Prozac (fluoxetine)
Prozac® is an antidepressant medication generally prescribed to treat major depression, anxiety disorders, and even autism in adults. It is an oral medication originally brought to the market by American pharmaceutical manufacturer Eli Lilly and was the first SSRI to be approved for use in the United States. The generic version, fluoxetine, is also available by prescription.
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Questions & Answers
Question
I was prescribed Prozac for depression, and I didn’t notice an improvement in my depression.
Side Effects & Adverse Reactions
As with all antidepressants, Prozac carries the FDA’s black box warning due to an increased risk of suicidal thoughts/ideation and actions, especially in children and young adults. (.pdf)
Common side effects include fatigue, insomnia, nausea, dry mouth, headache, diarrhea, dizziness, weight gain, and sexual dysfunction (difficulty achieving arousal, erection and/or orgasm).
Prozac is officially classified by the FDA as Category C, meaning that risk cannot be ruled out. Babies born to women taking Prozac during pregnancy have often shown to suffer similar withdrawal symptoms as adults as the drug leaves their body after birth, as well as requiring extra neonatal hospital care including respiratory support and tubal feeding. Infants exposed to SSRIs during pregnancy may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN), also known as persistent fetal circulation, which is where the circulation in a newborn reverts back to the way it worked in utero, mostly bypassing the lungs. (.pdf)
Like many other antidepressant medications, the discontinuation of regular use of Prozac can cause numerous unpleasant withdrawal side effects, including flu-like symptoms (nausea, vomiting, sweating, headaches, diarrhea), sleep disturbances (insomnia, nightmares, fatigue), sensory/movement disturbances (vertigo, dizziness, “zap” like electrical sensations in the brain or nerve paths), and mood disturbances (anxiety, dysphoria, agitation). Most cases of these withdrawal symptoms are mild and resolve themselves after 1-4 weeks. (ncbi.nlm.nih.gov)
Possible Adverse Interactions (Contraindications)
Prozac should not be taken with, or immediately after stopping use of, monoamine oxidase inhibitors (MAOIs), another class of commonly used antidepressants, as well as the antipsychotic drug Thioridazine, as this can cause serotonin syndrome or serotonin toxicity, a condition that can be fatal. Prozac is also contraindicated for use with the antipsychotic medication pimozide (Orap) due to the risk of serious heart problems. (.pdf)
Legal Issues
In the nearly 3 decades that Prozac has been available to the public, hundreds, if not thousands, of lawsuits have been filed against Eli Lilly alleging mental and physical side effects stemming from use of the drug. While they have never actually lost any of these cases, Lilly is reported to have paid in the tens of millions of dollars in settlements for cases related to suicides and murders, mostly undisclosed. Many of these cases predated the advent of the popular use of the internet, so information is scattered.
Some notable cases include:
- A lawsuit filed by the families of the victims of Joseph Wesbecker, who shot and killed 8 and injured 12 of his former coworkers at his former workplace, less than a month after starting Prozac. Lilly won this case initially, until a judge determined that the plaintiffs had been paid to withhold damaging evidence. (breggin.com), (cnn.com)
- A lawsuit filed by the husband of LaVerne Shell, who killed herself 11 days after starting Prozac.
- A lawsuit filed by Diane Cassidy, who survived a suicide attempt after being prescribed Prozac off-label for weight loss. This suit, as well as the Shell suit, was notable for its argument of the concept of “poor metabolizers” – people whose bodies lack the proper enzyme to break the drug down sufficiently, and therefore build up much higher amounts in their system than intended. Both cases settled out of court under undisclosed terms. (freerepublic.com)
In 1999, a settlement was reached in a patent infringement lawsuit filed by Lilly against three other pharmaceutical companies hoping to manufacture generic versions of Prozac. (nytimes.com)
FDA Safety Alerts
December 14, 2011
A general alert communication was sent out by the FDA regarding SSRI use and the risk of PPHN (persistent pulmonary hypotension in the newborn). (fda.gov)
July 2006
A communication was sent out by the FDA to healthcare professionals regarding the risks of PPHN and serotonin syndrome when using SSRIs. (fda.gov)
Manufacturer Warnings
May 2004
Two letters were sent to healthcare providers from British pharmaceutical manufacturer GlaxoSmithKline mentioning Prozac as part of a group of drugs that would now receive the FDA black box warning regarding the risk of suicidal thoughts or behavior. (.pdf), (.pdf)
FDA Labeling Changes
July 2013
Additions were made to the Warnings and Precautions section of the label, indicating that post-marketing observations of heart arrhythmia symptoms were seen in patients treated with fluoxetine. (fda.gov)
January 2013
Labeling changes were made to the Contraindications (interactions with MAOI antidepressants), Warnings and Precautions (Serotonin Syndrome), Use in Specific Populations (PPHN), and Medication Guide (MAOIs). (fda.gov)
June 2011
Updated information was added to the Warnings section (cautions regarding patients with Acute Narrow-Angle Glaucoma) and Adverse Reactions section (patients reporting persistence of sexual dysfunction after discontinuing use of Prozac, as well as memory impairment). (fda.gov)
April 2011
Additions were made to the Adverse Reactions section of the label, adding a handful of conditions including hypotension (low blood pressure), bruxism (teeth grinding), alopecia (hair loss), etc. There were also additions made to the Use in Specific Populations section regarding possible cardiovascular defects in babies born to women who used Prozac/fluoxetine in the first trimester. (fda.gov)
March 2009
Modifications were made to the medication guide section of the label. (fda.gov)
January 2009
Three warnings (one for each method of delivery available) were issued regarding the potential for the potentially fatal complication serotonin syndrome, also known as serotonin storm or serotonin toxicity, or a similar condition called neuroleptic malignant syndrome. Both of these conditions can occur when Prozac is taken in combination with MAOIs, or other drugs that alter the neurotransmission of serotonin. (fda.gov), (fda.gov), (fda.gov)
March 2008
Precautions were added to the label making changes to the following subjects: abnormal bleeding as a potential side effect, and interactions with drugs that interfere with the clotting and flow of blood (Non-selective NSAIDs, aspirin, warfarin, etc.). (fda.gov)
Uses
Prozac is used in the treatment of major depressive disorder, anxiety and panic disorders including social anxiety disorder (also known as social phobia), post-traumatic stress disorder, premenstrual dysphoric disorder, eating disorders (bulimia nervosa and binge eating disorder) and less commonly used in the treatment of cataplexy, alcohol dependence, and obesity. It has also been implemented in treatment of autism spectrum disorders in adults, with moderate success.
History
Prozac was the first ever SSRI, with a long and colorful history beginning in the early 1970’s. Scientists at Eli Lilly began to experiment with and synthesize new compounds using as a model the common antihistamine diphenhydramine (better known in US markets by its brand name, Benadryl), which was already known to have mild antidepressant-like qualities. Of these synthesized derivatives, the compound that would eventually be dubbed fluoxetine (in 1975) showed the most potent and selective inhibition of serotonin reuptake. It would be approved by the FDA in December of 1987.
Fluoxetine was originally intended as a medication to treat hypertension (high blood pressure), with which it seemed to have had success in animal testing trials, and obesity, but experienced unsuccessful human clinical trials for both purposes. It was noticed to have mood lifting effects in some trial patients, however, and a new antidepressant was born.
The introduction of Prozac to the market sparked a cultural phenomenon. It was hailed by some as a “wonder drug.” It was touted to relieve a wide range of conditions with little to none of the side effects that came along with its predecessors (tricyclic antidepressants, benzodiazepines, barbiturates). It was not sedating or intoxicating, making it easier to tolerate with everyday activities. Prozac even has its own entry in most English dictionaries, has been referred to as “bottled sunshine,” and has had books and films made detailing users’ experiences with the drug (Elizabeth Wurtzel’s Prozac Nation, Lauren Slater’s Prozac Diary). There are many testimonials indicating that Prozac has saved users’ lives or marriages. It has been used by millions of people, and has netted billions in revenue for Eli Lilly.
In contrast with its initial appeal, however, Prozac has also developed a dark reputation, and in turn has earned criticism just as widespread as its praises. Shortly after its introduction, accounts began pouring in regarding negative mental side effects such as disturbing thoughts, hostility, violent compulsions, and suicidal ideation and behavior, and those accounts do not appear to have ceased since. The use of, or discontinuation of, Prozac and similar drugs in its class have been associated with some of the biggest headlining violent crimes since its introduction, notably school/mass killings. Hundreds of lawsuits have been filed, and support groups for “survivors” of Prozac have been formed. As early as 1991, the FDA has heard the testimony of hundreds of people who represent the loved ones of those injured or killed while using Prozac or by someone else using Prozac. While much of this is often dismissed by the idea that it is the illness of depression that drives violent actions and/or suicide, the sheer number of these cases eventually drove the FDA to issue the standard black box warning that appears at the top of the labels for all antidepressants in 2004.
The patent for Prozac expired in 2001, allowing for the production of generic fluoxetine. Despite the variety of similar drugs available, it still remains very popular, with over 20 million prescriptions filled in the US in 2011. (psychcentral.com)
Other Information
DESCRIPTION
Prozac® (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79. The structural formula is:
Fluoxetine hydrochloride is a white to off–white crystalline solid with a solubility of 14 mg/mL in water.
Each Pulvule® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10– and 20–mg Pulvules also contain FDandC Blue No. 1, and the 40–mg Pulvule also contains FDnadC Blue No. 1 and FDandC Yellow No. 6.
The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.
Prozac Weekly™ capsules, a delayed–release formulation, contain enteric–coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 μmol) of fluoxetine. The capsules also contain DandC Yellow No. 10, FDandC Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients.
Sources
Prozac Manufacturers
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Stat Rx Usa
![Prozac (Fluoxetine Hydrochloride) Capsule [Stat Rx Usa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Prozac | Stat Rx Usa
DOSAGE AND ADMINISTRATION Major Depressive Disorder Initial TreatmentAdult — In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in major depressive disorder in most cases. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose.
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.
Pediatric (children and adolescents) — 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 (see CLINICAL TRIALS). Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased 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. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.
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.
As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see Geriatric Use under PRECAUTIONS), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see Liver disease and Renal disease under CLINICAL PHARMACOLOGY, and Use in Patients with Concomitant Illness under PRECAUTIONS).
Maintenance/Continuation/Extended TreatmentIt is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Daily DosingSystematic evaluation of Prozac in adult patients has shown that its efficacy in major depressive disorder is maintained for periods of up to 38 weeks following 12 weeks of open–label acute treatment (50 weeks total) at a dose of 20 mg/day (see CLINICAL TRIALS).
Weekly DosingSystematic evaluation of Prozac Weekly in adult patients has shown that its efficacy in major depressive disorder is maintained for periods of up to 25 weeks with once–weekly dosing following 13 weeks of open–label treatment with Prozac 20 mg once daily. However, therapeutic equivalence of Prozac Weekly given on a once–weekly basis with Prozac 20 mg given daily for delaying time to relapse has not been established (see CLINICAL TRIALS).
Weekly dosing with Prozac Weekly capsules is recommended to be initiated 7 days after the last daily dose of Prozac 20 mg (see Weekly dosing under CLINICAL PHARMACOLOGY).
If satisfactory response is not maintained with Prozac Weekly, consider reestablishing a daily dosing regimen (see CLINICAL TRIALS).
Switching Patients to a Tricyclic Antidepressant (TCA)Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued (see Other drugs effective in the treatment of major depressive disorder under PRECAUTIONS, Drug Interactions).
Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI)At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Prozac. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping Prozac before starting an MAOI (see CONTRAINDICATIONS and PRECAUTIONS).
Obsessive Compulsive Disorder Initial TreatmentAdult — 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 (see CLINICAL TRIALS). In 1 of these studies, no dose–response relationship for effectiveness was demonstrated. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose. Since there was a suggestion of a possible dose–response relationship for effectiveness in the second study, a dose increase may be considered after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.
Doses above 20 mg/day may be administered on a once–a–day (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 dose should not exceed 80 mg/day.
Pediatric (children and adolescents) — 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 (see CLINICAL TRIALS).
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.
All patients — As with the use of Prozac in the treatment of major depressive disorder, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see Geriatric Use under PRECAUTIONS), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see Liver disease and Renal disease under CLINICAL PHARMACOLOGY, and Use in Patients with Concomitant Illness under PRECAUTIONS).
Maintenance/Continuation TreatmentWhile there are no systematic studies that answer the question of how long to continue Prozac, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of Prozac after 13 weeks has not been documented in controlled trials, adult patients have been continued in therapy under double–blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment.
Bulimia Nervosa Initial TreatmentIn 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 (see CLINICAL TRIALS). Only the 60–mg dose was statistically significantly superior to placebo in reducing the frequency of binge–eating and vomiting. Consequently, the recommended dose is 60 mg/day, administered 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.
As with the use of Prozac in the treatment of major depressive disorder and OCD, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see Geriatric Use under PRECAUTIONS), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see Liver disease and Renal disease under CLINICAL PHARMACOLOGY, and Use in Patients with Concomitant Illness under PRECAUTIONS).
Maintenance/Continuation TreatmentSystematic evaluation of continuing Prozac 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking Prozac 60 mg/day during an 8–week acute treatment phase has demonstrated a benefit of such maintenance treatment (see CLINICAL TRIALS). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Panic Disorder Initial TreatmentIn 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 (see CLINICAL TRIALS). Treatment should be initiated with a dose of 10 mg/day. After 1 week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible–dose clinical trials was 20 mg/day.
A dose increase may be considered 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.
As with the use of Prozac in other indications, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see Geriatric Use under PRECAUTIONS), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see Liver disease and Renal disease under CLINICAL PHARMACOLOGY, and Use in Patients with Concomitant Illness under PRECAUTIONS).
Maintenance/Continuation TreatmentWhile there are no systematic studies that answer the question of how long to continue Prozac, panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient. Nevertheless, patients should be periodically reassessed to determine the need for continued treatment.
Special Populations Treatment of Pregnant Women During the Third TrimesterNeonates exposed to Prozac and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Prozac during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Prozac in the third trimester.
Discontinuation of Treatment with ProzacSymptoms associated with discontinuation of Prozac and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.
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Dista Products Company
Prozac | Dista Products Company
2.1 Major Depressive DisorderInitial Treatment
Adult — Initiate PROZAC 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 doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases [see Clinical Studies (14.1)].
Pediatric (children and adolescents) — Initiate PROZAC 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 [see Clinical Studies (14.1)].
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 PROZAC Weekly capsules 7 days after the last daily dose of PROZAC 20 mg [see Clinical Pharmacology (12.3)].
If satisfactory response is not maintained with PROZAC Weekly, consider reestablishing a daily dosing regimen [see Clinical Studies (14.1)].
Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [see Warnings and Precautions (5.2) and Drug Interactions (7.7)].
2.2 Obsessive Compulsive DisorderInitial Treatment
Adult — Initiate PROZAC 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 [see Clinical Studies (14.2)]. 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 [see Clinical Studies (14.2)].
Periodically reassess to determine the need for treatment.
2.3 Bulimia NervosaInitial Treatment — Administer PROZAC 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 [see Clinical Studies (14.3)]. 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.
2.4 Panic DisorderInitial Treatment — Initiate treatment with PROZAC 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 [see Clinical Studies (14.4)]. 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.
2.5 PROZAC and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I DisorderWhen using PROZAC 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 PROZAC and olanzapine versus Symbyax. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Symbyax1 and the Combination of PROZAC and Olanzapine1 Symbyax (olanzapine/fluoxetine HCL) is a fixed-dose combination of PROZAC and olanzapine.
For
Symbyax
(mg/day) Use in Combination Olanzapine
(mg/day) PROZAC
(mg/day) 3 mg olanzapine/25 mg fluoxetine 2.5 20 6 mg olanzapine/25 mg fluoxetine 5 20 12 mg olanzapine/25 mg fluoxetine 10+2.5 20 6 mg olanzapine/50 mg fluoxetine 5 40+10 12 mg olanzapine/50 mg fluoxetine 10+2.5 40+10PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
2.6 PROZAC and Olanzapine in Combination: Treatment Resistant DepressionWhen using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
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. Adjust dosage, if indicated, according to efficacy and tolerability within dose ranges of fluoxetine 20 to 50 mg and oral olanzapine 5 to 20 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination with a dose range of olanzapine 6 to 18 mg and fluoxetine 25 to 50 mg.
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. Table 1 demonstrates the appropriate individual component doses of PROZAC and olanzapine versus Symbyax. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability.
Periodically re-examine the need for continued pharmacotherapy.
Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.
PROZAC monotherapy is not indicated for the treatment of treatment resistant depression (Major Depressive Disorder in patients who do not respond to 2 antidepressants of adequate dose and duration in the current episode).
2.7 Dosing in Specific PopulationsTreatment of Pregnant Women — When treating pregnant women with PROZAC, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)].
Geriatric — Consider a lower or less frequent dosage for the elderly [see Use in Specific Populations (8.5)].
Hepatic Impairment — As with many other medications, use a lower or less frequent dosage in patients with hepatic impairment [see Clinical Pharmacology (12.4) and Use in Specific Populations (8.6)].
Concomitant Illness — Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [see Clinical Pharmacology (12.4) and Warnings and Precautions (5.12)].
PROZAC and Olanzapine in Combination — Use a starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. PROZAC and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age [see Warnings and Precautions (5.16) and Drug Interactions (7.7)].
2.8 Discontinuation of TreatmentSymptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.15)].
2.9 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with PROZAC. Conversely, at least 5 weeks should be allowed after stopping PROZAC before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.10 Use of PROZAC with Other MAOIs such as Linezolid or Methylene BlueDo not start PROZAC in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving PROZAC therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, PROZAC should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with PROZAC may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with PROZAC is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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