bulimia nervosa) and higher-dose OCD (Zwangsstörung) and treatment-resistant depression (therapieresistente Depression) per German-approved labeling.

France: Fluoxétine 60mg is available in France under multiple generic names for bulimia nervosa and higher-dose OCD. Subject to ANSM approval, prescription and reimbursement conditions.

Russia: Флуоксетин 60 мг is available in Russia under multiple brand and generic names. All require a valid prescription. Used for bulimia nervosa and treatment-resistant depression as the maximum approved dose.

South Korea: 플루옥세틴 60mg is registered for prescription use in South Korea per MFDS-approved labeling. Used for bulimia nervosa and higher-dose OCD.

Always follow the prescribing information for your country and the guidance of your licensed healthcare professional.

60mg is the maximum approved dose in all major markets. Doses above 60mg are not supported by approved labeling and are not recommended.

Why Is Fluoxetine 60mg the Dose for Bulimia Nervosa?

Clinical trials conducted during the development of Prozac® established that 60mg/day — not the standard antidepressant dose of 20mg — was required to produce clinically significant reductions in binge-purge episodes in patients with bulimia nervosa. The pivotal trials showed:

• Fluoxetine 60mg reduced binge eating frequency significantly versus placebo
• Fluoxetine 20mg showed some benefit but inferior to 60mg for bulimia outcomes
• 60mg/day is now the standard of care pharmacological dose for bulimia nervosa across FDA, MHRA, EMA and TGA guidelines

This is why fluoxetine 60mg tablets exist as a distinct product — to allow once-daily dosing at the approved bulimia dose without combining multiple lower-strength units.

Black Box Warning (USA): Antidepressants including fluoxetine carry an FDA Black Box Warning for increased suicidal thinking and behaviour in children, adolescents and young adults up to age 24 during early treatment. At 60mg — the maximum approved dose — monitoring is critical throughout treatment and at all dose changes.

Maximum Dose Warning: Fluoxetine 60mg is the ceiling dose. Do not exceed 60mg per day. Higher doses do not produce additional therapeutic benefit and carry substantially elevated risk of adverse effects.

Serotonin Syndrome: Risk is elevated at higher doses. Concomitant use with MAOIs, triptans, tramadol, lithium, fentanyl or other serotonergic agents significantly increases serotonin syndrome risk. Due to fluoxetine's long half-life, an MAOI-free washout period of at least 5 weeks is required after stopping fluoxetine 60mg before starting an MAOI.

CYP2D6 Inhibition: At 60mg, fluoxetine's potent CYP2D6 inhibition is maximised. Drugs metabolised by CYP2D6 — including codeine, tramadol, tamoxifen, tricyclic antidepressants and many antipsychotics — are substantially affected. Comprehensive drug interaction review is mandatory.

QT Prolongation: Higher SSRI doses have been associated with dose-dependent QT interval prolongation. Use with caution in patients with cardiac risk factors or those taking QT-prolonging medicines.

Hepatic Impairment: Fluoxetine is extensively hepatically metabolised. In patients with hepatic impairment, the 60mg dose should be used with caution and dose reduction considered. Consult your prescriber.

Pregnancy & Breastfeeding: Category C (USA). Neonatal adaptation syndrome reported. At higher doses, fetal exposure is increased. Fluoxetine is excreted in breast milk. Risk-benefit assessment required. Consult prescriber.

Supply, pack size and formulation vary by manufacturer and country. This information is for reference only and does not constitute medical advice.