2
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 (MAOIs): (2.9, 2.10, 4.1, 5.2)
• Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of
CYP2D6 enzyme pathway (7.7)
• Tricyclic Antidepressants (TCAs): Monitor TCA levels during
coadministration with PROZAC or when PROZAC has been
recently discontinued (5.2, 7.7)
• CNS Acting Drugs: Caution should be used when taken in
combination with other centrally acting drugs (7.2)
• Benzodiazepines: Diazepam – increased t½, alprazolam - further
psychomotor performance decrement due to increased levels
(7.7)
• Antipsychotics: Potential for elevation of haloperidol and
clozapine levels (7.7)
• Anticonvulsants: Potential for elevated phenytoin and
carbamazepine levels and clinical anticonvulsant toxicity (7.7)
• Serotonergic Drugs: (2.9, 2.10, 4.1, 5.2)
• Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin,
Warfarin): May potentiate the risk of bleeding (7.4)
• Drugs Tightly Bound to Plasma Proteins: May cause a shift in
plasma concentrations (7.6, 7.7)
• Olanzapine: When used in combination with PROZAC, also refer
to the Drug Interactions section of the package insert for Symbyax
(7.7)
• Drugs that Prolong the QT Interval: Do not use Prozac with
thioridazine or pimozide. Use with caution in combination with
other drugs that prolong the QT interval (4.2, 5.11, 7.7, 7.8)
------------------------USE IN SPECIFIC POPULATIONS-----------------------
• Pregnancy: PROZAC should be used during pregnancy only if the
potential benefit justifies the potential risks to the fetus (8.1)
• Nursing Mothers: Breast feeding is not recommended (8.3)
• Pediatric Use: Safety and effectiveness of PROZAC in patients
<8 years of age with Major Depressive Disorder and <7 years of
age with OCD have not been established. Safety and
effectiveness of PROZAC and olanzapine in combination in
patients <10 years of age for depressive episodes associated with
Bipolar I Disorder have not been established. (8.4)
• Hepatic Impairment: Lower or less frequent dosing may be
appropriate in patients with cirrhosis (8.6)
See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved Medication Guide.
Revised: 01/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Major Depressive Disorder
2.2 Obsessive Compulsive Disorder
2.3 Bulimia Nervosa
2.4 Panic Disorder
2.5 PROZAC and Olanzapine in Combination: Depressive
Episodes Associated with Bipolar I Disorder
2.6 PROZAC and Olanzapine in Combination: Treatment
Resistant Depression
2.7 Dosing in Specific Populations
2.8 Discontinuation of Treatment
2.9 Switching a Patient To or From a Monoamine Oxidase
Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
2.10 Use of PROZAC with Other MAOIs such as Linezolid or
Methylene Blue
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Monoamine Oxidase Inhibitors (MAOIs)
4.2 Other Contraindications
5 WARNINGS AND PRECAUTIONS
5.1 Suicidal Thoughts and Behaviors in Children,
Adolescents, and Young Adults
5.2 Serotonin Syndrome
5.3 Allergic Reactions and Rash
5.4 Screening Patients for Bipolar Disorder and Monitoring for
Mania/Hypomania
5.5 Seizures
5.6 Altered Appetite and Weight
5.7 Abnormal Bleeding
5.8 Angle-Closure Glaucoma
5.9 Hyponatremia
5.10 Anxiety and Insomnia
5.11 QT Prolongation
5.12 Use in Patients with Concomitant Illness
5.13 Potential for Cognitive and Motor Impairment
5.14 Long Elimination Half-Life
5.15 Discontinuation Adverse Reactions
5.16 PROZAC and Olanzapine in Combination
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Other Reactions
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors (MAOI)
7.2 CNS Acting Drugs
7.3 Serotonergic Drugs
7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDS,
Aspirin, Warfarin)
7.5 Electroconvulsive Therapy (ECT)
7.6 Potential for Other Drugs to affect PROZAC
7.7 Potential for PROZAC to affect Other Drugs
7.8 Drugs that Prolong the QT Interval
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2
Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE
9.3 Dependence
10 OVERDOSAGE
10.1 Human Experience
10.2 Animal Experience
10.3 Management of Overdose
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Specific Populations
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Major Depressive Disorder
14.2 Obsessive Compulsive Disorder
14.3 Bulimia Nervosa
14.4 Panic Disorder
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
Reference ID: 4036401