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












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



ANIMAL PHARMACOLOGY & OR TOXICOLOGY



SPL MEDGUIDE












  • ●     Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is first 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.














  • ●     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.


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:49349-409(NDC:65862-193)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE FLUOXETINE 20 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
white 16 mm E;91 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-409-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078619 2011-07-21


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.