Fluoxetine


Generic Medicine Info
Administration
May be taken with or without food.
Contraindications
Unstable seizure disorders/epilepsy. Severe renal (GFR <10 mL/min) impairment. Concomitant use or within 2 weeks of discontinuing MAOIs (e.g. iproniazid) or within 5 weeks of discontinuing fluoxetine. Concurrent use with metoprolol, linezolid, IV methylene blue, pimozide, and thioridazine.
Special Precautions
Patient with history of suicide-related events or pre-existing suicidal ideation; bipolar disorder, history of mania or hypomania; history of seizure disorder or conditions predisposing to seizures (e.g. brain damage, alcoholism), diabetes mellitus, history of bleeding disorders, CV disease (e.g. history of MI, unstable heart disease), risk factors for QT prolongation (e.g. congenital long QT syndrome, history of prolonged QT) or conditions predisposing to arrhythmias (e.g. hypokalaemia, hypomagnesaemia, bradycardia, acute MI, uncompensated heart failure); volume depletion, raised intraocular pressure or at risk of acute narrow-angle glaucoma. Patient where weight loss is undesirable. CYP2D6 poor metabolisers. Concomitant electroconvulsive therapy. Delayed-release cap: Bariatric surgery (refer to specific institutional protocols). Avoid abrupt withdrawal. Hepatic and mild to moderate renal impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness or drowsiness, if affected, do not drive or operate machinery. Do not switch between brands or dosage forms unless instructed by your doctor. Monitoring Parameters Monitor hepatic and renal function at baseline and as clinically indicated; serum Na in at-risk patients; blood glucose in diabetics. Assess ECG periodically in patients at-risk for QT prolongation. Closely monitor mental status for depression; signs and symptoms of clinical worsening, suicidality, or unusual behavioural changes (especially at the start of therapy and during dose adjustments); anxiety, mania, panic attacks, social functioning, serotonin syndrome and akathisia.
Adverse Reactions
Significant: Suicidal thoughts and behaviour in children, adolescents and young adults; activation of mania or hypomania, seizures, CNS depression, CNS effects (e.g. anxiety, insomnia, nervousness), QT prolongation and ventricular arrhythmias, including torsade de pointes; cutaneous bleeding events (e.g. ecchymosis, purpura), bone fractures, akathisia, mild pupillary dilation, sexual dysfunction, anorexia and/or weight loss, altered glycaemic control (e.g. hyper- or hypoglycaemia), syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatraemia, withdrawal symptoms. Cardiac disorders: Palpitation, dyspnoea. Eye disorders: Blurred vision, abnormal vision. Gastrointestinal disorders: Nausea, diarrhoea, vomiting, dyspepsia, dry mouth, dysgeusia. General disorders and administration site conditions: Lethargy, fatigue, chills, feeling jittery, asthenia, flu-like symptoms. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Headache, dizziness, drowsiness, tremor, abnormal thinking. Psychiatric disorders: Psychomotor restlessness, sleep abnormality, tension, abnormal dreams, attention disturbance. Renal and urinary disorders: Frequent urination, dysuria, urinary retention. Reproductive system and breast disorders: Decreased libido, erectile dysfunction, ejaculation disorder. Respiratory, thoracic and mediastinal disorders: Yawning, pharyngitis, sinusitis. Skin and subcutaneous tissue disorders: Pruritus, hyperhidrosis. Vascular disorders: Flushing.
Potentially Fatal: Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like events, haemorrhages, severe hyponatraemia. Rarely, significant allergic events and rash (e.g. vasculitis, lupus-like syndrome, pulmonary inflammatory disease; anaphylactoid reactions including bronchospasm, laryngospasm, angioedema, urticaria).
Drug Interactions
Increased risk of bleeding with warfarin, other oral anticoagulants, aspirin, NSAIDs and atypical antipsychotics (e.g. clozapine, phenothiazines); hyponatraemia with diuretics. May reduce plasma levels and efficacy of tamoxifen. Reduced antidepressant effect with cyproheptadine. Increased risk of QT prolongation with mequitazine and other drugs known to prolong QT interval (e.g. Class IA and III antiarrhythmics, erythromycin, moxifloxacin, pentamidine, halofantrine, mizolastine, astemizole). May increase serum concentration of benzodiazepines (e.g. diazepam, alprazolam). May increase the plasma levels of phenytoin, haloperidol, and carbamazepine.
CIMS Class
Antidepressants
ATC Classification
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Disclaimer: This information is independently developed by CIMS based on fluoxetine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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