Fluoxetine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Depression Initial: 20 mg once daily. Max: 80 mg/day in 2 divided doses. Bulimia nervosa 60 mg/day as a single or in divided doses. Obsessive compulsive disorder Initial: 20 mg once daily, increased up to 60 mg/day if necessary. Max: 80 mg/day in 2 divided doses. Panic disorder Initial: 10 mg once daily, increase to 20 mg/day after a wk. May further increase to 60 mg/day. Premenstrual dysphoric disorder 20 mg/day continuously or 20 mg/day to be started 14 days before menstruation and continued until 1st day of menses; repeat w/ each cycle.
Dosage Details
Oral
Depression
Adult: Initially, 20 mg once daily. May gradually increase up to max 80 mg daily in 2 divided doses, if no clinical response after several wk.
Child: ≥8 yr Initially, 10 mg daily, may increase to 20 mg daily after 1-2 wk. Low wt childn: Initially, 10 mg daily, may increase to 20 mg daily after several wk, only if clinical response is insufficient.
Elderly: Max: 60 mg daily.

Oral
Obsessive compulsive disorder
Adult: Initially, 20 mg once daily, increased up to 60 mg daily if no clinical response after several wk. Max: 80 mg daily in 2 divided doses.
Child: ≥7 yr Initially, 10 mg daily, may increase to 20 mg daily after 2 wk; increase further up to 60 mg daily after several wk as necessary. Low-wt childn: Initially, 10 mg daily, may increase to 20-30 mg daily after several wk, if required.
Elderly: Max: 60 mg daily.

Oral
Premenstrual dysphoric disorder
Adult: 20 mg daily continuously. Alternatively, 20 mg daily to be started 14 days before menstruation and continued until 1st day of menses; repeat w/ each cycle.

Oral
Bulimia nervosa
Adult: 60 mg daily as a single or in divided doses.

Oral
Panic disorder
Adult: Initially, 10 mg once daily, increase to 20 mg daily after a wk. May further increase to 60 mg daily, if no clinical response after several wk.
Hepatic Impairment
Reduce dose and/or dosing frequency.
Administration
May be taken with or without food.
Contraindications
Concomitant admin or w/in 2 wk of MAOI withdrawal. Concomitant use w/ pimozide or thioridazine.
Special Precautions
Patient w/ history of mania/hypomania, seizure disorder; DM, raised intraocular pressure or at risk of acute narrow-angle glaucoma. Patient w/ risk factors for QT prolongation. Hepatic and severe renal impairment. Elderly, childn. Pregnancy and lactation.
Adverse Reactions
Insomnia, nervousness, anxiety, restlessness, tension, sleep disorder, abnormal dreams, headache, attention disturbances, dizziness, lethargy, tremor, somnolence, dysgeusia, blurred vision, palpitations, flushing, yawning, vomiting, dry mouth, dyspepsia, urticaria, rash, pruritus, hyperhidrosis, frequent urination, arthralgia, gynaecological bleeding, erectile dysfunction, ejaculation disorder, fatigue, chills, feeling jittery; decreased appetite, wt and libido.
Potentially Fatal: Suicidal thoughts and behaviour, serotonin syndrome.
Patient Counseling Information
May impair ability to drive or operate machinery.
MonitoringParameters
Monitor closely for clinical worsening, suicidal behaviour or thoughts and unusual behavioural changes; signs/symptoms of serotonin syndrome.
Overdosage
Symptoms: Nausea, vomiting, seizure, CV dysfunction ranging from asymptomatic arrhythmias to cardiac arrest (including ventricular arrhythmias and nodal rhythm) or ECG changes indicative of QTc prolongation to cardiac arrest, pulmonary dysfunction, signs of altered CNS status ranging from excitation to coma. Management: Symptomatic and supportive treatment. May admin activated charcoal w/ sorbitol.
Drug Interactions
May lead to serotonin syndrome w/ serotonergic drugs (e.g. triptans, TCAs, fentanyl, tramadol, lithium, buspirone, tryptophan). May increase risk of bleeding w/ aspirin, NSAIDs, warfarin and other anticoagulants. May increase plasma levels of phenytoin.
Potentially Fatal: May increase risk of serotonin syndrome w/ concomitant admin or w/in 14 days of MAOIs withdrawal. May increase the QTc prolonging effect of pimozide and thioridazine.
Food Interaction
Increased risk of serotonin syndrome w/ St John's wort.
Action
Description: Fluoxetine selectively inhibits serotonin reuptake at the presynaptic neuronal membrane leading to increased synaptic concentrations of serotonin, resulting in numerous functional changes associated w/ enhanced serotonergic neurotransmission.
Onset: W/in a wk.
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract. Time to peak plasma concentration: Approx 6-8 hr.
Distribution: Widely distributed in the body; enters breast milk. Volume of distribution: 20-40 L/kg. Plasma protein binding: Approx 95%.
Metabolism: Extensively metabolised in the liver via demethylation to its main active metabolite norfluoxetine.
Excretion: Mainly via urine (approx 60%). Elimination half-life: Approx 1-3 days (fluoxetine); approx 4-16 days (norfluoxetine).
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 20-25°C. Protect from light.
MIMS Class
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 MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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