FLUOXETINE- fluoxetine_tablet, film coated

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: Protein Binding: in vitro 1 R S S S R S R - S S S R [see Drug Interactions (7. 7) Accumulation and Slow Elimination: [see Warnings and Precautions (5. 14) Liver Disease: [see Dosage and Administration (2. 7) Use in Specific Populations (8. 6) Geriatric Pharmacokinetics:.

Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years. 1 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years. 2 Acute and maintenance treatment of Bulimia Nervosa in adult patients. 3 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. 4 Fluoxetine tablets are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14. 1) [see Dosage and Administration (2. 1) Fluoxetine tablets are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14. 2) [see Dosage and Administration (2. 2) Fluoxetine tablets are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14. 3) [see Dosage and Administration (2. 3) Fluoxetine tablets are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14. 4) [see Dosage and Administration (2.

Indication Adult Pediatric MDD (2. 1) 20 mg/day in am 10 to 20 mg/day OCD (2. 2) 20 mg/day in am 10 mg/day Bulimia Nervosa (2. 3) 60 mg/day in am _ Panic Disorder (2. 4) 10 mg/day (initial dose) _ 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. 7 Initial Treatment: Adult: [see Clinical Studies (14. 1) [see Clinical Studies (14. 1) [see Warnings and Precautions (5. 2) Drug Interactions (7. 7) Initial Treatment: Adult: [see Clinical Studies (14. 2) [see Clinical Studies (14. 2) Initial Treatment: [see Clinical Studies (14. 3) [see Clinical Studies (14. 3) Initial Treatment: [see Clinical Studies (14. 4) 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) Symptoms associated with discontinuation of fluoxetine tablets, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5. 15) At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine tablets. Conversely, at least 5 weeks should be allowed after stopping fluoxetine tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4. 1) Do not start fluoxetine tablets 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.

When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax registered Most common adverse reactions (>= 5% and at least twice that for placebo) associated with: Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn. 1 Fluoxetine and olanzapine in combination en dash Also refer to the Adverse Reactions section of the package insert for Symbyax registered 6 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. Multiple doses of fluoxetine have been administered to 10,782 patients with various diagnoses in U. clinical trials. In addition, there have been 425 patients administered fluoxetine in panic clinical trials. Adverse reactions were recorded by clinical investigators using descriptive terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a limited (i. , reduced) number of standardized reaction categories. In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse reactions. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that reactions reported during therapy were not necessarily caused by it. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied. Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials (Excluding Data from Extensions of Trials): 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 OCD Bulimia Panic Disorder Body System/ Adverse Reaction Fluoxetine Placebo Fluoxetine Placebo Fluoxetine Placebo Fluoxetine Placebo 1 2 3 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, Bulimia, and Panic Disorder Combined Body System/ Fluoxetine Placebo 1 2 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 Infrequent: Rare: Infrequent: Rare: Frequent: Infrequent: 1 1 Rare: Rare: Infrequent: Rare: Frequent: Infrequent: Frequent: Infrequent: 2 1 2 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. Voluntary reports of adverse reactions temporally associated with fluoxetine that have been received since market introduction and that may have no causal relationship with the drug include the following: aplastic anemia, atrial fibrillation 1 1 1 1 1 1 1 1.

When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax registered 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. 1 Pimozide: Do not use. Risk of QT prolongation and drug interaction. 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. 8 When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax registered 4 The use of MAOIs intended to treat psychiatric disorders with fluoxetine tablets or within 5 weeks of stopping treatment with fluoxetine tablets are contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine tablets 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) The use of fluoxetine tablets are contraindicated with the following: 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 tablets can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine tablets 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 registered Pregnancy: 8. 1 Nursing Mothers: 8. 3 Pediatric Use: 8. 4 Hepatic Impairment: 8. 6 Teratogenic Effects. Pregnancy Category C: Nonteratogenic Effects: [see Warnings and Precautions (5. 7) [see Warnings and Precautions (5. 2) [see Dosage and Administration (2. 7) 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 ng/mL. 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 Fluoxetine 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. 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: ½ 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: registered 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: [see Clinical Pharmacology (12. 3) Pimozide: [see Contraindications (4. 2) Warnings and Precautions (5. 11) Drug Interactions (7. 8) [see Contraindications (4. 8) max [see Contraindications (4. 2) [see Warnings and Precautions (5. 2) Clinical Pharmacology (12. 3) [see Clinical Pharmacology (12. 3) Antipsychotics: Anticonvulsants: Lithium: [see Warnings and Precautions (5. 2) registered [see Clinical Pharmacology (12. 3) in vivo in vitro Symbyax registered 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 1,578 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) registered.
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
When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax registered Daily Dosing: Adult: Adult: Table 6: Outcome Classification (%) on CGI Improvement Scale for Completers in Pool of Two OCD Studies 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 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 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 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.
Medication Guide
Fluoxetine Tablets, USP (floo ox'' e teen) 10 mg and 20 mg Fluoxetine tablets 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 tablets are 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. 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 tablets may be associated with these serious side effects: 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. 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. registered registered 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. 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 11. Sexual problems (dysfunction). Symptoms in males may include: Delayed ejaculation or inability to have an ejaculation Decreased sex drive Problems getting or keeping an erection Symptoms in females may include: Decreased sex drive Delayed orgasm or inability to have an orgasm Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with fluoxetine tablets. There may be treatments your healthcare provider can suggest. 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 tablets? Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Bulimia Nervosa* Panic Disorder* *Not approved for use in children 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 registereddagger (thioridazine). Do not take Mellaril registereddagger take the antipsychotic medicine pimozide (Orap registereddagger 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 Amphetamines Tramadol and fentanyl Meperidine and methadone or other opioids 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 tablets. Tell your healthcare provider about all the medicines that you take, If you take fluoxetine tablets, you should not take any other medicines that contain fluoxetine hydrochloride including: Symbyax registereddagger Sarafem registereddagger Prozac Weekly registereddagger 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, call your healthcare provider or poison control center right away, or get emergency treatment. What should I avoid while taking fluoxetine tablets? See “What is the most important information I should know about fluoxetine tablets?” Problems with blood sugar control. 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. Store fluoxetine tablets at 20° to 25°C (68° to 77°F). Keep fluoxetine tablets away from light. Keep fluoxetine tablets bottle closed tightly. Keep fluoxetine tablets and all medicines out of the reach of children. tablets tablets? www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. Aurobindo Pharma Limited

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FLUOXETINE- fluoxetine_tablet, film coated Product manual source documgent