Generic Prozac Fluoxetine
What is Fluoxetine?
Fluoxetine (Fluoxetine) is a selective serotonin reuptake inhibitors (SSRI) antidepressant. The way Fluoxetine works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.
Fluoxetine is used to treat the major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, and panic disorder.
Fluoxetine is sometimes used together with another medication called olanzapine (Zyprexa). to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.
Fluoxetine may also be used for purposes not listed in this medication guide.
Major Depressive Disorder
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years.
The usefulness of the drug in adult and pediatric patients receiving Fluoxetine for extended periods should periodically be re-evaluated.
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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients.
The effectiveness of 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
How should I use Fluoxetine?
Use Fluoxetine delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fluoxetine delayed-release capsules come with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fluoxetine delayed-release capsules refilled.
- Take Fluoxetine delayed-release capsules by mouth with or without food.
- Swallow Fluoxetine delayed-release capsules whole. Do not break, crush, or chew before swallowing.
- Taking Fluoxetine delayed-release capsules at the same time each day will help you remember to take it.
- Continue to take Fluoxetine delayed-release capsules even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Fluoxetine delayed-release capsules without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Fluoxetine delayed-release capsules and whenever a change in dose is made.
- If you miss a dose of Fluoxetine delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Fluoxetine delayed-release capsules.
Uses of Fluoxetine in details
Fluoxetine is used to treat depression, panic attacks, obsessive-compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).
This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Fluoxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression. It may decrease binging and purging behaviors in bulimia.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug is also used to treat a certain other eating disorder (anorexia nervosa), post-traumatic stress disorder (PTSD), and certain nervous system/sleep disorders (cataplexy, narcolepsy). It may also be used to treat hot flashes that occur with menopause.
How to use Fluoxetine
Read the Medication Guide provided by your pharmacist before you start using Fluoxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily in the morning. If you are taking this medication twice a day, your doctor may direct you to take it in the morning and at noon.
If you are taking Fluoxetine for premenstrual problems, your doctor may direct you to take it every day of the month or just for the 2 weeks before your period through the first full day of your period. To help you remember, mark your calendar.
If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without first consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
You should see some improvement in 1 to 2 weeks. It may take 4 to 5 weeks before you feel the full benefit.
Tell your doctor if your condition does not improve or if it worsens.
Fluoxetine is the first agent of the class of antidepressants known as selective serotonin-reuptake inhibitors (SSRIs). Fluoxetine is a racemic mixture of the R- and S- enantiomers and are of equivalent pharmacologic activity. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur within the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Fluoxetine may be used to treat major depressive disorder (MDD), moderate to severe bulimia nervosa, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), panic disorder with or without agoraphobia, and in combination with olanzapine for treatment-resistant or bipolar I depression. Fluoxetine is the most anorexic and stimulating SSRI.
Major Depressive Disorder Initial TreatmentAdult — Initiate Fluoxetine 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon).The maximum Fluoxetine dose should not exceed 80 mg/day.
In controlled trials used to support the efficacy of Fluoxetine, patients were administered morning dosesranging from 20 to 80 mg/day. Studies comparing Fluoxetine 20, 40, and 60 mg/day to placebo indicatethat 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in mostcases.
Pediatric (children and adolescents) — Initiate Fluoxetine 10 or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20 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. Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of Fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered Fluoxetine doses of 10 to 20 mg/day.
All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.
Periodically reassess to determine the need for maintenance treatment.
Weekly Dosing — Initiate Fluoxetine Weekly capsules 7 days after the last daily dose of Fluoxetine 20 mg.
If satisfactory response is not maintained with Fluoxetine Weekly, consider reestablishing a daily dosing regimen.
Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, andplasma TCA concentrations may need to be monitored temporarily when Fluoxetine is coadministered or has been recently discontinued.
Obsessive Compulsive Disorder Initial TreatmentAdult — Initiate Fluoxetine 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Administer doses above 20 mg/day once daily in the morning or twice daily (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 dose should not exceed 80 mg/day.
In the controlled clinical trials of Fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of Fluoxetine or placebo. In one of these studies, no dose-response relationship for effectiveness was demonstrated.
Pediatric (children and adolescents) — In adolescents and higher weight children, initiate treatment with a dose of 10 mg/day. After 2 weeks, increase the dose to 20 mg/day. Consider additional dose increases 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, initiate treatment with a dose of 10 mg/day. Consider additional dose increases 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.
In the controlled clinical trial of Fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered Fluoxetine doses in the range of 10 to 60 mg/day.
Periodically reassess to determine the need for treatment.
Bulimia NervosaInitial Treatment — Administer Fluoxetine 60 mg/day in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. In the controlled clinical trials of Fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily Fluoxetine doses of 20 or 60 mg, or placebo. Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting.
Periodically reassess to determine the need for maintenance treatment.
Panic DisorderInitial Treatment — Initiate treatment with Fluoxetine 10 mg/day. After one week, increase the dose to 20 mg/day. Consider a dose increase after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder. In the controlled clinical trials of Fluoxetine supporting its effectiveness in the treatment of Panic Disorder, patients were administered Fluoxetine doses in the range of 10 to 60 mg/day. The most Frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day.
Periodically reassess to determine the need for continued treatment.
Fluoxetine And Olanzapine In Combination: Depressive Episodes Associated With Bipolar I DisorderWhen using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adult — Administer Fluoxetine 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. Make dosage adjustments, if indicated, according to efficacy and tolerability within dose ranges of Fluoxetine 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and Fluoxetine in combination with a dose range of olanzapine 6 to 12 mg and Fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg Fluoxetine has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.
Children and adolescents (10 -17 years of age) — Administer olanzapine and Fluoxetine combination once daily in the evening, generally beginning with 2.5 mg of olanzapine and 20 mg of Fluoxetine. Make dosage adjustments, if indicated, according to efficacy and tolerability. Safety of co-administration of doses above 12 mg of olanzapine with 50 mg of Fluoxetine has not been evaluated in pediatric clinical studies. Periodically re-examine the need for continued pharmacotherapy.
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 Dos e Corres pondence Between Symbyax and the Combination of Fluoxetine and Olanzapine
For Symbyax (mg/day)
The potential for interaction by a variety of mechanisms (for example, pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility.
Monoamine Oxidase Inhibitors (MAOI)Concomitant use of Fluoxetine (Fluoxetine) in patients taking MAOIs is contraindicated. There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued Fluoxetine and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine, including Fluoxetine, should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. Since Fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks (perhaps longer, especially if Fluoxetine has been prescribed chronically and/or at higher doses ) should be allowed after stopping Fluoxetine before starting an MAOI.
CNS Acting DrugsCaution is advised if the concomitant administration of Fluoxetine, including Fluoxetine, and other CNS acting 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.
Serotonergic DrugsBased on the mechanism of action of SNRIs and SSRIs, including Fluoxetine, and the potential for serotonin syndrome, caution is advised when Fluoxetine is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John’s Wort. The concomitant use of Fluoxetine with SNRIs, SSRIs, or tryptophan is not recommended.
TriptansThere have been rare postmarketing reports of serotonin syndrome with the use of an SSRI and a triptan. If concomitant treatment of Fluoxetine with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
TryptophanFive patients receiving Fluoxetine in combination with tryptophan experienced adverse reactions, including agitation, restlessness, and gastrointestinal distress. The concomitant use with tryptophan is not recommended.
Drugs That Interfere With Hemostasis (for example, NSAIDS, Aspirin, Warfarin)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.
Electroconvulsive Therapy (ECT)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.
Potential For Other Drugs To Affect Fluoxetine Drugs Tightly Bound to Plasma ProteinsBecause Fluoxetine is tightly bound to plasma proteins, adverse effects may result from displacement of protein-bound Fluoxetine by other tightly bound drugs.
Potential For Fluoxetine To Affect Other Drugs PimozideConcomitant use of Fluoxetine in patients taking pimozide is contraindicated. Clinical studies of pimozide with other antidepressants demonstrate an increase in drug interaction or QTc prolongation. While a specific study with pimozide and Fluoxetine has not been conducted, the potential for drug interactions or QTc prolongation warrants restricting the concurrent use of pimozide and Fluoxetine.
ThioridazineConcomitant use of Fluoxetine in patients taking thioridazine is contraindicated. Thioridazine should not be administered with Fluoxetine or within a minimum of 5 weeks after Fluoxetine has been discontinued.
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 Cmax 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, will produce elevated plasma levels of thioridazine.
Thioridazine administration produces a dose-related prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias, and sudden death. This risk is expected to increase with Fluoxetine-induced inhibition of thioridazine metabolism.
Drugs Metabolized by CYP2D6Fluoxetine inhibits the activity of CYP2D6, and may make individuals with normal CYP2D6 metabolic activity resemble a poor metabolizer. Coadministration of Fluoxetine with other drugs that are metabolized by CYP2D6, including certain antidepressants (for example, tricyclic antidepressants (TCAs)), antipsychotics (for example, phenothiazines and most atypicals), and antiarrhythmics (for example, propafenone, flecainide, and others) should be approached with caution. Therapy with medications that are predominantly metabolized by the CYP2D6 system and that have a relatively narrow therapeutic index should be initiated at the low end of the dose range if a patient is receiving Fluoxetine concurrently or has taken it in the previous 5 weeks. Thus, his/her dosing requirements resemble those of poor metabolizers. If Fluoxetine is added to the treatment regimen of a patient already receiving a drug metabolized by CYP2D6, the need for decreased dose of the original medication should be considered. Drugs with a narrow therapeutic index represent the greatest concern (for example, flecainide, propafenone, vinblastine, and TCAs). Due to the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, thioridazine should not be administered with Fluoxetine or within a minimum of 5 weeks after Fluoxetine has been discontinued.
Tricyclic Antidepressants (TCAs)In 2 studies, previously stable plasma levels of imipramine and desipramine have increased greater than 2- to 10-fold when Fluoxetine has been administered in combination. This influence may persist for 3 weeks or longer after Fluoxetine is discontinued. Thus, the dose of TCAs may need to be reduced and plasma TCA concentrations may need to be monitored temporarily when Fluoxetine is coadministered or has been recently discontinued.
BenzodiazapinesThe half-life of concurrently administered diazepam may be prolonged in some patients. Coadministration of alprazolam and Fluoxetine has resulted in increased alprazolam plasma concentrations and in further psychomotor performance decrement due to increased alprazolam levels.
AntipsychoticsSome clinical data suggests a possible pharmacodynamic and/or pharmacokinetic interaction between SSRIs and antipsychotics. Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant Fluoxetine.
AnticonvulsantsPatients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.
LithiumThere have been reports of both increased and decreased lithium levels when lithium was used concomitantly with Fluoxetine. Cases of lithium toxicity and increased serotonergic effects have been reported. Lithium levels should be monitored when these drugs are administered concomitantly.
Drugs Tightly Bound to Plasma ProteinsBecause Fluoxetine is tightly bound to plasma proteins, the administration of Fluoxetine to a patient taking another drug that is tightly bound to protein (for example, warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect.
Drugs Metabolized by CYP3A4In an in vivo interaction study involving coadministration of Fluoxetine with single doses of terfenadine (a CYP3A4 substrate), no increase in plasma terfenadine concentrations occurred with concomitant Fluoxetine.
Additionally, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least 100 times more potent than Fluoxetine or norfluoxetine as an inhibitor of the metabolism of several substrates for this enzyme, including astemizole, cisapride, and midazolam. These data indicate that Fluoxetine’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance.
Drug Abuse And Dependence DependenceFluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the pre-marketing clinical experience with Fluoxetine did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Fluoxetine (for example, development of tolerance, incrementation of dose, drug-seeking behavior).
Fluoxetine side effects
In one study, one of 112 dogs in the control group and three of 117 dogs that received Fluoxetine chewable tablets experienced the serious adverse reaction of seizures. One of the three dogs treated with Fluoxetine chewable tablets experienced two seizures 10 days after the end of therapy. Despite escalating phenobarbital doses, the seizures continued and this dog died in status epilepticus approximately six months after the first seizure. Another of the three dogs treated with Fluoxetine chewable tablets had experienced one seizure approximately 1½ years prior to study enrollment immediately after receiving head trauma. No additional seizures were reported to have occurred until 45 days after concluding treatment with Fluoxetine chewable tablets. During the 1½-year period since the second seizure, this dog’s seizure activity increased from single seizures to cluster seizures despite increasing doses of phenobarbital and the addition of oral potassium bromide and rectal diazepam. The third dog treated with Fluoxetine chewable tablets and the control dog experienced one seizure 24 days and 35 days, respectively, after the start of therapy; no anticonvulsant therapy was initiated and no further seizures were reported in either dog.
In the second study, one of 99 dogs treated with Fluoxetine chewable tablets and one of 99 dogs treated with the control tablet experienced the serious adverse reaction of seizures 9 and 27 days, respectively, after initiation of therapy. The dog treated with Fluoxetine chewable tablets was subsequently diagnosed with the vestibular disease and the control dog had a history of recurrent hind leg weakness.
1 Plumb DC. Amitriptyline. Veterinary Drug Handbook 5th Edition (Pocket Edition). Iowa State Press. Ames, IA. Page 39, 2002.
2 Hewson CJ, et.al. The pharmacokinetics of clomipramine and desmethylclomipramine in dogs: parameter estimates following a single oral dose and 28 consecutive daily doses of clomipramine. J Vet Pharmacol Therapy 21:214-222, 1998.
In a European multi-site study, 234 dogs were treated with daily doses of Fluoxetine chewable tablets ranging from 0.25 mg/kg to 4 mg/kg.
One dog treated with a daily dose of 0.4 mg/kg for one month experienced one seizure one week after discontinuing therapy. No anticonvulsant therapy was initiated and no further seizures were reported.
Of the dogs in the two North American field studies with bodyweight measurements throughout the study (n=196 and n=185 in the Fluoxetine chewable tablets and control group, respectively), a 5% or greater weight loss (when compared to initial, pre-study body weight) was observed in 58 (29.6%) of dogs treated with Fluoxetine chewable tablets and 24 (13.0%) of dogs in the control group. No dogs were withdrawn from clinical studies due to weight loss alone. The following table shows the number of dogs with weight loss, stratified by percent weight loss relative to initial body weight.
Table 2: Dogs with Weight Loss (stratified by percent loss relative to initial body weight) Treatment Group 5% to 10% 10 to 15% 15% Number (%) Number (%) Number (%)
This dog lost 20% of its initial body weight and was the same dog that died in status epilepticus.
Fluoxetine 44 (22.5%) 13 (6.6%) 1a (0.5%) chewable tablets Control 20 (10.8%) 4 (2.2%) 0 (0%)
Other adverse reactions:
Additional adverse reactions observed in dogs treated with Fluoxetine chewable tablets at a rate of 1% or greater were:
Table 3: Adverse Reactions Reported in the North American Field Studies Fluoxetine Chewable Tablets, N=216 Control,* N=211 Adverse Reaction n % n %
* The control group received the tablet formulation without Fluoxetine.
Calm/Lethargy/Depression 71 32.9 22 10.4 Decreased Appetite 58 26.9 13 6.2 Vomiting 37 17.1 28 13.3 Shaking/Shivering/Tremor 24 11.1 4 1.9 Diarrhea 21 9.7 17 8.1 Restlessness 16 7.4 8 3.8 Excessive Vocalization (Including Whining) 13 6.0 7 3.3 Aggression 9 4.2 13 6.2 Otitis Externa 6 2.8 2 0.9 Disorientation 5 2.3 1 0.5 Incoordination 5 2.3 0 0.0 Constipation 3 1.4 0 0.0 Excessive Salivation 3 1.4 4 1.9
Twenty dogs in the Fluoxetine chewable tablet group and five dogs in the control group required a reduction in dose due to unacceptable adverse reactions, generally anorexia, vomiting, shaking, and depression. Lowering the dose eliminated or reduced the severity of these adverse reactions in the Fluoxetine chewable tablet group only. Resumption of the full dose of Fluoxetine chewable tablets resulted in a return of the initial adverse reactions in approximately half of the affected dogs. The majority of these adverse reactions were intermittent and mild. However, one dog experienced a recurrence of severe adverse reactions, which necessitated withdrawal from the study for that dog. Additionally, two dogs required a second dose reduction of Fluoxetine chewable tablets. Effectiveness was maintained in a majority of those dogs in which a dose reduction was necessary.
Monoamine Oxidase Inhibitors
There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued Fluoxetine and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. Since Fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks [perhaps longer, especially if Fluoxetine has been prescribed chronically and/or at higher doses ] should be allowed after stopping Fluoxetine before starting an MAOI.
Concomitant use in patients taking pimozide is contraindicated.
Thioridazine should not be administered with Fluoxetine® or within a minimum of 5 weeks after Fluoxetine® has been discontinued.
Active ingredient matches for Fluoxetine:
Unit description / dosage (Manufacturer)Price, USD Capsule; Oral; Fluoxetine Hydrochloride 20 mg Tablet, Dispersible; Oral; Fluoxetine Hydrochloride 20 mg Solution; Oral; Fluoxetine Hydrochloride 20 mg / 5 ml Capsule; Oral; Fluoxetine Hydrochloride 10 mg Capsule; Oral; Fluoxetine Hydrochloride 40 mg Solution; Oral; 20 mg / 5 ml Tablet; Oral; Fluoxetine Hydrochloride 10 mg Tablet; Oral; Fluoxetine Hydrochloride 20 mg Tablet; Oral; Fluoxetine Hydrochloride 40 mg Capsule, Delayed Release; Oral; Fluoxetine Hydrochloride 90 mg PROzac 20 mg/5ml Solution 120ml Bottle$ 266.51 PROzac Weekly 1 Package = 4 capsule / 90 mg Disp Pack$ 140.77 Sarafem 7 10 mg tablet Box$ 61.08 Sarafem 7 20 mg tablet Each Box Contains 7 tablet$ 59.55 Prozac weekly 90 mg capsule$ 34.50 PROzac 40 mg capsule$ 13.89 Fluoxetine hcl powder$ 8.32 Sarafem 10 mg tablet$ 7.91 Sarafem 15 mg tablet$ 7.91 Sarafem 20 mg tablet$ 7.91 PROzac 20 mg capsule$ 2.02 PROzac 10 mg capsule$ 2.02 FLUoxetine HCl 40 mg capsule$ 5.54 PROzac 10 mg tablet$ 4.31 Fluoxetine hcl 20 mg tablet$ 4.26 Rapiflux 20 mg tablet$ 3.11 FLUoxetine HCl 20 mg capsule$ 2.77 Fluoxetine hcl 10 mg tablet$ 2.72 FLUoxetine HCl 10 mg capsule$ 2.70 Fxt 40 40 mg Capsule$ 2.30 Apo-Fluoxetine 10 mg Capsule$ 1.13 Co Fluoxetine 10 mg Capsule$ 1.13 Mylan-Fluoxetine 10 mg Capsule$ 1.13 Novo-Fluoxetine 10 mg Capsule$ 1.13 Nu-Fluoxetine 10 mg Capsule$ 1.13 Phl-Fluoxetine 10 mg Capsule$ 1.13 Pms-Fluoxetine 10 mg Capsule$ 1.13 Ratio-Fluoxetine Hydrochloride 10 mg Capsule$ 1.13 Sandoz Fluoxetine 10 mg Capsule$ 1.13 Apo-Fluoxetine 20 mg Capsule$ 1.06 Co Fluoxetine 20 mg Capsule$ 1.06 Mylan-Fluoxetine 20 mg Capsule$ 1.06 Novo-Fluoxetine 20 mg Capsule$ 1.06 Nu-Fluoxetine 20 mg Capsule$ 1.06 Phl-Fluoxetine 20 mg Capsule$ 1.06 Pms-Fluoxetine 20 mg Capsule$ 1.06 Ratio-Fluoxetine Hydrochloride 20 mg Capsule$ 1.06 Sandoz Fluoxetine 20 mg Capsule$ 1.06 FLUoxetine HCl 20 mg/5ml Solution$ 1.03 Apo-Fluoxetine 4 mg/ml Liquid$ 0.61 Capsules; Oral; Fluoxetine Hydrochloride 20 mg Tablets, Dispersible; Oral; Fluoxetine Hydrochloride 20 mg Capsules; Oral; Fluoxetine Hydrochloride 10 mg Capsules; Oral; Fluoxetine Hydrochloride 40 mg Tablets; Oral; Fluoxetine Hydrochloride 10 mg Tablets; Oral; Fluoxetine Hydrochloride 20 mg Tablets; Oral; Fluoxetine Hydrochloride 40 mg Capsules, Delayed Release; Oral; Fluoxetine Hydrochloride 90 mg Fluoxetine 20 mg Tablet$ 0.07 Fluoxetine solution 20 mg (Aa Pharma Inc (Canada)) Fluoxetine capsule 20 mg (Meliapharm Inc (Canada)) Fluoxetine capsule 10 mg (Sivem Pharmaceuticals Ulc (Canada)) Fluoxetine capsule 10 mg/1 (Av Pak (US)) Fluoxetine capsule 20 mg/1 (Cardinal Health (US)) Fluoxetine capsule 40 mg/1 (Alembic Pharmaceuticals Inc. (US)) Fluoxetine tablet, film coated 10 mg/1 (Mylan Pharmaceuticals Inc. (US)) Fluoxetine solution 20 mg/5mL (Aurobindo Pharma Limited (US)) Fluoxetine tablet 10 mg/1 (Torrent Pharmaceuticals Limited (US)) Fluoxetine liquid 20 mg/5mL (Silarx Pharmaceuticals, Inc (US)) Fluoxetine tablet, film coated 20 mg/1 (Mylan Pharmaceuticals Inc. (US)) Fluoxetine tablet 20 mg/1 (Torrent Pharmaceuticals Limited (US))
List of Fluoxetine substitutes (brand and generic names):
Fluoxetina Zentiva (Portugal) fluoxetine 20mg (Luxembourg) FLUOXETINE 20MG CAPSULE FLUOXETINE 20MG CAPSULE 1 strip / 10 capsules each (Jan Aushadhi)$ 0.13 Fluoxetine A (Netherlands) Fluoxetine A.M. Mangion (Malta) Fluoxetine Accord (United Kingdom) Fluoxétine Accord (France) Fluoxetine Actavis (Netherlands) Fluoxétine Actavis (France) Fluoxetine Actor (South Africa) Fluoxétine Almus (France) Fluoxetine Alsi (Russian Federation) Fluoxétine Alter (France) Fluoxetine Amdipharm (Netherlands) Fluoxetine AN (Australia) Fluoxetine Apotex (Belgium, Netherlands) Fluoxétine Arrow (France) Fluoxetine Aurobindo (United Kingdom) Fluoxetine Biochemie (Greece) Fluoxétine Biogaran (France) Fluoxétine Biogaran sans sucre (France) Fluoxetine Capsules Fluoxetine Capsules capsule 20 mg (Pharmascience Inc (Canada)) Fluoxetine Capsules capsule 10 mg (Pharmascience Inc (Canada)) Fluoxetine Capsules 20mg (United Kingdom) Fluoxetine Central Procurement (Malta) Fluoxetine CF (Netherlands) Fluoxetine Cherubino (Malta) Fluoxétine CristerS (France) Fluoxetine Delayed Release Capsules Fluoxetine Delayed-Release Capsules Fluoxetine EB (Netherlands) Fluoxétine EG (France) Fluoxetine EG (Belgium) Fluoxétine EG (France) Fluoxetine EG 20mg (Luxembourg) Fluoxetine Egis (Lithuania) Fluoxétine Evolugen (France) Fluoxetine generichealth (Australia) Fluoxetine Generics (Greece) Fluoxétine Gerda (France) See 1943 substitutes for Fluoxetine
- PubChem. “fluoxetine”. https://pubchem.ncbi.nlm.nih.gov/com…
- DrugBank. “fluoxetine”. http://www.drugbank.ca/drugs/DB00472
- DTP/NCI. “NSC283480: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.”. https://dtp.cancer.gov/dtpstandard/s…
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