Eli Lilly


Concise Prescribing Info
Fluoxetine HCl
Symptoms of depressive illness w/ or w/o associated anxiety symptoms, especially when sedation is not required. Obsessive-compulsive disorder. Reduction of binge-eating & purging activity in bulimia nervosa. Pre-menstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Adult & elderly Depression 20 mg/day. Obsessive compulsive disorder 20-60 mg/day. Bulimia nervosa 60 mg/day. PMDD 20 mg/day for 6 mth then reassess need for continued treatment. Hepatic impairment or in patients when concomitant medication has potential interaction Consider lower or less frequent dose (eg, 20 mg every 2nd day).
May be taken with or without food.
Hypersensitivity. Combination w/ a MAOI or reversible monoamine oxidase inhibition antidepressant (RIMA) or w/in 14 days of discontinuing treatment w/ MAOI or RIMA.
Special Precautions
Discontinue if rash or other allergic phenomena w/ unidentified alternative aetiology appears. Monitor for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour. Patients w/ conditions eg, congenital long QT syndrome, a family history of QT prolongation, or other clinical conditions that predispose to arrhythmias (eg, hypokalemia, hypomagnesemia, bradycardia, acute MI or uncompensated heart failure) or increased exposure to fluoxetine (eg, hepatic impairment), or concomitant use w/ medicinal products known to induce QT prolongation &/or torsades de pointes; consider an ECG review before treatment in patients w/ stable cardiac disease; w/draw & perform an ECG if signs of cardiac arrhythmia occur during treatment. Discontinue if rare but potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome-like events occur. History of mania & hypomania, potential cutaneous bleeding abnormalities eg, ecchymosis & purpura; concomitant use w/ oral anticoagulants, drugs known to affect platelet function or other drugs that may increase risk of bleeding; patients w/ history of bleeding disorders. Patients w/ history of seizures; discontinue if seizure develops or when there is an increase in seizure frequency; avoid in patients w/ unstable seizure disorder/epilepsy; monitor patients w/ controlled epilepsy. Rarely, prolonged seizures in concomitant ECT treatment. Avoid concomitant use w/ tamoxifen. Development of akathisia which is most likely to occur w/in 1st few wk of treatment. May alter glycaemic control of patients w/ diabetes. Wt loss may occur. Avoid abrupt discontinuation; gradually taper when discontinuing treatment over a period of at least 1-2 wk. Patients w/ raised IOP or those at risk of acute narrow-angle glaucoma. PMDD symptoms tend to return rapidly, usually w/in or 2 cycles following treatment cessation. May affect ability to drive & use machines. Patient w/ significant hepatic dysfunction. Pregnancy & lactation. Not recommended in childn.
Adverse Reactions
Insomnia; headache; diarrhoea, nausea; fatigue. Decreased appetite; anxiety, nervousness, restlessness, tension, decreased libido, sleep disorder, abnormal dreams; disturbance in attention, dizziness, dysgeusia, lethargy, somnolence, tremor; blurred vision; palpitations, prolonged ECG QT; flushing; yawning; vomiting, dyspepsia, dry mouth; rash, urticaria, pruritus, hyperhidrosis; arthralgia; frequent urination; gynaecological bleeding, erectile dysfunction, ejaculation disorder; jittery feeling, chills; decreased wt.
Drug Interactions
Serious & sometimes fatal reactions in combination use w/ MAOIs. Risk of metoprolol adverse events may be increased. Reduced efficacy of tamoxifen. Not recommended to be taken w/ alcohol. Inhibits mequitazine metabolism. Changes in blood levels of carbamazepine, haloperidol, clozapine, diazepam, alprazolam, lithium, phenytoin, & cyclic antidepressants (eg, imipramine & desipramine). Mild serotonin syndrome w/ lithium, tramadol, triptans, tryptophan, St. John's wort. Caution during use w/ medicinal products that prolong QT interval, eg, Class IA & III antiarrhythmics, antipsychotics, TCAs, certain antimicrobials (eg, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malarials particularly halofantrine, certain antihistamines (astemizole, mizolastine). Increased bleeding risk w/ oral anticoagulants, platelets antiaggregants including aspirin & NSAIDs. Reduced antidepressant activity w/ cyproheptadine. May lead to increased risk of hyponatremia if used in combination w/ other agents associated w/ hyponatremia (eg, diuretics, desmopressin, carbamazepine & oxcarbazepine). May lead to increased risk in seizures if used in combination w/ other agents which may lower the seizure threshold (eg, TCAs, other SSRIs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol). Potential drug interactions w/ other drugs metabolized by CYP2D6, notaby those w/ narrow therapeutic index (eg, flecainide, encainide, propaferone & nebivolol), otomoxetine carbamazepine, TCAs & risperidone,
MIMS Class
ATC Classification
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Prozac cap 20 mg
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