Fluoxetine hydrochloride (PROZAC®)

• Fluoxetine hydrochloride

• PROZAC®

• SSRI
• ANTIDEPRESSANT

• Major Depressive Disorder (MDD)
• Obsessive Compulsive Disorder (OCD)
• Bulimia Nervosa*
• Panic Disorder*
• Depressive episodes associated with Bipolar I Disorder, taken with olanzapine
• (Zyprexa)
• Treatment Resistant Depression (depression that has not gotten better with at least 2 other treatments), taken with olanzapine (Zyprexa) (Not approved for use in children)

• Major Depressive Disorder (MDD)
• Obsessive Compulsive Disorder (OCD)
• Bulimia Nervosa*
• Panic Disorder*
• Depressive episodes associated with Bipolar I Disorder, taken with olanzapine
• (Zyprexa)
• Treatment Resistant Depression (depression that has not gotten better with at least 2 other treatments), taken with olanzapine (Zyprexa) (Not approved for use in children)

• Tablets: 10,20,40
• DR: 20/5 mL

ADULT DOSING:

• Major depressive disorder
  • Dose: 20-80 mg PO qam; Start: 20 mg PO qam, may incr. dose after several wk; Max: 80 mg/day; Info: doses >20 mg/day may be divided bid; taper dose gradually to D/C
• MDD, treatment-resistant
  • Start: 20 mg PO qpm; Max: 50 mg/day; Info: for acute tx; give w/ olanzapine; periodically reassess need for tx; taper dose gradually to D/C
• Obsessive-compulsive disorder
  • Start: 20 mg PO qam, may incr. dose after several wk; Max: 80 mg/day; Info: doses >20 mg/day may be divided bid; taper dose gradually to D/C
• Bulimia nervosa
  • Info: may titrate dose to 60 mg/day over several days; taper dose gradually to D/C
• panic disorder
  • Start: 10 mg PO qam x7 days; Max: 60 mg/day; Info: taper dose gradually to D/C
• Premenstrual dysphoric disorder
  • Max: 80 mg/day; Alt: 20 mg PO qd on cycle days 15-28 and first day of menses; Info: no proven benefit at doses >20 mg/day; taper dose gradually to D/C
• Bipolar I disorder, acute depressive

Start: 20 mg PO qpm; Max: 50 mg/day; Info: give w/ olanzapine; periodically reassess need for tx; taper dose gradually to D/C

DOSE ADJUSTMENT:

• Renal dosing: no adjustment
• Hepatic dosing: in clients with hepatic impairment decrease dose or frequency, amount not defined

PEDIATRIC DOSING:

• major depressive disorder [8-18 yo]
  • Dose: 10-20 mg PO qd; Start: 10 mg PO qd x7 days; Info: slower titration in lower wt peds; taper dose gradually to D/C
• obsessive-compulsive disorder [7-17 yo]
  • Dose: 20-60 mg PO qd; Start: 10 mg PO qd, may incr. by 10 mg/day q14 days; Info: slower titration, max 20-30 mg/day in lower wt peds; taper dose gradually to D/C
• bipolar I disorder, acute depressive [10-17 yo]
  • Dose: 20-50 mg PO qpm; Start: 20 mg PO qpm; Max: 50 mg/day; Info: give w/ olanzapine; slower titration in lower wt peds; periodically reassess need for tx; taper dose gradually to D/C

DOSE ADJUSTMENT:

• Renal dosing: no adjustment needed
• Hepatic dosing: decrease dose or frequency in case hepatic impairment

Common possible side effects in people who take PROZAC include:

• unusual dreams
• sexual problems
• loss of appetite, diarrhea, indigestion, nausea or vomiting, weakness, or dry mouth
• flu symptoms
• feeling tired or fatigued
• change in sleep habits
• yawning
• sinus infection or sore throat
• tremor or shaking
• sweating
• feeling anxious or nervous
• hot flashes
• rash

Other side effects in children and adolescents include:

• increased thirst
• abnormal increase in muscle movement or agitation
• nose bleed
• urinating more often
• heavy menstrual periods
• possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with PROZAC.

• Fluoxetine can increase serum Methadone level
• Fluoxetine should not be prescribed with MAOIs or within 5 weeks of discontinuation of MAOIs

• Hypersensitivity
• MAOi use
• Thioridazine should not be prescribed concomitantly with fluoxetine or within 5 weeks after fluoxetine has been discontinued

• Flouxetine should be considered as an option during pregnancy only after the potential benefits justifies the potential risks
• Flouxetine has been found to reach high serum levels in infants who are breastfeeding. Mothers should be advised to avoid breast feeding when they are taking flouxetine unless it is necessary.

1. Suicidal thoughts or actions:
   1. PROZAC and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
   2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
   3. Watch for these changes and call your healthcare provider right away if you notice:
      1. New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
      2. Pay particular attention to such changes when PROZAC is started or when the dose is changed.
2. Serotonin Syndrome. This condition can be life-threatening and may include:
   1. agitation, hallucinations, coma or other changes in mental status
   2. coordination problems or muscle twitching (overactive reflexes)
   3. racing heartbeat, high or low blood pressure
   4. sweating or fever
   5. nausea, vomiting, or diarrhea
   6. muscle rigidity
   7. dizziness
   8. flushing
   9. tremor
   10. seizures
3. Severe allergic reactions:
   1. trouble breathing
   2. swelling of the face, tongue, eyes or mouth
   3. rash, itchy welts (hives) or blisters, alone or with fever or joint pain
4. Abnormal bleeding: PROZAC and other antidepressant medicines may increase
   1. your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. Seizures or convulsions
6. Manic episodes:
   1. greatly increased energy
   2. severe trouble sleeping
   3. racing thoughts
   4. reckless behavior
   5. unusually grand ideas
   6. excessive happiness or irritability
   7. talking more or faster than usual
7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
   1. headache
   2. weakness or feeling unsteady
   3. confusion, problems concentrating or thinking or memory problems
9. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsade de Pointes). This condition can be life threatening. The symptoms may include:
   1. fast, slow, or irregular heartbeat
   2. shortness of breath
   3. dizziness or fainting
10. Avoid using Fluoxetine with MAOis or within two weeks of discontinuation of MAOi, otherwise could cause:
    1. high fever
    2. uncontrolled muscle spasms
    3. stiff muscles
    4. rapid changes in heart rate or blood pressure
    5. confusion
    6. loss of consciousness (pass out)
11. Discontinuation syndrome

• Young SA, Hurt PH, Benedek DM, et al. Treatment of premenstrual dysphoric disorder with sertraline during the luteal phase: a randomized, double-blind, placebo-controlled crossover trial. J Clin Psychiatry, 1998 Feb, 59:2, 76-80.
• Brent, BrentDepression and suicide in children and adolescents. Pediatr Rev, 14 (1993), pp. 380–388.
• GJ Emslie, AJ Rush, WA Weinberg,et al. (1997) A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry, 54 (1997), pp. 1031–1037.
• Versiani M,Ontiveros A, Mazzotti G, Ospina J, Dávila J, Mata S, Pacheco A, Plewes J, Tamura R, Palacios M. Fluoxetine versus amitriptyline in the treatment of major depression with associated anxiety (anxious depression): a double-blind comparison. Int Clin Psychopharmacol. 1999 Nov;14(6):321-7.
• Michelson D,Amsterdam JD, Quitkin FM, Reimherr FW, Rosenbaum JF, Zajecka J, Sundell KL, Kim Y, Beasley CM Jr. Changes in weight during a 1-year trial of fluoxetine. Am J Psychiatry. 1999 Aug;156(8):1170-6.
• Ciraulo, DA, Creelman, W, and Shader, RI.Antidepressant drug-drug interactions. in: DA Ciraulo, W Creelman, DI Greenblat, RI Sgader (Eds.) Drug Interactions in Psychiatry. Williams & Wilkins , Baltimore; 1989: 52–53.
• Shopsin, B and Kline, NS.Monoamine oxidase inhibitors: potential for drug abuse. Biol Psychiatry. 1976; 11: 451–456.
• Wernicke, JF.The side effect profile and safety of fluoxetine. J Clin Psychiatry. 1985; 46: 59–67.