Fluoxetine Information
Fluoxetine (Fluoxetine) Indications And Usage
Fluoxetine (Fluoxetine) is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years
The usefulness of the drug in adult and pediatric patients receiving Fluoxetine (Fluoxetine) for extended periods, should periodically be re-evaluated
Fluoxetine (Fluoxetine) is 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)
The effectiveness of Fluoxetine (Fluoxetine) in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use Fluoxetine (Fluoxetine) for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient
Fluoxetine (Fluoxetine) is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa
The physician who elects to use Fluoxetine (Fluoxetine) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient
Fluoxetine (Fluoxetine) is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients
The effectiveness of Fluoxetine (Fluoxetine) in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use Fluoxetine (Fluoxetine) for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient
When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Clinical Studies section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules.
Fluoxetine (Fluoxetine) and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients.
Fluoxetine (Fluoxetine) monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine (Fluoxetine) Dosage And Administration
Initial Treatment
Adult
A dose increase may be considered after several weeks if insufficient clinical improvement is observed. Doses above 20 mg/day may be administered on a once-a-day (morning) or BID schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day.
However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.
All patients
Maintenance/Continuation/Extended Treatment
Initial Treatment
Doses above 20 mg/day may be administered on a once daily (i.e., morning) or BID schedule (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum Fluoxetine (Fluoxetine) dose should not exceed 80 mg/day.
In adolescents and higher weight children, treatment should be initiated with a dose of 10 mg/day. After 2 weeks, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended.
In lower weight children, treatment should be initiated with a dose of 10 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.
Maintenance/Continuation Treatment
A dose increase may be considered after several weeks if no clinical improvement is observed. Fluoxetine (Fluoxetine) doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder.
Maintenance/Continuation Treatment
When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Clinical Studies section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules.
Fluoxetine (Fluoxetine) should be administered in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of Fluoxetine (Fluoxetine) . Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of Fluoxetine (Fluoxetine) 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and Fluoxetine (Fluoxetine) in combination with a dose range of olanzapine 6 to 12 mg and Fluoxetine (Fluoxetine) 25 to 50 mg.
Safety and efficacy of Fluoxetine (Fluoxetine) in combination with olanzapine was determined in clinical trials supporting approval of olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules (fixed-dose combination of olanzapine and Fluoxetine (Fluoxetine) ). Olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules are dosed between 3 mg/25 mg (olanzapine/Fluoxetine (Fluoxetine) ) per day and 12 mg/50 mg (olanzapine/Fluoxetine (Fluoxetine) ) per day. The following table demonstrates the appropriate individual component doses of Fluoxetine (Fluoxetine) and olanzapine versus olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Olanzapine and Fluoxetine (Fluoxetine) Hydrochloride Capsules and the Combination of Fluoxetine (Fluoxetine) and Olanzapine
Olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules are a fixed-dose combination of Fluoxetine (Fluoxetine) and olanzapine.
While there is no body of evidence to answer the question of how long a patient treated with Fluoxetine (Fluoxetine) and olanzapine in combination should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically re-examine the need for continued pharmacotherapy.
Safety of coadministration of doses above 18 mg olanzapine with 75 mg Fluoxetine (Fluoxetine) has not been evaluated in clinical studies.
Fluoxetine (Fluoxetine) monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine (Fluoxetine) Dosage Forms And Strengths
Fluoxetine (Fluoxetine) capsules USP, 20 mg, contain Fluoxetine (Fluoxetine) hydrochloride, equivalent to 20 mg Fluoxetine (Fluoxetine) , and are available as hard gelatin capsules with an aqua blue cap imprinted with
and “4356” and an aqua blue body imprinted with “20 mg”.
Fluoxetine (Fluoxetine) Contraindications
The use of Fluoxetine (Fluoxetine) is contraindicated with the following:
Fluoxetine (Fluoxetine) Warnings And Precautions
When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules.
Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with Major Depressive Disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
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.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for Major Depressive Disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms
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.
It should be noted that Fluoxetine (Fluoxetine) is approved in the pediatric population only for Major Depressive Disorder and Obsessive Compulsive Disorder. Safety and effectiveness of Fluoxetine (Fluoxetine) and olanzapine in combination in patients less than 18 years of age have not been established.
The development of a potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Fluoxetine (Fluoxetine) treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
The concomitant use of Fluoxetine (Fluoxetine) with MAOIs intended to treat depression is contraindicated
If concomitant treatment of Fluoxetine (Fluoxetine) with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases
The concomitant use of Fluoxetine (Fluoxetine) with serotonin precursors (such as tryptophan) is not recommended
Treatment with Fluoxetine (Fluoxetine) and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above reactions occur, and supportive symptomatic treatment should be initiated.
In U.S. Fluoxetine (Fluoxetine) clinical trials as of May 8, 1995, 7% of 10,782 patients developed various types of rashes and/or urticaria. Among the cases of rash and/or urticaria reported in premarketing clinical trials, almost a third were withdrawn from treatment because of the rash and/or systemic signs or symptoms associated with the rash. Clinical findings reported in association with rash include fever, leukocytosis, arthralgias, edema, carpal tunnel syndrome, respiratory distress, lymphadenopathy, proteinuria, and mild transaminase elevation. Most patients improved promptly with discontinuation of Fluoxetine (Fluoxetine) and/or adjunctive treatment with antihistamines or steroids, and all patients experiencing these reactions were reported to recover completely.
In premarketing clinical trials, 2 patients are known to have developed a serious cutaneous systemic illness. In neither patient was there an unequivocal diagnosis, but one was considered to have a leukocytoclastic vasculitis, and the other, a severe desquamating syndrome that was considered variously to be a vasculitis or erythema multiforme. Other patients have had systemic syndromes suggestive of serum sickness.
Since the introduction of Fluoxetine (Fluoxetine) , systemic reactions, possibly related to vasculitis and including lupus-like syndrome, have developed in patients with rash. Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions.
Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported.
Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom.
Whether these systemic reactions and rash have a common underlying cause or are due to different etiologies or pathogenic processes is not known. Furthermore, a specific underlying immunologic basis for these reactions has not been identified. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, Fluoxetine (Fluoxetine) should be discontinued.
A major depressive episode may be the initial presentation of Bipolar Disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for Bipolar Disorder. Whether any of the symptoms described for clinical worsening and suicide risk represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder; such screening should include a detailed psychiatric history, including a family history of suicide, Bipolar Disorder, and depression. It should be noted that Fluoxetine (Fluoxetine) and olanzapine in combination is approved for the acute treatment of depressive episodes associated with Bipolar I Disorder []. Fluoxetine (Fluoxetine) monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
In U.S. placebo-controlled clinical trials for Major Depressive Disorder, mania/hypomania was reported in 0.1% of patients treated with Fluoxetine (Fluoxetine) and 0.1% of patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with Major Affective Disorder treated with other marketed drugs effective in the treatment of Major Depressive Disorder
In U.S. placebo-controlled clinical trials for OCD, mania/hypomania was reported in 0.8% of patients treated with Fluoxetine (Fluoxetine) and no patients treated with placebo. No patients reported mania/hypomania in U.S. placebo-controlled clinical trials for bulimia. In all U.S. Fluoxetine (Fluoxetine) clinical trials as of May 8, 1995, 0.7% of 10,782 patients reported mania/hypomania
Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with Fluoxetine (Fluoxetine) .
In U.S. placebo-controlled clinical trials for Major Depressive Disorder, 11% of patients treated with Fluoxetine (Fluoxetine) and 2% of patients treated with placebo reported anorexia (decreased appetite). Weight loss was reported in 1.4% of patients treated with Fluoxetine (Fluoxetine) and in 0.5% of patients treated with placebo. However, only rarely have patients discontinued treatment with Fluoxetine (Fluoxetine) because of anorexia or weight loss
In U.S. placebo-controlled clinical trials for OCD, 17% of patients treated with Fluoxetine (Fluoxetine) and 10% of patients treated with placebo reported anorexia (decreased appetite). One patient discontinued treatment with Fluoxetine (Fluoxetine) because of anorexia
In U.S. placebo-controlled clinical trials for Bulimia Nervosa, 8% of patients treated with Fluoxetine (Fluoxetine) 60 mg and 4% of patients treated with placebo reported anorexia (decreased appetite). Patients treated with Fluoxetine (Fluoxetine) 60 mg on average lost 0.45 kg compared with a gain of 0.16 kg by patients treated with placebo in the 16 week double-blind trial. Weight change should be monitored during therapy.
Hyponatremia has been reported during treatment with SNRIs and SSRIs, including Fluoxetine (Fluoxetine) . In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported and appeared to be reversible when Fluoxetine (Fluoxetine) was discontinued. Elderly patients may be at greater risk of developing hyponatremia with SNRIs and SSRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk . Discontinuation of Fluoxetine (Fluoxetine) should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death.
In U.S. placebo-controlled clinical trials for Major Depressive Disorder, 12% to 16% of patients treated with Fluoxetine (Fluoxetine) and 7% to 9% of patients treated with placebo reported anxiety, nervousness, or insomnia.
In U.S. placebo-controlled clinical trials for OCD, insomnia was reported in 28% of patients treated with Fluoxetine (Fluoxetine) and in 22% of patients treated with placebo. Anxiety was reported in 14% of patients treated with Fluoxetine (Fluoxetine) and in 7% of patients treated with placebo.
In U.S. placebo-controlled clinical trials for Bulimia Nervosa, insomnia was reported in 33% of patients treated with Fluoxetine (Fluoxetine) 60 mg, and 13% of patients treated with placebo. Anxiety and nervousness were reported, respectively, in 15% and 11% of patients treated with Fluoxetine (Fluoxetine) 60 mg and in 9% and 5% of patients treated with placebo.
Among the most common adverse reactions associated with discontinuation (incidence at least twice that for placebo and at least 1% for Fluoxetine (Fluoxetine) in clinical trials collecting only a primary reaction associated with discontinuation) in U.S. placebo-controlled Fluoxetine (Fluoxetine) clinical trials were anxiety (2% in OCD), insomnia (1% in combined indications and 2% in bulimia), and nervousness (1% in Major Depressive Disorder) [see ].
Clinical experience with Fluoxetine (Fluoxetine) in patients with concomitant systemic illness is limited. Caution is advisable in using Fluoxetine (Fluoxetine) in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
Cardiovascular
Glycemic Control
Fluoxetine (Fluoxetine) Adverse Reactions
When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules.
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 (Fluoxetine) had been administered to 10,782 patients with various diagnoses in U.S. clinical trials as of May 8, 1995. In addition, there have been 425 patients administered Fluoxetine (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.e., 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.
The most common adverse reaction (incidence at least 1% for Fluoxetine (Fluoxetine) and greater than placebo) associated with discontinuation in 3 pediatric placebo-controlled trials (N = 418 randomized; 228 Fluoxetine (Fluoxetine) -treated; 190 placebo-treated) was mania/hypomania (1.8% for Fluoxetine (Fluoxetine) -treated, 0% for placebo-treated). In these clinical trials, only a primary reaction associated with discontinuation was collected.
Male and female sexual dysfunction with SSRIs
There are no adequate and well-controlled studies examining sexual dysfunction with Fluoxetine (Fluoxetine) treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
Following is a list of treatment-emergent adverse reactions reported by patients treated with Fluoxetine (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.
Reactions are classified by body system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients.
The following adverse reactions have been identified during post approval use of Fluoxetine (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 (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, cataract, cerebrovascular accident, cholestatic jaundice, dyskinesia (including, for example, a case of buccal-lingual-masticatory syndrome with involuntary tongue protrusion reported to develop in a 77-year-old female after 5 weeks of Fluoxetine (Fluoxetine) therapy and which completely resolved over the next few months following drug discontinuation), eosinophilic pneumonia, epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, heart arrest, hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, kidney failure, movement disorders developing in patients with risk factors including drugs associated with such reactions and worsening of preexisting movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, QT prolongation, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia (including torsade de pointes–type arrhythmias), and vaginal bleeding, and violent behaviors.
1
Fluoxetine (Fluoxetine) Drug Interactions
As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility.
Drugs Tightly Bound to Plasma Proteins
[see Clinical Pharmacology ()].
In a study of 19 healthy male subjects, which included 6 slow and 13 rapid hydroxylators of debrisoquin, a single 25 mg oral dose of thioridazine produced a 2.4 fold higher C and a 4.5 fold higher AUC for thioridazine in the slow hydroxylators compared with the rapid hydroxylators. The rate of debrisoquin hydroxylation is felt to depend on the level of CYP2D6 isozyme activity. Thus, this study suggests that drugs which inhibit CYP2D6, such as certain SSRIs, including Fluoxetine (Fluoxetine) , will produce elevated plasma levels of thioridazine.
Thioridazine administration produces a dose-related prolongation of the QT interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias, and sudden death. This risk is expected to increase with Fluoxetine (Fluoxetine) -induced inhibition of thioridazine metabolism.
Anticonvulsants
Lithium
Additionally, studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least 100 times more potent than Fluoxetine (Fluoxetine) or norFluoxetine (Fluoxetine) as an inhibitor of the metabolism of several substrates for this enzyme, including astemizole, cisapride, and midazolam. These data indicate that Fluoxetine (Fluoxetine) ’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance.
Olanzapine
When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Drug Interactions section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules.
Fluoxetine (Fluoxetine) Use In Specific Populations
When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules
Pregnancy Category C
Treatment of Pregnant Women During the Third Trimester
Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. The study did not include enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk.
When treating pregnant women with Fluoxetine (Fluoxetine) during the third trimester, the physician should carefully consider both the potential risks and potential benefits of treatment. Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
The physician may consider tapering Fluoxetine (Fluoxetine) in the third trimester.
The efficacy of Fluoxetine (Fluoxetine) for the treatment of Major Depressive Disorder was demonstrated in two 8 to 9 week placebo-controlled clinical trials with 315 pediatric outpatients ages 8 to ≤ 18
The efficacy of Fluoxetine (Fluoxetine) for the treatment of OCD was demonstrated in one 13 week placebo-controlled clinical trial with 103 pediatric outpatients ages 7 to
The safety and effectiveness in pediatric patients
Fluoxetine (Fluoxetine) pharmacokinetics were evaluated in 21 pediatric patients (ages 6 to ≤ 18) with Major Depressive Disorder or OCD
The acute adverse reaction profiles observed in the 3 studies (N = 418 randomized; 228 Fluoxetine (Fluoxetine) -treated, 190 placebo-treated) were generally similar to that observed in adult studies with Fluoxetine (Fluoxetine) . The longer-term adverse reaction profile observed in the 19 week Major Depressive Disorder study (N = 219 randomized; 109 Fluoxetine (Fluoxetine) -treated, 110 placebo-treated) was also similar to that observed in adult trials with Fluoxetine (Fluoxetine)
Manic reaction, including mania and hypomania, was reported in 6 (1 mania, 5 hypomania) out of 228 (2.6%) Fluoxetine (Fluoxetine) -treated patients and in 0 out of 190 (0%) placebo-treated patients. Mania/hypomania led to the discontinuation of 4 (1.8%) Fluoxetine (Fluoxetine) -treated patients from the acute phases of the 3 studies combined. Consequently, regular monitoring for the occurrence of mania/hypomania is recommended.
As with other SSRIs, decreased weight gain has been observed in association with the use of Fluoxetine (Fluoxetine) in children and adolescent patients. After 19 weeks of treatment in a clinical trial, pediatric subjects treated with Fluoxetine (Fluoxetine) gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects treated with placebo. In addition, Fluoxetine (Fluoxetine) treatment was associated with a decrease in alkaline phosphatase levels. The safety of Fluoxetine (Fluoxetine) treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in duration. In particular, there are no studies that directly evaluate the longer-term effects of Fluoxetine (Fluoxetine) on the growth, development and maturation of children and adolescent patients. Therefore, height and weight should be monitored periodically in pediatric patients receiving Fluoxetine (Fluoxetine)
Fluoxetine (Fluoxetine) is approved for use in pediatric patients with MDD and OCD Anyone considering the use of Fluoxetine (Fluoxetine) in a child or adolescent must balance the potential risks with the clinical need.
Significant toxicity, including myotoxicity, long-term neurobehavioral and reproductive toxicity, and impaired bone development, has been observed following exposure of juvenile animals to Fluoxetine (Fluoxetine) . Some of these effects occurred at clinically relevant exposures.
In a study in which Fluoxetine (Fluoxetine) (3, 10, or 30 mg/kg) was orally administered to young rats from weaning (Postnatal Day 21) through adulthood (Day 90), male and female sexual development was delayed at all doses, and growth (body weight gain, femur length) was decreased during the dosing period in animals receiving the highest dose. At the end of the treatment period, serum levels of creatine kinase (marker of muscle damage) were increased at the intermediate and high doses, and abnormal muscle and reproductive organ histopathology (skeletal muscle degeneration and necrosis, testicular degeneration and necrosis, epididymal vacuolation and hypospermia) was observed at the high dose. When animals were evaluated after a recovery period (up to 11 weeks after cessation of dosing), neurobehavioral abnormalities (decreased reactivity at all doses and learning deficit at the high dose) and reproductive functional impairment (decreased mating at all doses and impaired fertility at the high dose) were seen; in addition, testicular and epididymal microscopic lesions and decreased sperm concentrations were found in the high dose group, indicating that the reproductive organ effects seen at the end of treatment were irreversible. The reversibility of Fluoxetine (Fluoxetine) -induced muscle damage was not assessed. Adverse effects similar to those observed in rats treated with Fluoxetine (Fluoxetine) during the juvenile period have not been reported after administration of Fluoxetine (Fluoxetine) to adult animals. Plasma exposures (AUC) to Fluoxetine (Fluoxetine) in juvenile rats receiving the low, intermediate, and high dose in this study were approximately 0.1 to 0.2, 1 to 2, and 5 to 10 times, respectively, the average exposure in pediatric patients receiving the maximum recommended dose (MRD) of 20 mg/day. Rat exposures to the major metabolite, norFluoxetine (Fluoxetine) , were approximately 0.3 to 0.8, 1 to 8, and 3 to 20 times, respectively, pediatric exposure at the MRD.
A specific effect of Fluoxetine (Fluoxetine) on bone development has been reported in mice treated with Fluoxetine (Fluoxetine) during the juvenile period. When mice were treated with Fluoxetine (Fluoxetine) (5 or 20 mg/kg, intraperitoneal) for 4 weeks starting at 4 weeks of age, bone formation was reduced resulting in decreased bone mineral content and density. These doses did not affect overall growth (body weight gain or femoral length). The doses administered to juvenile mice in this study are approximately 0.5 and 2 times the MRD for pediatric patients on a body surface area (mg/m) basis.
In another mouse study, administration of Fluoxetine (Fluoxetine) (10 mg/kg intraperitoneal) during early postnatal development (Postnatal Days 4 to 21) produced abnormal emotional behaviors (decreased exploratory behavior in elevated plus-maze, increase shock avoidance latency) in adulthood (12 weeks of age). The dose used in this study is approximately equal to the pediatric MRD on a mg/m basis. Because of the early dosing period in this study, the significance of these findings to the approved pediatric use in humans is uncertain.
Safety and effectiveness of Fluoxetine (Fluoxetine) and olanzapine in combination in patients less than 18 years of age have not been established.
U.S. Fluoxetine (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 For pharmacokinetic information in geriatric patients, No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. SNRIs and SSRIs, including Fluoxetine (Fluoxetine) , have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction
Clinical studies of olanzapine and Fluoxetine (Fluoxetine) in combination did not include sufficient numbers of patients ≥ 65 years of age to determine whether they respond differently from younger patients.
Fluoxetine (Fluoxetine) Overdosage
Worldwide exposure to Fluoxetine (Fluoxetine) hydrochloride is estimated to be over 38 million patients (circa 1999). Of the 1578 cases of overdose involving Fluoxetine (Fluoxetine) hydrochloride, alone or with other drugs, reported from this population, there were 195 deaths.
Among 633 adult patients who overdosed on Fluoxetine (Fluoxetine) hydrochloride alone, 34 resulted in a fatal outcome, 378 completely recovered, and 15 patients experienced sequelae after overdosage, including abnormal accommodation, abnormal gait, confusion, unresponsiveness, nervousness, pulmonary dysfunction, vertigo, tremor, elevated blood pressure, impotence, movement disorder, and hypomania. The remaining 206 patients had an unknown outcome. The most common signs and symptoms associated with non-fatal overdosage were seizures, somnolence, nausea, tachycardia, and vomiting. The largest known ingestion of Fluoxetine (Fluoxetine) hydrochloride in adult patients was 8 grams in a patient who took Fluoxetine (Fluoxetine) alone and who subsequently recovered. However, in an adult patient who took Fluoxetine (Fluoxetine) alone, an ingestion as low as 520 mg has been associated with lethal outcome, but causality has not been established.
Among pediatric patients (ages 3 months to 17 years), there were 156 cases of overdose involving Fluoxetine (Fluoxetine) alone or in combination with other drugs. Six patients died, 127 patients completely recovered, 1 patient experienced renal failure, and 22 patients had an unknown outcome. One of the six fatalities was a 9-year-old boy who had a history of OCD, Tourette’s syndrome with tics, attention deficit disorder, and fetal alcohol syndrome. He had been receiving 100 mg of Fluoxetine (Fluoxetine) daily for 6 months in addition to clonidine, methylphenidate, and promethazine. Mixed-drug ingestion or other methods of suicide complicated all 6 overdoses in children that resulted in fatalities. The largest ingestion in pediatric patients was 3 grams which was nonlethal.
Other important adverse reactions reported with Fluoxetine (Fluoxetine) overdose (single or multiple drugs) include coma, delirium, ECG abnormalities (such as QT interval prolongation and ventricular tachycardia, including torsade de pointes-type arrhythmias), hypotension, mania, neuroleptic malignant syndrome-like reactions, pyrexia, stupor, and syncope.
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.
The oral median lethal dose in rats and mice was found to be 452 and 248 mg/kg, respectively. Acute high oral doses produced hyperirritability and convulsions in several animal species.
Among 6 dogs purposely overdosed with oral Fluoxetine (Fluoxetine) , 5 experienced grand mal seizures. Seizures stopped immediately upon the bolus intravenous administration of a standard veterinary dose of diazepam. In this short-term study, the lowest plasma concentration at which a seizure occurred was only twice the maximum plasma concentration seen in humans taking 80 mg/day, chronically.
In a separate single-dose study, the ECG of dogs given high doses did not reveal prolongation of the PR, QRS, or QT intervals. Tachycardia and an increase in blood pressure were observed. Consequently, the value of the ECG in predicting cardiac toxicity is unknown. Nonetheless, the ECG should ordinarily be monitored in cases of human overdose
Treatment should consist of those general measures employed in the management of overdosage with any drug effective in the treatment of Major Depressive Disorder.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.
Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for Fluoxetine (Fluoxetine) are known.
A specific caution involves patients who are taking or have recently taken Fluoxetine (Fluoxetine) and might ingest excessive quantities of a TCA. In such a case, accumulation of the parent tricyclic and/or an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation
Based on experience in animals, which may not be relevant to humans, Fluoxetine (Fluoxetine) -induced seizures that fail to remit spontaneously may respond to diazepam.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the .
For specific information about overdosage with olanzapine and Fluoxetine (Fluoxetine) in combination, refer to the Overdosage section of the olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules package insert.
Fluoxetine (Fluoxetine) Description
Fluoxetine (Fluoxetine) capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, Fluoxetine (Fluoxetine) hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro--tolyl)oxy]propylamine hydrochloride and has the following structural formula:
CHFNO•HCl M.W. 345.79
Fluoxetine (Fluoxetine) hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
Each Fluoxetine (Fluoxetine) capsule, for oral administration, contains Fluoxetine (Fluoxetine) hydrochloride USP equivalent to 20 mg of Fluoxetine (Fluoxetine) and has the following inactive ingredients: black iron oxide, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, titanium dioxide.
Fluoxetine (Fluoxetine) Clinical Pharmacology
Studies at clinically relevant doses in man have demonstrated that Fluoxetine (Fluoxetine) blocks the uptake of serotonin into human platelets. Studies in animals also suggest that Fluoxetine (Fluoxetine) is a much more potent uptake inhibitor of serotonin than of norepinephrine.
Antagonism of muscarinic, histaminergic, and α-adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs. Fluoxetine (Fluoxetine) binds to these and other membrane receptors from brain tissue much less potently than do the tricyclic drugs.
Systemic Bioavailability
The capsule, tablet, and oral solution dosage forms of Fluoxetine (Fluoxetine) are bioequivalent. Food does not appear to affect the systemic bioavailability of Fluoxetine (Fluoxetine) , although it may delay its absorption by 1 to 2 hours, which is probably not clinically significant. Thus, Fluoxetine (Fluoxetine) may be administered with or without food.
1
Because Fluoxetine (Fluoxetine) ’s metabolism, like that of a number of other compounds including TCAs and other selective serotonin reuptake inhibitors (SSRIs), involves the CYP2D6 system, concomitant therapy with drugs also metabolized by this enzyme system (such as the TCAs) may lead to drug interactions
The long elimination half-lives of Fluoxetine (Fluoxetine) and norFluoxetine (Fluoxetine) assure that, even when dosing is stopped, active drug substance will persist in the body for weeks (primarily depending on individual patient characteristics, previous dosing regimen, and length of previous therapy at discontinuation). This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with Fluoxetine (Fluoxetine) and norFluoxetine (Fluoxetine) following the discontinuation of Fluoxetine (Fluoxetine) .
Renal Disease
Geriatric Pharmacokinetics
Pediatric Pharmacokinetics (children and adolescents
Higher average steady-state Fluoxetine (Fluoxetine) and norFluoxetine (Fluoxetine) concentrations were observed in children relative to adults; however, these concentrations were within the range of concentrations observed in the adult population. As in adults, Fluoxetine (Fluoxetine) and norFluoxetine (Fluoxetine) accumulated extensively following multiple oral dosing; steady-state concentrations were achieved within 3 to 4 weeks of daily dosing.
Fluoxetine (Fluoxetine) Nonclinical Toxicology
Carcinogenicity
2
2
Fluoxetine (Fluoxetine) Clinical Studies
Array
Daily Dosing
Two 6 week controlled studies (N = 671, randomized) comparing Fluoxetine (Fluoxetine) 20 mg and placebo have shown Fluoxetine (Fluoxetine) 20 mg daily to be effective in the treatment of elderly patients (≥ 60 years of age) with Major Depressive Disorder. In these studies, Fluoxetine (Fluoxetine) produced a significantly higher rate of response and remission as defined, respectively, by a 50% decrease in the HAM-D score and a total endpoint HAM-D score of ≤ 8. Fluoxetine (Fluoxetine) was well tolerated and the rate of treatment discontinuations due to adverse reactions did not differ between Fluoxetine (Fluoxetine) (12%) and placebo (9%).
A study was conducted involving depressed outpatients who had responded (modified HAMD-17 score of ≤ 7 during each of the last 3 weeks of open-label treatment and absence of Major Depressive Disorder by DSM-III-R criteria) by the end of an initial 12 week open-treatment phase on Fluoxetine (Fluoxetine) 20 mg/day. These patients (N = 298) were randomized to continuation on double-blind Fluoxetine (Fluoxetine) 20 mg/day or placebo. At 38 weeks (50 weeks total), a statistically significantly lower relapse rate (defined as symptoms sufficient to meet a diagnosis of Major Depressive Disorder for 2 weeks or a modified HAMD-17 score of ≥ 14 for 3 weeks) was observed for patients taking Fluoxetine (Fluoxetine) compared with those on placebo.
Pediatric (children and adolescents) —
In both studies independently, Fluoxetine (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.
Adult
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)
Subgroup analyses on outcome did not suggest any differential responsiveness on the basis of age or gender.
The effectiveness of Fluoxetine (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 (Fluoxetine) or placebo in the morning. Patients in the 16 week study received a fixed Fluoxetine (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 (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 (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 (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.
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 (Fluoxetine) 60 mg/day, were randomized to continuation of Fluoxetine (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 (Fluoxetine) 60 mg/day experienced a significantly longer time to relapse over the subsequent 52 weeks compared with those receiving placebo.
The effectiveness of Fluoxetine (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.
Study 1 (N = 180 randomized) was a 12 week flexible-dose study. Fluoxetine (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 (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 (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 (Fluoxetine) -treated patients were free from panic attacks at endpoint than placebo-treated patients, 62% versus 44%, respectively.
Fluoxetine (Fluoxetine) How Supplied/storage And Handling
Fluoxetine (Fluoxetine) Capsules USP 20 mg are available as white to off-white, powder-filled aqua blue opaque hard gelatin capsules, radial spin printed
and “4356” on the cap and “20 mg” on the body in black ink, containing Fluoxetine (Fluoxetine) hydrochloride equivalent to 20 mg Fluoxetine (Fluoxetine) packaged in blisterpacks of 30, and 31 Capsules.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Fluoxetine (Fluoxetine) Patient Counseling Information
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Fluoxetine (Fluoxetine) as monotherapy or in combination with olanzapine. When using Fluoxetine (Fluoxetine) and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for olanzapine and Fluoxetine (Fluoxetine) hydrochloride capsules.
Fluoxetine (Fluoxetine) Medication Guide
Read the Medication Guide that comes with Fluoxetine (Fluoxetine) capsules USP before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about Fluoxetine (Fluoxetine) capsules USP.
Fluoxetine (Fluoxetine) capsules USP are a prescription medicine used:
It is not known if Fluoxetine (Fluoxetine) and olanzapine (Zyprexa) taken together is safe and works in children under 18 years of age.
The symptoms of depression (Major Depressive Disorder and Bipolar I Disorder) include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. With treatment, some of your symptoms of depression may improve.
OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). With treatment, some of your symptoms of OCD may improve.
Panic Disorder is an anxiety disorder that includes panic attacks, which are sudden feelings of terror for no reason. You may also have physical symptoms, such as; fast heartbeat, chest pain, breathing difficulty, dizziness. With treatment, some of your symptoms of Panic Disorder may improve.
Bulimia Nervosa, involves periods of overeating followed by purging (e.g., vomiting, excessive laxative use). With treatment, some of your symptoms of Bulimia Nervosa may improve.
If you do not think you are getting better, call your doctor.
Ask your doctor or pharmacist if you are not sure if your medicine is an MAOI.
Fluoxetine (Fluoxetine) capsules USP may not be right for you. Before starting Fluoxetine (Fluoxetine) capsules USP, tell your doctor about all your medical conditions, including if you have or had any of the following:
You could take too much medicine (overdose).
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects with Fluoxetine (Fluoxetine) capsules USP. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Fluoxetine (Fluoxetine) capsules USP for a condition for which they were not prescribed. Do not give Fluoxetine (Fluoxetine) capsules USP to other people, even if they have the same condition. They may harm them.
This Medication Guide summarizes the most important information about Fluoxetine (Fluoxetine) capsules USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Fluoxetine (Fluoxetine) capsules USP that was written for healthcare professionals. For more information about Fluoxetine (Fluoxetine) capsules USP call 1-888-838-2872, MEDICAL AFFAIRS.
Symbyax and Sarafem are registered trademarks of Eli Lilly and Company.
Prozac Weekly is a trademark of Eli Lilly and Company.
Mellaril is a registered trademark of Novartis AG Corporation.
Orap is a registered trademark of Teva Pharmaceuticals USA.
Coumadin is a registered trademark of Bristol Myers Squibb.
Jantoven is a registered trademark of Upsher-Smith Laboratories Inc.
Zyprexa is a registered trademark of Eli Lilly and Company
Manufactured In Canada By:
Toronto, Canada M1B 2K9
Manufactured For:
Sellersville, PA 18960
Rev. C 3/2010
Fluoxetine (Fluoxetine) Principal Display Panel
Fluoxetine (Fluoxetine) Capsules,
USP 20mg
