Fluoxetine 20mg Tablets

Fluoxetine 20mg Tablets, also available as capsules, are a prescription-only generic equivalent of Prozac® 20mg, containing fluoxetine hydrochloride equivalent to fluoxetine 20mg per unit. Fluoxetine belongs to the selective serotonin reuptake inhibitor (SSRI) class — the most widely prescribed antidepressant class globally. The 20mg strength is the standard adult maintenance dose for the majority of approved indications, making it the most commonly dispensed fluoxetine product worldwide. Generic fluoxetine 20mg tablets and capsules are marketed internationally across the USA, UK, Australia, UAE, Germany, France, Russia, South Korea and worldwide under multiple brand and generic names.

Product Information

Generic Manufacturers — Fluoxetine 20mg

Generic fluoxetine 20mg is manufactured by a wide range of pharmaceutical companies globally:

• 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)
• Jubilee Pharmaceuticals (AU)
• Arrow Pharmaceuticals (AU)

Pack sizes, dosage form (tablet vs capsule), excipients and availability vary by manufacturer and market.

Fluoxetine 20mg is the standard maintenance dose for the following indications, subject to market-specific approved labeling:

Major Depressive Disorder (MDD) Fluoxetine 20mg once daily is the standard starting and maintenance dose for major depressive disorder in adults. In adolescents aged 12–18 in some markets, treatment is initiated at 10mg and titrated to 20mg. Fluoxetine 20mg is one of the first-line pharmacological treatments for depression recommended in national guidelines including NICE (UK), APA (USA) and S3 guidelines (Germany).

Obsessive-Compulsive Disorder (OCD) Fluoxetine 20mg is the recommended starting dose for OCD in adults and children aged 7 years and older (where approved). Doses may be titrated up to 60mg/day for OCD depending on response and tolerability.

Panic Disorder Fluoxetine 20mg is the standard maintenance dose for panic disorder with or without agoraphobia following initiation at 10mg. Higher doses up to 60mg may be used for inadequate responders.

Bulimia Nervosa For bulimia nervosa, the approved dose is fluoxetine 60mg/day; fluoxetine 20mg tablets allow step-wise titration toward the therapeutic dose under medical supervision.

Premenstrual Dysphoric Disorder (PMDD) In the USA, fluoxetine is approved for PMDD (marketed as Sarafem®). The 20mg dose is used either continuously or intermittently during the luteal phase of the menstrual cycle.

Bipolar Depression (adjunct) Fluoxetine 20mg is a component of Symbyax® (olanzapine/fluoxetine), FDA-approved for treatment-resistant depression and depressive episodes associated with bipolar I disorder.

United States: Fluoxetine 20mg is FDA-approved for major depressive disorder (adults and paediatric patients aged 8 and older), OCD (adults and children aged 7 and older), panic disorder, bulimia nervosa and PMDD. The 20mg capsule and tablet are available from multiple FDA-approved generic manufacturers including Teva, Mylan, Sandoz, Aurobindo, Dr. Reddy's, Hikma and Sun Pharma. Carries an FDA Black Box Warning regarding increased suicidal thinking and behaviour risk in children, adolescents and young adults.

United Kingdom / EU: Fluoxetine 20mg is indicated for major depressive disorder (adults and children aged 8 and above in combination with psychological therapy), OCD and bulimia nervosa per MHRA/EMA-approved labeling. NHS prescribing is supported under BNF guidance. Multiple MHRA-approved generic manufacturers supply the UK market. PIL and SPC are available for all authorised products.

Australia: Fluoxetine 20mg Australia products are listed on the Australian Register of Therapeutic Goods (ARTG). Generic fluoxetine 20mg is PBS-subsidised for approved indications subject to eligibility. Available from Chemist Warehouse, Priceline Pharmacy and other TGA-regulated dispensaries. Consult your prescriber regarding PBS authority requirements.

UAE / Gulf: Fluoxetine 20mg is registered with the UAE Ministry of Health and Prevention (MOHAP). Prescription-only (POM) across all GCC states. Available from UAE-licensed pharmacies in Dubai, Abu Dhabi and other emirates. Availability of specific generic products varies by registered manufacturer and emirate.

Germany: Fluoxetin 20mg is available in Germany as tablets and capsules from multiple authorised manufacturers. Prescription-only (rezeptpflichtig). Indicated for depression, OCD and bulimia nervosa per German-approved labeling. Reimbursable under statutory health insurance (GKV) for approved indications.

France: Fluoxétine 20mg is available as tablets and capsules in France under multiple generic names. Subject to prescription and social security reimbursement conditions. All products carry French-language patient information leaflets (notice) and are approved by the ANSM.

Russia: Флуоксетин 20 мг is available in Russia under multiple brand and generic names including Prouzak, Fluval, Prodep and others. All require a valid prescription. Product registration and pharmacovigilance are overseen by the Ministry of Health of the Russian Federation (Росздравнадзор).

South Korea: 플루옥세틴 20mg is registered for prescription use in South Korea per MFDS (식품의약품안전처) approved labeling. Available from Korean and international generic manufacturers. Indicated for depression and OCD.

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

Dose adjustments should always be made under medical supervision. The standard maintenance dose for most adults with depression is fluoxetine 20mg once daily, taken in the morning with or without food.

Black Box Warning (USA): Antidepressants including fluoxetine may increase the risk of suicidal thoughts and behaviours in children, adolescents and young adults (aged up to 24) during early treatment. Monitor all patients for worsening of depression, emergence of suicidality, and unusual changes in behaviour — particularly during the first few weeks of treatment and at dose changes.

Serotonin Syndrome: Fluoxetine may cause serotonin syndrome when co-administered with other serotonergic agents (MAOIs, triptans, tramadol, lithium, fentanyl, St John's Wort). Due to fluoxetine's and norfluoxetine's exceptionally long half-life, washout may take 5 weeks or more before initiating an MAOI.

CYP450 Interactions: Fluoxetine is a potent inhibitor of CYP2D6 and a moderate inhibitor of CYP3A4. Clinically significant interactions exist with tricyclic antidepressants, antipsychotics, antiarrhythmics, codeine, tamoxifen, warfarin and other drugs. Full medication review is required before prescribing.

Pregnancy & Breastfeeding: Category C (USA). Neonatal adaptation syndrome reported with third-trimester exposure. Fluoxetine is excreted in breast milk. Risk-benefit assessment required. Consult your prescriber.

Discontinuation: Fluoxetine's long half-life makes it one of the SSRIs least associated with discontinuation syndrome, but dose changes should still be medically supervised.

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