Prozac Fluoxetine hydrochloride

Drug Basics

Brand Name: Prozac

Generic Name: FLUOXETINE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE

Data Current As Of: 2020-05-18

indications & usage

PROZAC^® is indicated for the treatment of:

• Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
• Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
• Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
• Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].

PROZAC and Olanzapine in Combination is indicated for the treatment of:

• Acute treatment of depressive episodes associated with Bipolar I Disorder.
• Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).

PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ^®.

PROZAC^® is a selective serotonin reuptake inhibitor indicated for:

• Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
• Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
• Acute and maintenance treatment of Bulimia Nervosa (1)
• Acute treatment of Panic Disorder, with or without agoraphobia (1)

PROZAC and olanzapine in combination for treatment of:

• Acute Depressive Episodes Associated with Bipolar I Disorder (1)
• Treatment Resistant Depression (1)

drug abuse & dependence

dependence

PROZAC has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the premarketing clinical experience with PROZAC did not reveal any tendency for a withdrawal syndrome or any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, healthcare providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of PROZAC (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking PROZAC as monotherapy or in combination with olanzapine. When using PROZAC and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.

General Information

Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with PROZAC and to reread it each time the prescription is renewed.

Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PROZAC and should counsel them in its appropriate use. Healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking PROZAC.

When using PROZAC and olanzapine in combination, also refer to the Medication Guide for Symbyax.

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Box Warning and Warnings and Precautions (5.1)].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of PROZAC and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort [see Contraindications (4.1), Warnings and Precautions (5.2), and Drug Interactions (7.3)].

Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be cautioned to seek medical care immediately if they experience these symptoms.

Allergic Reactions and Rash

Patients should be advised to notify their healthcare provider if they develop a rash or hives [see Warnings and Precautions (5.3)]. Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing. Patients should be cautioned to seek medical care immediately if they experience these symptoms.

Abnormal Bleeding

Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions (5.7) and Drug Interactions (7.4)]. Patients should be advised to call their healthcare provider if they experience any increased or unusual bruising or bleeding while taking PROZAC.

Angle-Closure Glaucoma

Patients should be advised that taking Prozac can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.8)].

Hyponatremia

Patients should be advised that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including PROZAC. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death [see Warnings and Precautions (5.9)].

QT Prolongation

Patients should be advised that QT interval prolongation and ventricular arrhythmia including Torsades de Pointes have been reported in patients treated with PROZAC. Signs and symptoms of ventricular arrhythmia include fast, slow, or irregular heart rate, dyspnea, syncope, or dizziness, which may indicate serious cardiac arrhythmia [see Warnings and Precautions (5.11)].

Potential for Cognitive and Motor Impairment

PROZAC may impair judgment, thinking, or motor skills. Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected [see Warnings and Precautions (5.13)].

Use of Concomitant Medications

Patients should be advised to inform their healthcare provider if they are taking, or plan to take, any prescription medication, including Symbyax, Sarafem, or over-the-counter drugs, including herbal supplements or alcohol. Patients should also be advised to inform their healthcare providers if they plan to discontinue any medications they are taking while on PROZAC.

Discontinuation of Treatment

Patients should be advised to take PROZAC exactly as prescribed, and to continue taking PROZAC as prescribed even after their symptoms improve. Patients should be advised that they should not alter their dosing regimen, or stop taking PROZAC without consulting their healthcare provider [see Warnings and Precautions (5.15)]. Patients should be advised to consult with their healthcare provider if their symptoms do not improve with PROZAC.

Use in Specific Populations

Pregnancy — Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with PROZAC.

Advise patients that PROZAC use later in pregnancy may lead to increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1)].

Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PROZAC during pregnancy [see Use in Specific Populations (8.1)].

Lactation —Advise breastfeeding women using PROZAC to monitor infants for agitation, irritability, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

Pediatric Use of PROZAC — PROZAC is approved for use in pediatric patients with MDD and OCD [see Box Warning and Warnings and Precautions (5.1)]. Limited evidence is available concerning the longer-term effects of fluoxetine on the development and maturation of children and adolescent patients. Height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see Warnings and Precautions (5.6) and Use in Specific Populations (8.4)].

Pediatric Use of PROZAC and olanzapine in combination - Safety and efficacy of PROZAC and olanzapine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with Bipolar I Disorder [see Warnings and Precautions (5.16) and Use in Specific Populations (8.4)].

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Copyright © 1987, 2020, Eli Lilly and Company. All rights reserved.
PRZ-0006-USPI-20200428

Medication Guide

PROZAC^® (PRO-zac)

(fluoxetine capsules)

for oral use

Read the Medication Guide that comes with PROZAC before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about PROZAC?

PROZAC and other antidepressant medicines may cause serious side effects, including:

• Suicidal thoughts or actions:
  • 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.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when PROZAC is started or when the dose is changed.

  Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

  Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood

  Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. PROZAC may be associated with these serious side effects:

• Serotonin Syndrome. This condition can be life-threatening and may include:
  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures
• Severe allergic reactions:
  • trouble breathing
  • swelling of the face, tongue, eyes or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain
• Abnormal bleeding: PROZAC and other antidepressant medicines may increase 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.
• Visual problems:
  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

  Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

• Seizures or convulsions
• Manic episodes:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
• Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
• Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems
• Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes). This condition can be life threatening. The symptoms may include:
  • fast, slow, or irregular heartbeat
  • shortness of breath
  • dizziness or fainting

Do not stop PROZAC without first talking to your healthcare provider. Stopping PROZAC too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

What is PROZAC?

PROZAC is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

PROZAC is used to treat:

• 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

Talk to your healthcare provider if you do not think that your condition is getting better with PROZAC treatment.

Who should not take PROZAC?

Do not take PROZAC if you:

• are allergic to fluoxetine hydrochloride or any of the ingredients in PROZAC. See the end of this Medication Guide for a complete list of ingredients in PROZAC.
• take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 5 weeks of stopping PROZAC unless directed to do so by your physician.
  • Do not start PROZAC if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take PROZAC close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

• high fever
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• confusion
• loss of consciousness (pass out)

• take Mellaril ^® (thioridazine). Do not take Mellaril^® within 5 weeks of stopping PROZAC because this can cause serious heart rhythm problems or sudden death.
• take the antipsychotic medicine pimozide (Orap^®) because this can cause serious heart problems.

What should I tell my healthcare provider before taking PROZAC? Ask if you are not sure.

Before starting PROZAC, tell your healthcare provider if you:

• Are taking certain drugs or treatments such as:
  • Triptans used to treat migraine headache
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs, MAOIs or antipsychotics
  • Amphetamines
  • Tramadol and fentanyl
  • Over-the-counter supplements such as tryptophan or St. John's Wort
  • Electroconvulsive therapy (ECT)
• have liver problems
• have kidney problems
• have heart problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have a history of a stroke
• have high blood pressure
• have or had bleeding problems
• are pregnant or plan to become pregnant. Taking PROZAC late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
  • If you become pregnant while taking PROZAC, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or go to https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
• are breast-feeding or plan to breast-feed. PROZAC may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if taking PROZAC.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. PROZAC and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take PROZAC with your other medicines. Do not start or stop any medicine while taking PROZAC without talking to your healthcare provider first.

If you take PROZAC, you should not take any other medicines that contain fluoxetine hydrochloride including:

How should I take PROZAC?

• Take PROZAC exactly as prescribed. Your healthcare provider may need to change the dose of PROZAC until it is the right dose for you.
• PROZAC may be taken with or without food.
• If you miss a dose of PROZAC, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of PROZAC at the same time.
• If you take too much PROZAC, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking PROZAC?

PROZAC can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how PROZAC affects you. Do not drink alcohol while using PROZAC.

What are the possible side effects of PROZAC?

PROZAC may cause serious side effects, including:

• See “What is the most important information I should know about PROZAC?”
• Problems with blood sugar control. People who have diabetes and take PROZAC may have problems with low blood sugar while taking PROZAC. High blood sugar can happen when PROZAC is stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking PROZAC.
• Feeling anxious or trouble sleeping

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.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PROZAC. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store PROZAC?

• Store PROZAC at room temperature between 59°F and 86°F (15°C to 30°C).
• Keep PROZAC away from light.
• Keep PROZAC bottle closed tightly.

Keep PROZAC and all medicines out of the reach of children.

General information about PROZAC

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROZAC for a condition for which it was not prescribed. Do not give PROZAC to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about PROZAC. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about PROZAC that is written for healthcare professionals.

For more information about PROZAC call 1-800-Lilly-Rx (1-800-545-5979).

What are the ingredients in PROZAC?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients:

• PROZAC pulvules: starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10 and 20 mg Pulvules also contain FD&C Blue No. 1, and the 40 mg Pulvules also contains FD&C Blue No. 1 and FD&C Yellow No. 6.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised April, 2020

Marketed by: Lilly USA, LLC

Indianapolis, IN 46285, USA

Copyright © 2009, 2020, Eli Lilly and Company. All rights reserved.

PRZ-0004-MG-20200428

PACKAGE LABEL- Prozac 10 mg, bottle of 100

NDC 0777-3104-02

100 PULVULES^®

No. 3104

PROZAC^®

FLUOXETINE CAPSULES, USP

Equiv. to 10 mg Fluoxetine

Rx only

DISTA

PACKAGE LABEL- Prozac 20 mg, bottle of 100

NDC 0777-3105-02

100 PULVULES^® No. 3105

PROZAC^®

FLUOXETINE CAPSULES, USP

Equiv. to 20 mg Fluoxetine

Rx only

DISTA

PACKAGE LABEL- Prozac 40 mg, bottle of 30

NDC 0777-3107-30

30 PULVULES^® No. 3107

PROZAC^®

FLUOXETINE CAPSULES, USP

Equiv. to 40 mg Fluoxetine

Rx only

DISTA

also known as

• Fluoxetine (capsule)
• Fluoxetine (liquid)
• Fluoxetine (solution)
• Fluoxetine (tablet)
• FLUOXETINE HCL (capsule)
• Fluoxetine HCl (tablet, film coated)
• Fluoxetine Hydrochloride (capsule)
• Fluoxetine Hydrochloride (tablet, film coated)
• SARAFEM (tablet)