Table Of Contents
- fluoxetine Price Comparison Table
- fluoxetine Information
- How Does fluoxetine Work?
- fluoxetine Ingredients and Composition
- How To Take fluoxetine and fluoxetine Dosage and Administration
- If you suspect a fluoxetine Overdose
- Contraindications to fluoxetine
- fluoxetine Side Effects
- fluoxetine Precautions and Contraindications
- fluoxetine Clinical Trials and Studies
- fluoxetine Lawsuit and Litigation
- Articles and information related to fluoxetine
- Other Websites about fluoxetine
- Credits for fluoxetine Information
Brand names: Prozac
fluoxetine Price Comparison Table
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fluoxetine Information
Other Brand Names: Fontex, Prozac Durapack
Generic Name: Fluoxetine
Other Common Names: Fluoxetina
Prozac (Fluoxetine HCl) is indicated for the treatment of depression. The efficacy of fluoxetine HCl was established in 5- and 6-week trials with depressed outpatients (<18 years of age) whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder.
Fluoxetine HCl is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; (i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning).
Fluoxetine HCl is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa.
How Does fluoxetine Work?
The antidepressant, antiobsessive-compulsive, and antibulimic actions of Prozac (Fluoxetine HCl) are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine.
Antagonism of muscarinic, histaminergic, and a1-adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant drugs. Fluoxetine binds to these and other membrane receptors from brain tissue much less potently in vitro than do the tricyclic drugs.
fluoxetine Ingredients and Composition
Fluoxetine hydrochloride is an antidepressant for oral administration; it is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. It is designated (±)-N-methyl-3-phenyl-3-[(a,a,a-trifluoro-p-tolyl)-oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79.
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/ml in water.
Each Prozac Pulvule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 mcmol), 20 mg (64.7 mcmol), or 40 mg (129.3 mmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron dioxide, and other inactive ingredients. The 10 mg and 20 mg Pulvules also contain FD&C blue no. 1, and the 40 mg Pulvule also contains FD&C blue no. 1 and FD&C yellow no. 6.
Each Prozac tablet contains fluoxetine HCl equivalent to 10 mg (32.3 mmol) of fluoxetine. The tablets also contain microcrystalline cellulose, magnesium stearate, crospovidone, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and yellow iron oxide. In addition to the above ingredients, the 10 mg tablet contains FD&C blue no. 1 aluminum lake, and polysorbate 80.
The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 ml (64.7 mcmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.
How To Take fluoxetine and fluoxetine Dosage and Administration
Depression
Initial Treatment: In controlled trials used to support the efficacy of Prozac (fluoxetine), patients were administered morning doses ranging from 20 mg to 80 mg/day. Studies comparing Prozac (fluoxetine) 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory antidepressant response 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 no clinical improvement is observed. Doses above 20 mg/day may be administered on a once a day (morning) or b.i.d. schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day.
As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer.
As with many other medications, a lower or less frequent Prozac (fluoxetine) dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly , and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary.
Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Systematic evaluation of Prozac (fluoxetine) has shown that its antidepressant efficacy 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.
Obsessive-Compulsive Disorder
Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of obsessive-compulsive disorder, patients were administered fixed daily doses of 20, 40, or 60 mg of Prozac (fluoxetine) or placebo. In one 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 b.i.d. 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.
As with the use of Prozac (fluoxetine) in depression, 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, and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary.
Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue Prozac (fluoxetine), OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine HCl after 13 weeks has not been documented in controlled trials, 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 Treatment: In the controlled clinical trials of Prozac (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. 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. Prozac (fluoxetine) doses above 60 mg/day have not been systematically studied in patients with bulimia.
As with the use of Prozac (fluoxetine) in depression 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, and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary.
Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue Prozac (fluoxetine), bulimia is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of Prozac (fluoxetine) after 16 weeks has not been documented in controlled trials, some patients have been continued in therapy under double- blind conditions for up to an additional 6 months without loss of benefit. However, patients should be periodically reassessed to determine the need for continued treatment.
If you suspect a fluoxetine Overdose
As of December 1987, there were 2 deaths among approximately 38 reports of acute overdose with fluoxetine, either alone or in combination with other drugs and/or alcohol. One death involved a combined overdose with approximately 1800 mg of fluoxetine and an undetermined amount of maprotiline. Plasma concentrations of fluoxetine and maprotiline were 4.57 mg/L and 4.18 mg/L, respectively. A second death involved 3 drugs yielding plasma concentrations as follows: fluoxetine, 1.93 mg/L; norfluoxetine, 1.10 mg/L; codeine, 1.80 mg/L; temazepam, 3.80 mg/L.
One other patient who reportedly took 3000 mg of fluoxetine experienced 2 grand mal seizures that remitted spontaneously without specific anticonvulsant treatment (see Management of Overdose). The actual amount of drug absorbed may have been less due to vomiting.
Nausea and vomiting were prominent in overdoses involving higher fluoxetine doses. Other prominent symptoms of overdose included agitation, restlessness, hypomania, and other signs of CNS excitation. Except for the 2 deaths noted above, all other overdose cases recovered without residua.
Since introduction, reports of death attributed to overdosage of fluoxetine alone have been extremely rare.
Overdose Management
Treatment should consist of those general measures employed in the management of overdosage with any antidepressant.
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 wtih 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 are known.
A specific caution involves patients who are taking or have recently taken fluoxetine and might ingest excessive quantities of a tricyclic antidepressant. 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-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.
Contraindications to fluoxetine
Fluoxetine HCl is contraindicated in patients known to be hypersensitive to it.
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 HCl 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 HCl before starting an MAOI.
fluoxetine Side Effects
Prozac (Fluoxetine HCl) may cause:
- anxiety
- nervousness
- drowsiness
- dizziness
- lightheadedness
- insomnia
- fatigue
- weakness
- tremor
- sweating
- stomache complaints
- including anorexia
- nausea
- diarrhea
fluoxetine Precautions and Contraindications
Do not take any other drugs, including over-the-counter medicines and alcohol, without consulting your physician.
Fluoxetine may cause dizziness or drowsiness, use caution while driving or operating hazardous machinery.
fluoxetine Clinical Trials and Studies
Depression:
The efficacy of Prozac (Fluoxetine HCl) for the treatment of patients with depression (18 years of age) has been studied in 5- and 6-week placebo-controlled trials. Prozac (Fluoxetine HCl) was shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D). Fluoxetine HCl was also significantly more effective than placebo on the HAM-D subscores for depressed mood, sleep disturbance, and the anxiety subfactor.
Two 6-week controlled studies comparing Prozac (Fluoxetine HCl), 20 mg, and placebo have shown fluoxetine HCl, 20 mg daily, to be effective in the treatment of elderly patients (> 60 years of age) with depression. In these studies, Prozac (Fluoxetine HCl) 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 <7. Prozac (Fluoxetine HCl) was well tolerated and the rate of treatment discontinuations due to adverse events did not differ between Prozac (Fluoxetine HCl) (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 depression by DSM-III-R criteria) by the end of an initial 12-week open treatment phase on Prozac (Fluoxetine HCl) 20 mg/day. These patients (N=298) were randomized to continuation on double-blind Prozac (Fluoxetine HCl) 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 depression for 2 weeks or a modified HAMD-17 score of <14 for 3 weeks) was observed for patients taking fluoxetine HCl compared to those on placebo.
Obsessive Compulsive Disorder:
The effectiveness of Prozac (Fluoxetine HCl) for the treatment for obsessive compulsive disorder (OCD) was demonstrated in two 13-week, multicenter, parallel group studies (Studies 1 and 2) of adult outpatients who received fixed Prozac (Fluoxetine HCl) doses of 20, 40, or 60 mg/day (on a once a day schedule, in the morning) or placebo. Patients in both studies had moderate to severe OCD (DSM-III-R), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS, total score) ranging from 22 to 26. In Study 1, patients receiving Prozac (Fluoxetine HCl) experienced mean reductions of approximately 4 to 6 units on the YBOCS total score, compared to a 1-unit reduction for placebo patients. In Study 2, patients receiving Prozac (Fluoxetine HCl) experienced mean reductions of approximately 4 to 9 units on the YBOCS total score, compared to a 1-unit reduction for placebo patients. While there was no indication of a dose response relationship for effectiveness in Study 1, a dose response relationship was observed in Study 2, with numerically better responses in the 2 higher dose groups.
Bulimia Nervosa:
The effectiveness of Prozac (Fluoxetine HCl) 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 mg/day or 60 mg/day of fluoxetine HCl or placebo in the morning. Patients in the 16-week study received a fixed fluoxetine HCl 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 HCl, 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 vs placebo was present as early as week 1 and persisted throughout each study. The Prozac (Fluoxetine HCl) 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 HCl, 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.
fluoxetine Lawsuit and Litigation
Fluoxetine was introduced in the US in 1987 and was initially very popular, over a million Americans were prescibed the drug a year. In the late 1990s there was something of a backlash with accusations that the drug made users feel suicidal and other serious side effects.
There is a lot of controversy surrounding Eli Lilly and Company, the producent of Prozac. A class action lawsuit has been filed recently against Eli Lilly after several people received free samples of Prozac Weekly in the mail.
The controversial Prozac approval process described, as well as side effects of other SSRIs and other types of medication, can be found on Prozac Truth, The Untold Story website.
Articles and information related to fluoxetine
- Depression
- Anxiety
- Stress
- Post-Traumatic Stress Disorder
Other Websites about fluoxetine
Credits for fluoxetine Information
fluoxetine information on this page is copyright by Drug Information at Pharma-Help.com, reprinted with Permission. All Rights Reserved. Other pages with reprint permission include fluoxetine.