Fluoxetine Hydrochloride (Page 11 of 11)

17.12 Use in Specific Population

Pregnancy — Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].

Nursing Mothers — Patients should be advised to notify their physician if they intend to breast-feed an infant during therapy. Because fluoxetine is excreted in human milk, nursing while taking fluoxetine is not recommended [see Use in Specific Populations (8.3)].

Pediatric Use of fluoxetine — Fluoxetine 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)].

SPL MED GUIDE

Medication Guide

Fluoxetine Tablets, USP

( floo-OX-e-teen)

Read the Medication Guide that comes with fluoxetine tablets 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 fluoxetine tablets?

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

1. Suicidal thoughts or actions:

  • Fluoxetine tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within thefirst few months of treatment or when the dose is changed.
  • Depressionor 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 fluoxetine tablets 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. Fluoxetine may be associated with these serious side effects:

2. 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

3. 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

4. Abnormal bleeding: Fluoxetine 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.

5. 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.

6. Seizures or convulsions

7. 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

8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. 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

10. 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 fluoxetine tablets without first talking to your healthcare provider. Stopping fluoxetine tablets 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 are fluoxetine tablets?

Fluoxetine tablets are 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.

Fluoxetine is used to treat:

  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Bulimia Nervosa*
  • Panic Disorder*

*Not approved for use in children

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

Who should not take fluoxetine tablets?

Do not take fluoxetine tablets if you:

  • are allergic to fluoxetine hydrochloride or any of the ingredients in fluoxetine tablets. See the end of this Medication Guide for a complete list of ingredients in fluoxetine tablets.
  • 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 fluoxetine tablets unless directed to do so by your physician.
    • Do not start fluoxetine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take fluoxetine tablets 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 fluoxetine tablets 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 fluoxetine tablets? Ask if you are not sure.

Before starting fluoxetine tablets, 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
    • 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. It is not known if fluoxetine will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
    • are breast-feeding or plan to breast-feed. Some fluoxetine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluoxetine.

Tell your healthcare provider about all the medicines that you take , including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine tablets 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 fluoxetine tablets with your other medicines. Do not start or stop any medicine while taking fluoxetine tablets without talking to your healthcare provider first.

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

  • Symbyax
  • Sarafem
  • Prozac Weekly

How should I take fluoxetine tablets?

  • Take fluoxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine tablets until it is the right dose for you.
  • Fluoxetine tablets may be taken with or without food.
    • If you miss a dose of fluoxetine tablets, 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 fluoxetine tablets at the same time.
    • If you take too much fluoxetine tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking fluoxetine tablets?

Fluoxetine tablets 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 fluoxetine tablets affects you. Do not drink alcohol while using fluoxetine tablets.

What are the possible side effects of fluoxetine tablets?

Fluoxetine tablets may cause serious side effects, including:

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

Common possible side effects in people who take fluoxetine tablets 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 fluoxetine tablets.

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 fluoxetine tablets. 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 fluoxetine tablets?

  • Store at68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature].
  • Keep fluoxetine tablets away from light.
  • Keep fluoxetine tablets bottle closed tightly.

Keep fluoxetine tablets and all medicines out of the reach of children.

General information about fluoxetine tablets

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

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

For more information about fluoxetine tablets call Par Pharmaceutical at 1-800-828-9393.

What are the ingredients in fluoxetine tablets?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: microcrystalline cellulose, crospovidone, magnesium stearate, corn starch, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

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

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical.

For Medication Guide, please visit www.parpharm.com

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.


Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam — 603 103.
Made in India


Mfg. Lic. No.: TN00002121
OS335-01-74-03Revised: 11/2019

Fluoxetine Hcl 20 mg Tablet, #30

Label
(click image for full-size original)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2199(NDC:49884-336)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score 2 pieces
Shape OVAL (White to off-white, film-coated, oval-shaped tablets) Size 13mm
Flavor Imprint Code EP;362
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-2199-1 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203836 08/22/2016
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-2199), RELABEL (63629-2199)

Revised: 04/2022 Bryant Ranch Prepack

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