Fluoxetine
Indications
Registered South African indications:
- Major depressive episodes
- Bulimia nervosa
- Obsessive-compulsive disorder
Cautions
Contraindications
South African manufacturer recommendations
- Hypersensitivity to the active ingredient or any of its excipients
- Severe renal impairment (GFR <30ml/min/1.73m2)
- Coadministration with linezolid
- Coadministration with metoprolol when used in cardiac failure
- Coadministration with pimozide
- Coadministration with monoamine oxidase inhibitors or within 14 days of their use
- Children <18 years
International manufacturer recommendations
- Hypersensitivity to the active ingredient or any of its excipients
- Coadministration with irreversible, non-selective monoamine oxidase inhibitors or within 14 days of their use
- Coadministration with metoprolol used in cardiac failure
Cautions
South African manufacturer recommendations
- Pregnancy
- Breastfeeding
- Mild to moderate renal impairment (GFR ≥30-80ml/min/1.73m2)
- Hepatic impairment
- Elderly
- Young adults (<25 years of age)
- Greater severity of depression prior treatment
- Presence of thoughts of death prior treatment
- Patients entering a manic phase
- History of mania/ hypomania
- Seizure disorders or history thereof
- Uncontrolled epilepsy
- Controlled epilepsy - Electroconvulsive therapy
- Extrapyramidal disorders
- Parkinson's disease - Abrupt withdrawal
- Suicide/suicidal thoughts or clinical worsening
- Serotonin syndrome
- Cardiac disease
- Congenital long QT syndrome
- Family history of QT prolongation
- Clinical conditions that predispose to arrhythmias
- Hypokalemia
- Hypomagnesemia
- Bradycardia
- Acute myocardial infarction
- Uncompensated heart failure - Clinical conditions that predispose to increased exposure to fluoxetine
- Hepatic impairment - Diabetes mellitus
- Pre-existing underweight depressed patients
- Raised intraocular pressure
- Risk of acute narrow-angle glaucoma
- Pre-existing sexual dysfunction
- Monoamine oxidase inhibitor use within 5 weeks of discontinuation of fluoxetine
- History of bleeding disorders
- Von Willebrand disease
- Haemophilia A
- Deficiency in F VIII
- Haemophilia B - Comorbid bleeding disorders
- Multiple pregnancies
- Gestational hypertension
- Preeclampsia - Coadministration with agents known to induce QT prolongation and/or torsade de pointes
- Coadministration with oral anticoagulants
- Coadministration with agents known to affect platelet function or other agents that may increase risk of bleeding
- Coadministration with CNS active agents
- Coadministration with other serotonergic agents
- Coadministration with tamoxifen
- Coadministration with agents lowering the epileptogenic threshold
International manufacturer recommendations
- Pregnancy
- Breastfeeding
- Hepatic impairment
- Elderly
- Children <18 years
- Patients entering a manic phase
- History of mania/ hypomania
- Seizure disorders or history thereof
- Unstable seizure disorders
- Controlled epilepsy - Electroconvulsive therapy
- Congenital long QT syndrome
- Family history of QT prolongation
- Clinical conditions that predispose to arrhythmias
- Hypokalemia
- Hypomagnesemia
- Bradycardia
- Acute myocardial infarction
- Uncompensated heart failure - Clinical conditions that predispose to increased exposure to fluoxetine
- Hepatic impairment - Diabetes mellitus
- History of suicidal related events
- Significant degree of suicidal ideation or clinical worsening
- Akathisia / psychomotor restlessness
- Underweight depressed or bulimic patients
- Abrupt withdrawal
- History of bleeding disorders
- Postpartum haemorrhage
- Raised intraocular pressure
- Risk of acute narrow-angle glaucoma
- Pre-existing sexual dysfunction
- Coadministration with medicinal agents known to induce QT prolongation and/or torsade de pointes
- Coadministration with oral anticoagulants
- Coadministration with drugs known to affect platelet function or other agents that may increase risk of bleeding
- Coadministration with buprenorphine/ opioids
- Coadministration with other serotonergic (among others L-tryptophan) and/or neuroleptic agents
- Coadministration with tamoxifen
- Coadministration with agents lowering the epileptogenic threshold
- Sulphur hypersensitivity (dsp)
- Fructose intolerance (dsp)
Adult dosage
Forms avail. in SA and covered in this monograph: cap, dsp, tab
Dosages below include:
- South African manufacturer recommendations
- International manufacturer recommendations
South African manufacturer recommendations
Major depressive disorder
- Oral (cap, dsp, tab): Initial: 20mg, dly, preferably in the morning
Bulimia nervosa
- Oral (cap, dsp, tab): 60mg, dly
Obsessive compulsive disorder
- The obsessions or compulsions must be experienced as intrusive, markedly distressing, time consuming or interfering significantly with the person's social or occupational functioning
- Oral (cap, dsp, tab): 20-60mg, dly
The recommended dose may be increased or decreased
Fluoxetine 20mg capsules cannot be used for downward dose titration
Doses above 80mg/day are not recommended for any indication. Upward dose titration is advised at intervals of several weeks due to the kinetic properties of fluoxetine
Fluoxetine 20mg may be administered with or without food (cap)
The tablets may be swallowed whole or be dispersed in approx. 100ml water (tab)
International manufacturer recommendations
Major depressive episodes
- Symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required
- Oral (cap, dsp): Initial: 20mg, dly; Titrate gradually up to 60mg, dly, if required; Maintenance: 20-60mg, dly; Max: 60mg/24hrs
Dosage should be reviewed and adjusted if necessary, within 3-4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms
Obsessive-compulsive disorder
- Oral (cap, dsp): Initial: 20mg, dly; If after 2 weeks there is insufficient response to 20 mg, titrate gradually up to a maximum of 60mg, dly; Maintenance: 20-60mg, dly; Max: 60mg/24hrs
If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis
While there are no systematic studies to answer the question of how long to continue treatment, obsessive-compulsive disorder (OCD) is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy
Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD
Bulimia nervosa
- As a complement of psychotherapy for the reduction of binge-eating and purging activity
- Oral (cap, dsp): 60mg, dly
Long-term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa
All indications:
- The recommended dose may be increased or decreased. Doses above 80mg/day have not been systematically evaluated
- Fluoxetine may be administered as a single or divided dose, during or between meals
- When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment
The dispersible tablet (or half tablet) should be swallowed with a sufficient amount of fluid (e.g. half a glass of water). Alternatively, the tablet (or half tablet) can be dispersed in half a glass of water just before taking the dose. Do not crush or chew the tablets
See additional prescribing points for information on the withdrawal of fluoxetine treatment
Paediatric dosage
Forms avail. in SA and covered in this monograph: cap, dsp
Paed. dosages below include:
- South African manufacturer recommendations
- International manufacturer recommendations
South African manufacturer recommendations
- Not established for use in children below 18 years
International manufacturer recommendations
Major depressive episode - moderate to severe
- If depression is unresponsive to psychological therapy after 4-6 sessions
Younger than 8 years
- Not established for use
8 years and older
- Oral (cap, dsp): Initial: 10mg, dly; Titrate to 20mg, dly after 1-2 weeks; Maintenance: 20mg, dly; Max: 20mg/24hrs
Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy
Treatment should be initiated and monitored under specialist supervision
Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose. Clinical trial experience with daily doses greater than 20mg is minimal. There is only limited data on treatment beyond 9 weeks
Lower weight children: Due to higher plasma levels in lower weight children, the therapeutic effect may be achieved with lower doses
For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered
Special populations
Pregnancy
South African manufacturer recommendations
- Caution; not recommended
- Use should be considered during pregnancy only if the potential benefit justifies the potential risk to the foetus, taking into account the risks of untreated depression
- Some epidemiological studies assessing the risk of fluoxetine exposure in early pregnancy have been inconsistent and have not provided conclusive evidence of an increased risk of congenital malformations
- One meta-analysis suggests a potential risk of cardiovascular defects in infants of women exposed to fluoxetine 20mg during the first trimester of pregnancy compared to infants of women who were not exposed to fluoxetine 20mg
- Caution should be exercised in the 3rd trimester, as transitory withdrawal symptoms (e.g. transient jitteriness, difficulty feeding, tachypnoea and irritability) have been reported rarely in the neonate after maternal use near term
- Some neonates exposed to fluoxetine late in the third trimester developed complications resulting in prolonged hospitalisation, respiratory support and tube feeding. Such complications can arise immediately upon delivery
- Reported clinical findings have included respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly, withdrawal syndrome. In some cases, the clinical picture is consistent with serotonin syndrome
- Use of fluoxetine late in the third trimester of pregnancy may increase the risk of persistent pulmonary hypertension in the newborn
- Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth
International manufacturer recommendations
- Caution; not recommended
- Some epidemiological studies suggest an increased risk of cardiovascular defects associated with the use of fluoxetine during the first trimester. The mechanism is unknown. Overall the data suggest that the risk of having an infant with a cardiovascular defect following maternal fluoxetine exposure is in the region of 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population
- Epidemiological data have suggested that the use of selective serotonin reuptake inhibitors in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population, 1 to 2 cases of PPHN per 1000 pregnancies occur
- Fluoxetine should not be used during pregnancy unless the clinical condition of the woman requires treatment with fluoxetine and justifies the potential risk to the foetus. Abrupt discontinuation of therapy should be avoided during pregnancy
- Although fluoxetine can be used during pregnancy, caution should be exercised, especially during late pregnancy or just prior to the onset of labour since some other effects have been reported in neonates: irritability, tremor, hypotonia, persistent crying, difficulty in feeding or in sleeping. These symptoms may indicate either serotonergic effects or a withdrawal syndrome. The time to occur and the duration of these symptoms may be related to the long half-life of fluoxetine (4-6 days) and its active metabolite, norfluoxetine (4-16 days)
- Postpartum haemorrhage (PPH) is a leading cause of maternal mortality. Treatment with SSRIs and SNRIs within one month prior to birth may increase the risk of PPH (See additional prescribing points)
- Observational data indicate an increased risk of PPH following SSRI/ SNRI exposure within the month prior to delivery. Healthcare professionals should be aware of the potential risk of PPH while making treatment decisions for prescribing SSRI/ SNRI towards the end of pregnancy
Breastfeeding
- Caution; not recommended
- Fluoxetine and its metabolite norfluoxetine, are known to be excreted in human breast milk. Adverse events have been reported in breastfeeding infants. If treatment with fluoxetine is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed
Fertility
- Animal data have shown that fluoxetine may affect sperm quality
- Human case reports with some selective serotonin reuptake inhibitors have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far
Renal Impairment
South African manufacturer recommendations
- GFR≥30-80ml/min/1.73m2: Caution; dose adjustment recommended
A lower dose, e.g. alternate day dosing, is recommended in patients with significant mild to moderate renal failure - GFR<30ml/min/1.73m2: Contraindicated
International manufacturer recommendations
Hepatic Impairment
- Caution; dose adjustment recommended
A lower or less frequent dose should be considered (e.g. 20mg, every second day)
Elderly
South African manufacturer recommendations
- Caution; no dose adjustment recommended
Caution in all elderly patients, particularly if they have a systemic illness or are receiving multiple medications for concomitant diseases
Dosages >20mg, dly are not recommended
International manufacturer recommendations
- Caution; no dose adjustment recommended
Caution is recommended when increasing the dose, and the daily dose should generally not exceed 40mg. Maximum recommended dose is 60mg/day
Porphyria Information
Drugs in Sport
- Permitted - No warnings
Adverse reactions
Central Nervous System Disorders
- Insomnia
- Early morning awakening
- Initial insomnia
- Middle insomnia - Anxiety
- Nervousness
- Restlessness
- Tension
- Decreased libido
- Loss of libido - Sleep disorder
- Abnormal dreams
- Nightmares - Depersonalisation
- Euphoric mood
- Abnormal thinking
- Abnormal orgasm
- Anorgasmia - Bruxism
- Suicidal thoughts and behaviour
- Completed suicide
- Suicidal depression
- Intentional self-injury
- Self-injurious ideation
- Suicidal ideation
- Suicide attempt
- Morbid thoughts
- Self-injurious behaviour - Hypomania
- Mania
- Hallucinations
- Agitation
- Panic attacks
- Confusion
- Dysphemia
- Aggression
- Headache
- Disturbances in attention
- Dizziness
- Dysgeusia
- Lethargy
- Somnolence
- Hypersomnia
- Sedation - Tremor
- Psychomotor hyperactivity
- Dyskinesia
- Ataxia
- Balance disorder
- Myoclonus
- Memory impairment
- Seizures
- Akathisia
- Buccoglossal syndrome
- Serotonin syndrome
- Fatigue
Cardiovascular Disorders
- Palpitations
- Ventricular arrhythmia, including torsades de pointes
- Prolonged QT interval (QTcF ≥450msec)
- Flushing
- Hot flush - Hypotension
- Vasculitis
- Vasodilatation
Respiratory Disorders
- Yawning
- Dyspnoea
- Epistaxis
- Pharyngitis
- Pulmonary events (inflammatory processes of varying histopathology and/or fibrosis)
- Atelectasis
- Interstitial lung disease
- Pneumonitis
Gastrointestinal Disorders
- Diarrhoea
- Nausea and vomiting
- Dyspepsia
- Dry mouth
- Dysphagia
- Gastrointestinal haemorrhage
- Gingival bleeding
- Haematemesis
- Haematochezia
- Rectal haemorrhage
- Haemorrhagic diarrhoea
- Melaena
- Gastric ulcer
- Haemorrhage - Oesophageal pain
Hepatobiliary Disorders
- Idiosyncratic hepatitis
- Increased transaminases
- Increased gamma-glutamyltransferase
Genitourinary Disorders
- Gynaecological bleeding
- Cervix haemorrhage
- Uterine dysfunction
- Uterine bleeding
- Genital haemorrhage
- Menometrorhagia
- Menorrhagia
- Metrorrhagia
- Polymenorrhea
- Postmenopausal haemorrhage
- Uterine haemorrhage
- Vaginal haemorrhage - Erectile dysfunction
- Ejaculation disorder
- Ejaculation failure
- Ejaculation dysfunction
- Premature ejaculation
- Delayed ejaculation
- Retrograde ejaculation - Sexual dysfunction (occasionally persisting after treatment discontinuation)
- Priapism
- Frequent urination
- Pollakiuria - Dysuria
- Urinary retention
- Micturition disorder
- Postpartum haemorrhage
Endocrine and Metabolic Disorders
- Inappropriate antidiuretic hormone secretion
- Decreased appetite
- Anorexia - Decreased weight
- Hyponatraemia
- Galactorrhoea
- Hyperprolactinemia
Musculoskeletal Disorders
- Arthralgia
- Muscle twitching
- Myalgia
Skin and Subcutaneous Tissue Disorders
- Rash
- Erythema
- Exfoliative rash
- Heat rash
- Erythematous rash
- Follicular rash
- Generalised rash
- Macular rash
- Macular-papular rash
- Morbilliform rash
- Papular rash
- Pruritic rash
- Vesicular rash
- Umbilical erythema rash - Urticaria
- Pruritus
- Hyperhidrosis
- Alopecia
- Increased tendency to bruise
- Cold sweat
- Angioedema
- Ecchymosis
- Photosensitivity reaction
- Purpura
- Erythema multiforme
- Stevens-Johnson syndrome
- Toxic Epidermal Necrolysis (Lyell Syndrome)
- Mucosal haemorrhage
Immune, Blood and Lymphatic System Disorders
- Thrombocytopenia
- Neutropenia
- Leucopenia
- Anaphylactic reaction
- Serum sickness
- Fever
- Chills
Sensory Disorders
- Blurred vision
- Mydriasis
- Tinnitus
Others
- Abnormal feeling
- Feeling cold
- Feeling hot
- Feeling jittery
Interactions
- Irreversible, non-selective monoamine oxidase Inhibitors
- Iproniazid
- Metoprolol
- Tamoxifen
- Monoamine oxidase-A inhibitors
- Linezolid
- Methylthioninium chloride (methylene blue)
- Mequitazine
- Phenytoin
- Serotonergic agents
- Lithium
- Tramadol
- Triptans
- Tryptophan
- Selegiline (Monoamine oxidase-B inhibitor)
- Buprenorphine
- Opioids
- Medicinal agents that prolong the QT interval
- Class IA and III antiarrhythmics
- Antipsychotics
- Phenothiazine derivatives
- Pimozide
- Haloperidol
- Tricyclic antidepressants
- Certain antimicrobial agents
- Sparfloxacin
- Moxifloxacin
- Erythromycin IV
- Pentamidine
- Anti-malaria treatment
- Halofantrine
- Antihistamines
- Astemizole
- Mizolastine
- Agents that affect haemostasis
- Oral anticoagulants
- Platelets antiaggregants
- Aspirin
- Non-steroidal anti-inflammatory drugs
- Cyproheptadine
- Agents inducing hyponatremia
- Diuretics
- Desmopressin
- Carbamazepine
- Oxcarbazepine
- Agents lowering the epileptogenic threshold
- Other selective serotonin reuptake inhibitors
- Phenothiazines
- Butyrophenones
- Mefloquine
- Chloroquine
- Bupropion
- Other CYP2D6 substrates
- Flecainide
- Encainide
- Vinblastine
- Propafenone
- Nebivolol
- Atomoxetine
- Carbamazepine
- Risperidone
Other interactions
- Alcohol
- St. John's Wort (Hypericum perforatum)
Monitoring
None routine. Specific cases may require
- Electrocardiogram
- Growth in children
- Serum sodium
- Blood glucose
- Hepatic function
- Renal function
- Vital signs
Additional observations
- Risk factors for QT prolongation and ventricular arrhythmia
- Depression
- Clinical worsening, suicidality, or unusual changes in behaviour
- Signs and symptoms of serotonin syndrome
- Mental status
- Autonomic instability
- Neuromuscular changes
- Gastrointestinal symptoms
- Seizures - Blood loss
- Signs of anaemia
- Fatigue
- Shortness of breath
- Chest pain
- Lactation problems
Prescribing points
Fluoxetine Capsule - EML (Primary)
Risk of postpartum haemorrhage (PPH)
- PPH is a leading cause of maternal mortality. Treatment with SSRIs and SNRIs within one month prior to birth may increase the risk of PPH
- Observational data indicate an increased risk of PPH following SSRI/ SNRI exposure within the month prior to delivery
- Healthcare professionals should be aware of the potential risk of PPH while making treatment decisions for prescribing SSRI/ SNRI towards the end of pregnancy
- Patients should be advised to inform their doctors before taking SSRI/ SNRI containing medicines if they have history of bleeding disorders (e.g von Willebrand disease, haemophilia A, deficiency in F VIII, and haemophilia B); and comorbid bleeding disorders (e.g multiple pregnancy, gestational hypertension or preeclampsia)
Withdrawal of fluoxetine treatment
- Abrupt discontinuation should be avoided. When stopping treatment with fluoxetine the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions
- If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate
- Discontinuation of fluoxetine commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions
- Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment
- Generally, these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that fluoxetine should be gradually tapered when discontinuing treatment over a period of at least one to two weeks, according to the patient's needs
Paediatric population
International manufacturer recommendations
- Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo
- Fluoxetine should only be used in children and adolescents aged 8-18 years for the treatment of moderate to severe major depressive episodes and it should not be used in other indications
- If based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, only limited evidence is available concerning long-term effect on safety in children and adolescents, including effects on growth, sexual maturation and cognitive, emotional and behavioural developments
- In a 19-week clinical trial decreased height and weight gain was observed in children and adolescents treated with fluoxetine
- It has not been established whether there is an effect on achieving normal adult height
- The possibility of a delay in puberty cannot be ruled out
- Growth and pubertal development (height, weight, and TANNER staging) should therefore be monitored during and after treatment with fluoxetine. If either is slowed, referral to a paediatrician should be considered
- In paediatric trials, mania and hypomania were commonly reported. Therefore, regular monitoring for the occurrence of mania/hypomania is recommended
- Fluoxetine should be discontinued in any patient entering a manic phase
- It is important that the prescriber discusses carefully the risks and benefits of treatment with the child/young person and/or their parents
South African manufacturer recommendations
- Patients with major depressive disorder, both adults and children, may experience worsening of their depression and/or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medicines. This risk may persist until significant remission occurs
- Isolated cases of suicidal ideation and suicidal behaviours have been reported during therapy with fluoxetine or early after treatment discontinuation. Although a causal role for fluoxetine alone in inducing such behaviours has not been established, some pooled analyses from studies of patients using antidepressants in psychiatric conditions indicate an increased risk for suicidal ideation and suicidal behaviours in paediatric and young adult (<25 years of age) patients
Mechanism of action
Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action. Fluoxetine has practically no affinity to other receptors such as α-, α-, and β-adrenergic; serotonergic; dopaminergic; histaminergic; muscarinic; and GABA receptors.
Dosage forms
- Capsule
- Dispersible tablet
- Tablet
Formulation
Tablet 20mg
- Lorien (Pharmacare)
- Prozac (Eli Lilly) originator
Tablet dispersible 20mg
- Prohexal (Sandoz)
Tablet dispersible 40mg
- Prohexal (Sandoz)
Capsule 20mg
- A-Lennon Fluoxetine (Pharmacare)
- Fluoxetine 20 Unimed (Unimed Healthcare)
- Fluoxetine Actor (Cipla)
- Fluoxetine Biotech 20 (Biotech)
- Fluoxetine Oethmaan (Oethmaan)
- Flutinol (Pharmaplan)
- Lilly Fluoxetine (Eli Lilly) originator
- Lorien (Pharmacare)
- Nuzak (Cipla)
- Prohexal (Sandoz)
- Prolax (Dezzo Trading)
- Prozac (Eli Lilly) originator
- Ranflocs (Ranbaxy)
- Sandoz Fluoxetine (Sandoz)
- Zydus Fluoxetine (Zydus)
References
1. SmPC: Fluoxetine 20mg hard capsules. Eli Lilly and Company Limited; Last updated on eMC: 14 May 2018; Downloaded online 28 Aug 2018 [https://www.medicines.org.uk/emc/product/3768/smpc] 2. SmPC: Fluoxetine 20mg Dispersible Tablets, Concordia International - formerly AMCo; Last updated on eMC: 14 Mar 2017; Downloaded online 28 Aug 2018 [https://www.medicines.org.uk/emc/product/5358/smpc] 3. SAMF Page 496 12th Edition 4. https://drive.google.com/drive/folders/1yJ7FfUaoAbXUPRM4s0741YKZ91FdRdAB (05/1998_Cipla_Nuzak_20mg_caps) 5. https://drive.google.com/drive/folders/1yJ7FfUaoAbXUPRM4s0741YKZ91FdRdAB (1/03/2013_Pharmacare_Lorien_20mg tab; 20mg caps) 6. https://drive.google.com/drive/folders/1yJ7FfUaoAbXUPRM4s0741YKZ91FdRdAB (14/08/2002_Sandoz_Prohexal_20 caps; 20T; 40mg disp tab) 7. https://drive.google.com/drive/folders/1yJ7FfUaoAbXUPRM4s0741YKZ91FdRdAB (Lilly Fluoxetine_20mg_caps) 8. https://drive.google.com/drive/folders/1yJ7FfUaoAbXUPRM4s0741YKZ91FdRdAB (06/05/2011_Dezzo_Prolax_20mg_caps) 9. U2D: Fluoxetine: Drug information, UpToDate; Downloaded online 28 Aug 2018 [https://www.uptodate.com/contents/fluoxetine-drug-information] - U2D: Fluoxetine: Drug information, UpToDate; Downloaded online 02 June 2021 [https://drive.google.com/drive/folders/1UTYwGDJVP2oW5n7ta92u9V2R58u94yef] 10. NAPOS The Drug Database for Acute Porphyria: N06AB03 Fluoxetine; Accessed online 28 Aug 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N06AB03] 11. South African Institute for Drug-Free Sport: Prozac Capsules, Tablets; Accessed online 28 Aug 2018 [http://www.drugfreesport.org.za/online-medication-check/] 12. Afritox: Fluoxetine; Accessed online 17 May 2019 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=6585] 13. SmPC: Olena 20mg Dispersible Tablets, ADVANZ Pharma: Last updated on eMC: 20 Apr 2021; Downloaded online 02 June 2021 [https://drive.google.com/drive/folders/1UTYwGDJVP2oW5n7ta92u9V2R58u94yef] 14. SmPC: Fluoxetine 20 mg hard capsules, Brown & Burk UK Ltd: Last updated on eMC: 12 Apr 2021; Downloaded online 02 June 2021 [https://drive.google.com/drive/folders/1UTYwGDJVP2oW5n7ta92u9V2R58u94yef] 14.1 SmPC: Fluoxetine 20 mg hard capsules, Brown & Burk UK Ltd: Last updated on eMC: 24 Sep 2021; Downloaded online 23 Feb 2022 [https://drive.google.com/drive/u/0/folders/1DuBN4sfaemzo9tNCc_QFNx9QzCyKmUn7] 15. PI: Prozac, Eli Lily: Date of Registration: 26 May 2006 [https://drive.google.com/drive/folders/1UTYwGDJVP2oW5n7ta92u9V2R58u94yef] 16. PI: Lilly- Fluoxetine; Date of Registration: 26 May 2006 [https://drive.google.com/drive/folders/1UTYwGDJVP2oW5n7ta92u9V2R58u94yef] 16.1 PI: Lilly- Fluoxetine; Date of Registration: 26 May 2006; Revision of text: 17 January 2022. [https://drive.google.com/drive/u/0/folders/1DuBN4sfaemzo9tNCc_QFNx9QzCyKmUn7] 17. AfriTox: Fluoxetine; Downloaded online: 08 July 2021 [https://www.afritox.co.za/single-toxins/2368/] 18. Important Medicine Safety Information: SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIs) AND SEROTONIN–NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIs) ASSOCIATED WITH THE RISK OF POSTPARTUM HAEMORRHAGE; Dated: 21 June 2021 [https://drive.google.com/drive/folders/1UTYwGDJVP2oW5n7ta92u9V2R58u94yef]
Brands & products
22 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days oldcapsuleGeneric· 18 products
from R1.62/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Fluoxetine 20 oethmaan | 20 mg | 100 | S5 | R162.35 | R1.62 | R68.05 | 838713019 |
| Rezak | 20 mg | 30 | S5 | R57.35 | R1.91 | R31.72 | 707426001 |
| Fluoxetine 20 oethmaan | 20 mg | 30 | S5 | R61.43 | R2.05 | R33.14 | 838713009 |
| Fluoxetine 20 oethmaan | 20 mg | 28 | S5 | R58.54 | R2.09 | R32.14 | 838713018 |
| Fluoxetine unimed | 20 mg | 30 | S5 | R63.15 | R2.10 | R33.73 | 705377001 |
| Fluoxetine Biotech 20 | 20 mg | 100 | S5 | R231.48 | R2.31 | R88.89 | 3001358002 |
| Prolax | 20 mg | 28 | S5 | R69.87 | R2.50 | R36.06 | 719658001 |
| Zydus fluoxetine | 20 mg | 30 | S5 | R75.14 | R2.50 | R37.88 | 705064001 |
| Trizac 20 Mg | 20 mg | 30 | S5 | R80.87 | R2.70 | R39.86 | 705174001 |
| Ranflocs | 20 mg | 30 | S5 | R81.56 | R2.72 | R40.10 | 700686001 |
| Fluoxetine Biotech 20 | 20 mg | 30 | S5 | R83.58 | R2.79 | R40.80 | 3001358001 |
| Fluoxetine actor | 20 mg | 30 | S5 | R85.68 | R2.86 | R41.53 | 716520001 |
| A-Lennon Fluoxetine | 20 mg | 28 | S5 | R80.81 | R2.89 | R39.84 | 703391001 |
| Lorien | 20 mg | 28 | S5 | R118.33 | R4.23 | R52.82 | 821063006 |
| Nuzak | 20 mg | 30 | S5 | R129.14 | R4.30 | R56.56 | 840653018 |
| Prohexal | 20 mg | 30 | S5 | R129.92 | R4.33 | R56.83 | 879282010 |
| Lilly-fluoxetine | 20 mg | 28 | S5 | R332.38 | R11.87 | R116.65 | 820016004 |
| Prozac | 20 mg | 30 | S5 | R724.03 | R24.13 | R190.98 | 757969011 |
tabletGeneric· 2 products
from R7.28/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Lorien | 20 mg | 30 | S5 | R218.35 | R7.28 | R85.28 | 700877003 |
| Prozac | 20 mg | 30 | S5 | R724.06 | R24.14 | R190.98 | 822981017 |
effervescent tabletGeneric· 2 products
from R7.52/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Prohexal 20t | 20 mg | 30 | S5 | R225.46 | R7.52 | R87.23 | 894243001 |
| Prohexal | 40 mg | 30 | S5 | R416.45 | R13.88 | R139.77 | 894249002 |
- A-Lennon Fluoxetine
- Fluoxetine Unimed
- Fluoxetine Actor
- Fluoxetine Biotech
- Fluoxetine Oethmaan
- Flutinol
- Lorien
- Nuzak
- Prohexal
- Prolax
- Ranflocs
- Sandoz Fluoxetine
- Zydus Fluoxetine
- Lilly Fluoxetine 20
- Prozac
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
Interacts with 43 known drugs
Check against other drugs →- Alprazolam
- Aripiprazole
- Aspirin
- Atomoxetine Hydrochloride
- Buprenorphine
- Carbamazepine
- Clopidogrel
- Cyproheptadine
- Desmopressin
- Donepezil
- Erythromycin
- Flecainide Acetate
- Galantamine
- Glimepiride
- Halofantrine
- Haloperidol
- Insulin Glargine
- Insulin Glulisine
- Lercanidipine Hydrochloride
- Linezolid
- Mefloquine
- Metoclopramide
- Metoprolol
- Mizolastine
- Moxifloxacin
- Nebivolol
- Oxcarbazepine
- Phenytoin
- Pimozide
- Pirfenidone
- Rasagiline
- Reboxetine
- Risperidone
- Ritonavir
- Sertraline
- Tamoxifen
- Timolol Maleate
- Tranylcypromine
- Trazodone
- Vinblastine
- + 3 more
Cited in 46 documents
- GuidelinesReferences16×
- GuidelinesReferences - Medicines used in Palliative Care8×
- GuidelinesReferences - Mental Health Conditions8×
- GuidelinesReferences - Mental Health Conditions6×
- GuidelinesDepression in Childhood and Adolescence5×
- GuidelinesGeneralised Anxiety Disorders (GAD)5×
- GuidelinesAnxiety4×
- GuidelinesAnxiety And Obsessive-Compulsive Disorders4×
- GuidelinesDepression4×
- GuidelinesDepressive Disorders4×
- GuidelinesDepressive Disorders4×
- GuidelinesNeuropsychiatric Conditions4×
- GuidelinesReferences - Medicines used in Palliative Care4×
- GuidelinesTreatment4×
- GuidelinesAnxiety Disorders3×
- GuidelinesObsessive Compulsive Disorder (OCD)3×
- GuidelinesPost Traumatic Stress Disorder (PTSD)3×
- GuidelinesReferences3×
- GuidelinesTreatment3×
- GuidelinesAnxiety - Paediatric Palliative Care2×
- GuidelinesDepression2×
- GuidelinesReferences - Gynaecology2×
- GuidelinesTrauma and Stress-Related Disorders2×
- GuidelinesTreatment2×
- GuidelinesTreatment2×
- GuidelinesTreatment2×
- GuidelinesTreatment2×
- GuidelinesTreatment2×
- GuidelinesAnorexia Nervosa
- GuidelinesAnxiety
- GuidelinesCommon Medications Used in Psychiatry and Their Side Effects
- GuidelinesCommon prescribed drug dosage for children
- GuidelinesDepression - Paediatric Palliative Care
- GuidelinesDiscontinuation Symptoms of Serotonin Reuptake Inhibitors
- GuidelinesFever and Sweating
- GuidelinesManagement of Drug-induced Seizures
- GuidelinesMenopause and Perimenopausal Syndrome
- GuidelinesPsychiatric Presentations in HIV Infected Children and Adolescents
- GuidelinesReferences - Emergencies and Injuries
- GuidelinesReferences - Poisoning
- GuidelinesSpecial Considerations
- GuidelinesSummary points
- GuidelinesSummary points
- GuidelinesSummary points
- GuidelinesSummary points
- GuidelinesSymptom Management in ESKD