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FLUOXETINE is a brand name for Fluoxetine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults: Major depressive episodes. Fluoxetine is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required. Obsessive-compulsive disorder. Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Major depressive episodes Adults and the Elderly:
The recommended dose is 20 mg daily. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. 1). 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 Adults and the Elderly:
The recommended dose is 20 mg daily. Although there may be an increased potential for undesirable effects at higher doses in some patients, if after two weeks there is insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 mg.
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 fluoxetine treatment, 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:
Adults and the elderly: A dose of 60 mg/day is recommended. Long-term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa.
All indications:
Adults: The recommended dose may be increased or decreased. Doses above 80 mg/day have not been systematically evaluated.
Paediatric population:
a)Summary of the safety profile The most commonly reported adverse reactions in patients treated with fluoxetine were headache, nausea, insomnia, fatigue and diarrhoea. Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
b)Tabulated list of adverse reactions The table below gives the adverse reactions observed with fluoxetine treatment in adult and paediatric populations. Some of these reactions are in common with other SSRIs, The following frequencies have been calculated from clinical trials in adults (n = 9297) and from spontaneous reporting.
Frequency estimate:
Very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to < 1/1,000). System Organ Class Frequency Adverse reactions Blood and lymphatic system disorders Rare Thrombocytopenia Neutropenia Leucopenia Immune system disorders Rare Anaphylactic reaction Serum sickness Endocrine disorders Rare Inappropriate antidiuretic hormone secretion Common Decreased appetite1 Metabolism and nutrition disorders Rare Hyponatraemia Very common Insomnia2 Common Anxiety Nervousness Restlessness Tension Libido decreased3 Sleep disorder Abnormal dreams4 Uncommon Depersonalisation Elevated mood Euphoric mood Thinking abnormal Orgasm abnormal5 Bruxism Suicidal thoughts and behaviour6 Psychiatric disorders Rare Hypomania Mania Hallucinations Agitation Panic attacks Confusion Dysphemia Aggression Very common Headache Common Disturbance in attention Dizziness Dysgeusia Lethargy Somnolence7 Tremor Uncommon Psychomotor hyperactivity Dyskinesia Ataxia Balance disorder Myoclonus Memory impairment Rare Convulsion Akathisia Buccoglossal syndrome Serotonin syndrone Nervous system disorders Not known Hypoesthesia Common Vision blurredEye disorders Uncommon Mydriasis Ear and labyrinth disorders Uncommon Tinnitus Common Palpitations Electrocardiogram QT prolonged (QTcF ≥450 msec)8 Cardiac disorders Rare Ventricular arrhythmia including torsade de pointes Common Flushing9 Uncommon Hypotension Vascular disorders Rare Vasculitis Vasodilatation Common Yawning Uncommon Dyspnoea Epistaxis Dysphonia Respiratory, thoracic and mediastinal disorders Rare Pharyngitis Pulmonary events (inflammatory processes of varying histopathology and/or fibrosis)10 Very common Diarrhoea Nausea Common Vomiting Dyspepsia Dry mouth Uncommon Dysphagia Gastrointestinal haemorrhage11 Gastrointestinal disorders Rare Oesophageal pain Hepato-biliary disorders Rare Idiosyncratic hepatitis Common Rash12 Urticaria Pruritus Hyperhidrosis Uncommon Alopecia Increased tendency to bruise Cold sweat Rare Angioedema Ecchymosis Photosensitivity reaction Purpura Erythema multiforme Stevens-Johnson syndrome Toxic Epidermal Necrolysis (Lyell Syndrome) Skin and subcutaneous tissue disorders Not known Erythromelalgia Common Arthralgia Uncommon Muscle twitching Musculoskeletal, connective tissue and bone disorders Rare Myalgia Common Frequent urination13 Uncommon Dysuria Renal and urinary disorders Rare Urinary retention Micturition disorder Common Gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15 Uncommon Sexual dysfunction Reproductive system and breast disorders Rare Galactorrhoea Hyperprolactinaemia Priapism Not known Postpartum haemorrhage16 Very common Fatigue17 Common Feeling jittery Chills Uncommon Malaise Feeling abnormal Feeling cold Feeling hot General disorders and administration site conditions Rare Mucosal haemorrhage Common Weight decreaseInvestigations Uncommon Transaminases increased Gamma-glutamyltransferase increased Abnormal liver function tests 1 Includes anorexia 2 Includes early morning awakening, initial insomnia, middle insomnia 3 Includes loss of libido 4 Includes nightmares 5 Includes anorgasmia 6 Includes completed suicide, depression suicidal, intentional self-injury, self- injurious ideation, suicidal behavior, suicidal ideation, suicide attempt, morbid thoughts, self injurious behaviour.
Paediatric population-Children and adolescents under 18 years of age:
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 to 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.
3). 8). It has not been established whether there is an effect on achieving normal adult height. 8). 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. 8). 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.
Suicide/suicidal thoughts or clinical worsening:
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which fluoxetine is prescribed can also be associated with an increased risk of suicide-related events.
1. g. 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Children and adolescents aged 8 years and above (moderate to severe major depressive episode): Treatment should be initiated and monitored under specialist supervision. 5 ml of the Fluoxetine liquid formulation. Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.
After one to two weeks, the dose may be increased to 20 mg/day. Clinical trial experience with daily doses greater than 20 mg is minimal. There is only limited data on treatment beyond 9 weeks. 2). 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.
Elderly:
Caution is recommended when increasing the dose and the daily dose should generally not exceed 40 mg. Maximum recommended dose is 60 mg/day. g. 5).
Withdrawal symptoms seen on discontinuation of Fluoxetine:
Abrupt discontinuation should be avoided. 8). 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.
Method of administration For oral administration. 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
4).
Bone fractures:
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRs and TCAs. The mechanism leading to this risk is unknown.
Withdrawal symptoms seen on discontinuation of fluoxetine treatment:
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 events are mild to moderate and are […]
In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Rashes and allergic reactions:
Rash, anaphylactoid events and progressive systemic events, sometimes serious (involving skin, kidney, liver or lung), have been reported. Upon the appearance of rash or of other allergic phenomena for which an alternative aetiology cannot be identified, fluoxetine should be discontinued.
Seizures:
Seizures are a potential risk with antidepressant drugs. Therefore, as with other antidepressants, fluoxetine should be introduced cautiously in patients who have a history of seizures. Treatment should be discontinued in any patient who develops seizures or where there is an increase in seizure frequency.
5) Mania: Antidepressants should be used with caution in patients with a history of mania/hypomania. As with all antidepressants, fluoxetine should be discontinued in any patient entering a manic phase.
Hepatic/Renal function:
Fluoxetine is extensively metabolised by the liver and excreted by the kidneys. g. alternate day dosing, is recommended in patients with significant hepatic dysfunction. When given fluoxetine 20 mg/day for 2 months, patients with severe renal failure (GFR <10 ml/min) requiring dialysis showed no difference in plasma levels of fluoxetine or norfluoxetine compared to controls with normal renal function.
Tamoxifen:
Fluoxetine, a potent inhibitor of CYP2D6, may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen. 5). 9). , hepatic impairment) or concomitant use with medicinal products known to induce QT […]