Eli Lilly


Zuellig Pharma
Concise Prescribing Info
Fluoxetine HCl
Symptomatic treatment of depression w/ or w/o anxiety. Obsessive compulsive disorder, pre-menstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Depression w/ or w/o anxiety & obsessive-compulsive disorder 20 mg daily, may be increased gradually up to max: 60 mg. PMDD 20 mg daily. Elderly Daily dose: Not to exceed 40 mg. Max: 60 mg daily.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ irreversible & non-selective MAOIs, metoprolol.
Special Precautions
Rash & allergic reactions. Suicide/suicidal thoughts, history of suicide-related events; congenital long QT syndrome, family history of QT prolongation, hypokalemia, hypomagnesemia, bradycardia, acute MI or uncompensated heart failure; serotonin-syndrome or NMS-like events; history of mania/hypomania; history of bleeding disorders; unstable seizure disorders/epilepsy, controlled epilepsy; patients receiving electoconvulsive therapy; akathisia/psychomotor restlessness; diabetes; raised IOP or at risk of narrow-angle glaucoma. Avoid abrupt w/drawal. Discontinue use in any patient entering manic phase. Concomitant use w/ medicinal products inducing QT prolongation &/or Torsade de pointes; oral anticoagulants, atypical antipsychotics, TCAs, aspirin, NSAIDs, drugs increasing risk of bleeding, tamoxifen. Hepatic & renal function. May affect ability to drive & use machines. Not be used during pregnancy & lactation. Suicidality in childn & adolescents. Elderly.
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, ECG QT prolongation; flushing; yawning; vomiting, dyspepsia, dry mouth; rash, urticaria, pruritus, hyperhidrosis; arthralgia; frequent urination; gynaecological bleeding, erectile dysfunction, ejaculation disorder; feeling jittery, chills; decreased wt.
Drug Interactions
Risk of serotonin syndrome w/ irreversible, non-selective MAOIs, linezolid & methylene blue. Inhibited metabolism of metoprolol, mequitazine. Reduced efficacy of tamoxifen. Changes in blood levels w/ phenytoin. Prolonged QT interval w/ class IA & III antiarrythmics, antipsychotics, TCAs, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, halofantrine, astemizole, mizolastine. Risk of increased bleeding w/ oral anticoagulant, aspirin & NSAIDs. Reduced antidepressant activity w/ cyproheptadine. Increased risk of hyponatremia w/ diuretics, desmopressin, carbamazepine, oxcarbazepine. Lowered seizure threshold w/ TCAs, other SSRIs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol. Drugs metabolized by CYP2D6 eg, fleicainide, propafenone, nebivolol, atomoxetine, carbamazepine. Iproniazid, alcohol, lithium, tramadol, triptans, tryptophan, selegiline, St. John's wort, flecainide, propafenone, nebivolol, atomoxetine, 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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