FLUOXETINE- fluoxetine hydrochloride_capsule

Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine. 1 in vitro Systemic Bioavailability in vitro 1 R S S S R S R S S S R [see Drug Interactions (7. 7) [see Warnings and Precautions (5. 14) Liver Disease [see Dosage and Administration (2. 7 Use in Specific Populations (8.

Fluoxetine 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) Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. registered Fluoxetine capsules are 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 Fluoxetine capsules and olanzapine in combination for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder ( 1.

Indication Adult Pediatric MDD ( 2. 1 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD ( 2. 2 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa ( 2. 3 60 mg/day in am Panic Disorder ( 2. 4 10 mg/day (initial dose) Depressive Episodes 2. 5 Oral in combination with Oral in combination with A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications ( 2. 7 Fluoxetine capsules and olanzapine in combination: Dosage adjustments should be made with the individual components according to efficacy and tolerability ( 2. 5 Fluoxetine monotherapy is not indicated for the treatment of Depressive Episodes associated with Bipolar I Disorder ( 2. 5 Safety of the coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults. 5 Safety of the coadministration of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17 ( 2. 5 Initial Treatment [see Clinical Studies (14. 1) [see Clinical Studies (14. 1) [see Warnings and Precautions (5. 2) Drug Interactions (7. 7) Initial Treatment [see Clinical Studies (14. 2) [see Clinical Studies (14. 2) Initial Treatment [see Clinical Studies (14. 3) Initial Treatment [see Clinical Studies (14. 4) When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. Adult em dash Children and adolescents (10-17 years of age) em dash Safety and efficacy of fluoxetine in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of fluoxetine and olanzapine versus Symbyax. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability. Table 1: Approximate Dose Correspondence Between Symbyax 1 For Symbyax (mg/day) Use in Combination Olanzapine Fluoxetine 1 3 mg olanzapine/25 mg fluoxetine 2. 5 20 6 mg olanzapine/25 mg fluoxetine 5 20 12 mg olanzapine/25 mg fluoxetine 10+2. 5 20 6 mg olanzapine/50 mg fluoxetine 5 40+10 12 mg olanzapine/50 mg fluoxetine 10+2. 5 40+10 Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. Treatment of Pregnant Women [see Use in Specific Populations (8. 1) [see Use in Specific Populations (8. 5) [see Clinical Pharmacology (12. 4) Use in Specific Populations (8. 6) [see Clinical Pharmacology (12. 4) Warnings and Precautions (5. 12) [see Warnings and Precautions (5. 16) Drug Interactions (7. 7) Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5. At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine. Conversely, at least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4. 1) Do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4. 2) [see Warnings and Precautions (5.

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning Warnings and Precautions (5. 1) Serotonin Syndrome [see Warnings and Precautions (5. 2) Allergic Reactions and Rash [see Warnings and Precautions (5. 3) Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [see Warnings and Precautions (5. 4) Seizures [see Warnings and Precautions (5. 5) Altered Appetite and Weight [see Warnings and Precautions (5. 6) Abnormal Bleeding [see Warnings and Precautions (5. 7) Angle-Closure Glaucoma [see Warnings and Precautions (5. 8) Hyponatremia [see Warnings and Precautions (5. 9) Anxiety and Insomnia [see Warnings and Precautions (5. 10) QT Prolongation [see Warnings and Precautions (5. 11) Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5. 13) Discontinuation Adverse Reactions [see Warnings and Precautions (5. 15) When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Most common adverse reactions (>=5% and at least twice that for placebo) associated with: 6. 1 Fluoxetine and olanzapine in combination 6 www. gov/medwatch Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Table 3: Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1,2 Percentage of Patients Reporting Event Major Depressive Disorder OCD Bulimia Panic Disorder 1 2 3 Body System/Adverse Reaction Fluoxetine Placebo Fluoxetine Placebo Fluoxetine Placebo Fluoxetine Placebo Body as a Whole Asthenia 9 5 15 11 21 9 7 7 Flu syndrome 3 4 10 7 8 3 5 5 Cardiovascular System Vasodilatation 3 2 5 -- 2 1 1 -- Digestive System Nausea 21 9 26 13 29 11 12 7 Diarrhea 12 8 18 13 8 6 9 4 Anorexia 11 2 17 10 8 4 4 1 Dry mouth 10 7 12 3 9 6 4 4 Dyspepsia 7 5 10 4 10 6 6 2 Nervous System Insomnia 16 9 28 22 33 13 10 7 Anxiety 12 7 14 7 15 9 6 2 Nervousness 14 9 14 15 11 5 8 6 Somnolence 13 6 17 7 13 5 5 2 Tremor 10 3 9 1 13 1 3 1 Libido decreased 3 -- 11 2 5 1 1 2 Abnormal dreams 1 1 5 2 5 3 1 1 Respiratory System Pharyngitis 3 3 11 9 10 5 3 3 Sinusitis 1 4 5 2 6 4 2 3 Yawn -- -- 7 -- 11 -- 1 -- Skin and Appendages Sweating 8 3 7 -- 8 3 2 2 Rash 4 3 6 3 4 4 2 2 Urogenital System Impotence 3 2 -- -- -- 7 -- 1 -- Abnormal ejaculation 3 -- -- 7 -- 7 -- 2 1 Table 4: Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1, 2 Percentage of Patients Reporting Event Major Depressive Disorder, OCD, 1 2 Body System/Adverse Reaction Fluoxetine Placebo Body as a Whole Headache 21 19 Asthenia 11 6 Flu syndrome 5 4 Fever 2 1 Cardiovascular System Vasodilatation 2 1 Digestive System Nausea 22 9 Diarrhea 11 7 Anorexia 10 3 Dry mouth 9 6 Dyspepsia 8 4 Constipation 5 4 Flatulence 3 2 Vomiting 3 2 Metabolic and Nutritional Disorders Weight loss 2 1 Nervous System Insomnia 19 10 Nervousness 13 8 Anxiety 12 6 Somnolence 12 5 Dizziness 9 6 Tremor 9 2 Libido decreased 4 1 Thinking abnormal 2 1 Respiratory System Yawn 3 -- Skin and Appendages Sweating 7 3 Rash 4 3 Pruritus 3 2 Special Senses Abnormal vision 2 1 Associated with discontinuation in Major Depressive Disorder, OCD, bulimia, and Panic Disorder placebo-controlled clinical trials (excluding data from extensions of trials) Table 5: Most Common Adverse Reactions Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1 1 Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined Major Depressive Disorder OCD Bulimia Panic Disorder Anxiety (1%) -- Anxiety (2%) -- Anxiety (2%) -- -- -- Insomnia (2%) -- -- Nervousness (1%) -- -- Nervousness (1%) -- -- Rash (1%) -- -- Other adverse reactions in pediatric patients (children and adolescents) Following is a list of treatment-emergent adverse reactions reported by patients treated with fluoxetine in clinical trials. This listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo. Frequent: Infrequent: Rare: Frequent: Infrequent: 1 Digestive System Infrequent: Rare: Hemic and Lymphatic System Infrequent: Rare: Frequent: 3 Nervous System Frequent: Infrequent: 1 1 Rare: Respiratory System Rare: Skin and Appendages Infrequent: Rare: Special Senses Frequent: Infrequent: Urogenital System Infrequent: 2 1 2 3 The following adverse reactions have been identified during post approval use of fluoxetine. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure. 1 1 1 1 1 1 1 1.

When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4. 1 Pimozide: Do not use. Risk of QT prolongation and drug interaction ( 4. 8 Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine. Do not use thioridazine within 5 weeks of discontinuing fluoxetine ( 4. 8 When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ( 4 The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2. 9) Warnings and Precautions (5. 2) [see Dosage and Administration (2. 10) Warnings and Precautions (5. 2) Pimozide [see Warnings and Precautions (5. 11) Drug Interactions (7. 8) Thioridazine [see Warnings and Precautions (5. 8) Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval.

When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax. Pregnancy: 8. 1 Nursing Mothers: 8. 3 Pediatric Use: 8. 4 Hepatic Impairment: 8. 6 Pregnancy Category C Treatment of Pregnant Women during the First Trimester Nonteratogenic Effects [see Warnings and Precautions (5. 2) [see Dosage and Administration (2. 7) Animal Data 2 2 2 2 The effect of fluoxetine on labor and delivery in humans is unknown. However, because fluoxetine crosses the placenta and because of the possibility that fluoxetine may have adverse effects on the newborn, fluoxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus. Because fluoxetine is excreted in human milk, nursing while on fluoxetine is not recommended. In one breast-milk sample, the concentration of fluoxetine plus norfluoxetine was 70. The concentration in the mother’s plasma was 295. No adverse effects on the infant were reported. In another case, an infant nursed by a mother on fluoxetine developed crying, sleep disturbance, vomiting, and watery stools. The infant’s plasma drug levels were 340 ng/mL of fluoxetine and 208 ng/mL of norfluoxetine on the second day of feeding. Use of fluoxetin e in children - [see Clinical Studies (14. 1) [see Clinical Studies (14. 2) ] [see Clinical Pharmacology (12. 3) [see Adverse Reactions (6. 1) [see Warnings and Precautions (5. 6) [see Box Warning Warnings and Precautions (5. 1 ] Animal Data 2 Use of fluoxetine in combination with olanzapine in children and adolescents: US fluoxetine clinical trials included 687 patients >=65 years of age and 93 patients >=75 years of age. The efficacy in geriatric patients has been established [see Clinical Studies (14. 1) [see Clinical Pharmacology (12. 4) [see Warnings and Precautions (5. 9) In subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances. A lower or less frequent dose of fluoxetine should be used in patients with cirrhosis. Caution is advised when using fluoxetine in patients with diseases or conditions that could affect its metabolism [see Dosage and Administration (2. 7 Clinical Pharmacology (12.

As with all drugs, the potential for interaction by a variety of mechanisms (e. , pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc. ) is a possibility. Monoamine Oxidase Inhibitors (MAOIs): 2. 2 Drugs Metabolized by CYP2D6: 7. 7 Tricyclic Antidepressants (TCAs): 5. 7 CNS Acting Drugs: 7. 2 Benzodiazepines: 7. 7 Antipsychotics: 7. 7 Anticonvulsants: 7. 7 Serotonergic Drugs: 2. 2 Drugs that Interfere with Hemostasis (e. NSAIDs, Aspirin, Warfarin): 7. 4 Drugs Tightly Bound to Plasma Proteins: 7. 7 Olanzapine: 7. 7 Drugs that Prolong the QT Interval: 4. 8 [see Dosage and Administration (2. 10) Contraindications (4. 1) Warnings and Precautions (5. 2) Caution is advised if the concomitant administration of fluoxetine and such drugs is required. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status [see Clinical Pharmacology (12. 3) [see Dosage and Administration (2. 2) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SNRIs or SSRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinued [see Warnings and Precautions (5. 7) There are no clinical studies establishing the benefit of the combined use of ECT and fluoxetine. There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment. Drugs Tightly Bound to Plasma Proteins em dash [see Clinical Pharmacology (12. 3) Pimozide em dash [see Contraindications (4. 2) Warnings and Precautions (5. 11) Drug Interactions (7. 8) [see Contraindications (4. 8) max [see Contraindications (4. 2 em dash [see Warnings and Precautions (5. 2) Clinical Pharmacology (12. 3) em dash [see Clinical Pharmacology (12. 3) Lithium em dash [see Warnings and Precautions (5. em dash [see Clinical Pharmacology (12. 3) em dash in vivo in vitro em dash Symbyax. Do not use fluoxetine in combination with thioridazine or pimozide. Use fluoxetine with caution in combination with other drugs that cause QT prolongation. These include: specific antipsychotics (e. , ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e. , erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e. , quinidine, procainamide); Class III antiarrhythmics (e. , amiodarone, sotalol); and others (e. , pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). Fluoxetine is primarily metabolized by CYP2D6. Concomitant treatment with CYP2D6 inhibitors can increase the concentration of fluoxetine. Concomitant use of other highly protein-bound drugs can increase the concentration of fluoxetine [see Contraindications (4. 7) Clinical Pharmacology (12.

OVERDOSAGE
Worldwide exposure to fluoxetine hydrochloride is estimated to be over 38 million patients (circa 1999). Of the 1578 cases of overdose involving fluoxetine hydrochloride, alone or with other drugs, reported from this population, there were 195 deaths. Studies in animals do not provide precise or necessarily valid information about the treatment of human overdose. However, animal experiments can provide useful insights into possible treatment strategies. [see Overdosage (10. 3) For current information on the management of fluoxetine overdose, contact a certified poison control center (1-800-222-1222 or www. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multi-drug overdose. [see Drug Interactions (7. 7) For specific information about overdosage with olanzapine and fluoxetine in combination, refer to the Overdosage section of the Symbyax package insert.
NONCLINICAL TOXICOLOGY
Carcinogenicity 2 in vivo 2 [see Use in Specific Populations (8. 4) Phospholipids are increased in some tissues of mice, rats, and dogs given fluoxetine chronically. This effect is reversible after cessation of fluoxetine treatment. Phospholipid accumulation in animals has been observed with many cationic amphiphilic drugs, including fenfluramine, imipramine, and ranitidine. The significance of this effect in humans is unknown.
CLINICAL STUDIES
Efficacy for fluoxetine was established for the: Acute and maintenance treatment of Major Depressive Disorder in adults, and children and adolescents (8 to 18 years) in 7 short-term and 2 long-term, placebo-controlled trials [see Clinical Studies 14. 1 Acute treatment of obsessions and compulsions in adults, and children and adolescents (7 to 17 years) with Obsessive Compulsive Disorder (OCD) in 3 short-term placebo-controlled trials [see Clinical Studies (14. 2) Acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa in 3 short-term and 1 long-term, placebo-controlled trials [see Clinical Studies (14. 3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients in 2 short-term, placebo-controlled trials [see Clinical Studies (14. 4) Efficacy for fluoxetine and olanzapine in combination was established for the: Acute treatment of depressive episodes in Bipolar I Disorder in adults, and children and adolescents (10 to 17 years) in 3 short-term, placebo-controlled trials. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. Daily Dosing. em dash Adult Table 6 Outcome Classification (%) on CGI Improvement Scale for Fluoxetine Outcome Classification Placebo 20 mg 40 mg 60 mg Worse 8% 0% 0% 0% No change 64% 41% 33% 29% Minimally improved 17% 23% 28% 24% Much improved 8% 28% 27% 28% Very much improved 3% 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. 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 3 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 3 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 3 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 1 to 2 episodes per week for binge-eating and 2 to 4 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. The effectiveness of fluoxetine in the treatment of Panic Disorder was demonstrated in 2 double-blind, randomized, placebo-controlled, multicenter studies of adult outpatients who had a primary diagnosis of Panic Disorder (DSM-IV), with or without agoraphobia.
Medication Guide
Fluoxetine Capsules, USP What is the most important information I should know about fluoxetine capsules? 1. Suicidal thoughts or actions: Fluoxetine capsules and other antidepressant medicines may increase suicidal thoughts or actions 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 fluoxetine capsules 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 capsules 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: registered registered 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. 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. Low salt (sodium) levels in the blood. headache weakness or feeling unsteady confusion, problems concentrating or thinking or memory problems fast, slow, or irregular heartbeat shortness of breath dizziness or fainting Do not stop fluoxetine capsules without first talking to your healthcare provider. 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 capsules? Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Bulimia Nervosa* Panic Disorder* Depressive episodes associated with Bipolar I Disorder, taken with olanzapine (Zyprexa) *Not approved for use in children Who should not take fluoxetine capsules? are allergic to fluoxetine hydrochloride or any of the ingredients in fluoxetine capsules. See the end of this Medication Guide for a complete list of ingredients in fluoxetine capsules. 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 capsules unless directed to do so by your physician. Do not start fluoxetine capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. People who take fluoxetine capsules 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 registered registered take the antipsychotic medicine pimozide (Orap registered What should I tell my healthcare provider before taking fluoxetine capsules? Ask if you are not sure. 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. It is not known if fluoxetine capsules 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 capsules may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluoxetine capsules. Tell your healthcare provider about all the medicines that you take, If you take fluoxetine capsules, you should not take any other medicines that contain fluoxetine hydrochloride including : Symbyax Sarafem Prozac Weekly How should I take fluoxetine capsules? Take fluoxetine capsules exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine capsules until it is the right dose for you. Fluoxetine capsules may be taken with or without food. 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. If you take too much fluoxetine capsules, call your healthcare provider or poison control center right away, or get emergency treatment. What should I avoid while taking fluoxetine capsules? What are the possible side effects of fluoxetine capsules? See “What is the most important information I should know about fluoxetine capsules?” Problems with blood sugar control. Feeling anxious or trouble sleeping Common possible side effects in people who take fluoxetine capsules 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 capsules. 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 capsules. 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 capsules? Store fluoxetine capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [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? Symbyax registered registered registered registered registered registered registered This Medication Guide has been approved by the U. Food and Drug Administration. Manufactured for: Vensun Pharmaceuticals, Inc. Manufactured by: ScieGen Pharmaceuticals, Inc. 03, April 2017.

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FLUOXETINE- fluoxetine hydrochloride_capsule Product manual source documgent