United Lab
Concise Prescribing Info
Fluoxetine HCl
Major depressive, obsessive-compulsive & panic disorder; bulimia nervosa; premenstrual dysphoric disorder. Combination therapy w/ olanzapine for the acute treatment of depressive episodes associated w/ bipolar I disorder & resistant depression in adults.
Dosage/Direction for Use
Major depressive disorder (MDD) Initial dose: Adult ≥18 yr 20 mg/day as single dose in the morning or in 2 divided doses in the morning & at noon. Max: 80 mg/day. Childn & adolescent 8 to <18 yr 10 mg/day, may be increased to 20 mg/day after a wk or if improvement is observed. Maintenance/continuation/extended treatment: Adult ≥18 yr 20 mg/day up to 38 wk. Obsessive compulsive disorder Initial dose: Adult ≥18 yr 20 mg/day as single dose in the morning or in 2 divided doses in the morning & at noon. Max: 80 mg/day. Childn & adolescent 7 to <18 yr Initially, 10 mg/day, may be increased to 20 mg/day after 2 wk or if improvement is observed. Bulimia nervosa Initial dose: 60 mg/day in the morning. Maintenance/continuation/extended treatment: Adult ≥18 yr 60 mg/day for up to 52 wk. Panic disorder Initial dose: Adult ≥18 yr 10 mg/day, may be increased to 20 mg/day after a wk. Max: 60 mg/day. Premenstrual dysphoric disorder Initial dose: Adult ≥18 yr 20 mg/day either every day of the menstrual cycle or 14 days before the expected onset of menstruation. Max: 60 mg/day. Depressive episodes associated w/ bipolar I disorder or treatment resistant depression Adult >18 yr Initially fluoxetine 20 mg & olanzapine 5 mg once daily in the evening.
May be taken with or without food.
Hypersensitivity. Patients receiving MAOIs, thioridazine, pimozide.
Special Precautions
Screen patients for bipolar disorder, history of seizures, concomitant illness eg, diabetic patients. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn <8 yr w/ major depressive disorder, <7 yr w/ obsessive compulsive disorder; bulimia nervosa, panic disorder & premenstrual dysphoric disorder. Elderly.
Adverse Reactions
Chills, chills & fever, face edema, intentional injury, fever, flu syndrome, asthenia, malaise, hypothermia; vasodilation, hemorrhage, HTN, palpitation, angina pectoris, arrhythmia, CHF, hypotension, MI, chest pain, postural hypotension, syncope, tachycardia, vascular headache, atrial fibrillation, bradycardia, cerebral embolism/ischemia, CVA, extrasystoles, heart arrest/block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasospasm, ventricular arrhythmia/extrasystoles/fibrillation; constipation, diarrhea, dry mouth, dyspepsia, flatulence, nausea, vomiting, aphthous stomatitis, cholelithiasis, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, glossitis, gum hemorrhage, hyperchlorhydria, increased salivation, abnormal liver function tests, melena, mouth ulceration, nausea/vomiting/diarrhea, stomach ulcer, stomatitis, thirst, biliary pain, bloody diarrhea, cholecystitis, duodenal ulcer, enteritis, esophageal ulcer, fecal incontinence, GI hemorrhage, hematemesis, colon hemorrhage, hepatitis, intestinal obstruction, liver fatty deposit, pancreatitis, peptic ulcer, rectal hemorrhage, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema, acute abdominal syndrome; anemia, ecchymosis, blood dyscrasia, hypochromic anemia, leukopenia, lymphedema, lymphocytosis, petechia, purpura, thrombocytopenia; anorexia, wt loss/gain, increased appetite, dehydration, generalized edema, gout, hypercholesterolemia, hyperlipemia, hypokalemia, peripheral edema, alcohol intolerance, increased alkaline phosphatase, increased BUN, increased creatinine phosphokinase, hyperkalemia, hyperuricemia, hypocalcemia, Fe deficiency anemia, increased ALT, hyponatremia, hypothyroidism, diabetic acidosis, DM, decreased/increased libido, impotence, sexual dysfunction, priapism, galactorrhea; arthritis, bone pain/fractures, bursitis, leg cramps, tenosynovitis, arthrosis, chondrodystrophy, myasthenia, myopathy, myositis, osteomyelitis, osteoporosis, RA, arthralgia, myalgia, pelvic pain; abnormal dreams/thinking, anxiety, dizziness, nervousness, somnolence, tremor, insomnia, agitation, amnesia, confusion, emotional lability, sleep disorder, abnormal gait, acute brain syndrome, akathisia, apathy, ataxia, buccoglossal syndrome, CNS depression/stimulation, depersonalization, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, hypoesthesia; incoordination, myoclonus, neuralgia, neuropathy, neurosis, paranoid reaction, personality disorder, psychosis, vertigo, abnormal ECG, antisocial reaction, circumoral paresthesia, coma, delusions, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, decreased/increased reflexes, stupor, headache, migraine, neuroleptic malignant syndrome-like events, suicidal ideation; pharyngitis, sinusitis, yawn, asthma, epistaxis, hiccups, hyperventilation, apnea, atelectasis, decreased cough, emphysema, hemoptysis, hypoventilation, hypoxia, larynx/lung edema, pneumothorax, stridor, dyspnea; sweating, pruritus, rash, urticaria, anaphylactoid reaction, vasculitis, angioedema, serum sickness-like reaction, acne, alopecia, contact dermatitis, eczema, maculopapular rash, skin discoloration, skin ulcer, vesiculobullous rash, furunculosis, herpes zoster, hirsutism, petechial rash, psoriasis, purpuric/pustular rash, seborrhea, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity reaction; abnormal vision, conjunctivitis, dry eyes, mydriasis, photophobia, blepharitis, diplopia, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, iritis, parosmia, scleritis, strabismus, visual field defect, ear pain, tinnitus, taste perversion, taste loss; abnormal ejaculation, urinary frequency, abortion, albuminuria, amenorrhea, anorgasmia, breast enlargement/pain, cystitis, dysuria, female lactation, fibrocystic breast, hematuria, leukorrhea, menorrhagia, metrorrhagia, nocturia, polyuria, urinary incontinence/retention/urgency, vag hemorrhage, glycosuria, hypomenorrhea, kidney pain, oliguria, uterine hemorrhage, uterine fibroids enlargement.
Drug Interactions
May lead to neuroleptic malignant-like syndrome w/ MAOIs eg, tranylcypromine, isocarboxazid, phenelzine & selegeline (or w/in a min of 14 days after MAOIs). May increase plasma levels of thioridazine (w/ or w/in a min of 5 wk after administration). May inhibit the activity of drugs metabolized by CYP2D6 [antidepressants (eg, TCAs), antipsychotics (eg, phenothiazines & most atypicals), antiarrhythmics (eg, propafenone, flecainide & others)]. May precipitate serotonin syndrome w/ serotonergic drugs (eg, linezolid, tramadol or St. John's wort); triptans. May cause adverse reactions eg, agitation, restlessness & GI distress w/ tryptophan. May cause a shift in plasma conc w/ drugs highly bound to plasma proteins (eg, NSAIDs, aspirin, warfarin). Lower initial doses using conservative titration schedules & monitoring clinical status w/ CNS-active drugs. May increase conc of TCAs (eg, imipramine, desipramine). May increase plasma levels or toxicity of anticonvulsants (eg, phenytoin, carbamazepine). May increase blood levels of haloperidol & clozapine; may potentially lead to QC prolongation w/ pimozide & small increase in max conc & small decrease in clearance of olanzapine. May prolong t½ of benzodiazepines (eg, diazepam, alprazolam). May increase lithium levels resulting to toxicity & serotonergic effects. May experience prolonged seizures in patients receiving electroconvulsive therapy.
MIMS Class
ATC Classification
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Motivest cap 20 mg
30's (P1,462.5/pack, P48.75/cap)
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