Names and pronunciation
(floo-ox′eh-teen) PROzac, Sarafem
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Individual generic drug information
Extracted information for fLUoxetine only.
(floo-ox′eh-teen) PROzac, Sarafem
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Func. class.: Antidepressant, SSRI (selective serotonin reuptake inhibitor)
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Do not confuse: PROzac/PriLOSEC/Prograf/Provera Sarafem/Serophene fluoxetine/duloxetine/loxitane/paroxetine
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ACTION: Inhibits CNS neuron uptake of serotonin but not of norepinephrine
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USES: Major depressive disorder, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), panic disorder
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Unlabeled uses: Binge eating disorder, body dysmorphic disorder, fibromyalgia, generalized anxiety disorder, posttrau- matic stress disorder, premature ejacula- tion, selective mutism, social anxiety disorder
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Extracted information for fLUoxetine only.
CONTRAINDICATIONS: Hyper- sensitivity, MAOI therapy Precautions: Pregnancy, breastfeeding, geriatric patients, diabetes mellitus, nar- row-angle glaucoma, cardiac malforma- tions in infants (exposed to FLUoxetine in utero), osteoporosis, QT prolongation
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Black Box Warning: Children, suicidal ideation Black Box Warning: Mental status: mood, sensorium, affect, suicidal ten- dencies (child/young adult), increase in psychiatric symptoms, depression, panic; monitor for seizures, seizure potential increased, Sarafem is not approved for children • Serotonin syndrome: symptoms can occur anytime after first dose; nausea/ vomiting, sedation, dizziness, diaphoresis, mental changes, elevated B/P; if these occur, product should be stopped, notify prescriber • QT prolongation: may be more severe in those with history of QT prolongation; if thioridazine is being used, discontinue for 5 wk prior to using this product • Neuroleptic malignant syndrome: fever, seizures, diaphoresis, dyspnea, hy- per/hypotension; report immediately • Bulimia nervosa: appetite, weight daily, increase nutritious foods in diet, watch for bingeing and vomiting • Allergic reactions/serious skin reac- tions: angioedema, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epi- dermal necrolysis, itching, rash, urticaria; product should be discontinued, may need to give antihistamine • B/P (lying/standing), pulse; if systolic B/P drops 20 mm Hg, hold product, no- tify prescriber; ECG for flattening of T wave, bundle branch, AV block, dysrhyth- mias in cardiac patients • Blood studies: CBC, leukocytes, dif- ferential, cardiac enzymes if patient is receiving long-term therapy; check plate- lets; bleeding can occur, thyroid func- tion, growth rate (children), weight • Hepatic studies: AST, ALT, bilirubin, creatinine, weight weekly; appetite may decrease with product • Safety measures, primarily for geriatric patients • Beers: avoid use in older adults unless safer alternative is unavailable; may cause ataxia, impaired psychomotor function • Pregnancy/breastfeeding: no well- controlled studies; use only if benefits outweigh fetal risk; not recommended in breastfeeding Black Box Warning: That suicidal thoughts/behaviors may occur in young adults, children, usually during early treatment, to report immediately • That decreased libido, erectile dysfunc- tion may occur • To notify prescriber of worsening symptoms, or if insomnia, anxiety, or depression continues • Serotonin syndrome: to report fever, sweating, diarrhea, poor coordination, nausea/vomiting, sedation, flushing, men- tal changes
Source pages 579, 580, 581
SIDE EFFECTS CNS: Headache, nervousness, insomnia, F drowsiness, anxiety, tremor, dizziness, fatigue, sedation, poor concentration, abnormal dreams, agitation, seizures, apathy, euphoria, hallucinations, delusions, psychosis, suicidal ideation, neuroleptic malignant syndrome–like reactions CV: Hot flashes, palpitations, angina pec- toris, hypertension, tachycardia, 1st-degree AV block, bradycardia, MI, thrombophlebitis, generalized edema, torsades de pointes EENT: Visual changes, ear/eye pain, pho- tophobia, tinnitus, increased intraocular pressure GI: Nausea, diarrhea, dry mouth, anorexia, dyspepsia, constipation, taste changes, flatulence, decreased appetite GU: Dysmenorrhea, decreased libido, urinary frequency, UTI, amenorrhea, cystitis, impotence, urine retention HEMA: Hemorrhage INTEG: Sweating, rash, pruritus, acne, alopecia, urticaria, angioedema, exfolia- tive dermatitis, Stevens-Johnson syn- drome, toxic epidermal necrolysis META: Hyponatremia MS: Pain, arthritis, twitching RESP: Pharyngitis, cough, dyspnea, bronchitis, asthma, hyperventilation, pneumonia SYST: Asthenia, serotonin syndrome, flu- like symptoms, neonatal abstinence syndrome
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INTERACTIONS Increase: serotonin syndrome—SSRIs, SNRIs, serotonin-receptor agonists, sele- giline, busPIRone, tryptophan, phenothi- azines, haloperidol, loxapine, thiothixene, tricyclics, linezolid, traZODone, traMADol Increase: QT prolongation—pimozide, thioridiazine, antidysrhythmics class III Increase: bleeding risk—platelet inhibi- tors, thrombolytics, NSAIDs, salicylates, anticoagulants • Do not use MAOIs, linezolid, methylene blue with or 14 days before FLUoxetine Increase: levels or toxicity of carBA Mazepine, lithium, digoxin, warfarin, phenytoin, diazepam, vinBLAStine, donepezil, antidiabetics, dorifenacin, paricalcitrol, budesonide, bosentan, thioridazine Increase: CNS depression—alcohol, anti- depressants, opioids, sedatives Decrease: FLUoxetine effect—cyprohep- tadine Drug/Herb • Do not use together; increased risk of serotonin syndrome: St. John’s wort, SAM-e Increase: CNS effect—hops, kava, laven- der, valerian
Source page 580
Extracted information for fLUoxetine only.
DOSAGE AND ROUTES Depression/obsessive-compulsive disorder • Adult: PO 20 mg/day in AM; after 4 wk, if no clinical improvement is noted, dose may be increased to 20 mg bid in AM, PM, max 80 mg/day • Geriatric: PO 10 mg/day, increase as needed • Child 7-17 yr: PO 10 mg/day, max 20 mg/day Premenstrual dysphoric disorder (Sarafem) • Adult: PO 20 mg/day, may be taken daily 14 days before menses Anorexia nervosa (unlabeled) • Adult: PO 10 mg daily, max 60 mg/day Posttraumatic stress disorder (unlabeled) • Adult: PO 10-80 mg/day
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Available forms: Caps 10, 20, 40 mg; tabs 10, 20, 60 mg; oral sol 20 mg/5 mL
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Administer: • Without regard to meals • Crushed if patient is unable to swallow medication whole (tab only) • Immediate-release product should be given in the AM unless sedation occurs • Gum, hard candy, frequent sips of wa- ter for dry mouth • Sarafem is used only for premenstrual dysphoric disorder • Store at room temperature; do not freeze • Oral sol: use oral syringe or calibrated measuring device
Source page 579
Extracted information for fLUoxetine only.
Assess:
Source page 580
Evaluate: • Therapeutic response: decreased de- pression, symptoms of OCD, absence of suicidal thoughts decreased symptoms of PMDD
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That therapeutic effect may take 1-4 wk, not to discontinue abruptly, that fol- low-up will be required • To use caution when driving, perform- ing other activities requiring alertness because of drowsiness, dizziness, blurred vision • To avoid alcohol, other CNS depres- sants • To notify prescriber if pregnant, plan- ning to become pregnant, or breastfeeding • To change positions slowly because orthostatic hypotension may occur • To avoid all OTC products unless ap- proved by prescriber • To notify prescriber if allergic reactions occur (rash, trouble breathing, itching)
Source pages 580, 581
Extracted information for fLUoxetine only.
PHARMACOKINETICS PO: Peak 6-8 hr, metabolized in liver to norfluoxetine active metabolite by CYP2D6 isoenzyme, some patients may be poor metabolizers; excreted in urine, half-life 2-3 days, half-life 4-16 days, protein bind- ing 94%
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Filter the extracted dose blocks for this individual drug.
Depression/obsessive-compulsive disorder
• Adult: PO 20 mg/day in AM; after 4 wk, if no clinical improvement is noted, dose may be increased to 20 mg bid in AM, PM, max 80 mg/day
Candidate age grouping · source page 579
Depression/obsessive-compulsive disorder
• Adult: PO 20 mg/day, may be taken daily 14 days before menses Anorexia nervosa (unlabeled)
Candidate age grouping · source page 579
Depression/obsessive-compulsive disorder
• Adult: PO 10 mg daily, max 60 mg/day Posttraumatic stress disorder (unlabeled)
Candidate age grouping · source page 579
Depression/obsessive-compulsive disorder
• Adult: PO 10-80 mg/day
Candidate age grouping · source page 579