1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PROZAC safely and effectively. See full prescribing information for
PROZAC.
PROZAC (fluoxetine hydrochloride) Pulvules for oral use
PROZAC (fluoxetine hydrochloride) delayed-release capsules for oral use
Initial U.S. Approval: 1987
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning.
Increased risk of suicidal thinking and behavior in children, adolescents,
and young adults taking antidepressants for Major Depressive
Disorder (MDD) and other psychiatric disorders (5.1).
When using PROZAC and olanzapine in combination, also refer to Boxed
Warning section of the package insert for Symbyax.
--------------------------- RECENT MAJOR CHANGES --------------------------
------------------------INDICATIONS AND USAGE---------------------------
PROZAC
®
is a selective serotonin reuptake inhibitor indicated for:
• Acute and maintenance treatment of Major Depressive Disorder (MDD)
in adult and pediatric patients aged 8 to 18 years (1.1)
• Acute and maintenance treatment of Obsessive Compulsive
Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2)
• Acute and maintenance treatment of Bulimia Nervosa in adult patients
(1.3)
• Acute treatment of Panic Disorder, with or without agoraphobia, in adult
patients (1.4)
PROZAC and olanzapine in combination for:
• Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1.5)
• Acute treatment of Treatment Resistant Depression in adults (Major
Depressive Disorder in adult patients who do not respond to 2 separate
trials of different antidepressants of adequate dose and duration in the
current episode) (1.6)
----------------------- DOSAGE AND ADMINISTRATION ----------------------
Indication Adult Pediatric
MDD (2.1) 20 mg/day in am (initial dose) 10 to 20 mg/day
(initial dose)
OCD (2.2) 20 mg/day in am (initial dose) 10 mg/day (initial
dose)
Bulimia Nervosa
(2.3)
60 mg/day in am -
Panic Disorder (2.4) 10 mg/day (initial dose) -
Depressive Episodes
Associated with
Bipolar I Disorder
(2.5)
Oral in combination with
olanzapine: 5 mg of oral
olanzapine and 20 mg of
fluoxetine once daily (initial
dose)
-
Treatment Resistant
Depression (2.6)
Oral in combination with
olanzapine: 5 mg of oral
olanzapine and 20 mg of
fluoxetine once daily (initial
dose)
-
• Consider tapering the dose of fluoxetine for pregnant women during the
third trimester (2.7)
• A lower or less frequent dosage should be used in patients with hepatic
impairment, the elderly, and for patients with concurrent disease or on
multiple concomitant medications (2.7)
• Dosing with PROZAC Weekly capsules - initiate 7 days after the last
daily dose of PROZAC 20 mg (2.1)
PROZAC and olanzapine in combination:
• Dosage adjustments, if indicated, should be made with the individual
components according to efficacy and tolerability (2.5, 2.6)
• Fluoxetine monotherapy is not indicated for the treatment of Depressive
Episodes associated with Bipolar I Disorder or treatment resistant
depression (2.5, 2.6)
• Safety of the coadministration of doses above 18 mg olanzapine with 75
mg fluoxetine has not been evaluated (2.5, 2.6)
----------------------DOSAGE FORMS AND STRENGTHS ---------------------
• Pulvules: 10 mg, 20 mg, 40 mg (3)
• Weekly capsules: 90 mg (3)
-------------------------------CONTRAINDICATIONS------------------------------
• Do not use with an MAOI or within 14 days of discontinuing an MAOI
due to risk of drug interaction. At least 5 weeks should be allowed after
stopping PROZAC before treatment with an MAOI (4, 7.1)
• Do not use with pimozide due to risk of drug interaction or QT
c
prolongation (4, 7.9)
• Do not use with thioridazine due to QT
c
interval prolongation or
potential for elevated thioridazine plasma levels. Do not use thioridazine
within 5 weeks of discontinuing PROZAC (4, 7.9)
• When using PROZAC and olanzapine in combination, also refer to the
Contraindications section of the package insert for Symbyax (4)
------------------------WARNINGS AND PRECAUTIONS -----------------------
• Clinical Worsening and Suicide Risk: Monitor for clinical worsening
and suicidal thinking and behavior (5.1)
• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like
Reactions: Have been reported with PROZAC. Discontinue PROZAC
and initiate supportive treatment (5.2)
• Allergic Reactions and Rash: Discontinue upon appearance of rash or
allergic phenomena (5.3)
• Activation of Mania/Hypomania: Screen for Bipolar Disorder and
monitor for mania/hypomania (5.4)
• Seizures: Use cautiously in patients with a history of seizures or with
conditions that potentially lower the seizure threshold (5.5)
• Altered Appetite and Weight: Significant weight loss has occurred (5.6)
• Abnormal Bleeding: May increase the risk of bleeding. Use with
NSAIDs, aspirin, warfarin, or drugs that affect coagulation may
potentiate the risk of gastrointestinal or other bleeding (5.7)
• Hyponatremia: Has been reported with PROZAC in association with
syndrome of inappropriate antidiuretic hormone (SIADH) (5.8)
• Anxiety and Insomnia: May occur (5.9)
• Potential for Cognitive and Motor Impairment: Has potential to impair
judgment, thinking, and motor skills. Use caution when operating
machinery (5.11)
• Long Half-Life: Changes in dose will not be fully reflected in plasma for
several weeks (5.12)
• PROZAC and Olanzapine in Combination: When using PROZAC and
olanzapine in combination, also refer to the Warnings and Precautions
section of the package insert for Symbyax (5.14)
-------------------------------ADVERSE REACTIONS ------------------------------
Most common adverse reactions (≥5% and at least twice that for placebo)
associated with:
Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and
Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety,
asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia,
libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis,
somnolence, sweating, tremor, vasodilatation, and yawn (6.1)
PROZAC and olanzapine in combination – Also refer to the Adverse
Reactions section of the package insert for Symbyax (6)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and
Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch
-------------------------------DRUG INTERACTIONS ------------------------------
• Monoamine Oxidase Inhibitors (MAOI): PROZAC is contraindicated for
use with MAOI’s, or within 14 days of discontinuing an MAOI due to
risk of drug interaction. At least 5 weeks should be allowed after
stopping PROZAC before starting treatment with an MAOI (4, 7.1)
• Pimozide: PROZAC is contraindicated for use with pimozide due to risk
of drug interaction or QT
c
prolongation (4, 7.9)
• Thioridazine: PROZAC is contraindicated for use with thioridazine due
to QT
c
interval prolongation or potential for elevated thioridazine plasma
levels. Do not use thioridazine within 5 weeks of discontinuing
PROZAC (4, 7.9)
• Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of
CYP2D6 enzyme pathway (7.9)
Reference ID: 2927282