Fluoxetine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Fluoxetine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluoxetine is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)


FLUOXETINE HYDROCHLORIDE DESCRIPTION


Fluoxetine Hydrochloride




CLINICAL PHARMACOLOGY

Pharmacodynamics



Absorption, Distribution, Metabolism, and Excretion

Systemic bioavailability



Protein binding


Enantiomers


Metabolism


Clinical issues related to metabolism/elimination


Variability in metabolism



Accumulation and slow elimination



Liver disease


Renal disease


Age

Geriatric pharmacokinetics


Pediatric pharmacokinetics (children and adolescents)



CLINICAL TRIALS

Major Depressive Disorder

Daily Dosing

Adult




Pediatric (children and adolescents)
has been studied in two 8- to 9-week placebo-controlled clinical trials.
In both studies independently, fluoxetine produced a statistically significantly greater mean change on the Childhood Depression Rating Scale-Revised (CDRS-R) total score from baseline to endpoint than did placebo.
Subgroup analyses on the CDRS-R total score did not suggest any differential responsiveness on the basis of age or gender.

Obsessive Compulsive Disorder

Adult
The effectiveness of fluoxetine for the treatment of obsessive compulsive disorder (OCD) was demonstrated in two 13-week, multicenter, parallel group studies (Studies 1 and 2) of adult outpatients who received fixed fluoxetine doses of 20, 40, or 60 mg/day (on a once-a-day schedule, in the morning) or placebo. Patients in both studies had moderate to severe OCD (DSM-III-R), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS, total score) ranging from 22 to 26. In Study 1, patients receiving fluoxetine experienced mean reductions of approximately 4 to 6 units on the YBOCS total score, compared with a 1-unit reduction for placebo patients. In Study 2, patients receiving fluoxetine experienced mean reductions of approximately 4 to 9 units on the YBOCS total score, compared with a 1-unit reduction for placebo patients. While there was no indication of a dose-response relationship for effectiveness in Study 1, a dose-response relationship was observed in Study 2, with numerically better responses in the two higher dose groups. The following table provides the outcome classification by treatment group on the Clinical Global Impression (CGI) improvement scale for Studies 1 and 2 combined:

Outcome Classification (%) on CGI Improvement Scale for Completers in Pool of Two OCD Studies
FluoxetineOutcome ClassificationPlacebo20 mg40 mg60 mgWorse8%0%0%0%No change64%41%33%29%Minimally improved17%23%28%24%Much improved8%28%27%28%Very much improved3%8%12%19%Exploratory analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.

Pediatric (children and adolescents)
's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
Subgroup analyses on outcome did not suggest any differential responsiveness on the basis of age or gender.

Bulimia Nervosa
The effectiveness of fluoxetine for the treatment of bulimia was demonstrated in two 8-week and one 16-week, multicenter, parallel group studies of adult outpatients meeting DSM-III-R criteria for bulimia. Patients in the 8-week studies received either 20 or 60 mg/day of fluoxetine or placebo in the morning. Patients in the 16-week study received a fixed fluoxetine dose of 60 mg/day (once a day) or placebo. Patients in these three studies had moderate to severe bulimia with median binge-eating and vomiting frequencies ranging from 7 to 10 per week and 5 to 9 per week, respectively. In these three studies, fluoxetine 60 mg, but not 20 mg, was statistically significantly superior to placebo in reducing the number of binge-eating and vomiting episodes per week. The statistically significantly superior effect of 60 mg versus placebo was present as early as Week 1 and persisted throughout each study. The fluoxetine-related reduction in bulimic episodes appeared to be independent of baseline depression as assessed by the Hamilton Depression Rating Scale. In each of these three studies, the treatment effect, as measured by differences between fluoxetine 60 mg and placebo on median reduction from baseline in frequency of bulimic behaviors at endpoint, ranged from one to two episodes per week for binge-eating and two to four episodes per week for vomiting. The size of the effect was related to baseline frequency, with greater reductions seen in patients with higher baseline frequencies.
Although some patients achieved freedom from binge-eating and purging as a result of treatment, for the majority, the benefit was a partial reduction in the frequency of binge-eating and purging.
In a longer-term trial, 150 patients meeting DSM-IV criteria for bulimia nervosa, purging subtype, who had responded during a single-blind, 8-week acute treatment phase with fluoxetine 60 mg/day, were randomized to continuation of fluoxetine 60 mg/day or placebo, for up to 52 weeks of observation for relapse. Response during the single-blind phase was defined by having achieved at least a 50% decrease in vomiting frequency compared with baseline. Relapse during the double-blind phase was defined as a persistent return to baseline vomiting frequency or physician judgment that the patient had relapsed. Patients receiving continued fluoxetine 60 mg/day experienced a significantly longer time to relapse over the subsequent 52 weeks compared with those receiving placebo.

Panic Disorder
The effectiveness of fluoxetine in the treatment of panic disorder was demonstrated in two double-blind, randomized, placebo-controlled, multicenter studies of adult outpatients who had a primary diagnosis of panic disorder (DSM-IV), with or without agoraphobia.
Study 1 (N=180 randomized) was a 12-week flexible-dose study. Fluoxetine was initiated at 10 mg/day for the first week, after which patients were dosed in the range of 20 to 60 mg/day on the basis of clinical response and tolerability. A statistically significantly greater percentage of fluoxetine-treated patients were free from panic attacks at endpoint than placebo-treated patients, 42% versus 28%, respectively.
Study 2 (N=214 randomized) was a 12-week flexible-dose study. Fluoxetine was initiated at 10 mg/day for the first week, after which patients were dosed in a range of 20 to 60 mg/day on the basis of clinical response and tolerability. A statistically significantly greater percentage of fluoxetine-treated patients were free from panic attacks at endpoint than placebo-treated patients, 62% versus 44%, respectively.

INDICATIONS & USAGE

Major Depressive Disorder


Adult





Pediatric (children and adolescents)



Obsessive Compulsive Disorder

Adult





Pediatric (children and adolescents)


Bulimia Nervosa




Panic Disorder





FLUOXETINE HYDROCHLORIDE CONTRAINDICATIONS



Monoamine oxidase inhibitors


Pimozide


Thioridazine


WARNINGS

Clinical Worsening and Suicide Risk






All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.



Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.

Screening Patients for Bipolar Disorder


Rash and Possibly Allergic Events







Serotonin Syndrome





Potential Interaction with Thioridazine



PRECAUTIONS

General

Abnormal Bleeding


Anxiety and Insomnia





Altered Appetite and Weight





Activation of Mania/Hypomania



Hyponatremia


Seizures


The Long Elimination Half-Lives of Fluoxetine and its Metabolites


Use in Patients With Concomitant Illness





Interference With Cognitive and Motor Performance


Discontinuation of Treatment with Fluoxetine


INFORMATION FOR PATIENTS




Clinical Worsening and Suicide Risk


Serotonin Syndrome








LABORATORY TESTS



DRUG INTERACTIONS



Drugs metabolized by CYP2D6



Drugs metabolized by CYP3A4


CNS active drugs


Anticonvulsants


Antipsychotics


Benzodiazepines


Lithium


Tryptophan


Monoamine oxidase inhibitors


Other drugs effective in the treatment of major depressive disorder


Serotonergic drugs


Triptans


Potential effects of coadministration of drugs tightly bound to plasma proteins


Drugs that interfere with hemostasis (NSAIDs, aspirin, warfarin, etc.)


Warfarin


Electroconvulsive therapy (ECT)


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



Carcinogenicity


Mutagenicity


Impairment of fertility


PREGNANCY

Pregnancy Category C


Nonteratogenic effects


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE














GERIATRIC USE



FLUOXETINE HYDROCHLORIDE ADVERSE REACTIONS





Incidence in major depressive disorder, OCD, bulimia, and panic disorder placebo-controlled clinical trials (excluding data from extensions of trials).












Associated with discontinuation in major depressive disorder, OCD, bulimia, and panic disorder placebo-controlled clinical trials (excluding data from extensions of trials)





Other adverse events in pediatric patients (children and adolescents)



Male and female sexual dysfunction with SSRIs





Other Events Observed in Clinical Trials



Body as a Whole


Cardiovascular System


Digestive System


Endocrine System


Hemic and Lymphatic System


Metabolic and Nutritional


Musculoskeletal System


Nervous System


Respiratory System


Skin and Appendages


Special Senses


Urogenital System





Postintroduction Reports


DRUG ABUSE AND DEPENDENCE

Controlled substance class


Physical and psychological dependence


OVERDOSAGE


Human Experience





Animal Experience





Management of Overdose







DOSAGE & ADMINISTRATION


Major Depressive Disorder

Initial Treatment

Adult



Pediatric (children and adolescents)



All patients



Maintenance/Continuation/Extended Treatment


Daily Dosing


Switching Patients to a Tricyclic Antidepressant (TCA)


Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI)


Obsessive Compulsive Disorder

Initial Treatment

Adult



Pediatric (children and adolescents)




All Patients


Maintenance/Continuation Treatment


Bulimia Nervosa

Initial Treatment



Maintenance/Continuation Treatment


Panic Disorder

Initial Treatment




Maintenance/Continuation Treatment


Special Populations

Treatment of Pregnant Women During the Third Trimester


Discontinuation of Treatment with Fluoxetine


HOW SUPPLIED






















STORAGE AND HANDLING



INFORMATION FOR PATIENTS

FDA-approved Medication Guide



General Information










Clinical Worsening and Suicide Risk

Box WarningWarnings and Precautions (5.1)
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

Warnings and Precautions (5.2Drug Interactions (7.3


Allergic Reactions and Rash

Warnings and Precautions (5.3)
Abnormal Bleeding

Warnings and Precautions (5.7)Drug Interactions (7.6)
Hyponatremia

Warnings and Precautions (5.8)
Potential for Cognitive and Motor Impairment

Warnings and Precautions (5.11)
Use of Concomitant Medications


Discontinuation of Treatment

Warnings and Precautions (5.13)
Use in Specific Populations

Use in Specific Populations (8.1)

Use in Specific Populations (8.3)

Box WarningWarnings and Precautions (5.1)Warnings and Precautions (5.6)Use in Specific Populations (8.4)


SPL MEDGUIDE






What is the most important information I should know about fluoxetine capsules?

Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

Talk to your, or your family member's, healthcare provider about:

  • ●     all risks and benefits of treatment with antidepressant medicines
  • ●     all treatment choices for depression or other serious mental illness
     1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
     2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions

     3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

  • ●     Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • ●     Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • ●     Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • ●     thoughts about suicide or dying
  • ●     attempts to commit suicide
  • ●     new or worse depression
  • ●     new or worse anxiety
  • ●     feeling very agitated or restless
  • ●     panic attacks
  • ●     trouble sleeping (insomnia)
  • ●     new or worse irritability
  • ●     acting aggressive, being angry, or violent
  • ●     acting on dangerous impulses
  • ●     an extreme increase in activity and talking (mania)
  • ●     or other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?
  • ●     Never stop an antidepressant medicine without first talking to a healthcare provider . Stopping an antidepressant medicine suddenly can cause other symptoms.
  •      Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  •      Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  •      Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes.Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  •      Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child's healthcare provider for more information.

What are fluoxetine capsules?


  • ●     for short and long-term treatment of depression in adults and children over the age of 8.
  • ●     for short and long-term treatment of Obsessive Compulsive Disorder (OCD) in adults and children over the age of 7.
  • ●     for short and long-term treatment of Bulimia Nervosa in adults.
  • ●     for short-term treatment of Panic Disorder, with or without agoraphobia, in adults.
  • ●     with the medicine olanzapine (Zyprexafor the short-term treatment of episodes of depression that happen with Bipolar I Disorder.












Who should not take fluoxetine capsules?
  • ●     Do not take fluoxetine capsules if you take a Monoamine Oxidase Inhibitor (MAOI) or if you stopped taking an MAOI in the last2weeks.
  • ●     Do not take an MAOIwithin 5 weeks of stopping fluoxetine capsules. People who take fluoxetine capsules close in time to an MAOI can have serious and life-threatening side effects, with symptoms including:
  • ●               high fever
  • ●               continued muscle spasms that you can not control
  • ●               rigid muscles
  • ●               changes in heart rate and blood pressure that happen fast
  • ●               confusion
  • ●               unconsciousness


  • ●     Do not take fluoxetine capsules if you take Mellaril(thioridazine). Do not take Mellarilwithin 5 weeks of stopping fluoxetine capsules. Mellaril can cause serious heart rhythm problems and you could die suddenly.
  • ●     Do not take fluoxetine capsules if you take the antipsychotic medicine pimozide (Orap
What should I tell my doctor before taking fluoxetine capsules?


  • ●     seizures (convulsions)
  • ●     bipolar disorder (mania)
  • ●     are pregnant or plan to become pregnant. It is not known if fluoxetine capsules will harm your unborn baby.
  • ●     are breast-feeding or plan to breast-feed. Fluoxetine can pass into your breast milk and may harm your baby. You should not breast-feed while taking fluoxetine capsules. Talk to your doctor about the best way to feed your baby if you take fluoxetine capsules.

Tell your doctor about all the medicines that you take,

If you take fluoxetine capsules, you should not take any other medicines that contain fluoxetine hydrochloride:
  • ●     Symbyax
  • ●     Sarafem



How should I take fluoxetine capsules?
  • ●     Take fluoxetine capsules exactly as prescribed. Your doctor may need to change (adjust) the dose of fluoxetine capsules until it is right for you.
  • ●     If you miss a dose of fluoxetine capsules, 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 capsules at the same time.
  •      To prevent serious side effects, do not stop taking fluoxetine capsules suddenly. If you need to stop taking fluoxetine capsules, your doctor can tell you how to safely stop taking them.
  • ●     If you take too much fluoxetine capsules, call your doctor or poison control center right away, or get emergency treatment.
  • ●     Fluoxetine capsules can be taken with or without food.
  • ●     Fluoxetine capsules are usually taken once a day, depending on how your doctor prescribes your medicine.
  • ●     If you do not think you are getting better or have any concerns about your condition while taking fluoxetine capsules, call your doctor.


What should I avoid while taking fluoxetine capsules?
  • ●     Fluoxetine capsules can cause sleepiness and 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 capsules affect you.

What are the possible side effects of fluoxetine capsules?


  • ●     Serotonin Syndrome: This is a condition that can be life threatening. Call your doctor right away if you become severely ill and have some or all of these symptoms:
  • ●               agitation
  • ●               hallucinations
  • ●               problems with coordination
  • ●               racing heart beat
  • ●               over-active reflexes
  • ●               fever
  • ●               nausea, vomiting, and diarrhea
  •      Severe allergic reactions:Tell your doctor right away if you get red itchy welts (hives) or, a rash alone or with fever and joint pain, while taking fluoxetine capsules. Call your doctor right away if you become severely ill and have some or all of these symptoms:
  • ●               swelling of your face, eyes, or mouth
  • ●               trouble breathing
  •      Abnormal bleeding:Tell your doctor if you notice any increased or unusual bruising or bleeding while taking fluoxetine capsules, especially if you take one of these medicines:
  • ●               the blood thinner warfarin (CoumadinJantoven
  • ●               a non-steroidal anti-inflammatory drug (NSAID)
  • ●               aspirin
  •      Mania:You may have a high mood, become extremely irritable, have too much energy, feel pressure to keep talking, or have a decreased need for sleep.
  •      Seizures
  • ●     Loss of appetite
  • ●     Low salt (sodium) levels in the blood (hyponatremia): Call your doctor right away if you become severely ill and have some or all of these symptoms:
  • ●               headache
  • ●               feel weak
  • ●               confusion
  • ●               problems concentrating
  • ●               memory problems
  • ●               feel unsteady

Common possible side effects of fluoxetine capsules include:







How should I store fluoxetine capsules?
  • ●     Store fluoxetine capsules at 20to 25(68to 77to 30(59to 86[see USP Controlled Room Temperature].
  • ●     Keep fluoxetine capsules away from light.
  • ●     Keep fluoxetine capsules bottle closed tightly.

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

General information about fluoxetine capsules






What are the ingredients in fluoxetine capsules?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients:












PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-518(NDC:65862-192)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE FLUOXETINE 10 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
FD&C BLUE NO. 1
FERRIC OXIDE YELLOW
titanium dioxide
SODIUM LAURYL SULFATE
GELATIN
FERROSOFERRIC OXIDE
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
green 16 mm E;88 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-518-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078619 2011-09-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.