Adult Dosing
Major depressive disorder
Immediate release [Except Sarafem]
- Start 20 mg PO qam
- May increase after several weeks if clinically indicated to doses above 20 mg qd (morning) or bid (morning and noon); usual 20-80 mg/day
- Max: 80 mg/day
Delayed release [fluoxetine, Prozac Weekly]
- Patients stabilized on 20 mg/day may be switched to ECAPS at dose of 90 mg qwk, initiated 7 days after the last daily dose of 20 mg
Obsessive compulsive disorder [Immediate release except Sarafem]
- Start 20 mg PO qam
- Titrate the dose after several weeks if clinically indicated to doses above 20 mg qd (morning) or bid (morning and noon); usual 20-60 mg/day
- Max: 80 mg/day
Bulimia nervosa [Immediate release except Sarafem]
- Start 20-60 mg PO qam x 8 wks
- Maintenance dose 60 mg PO qd x 52 wks
Panic disorder [Immediate release except Sarafem]
- Start 10 mg PO qd for 1 wk; after 1 wk increase the dose to 20 mg/day
- May be increased as needed/tolerated up to 60 mg/day
Premenstrual dysphoric disorder (PMDD) [Sarafem]
- Start 20 mg PO qd (qd of the menstrual cycle) x 6 months; Alt: Start a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle for 3 months
- Doses above 20 mg/day were not found to be more efficacious than 20 mg/day dose
Note:
- Taper dose gradually to discontinue
Depressive episodes associated with Bipolar I disorder, treatment resistant depression (Prozac, Prozac Weekly, Sarafem)
- 20 mg PO qpm. Max: 50 mg/day
- Dose should be adjusted within the range of 20-50 mg
- Administer with olanzapine 5 mg and adjust olanzapine dose within the range of 5-12.5 mg
- Taper dose gradually to discontinue
Pediatric Dosing
Major depressive disorder
- Safety and efficacy in pediatric patients <8 yrs of age has not been established
Child >8 yrs [Immediate release except Sarafem]
- Start 10-20 mg PO qd
- Increase the dose after 1 wk at 10 mg/day if clinically indicated to 20 mg/day
- In lower weight children: Start 10 mg PO qd and increase after several weeks to 20 mg/day if needed
- Max: 20 mg/day
Obsessive compulsive disorder
- Safety and efficacy in pediatric patients <7 yrs of age has not been established
Child >7 yrs [Immediate release except Sarafem]
- Start 10 mg PO qd; after 2 wks, increase the dose to 20 mg/day
- Titrate the dose after several wks if needed to doses above 20 mg/day; dose range 20-60 mg/day
- In lower weight children: Start 10 mg PO qd and increase after several weeks to 20-30 mg/day if needed
Note:
- Taper dose gradually to discontinue
[Outline]
See Supplemental Patient Information
- Therapy may increase the risk of suicidality in patients with MDD or other psychiatric disorders [US Black Box Warning]
- Studies suggested that suicidality risk was not increased in patients >24 yrs and the risk decreased in patients >65 yrs [US Black Box Warning]
- During the initial few months of a course of drug therapy, or at times of dose modifications, all patients treated with antidepressants should be appropriately monitored for clinical worsening, suicidality, or unusual changes in behavior [US Black Box Warning]
- The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants drugs
- Discontinue therapy by gradually tapering the dose in patients with depression or suicidality
- Close supervision by families and caregivers should be done during therapy. Fluoxetine (except Sarafem) is approved for use in pediatric patients with MDD and OCD [US Black Box Warning]
- Patients with depressive symptoms should be screened prior to initiating antidepressant treatment to determine if they are at risk for bipolar disorder as it may increase the possibility of precipitation of a mixed/manic episode in such patients
- Life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions may occur with SNRIs and SSRIs alone, including fluoxetine treatment, but particularly with concomitant use of serotonergic drugs (including triptans) or with antipsychotics or other dopamine antagonists
- Concomitant use of fluoxetine with MAOIs intended to treat depression is contraindicated
- Do not use fluoxetine with serotonin precursors (such as tryptophan)
- Co-administration of thioridazine and fluoxetine may prolong QTc interval, which is associated with serious ventricular arrhythmias
- Patients should be cautioned against performing hazardous tasks such as operating machinery or driving automobiles, as fluoxetine may impair judgment, thinking, or motor skills
- Discontinue fluoxetine on appearance of a rash or other allergic reactions
- Hyponatremia may occur during treatment with fluoxetine and this could be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- Fluoxetine may cause significant weight loss and anorexia, especially in underweight depressed or bulimic patients; monitor weight changes during treatment
- Changes in fluoxetine doses do not reflect in plasma for several because of its long elimination half-lives, which may significantly affect treatment strategies like final dose titration and treatment discontinuation
- Avoid abrupt discontinuation of fluoxetine therapy as it may cause adverse reactions such as irritability, agitation, anxiety, headache, dysphoric mood, emotional lability, sensory disturbances, insomnia, hypomania, confusion and lethargy
Cautions: Use cautiously in
- Hepatic impairment
- Diabetes mellitus
- Volume depletion
- Concomitant administration of diuretics
- Fluid and electrolyte imbalance
- History of seizure disorder
- Patients with diseases or conditions that could affect metabolism or hemodynamic responses
- History of mania/hypomania
- Co-administration of NSAID's (may increase risk of bleeding)
- Pregnancy (3rd trimester)
- Elderly patients
- Alcohol use
Supplemental Patient Information
- Caution patients against driving vehicle and operating hazardous machinery as fluoxetine may cause cognitive and motor impairment
Pregnancy Category:C
Breastfeeding: Average concentration of fluoxetine has been observed in breastmilk. The active metabolite, norfluoxetine, is detectable in the serum of most breastfed infants during the first 2 months. Adverse effects such as colic, fussiness, and drowsiness have been reported in some breastfed infants and decreased weight gain has been observed in one study (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 January 2011). As fluoxetine is excreted in human milk, manufacturer advises nursing women not to breastfeed their infants.
US Trade Name(s)
- Prozac
- Prozac Weekly
- Sarafem
- Selfemra
US Availability
fluoxetine (generic)
- TABS: 10, 20, 60 mg
- CAPS: 10, 20, 40 mg
- Delayed Release CAPS: 90 mg
- SOLN: 20 mg/5 mL
Prozac
Prozac weekly
- Delayed Release CAPS: 90 mg
Sarafem
- TABS: 10, 15, 20 mg
- CAPS: 10, 20 mg
Selfemra
Canadian Trade Name(s)
Canadian Availability
fluoxetine (generic)
- CAPS: 10, 20 mg
- SOLN: 20 mg/5 mL
Prozac
FXT 40
UK Trade Name(s)
UK Availability
fluoxetine (generic)
- CAPS: 20 mg
- SOLN: 20 mg/5 mL
Oxactin
Prozac
- CAPS: 20 mg
- SOLN: 20 mg/5 mL
Prozit
Australian Trade Name(s)
- Auscap
- Fluohexal
- Fluoxebell
- Lovan
- Prozac
- Zactin
Australian Availability
fluoxetine (generic)
Auscap, Fluohexal, Fluoxebell, Zactin
Lovan, Prozac
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Prozac 10 MG CAPS [Bottle] (DISTA)
30 mg = $214
90 mg = $592.96 - Selfemra 20 MG CAPS [Box] (TEVA PHARMACEUTICALS USA)
28 mg = $27.98
84 mg = $79.95 - PROzac 20 MG CAPS [Bottle] (DISTA)
30 mg = $218.99
90 mg = $630.95 - FLUoxetine HCl 90 MG CPDR [Box] (DR.REDDY'S LABORATORIES)
INC. mg = $4
mg = $8 - PROzac Weekly 90 MG CPDR [Disp Pack] (LILLY)
4 mg = $153.99
12 mg = $425.95 - PROzac 20 MG/5ML SOLN [Bottle] (DISTA)
120 5ml = $252.98
360 5ml = $712.97 - Sarafem 20 MG TABS [Box] (WARNER CHILCOTT PROF PROD DIV)
7 mg = $66.99
21 mg = $181.97 - PROzac 40 MG CAPS [Bottle] (DISTA)
30 mg = $420.01
90 mg = $1218.94 - FLUoxetine HCl 10 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $14.99
90 mg = $26.97 - Sarafem 10 MG TABS [Box] (WARNER CHILCOTT PROF PROD DIV)
7 mg = $66.99
21 mg = $183.97 - FLUoxetine HCl 40 MG CAPS [Bottle] (PAR)
30 mg = $40.99
90 mg = $119.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
