Concise Prescribing Info
Symptomatic relief of major depressive disorder. Bulimia nervosa. Symptomatic treatment of obsessive-compulsive disorder (OCD).
Dosage/Direction for Use
Adult Depression Initially 20 mg once daily in the morning, can be gradually increased following a trial period of several wk if the expected clinical improvement does not occur. Max: 60 mg/day. Bulimia nervosa 60 mg/day. OCD 20-60 mg/day.
May be taken with or without food.
Hypersensitivity. Combination w/ MAOI (including linezolid or methylene blue) or w/in 14 days of discontinuing therapy w/ MAOI. Combination w/ thioridazine or w/in 2 wk after thioridazine has been discontinued.
Special Precautions
Potential association w/ behavioral & emotional changes, including self-harm. Monitor patients for emergence of suicidal ideation or behaviour. Long elimination half-life of fluoxetine (several wk). Significant wt loss. Allergic reactions. Increased risk of bone fractures; QTc interval prolongation. Monitor ECG in patients w/ risk factors for torsades de pointes. Hypokalemia due to self-induced vomiting in bulimic patients, which may lower seizure threshold &/or may lead to cardiac conduction abnormalities. Patients w/ concomitant illness especially those w/ diseases or conditions that could affect metabolism or hemodynamic responses. May alter glycemic control in DM patients. Increased risk of bleeding events. Discontinue in case of serotonin syndrome or neuroleptic malignant syndrome-like events. Use w/ caution in combination w/ other serotonergic drugs (eg, triptans, certain TCAs, lithium, tramadol, St. John's Wort). Can cause mydriasis which may trigger an angle-closure attack in patient w/ anatomically narrow ocular angle. Activation of mania/hypomania. Hyponatremia & syndrome of inappropriate antidiuretic hormone secretion (SIADH) especially in elderly & patients taking diuretics or who are vol depleted. Patients w/ a seizure disorder or history of convulsive disorders. Avoid concurrent administration w/ electroshock therapy. Concomitant use w/ tamoxifen. Patients w/ hepatic impairment or severe renal impairment. Psychomotor impairment; caution against driving or operating hazardous machinery. May affect sperm quality. Pregnancy & lactation. Possible risk of CV malformations following 1st trimester exposure to SSRIs. Risk of neonatal complications & persistent pulmonary HTN of the newborn (PPHN) following exposure to SSRIs in late 3rd trimester of pregnancy. Not indicated for use in childn <18 yr. Elderly ≥60 yr.
Adverse Reactions
Headache, nervousness, insomnia, drowsiness, fatigue or asthenia, anxiety, tremor, dizziness or light-headedness; nausea, diarrhea, dry mouth, anorexia; excessive sweating.
Drug Interactions
Additive effect on QT interval w/ thioridazine, QTc-prolonging drugs & drugs that decrease electrolyte levels. Increased risk of serotonin syndrome or neuroleptic malignant syndrome w/ MAOIs & other serotonergic drugs (eg, tryptophan, triptans, serotonin reuptake inhibitors, linezolid, lithium, tramadol, fentanyl & its analogues, dextromethorphan, tapentadol, meperidine, methadone, pentazocine or St. John's Wort). Increased risk of bleeding w/ NSAID, aspirin or other anticoagulants. Altered anticoagulant effects of warfarin. Co-administration w/ drug which is also highly bound to protein (eg, warfarin, digoxin) may result in adverse effects due to increased plasma levels of either unbound drug. Increased plasma conc of CYP2D6 substrates w/ a narrow therapeutic index (eg, flecainide, encainide, vinblastine, carbamazepine, TCAs); alprazolam; phenytoin. Reduced efficacy of tamoxifen. Increased/decreased levels of lithium. Adverse reactions including agitation, restlessness & GI distress w/ tryptophan. Prolonged half-life of diazepam. Not recommended w/ alcohol. Elevated blood levels of haloperidol & clozapine.
MIMS Class
ATC Classification
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
pms-Fluoxetine cap 10 mg
pms-Fluoxetine cap 20 mg
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