[82], Fluoxetine increases the concentration of circulating allopregnanolone, a potent GABAA receptor positive allosteric modulator, in the brain. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. [110] In the U.S., the FDA gave its final approval in December 1987,[111] and a month later Eli Lilly began marketing Prozac; annual sales in the U.S. reached $350 million within a year. All rights reserved. Drugs lowering the epileptogenic threshold: Seizures are an undesirable effect of fluoxetine. Drugs metabolized by CYP3A4—In an in vivo interaction study involving co-administration of Fluoxetine with single doses of terfenadine (a CYP3A4 substrate), no increase in plasma terfenadine concentrations occurred with concomitant Fluoxetine. [129], Since 2003, a number of studies have reported fluoxetine-induced impacts on a number of behavioural and physiological endpoints, inducing antipredator behaviour,[131][132][133] reproduction,[134][135][135] and foraging[136][137] at or below field-detected concentrations. The symptoms may include: Do not stop Fluoxetine tablets without first talking to your healthcare provider. iproniazide). As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. Carbamazepine: Elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment. Fluoxetine tablets may be associated with these serious side effects: 2. No specific antidote is known. For more information about Fluoxetine tablets, call Aurobindo Pharma USA, Inc. at 1-866-850-2876. Greenwood Village, CO: Thomsen Healthcare; 2013. Nervous System—Frequent: emotional lability; Infrequent: akathisia, ataxia, balance disorder1, bruxism1, buccoglossal syndrome, depersonalization, euphoria, hypertonia, libido increased, myoclonus, paranoid reaction; Rare: delusions. [6] If already on the medication, it may be reasonable to continue during breastfeeding. Study 1 (N = 180 randomized) was a 12-week, flexible-dose study. It should be noted that Fluoxetine is approved in the pediatric population only for MDD and OCD. Irreversible non-selective Monoamine Oxidase Inhibitors (e.g. "[39] Sertraline is often the preferred SSRI during pregnancy due to the relatively minimal fetal exposure observed and its safety profile while breastfeeding. Patients receiving warfarin therapy should be carefully monitored when Fluoxetine is initiated or discontinued [see Warnings and Precautions (5.7)]. The pooled results of these trials demonstrated that 47% of completers treated with the highest dose were "much improved" or "very much improved" after 13 weeks of treatment, compared to 11% in the placebo arm of the trial. Conditions: diabetes. Read the Medication Guide that comes with Fluoxetine tablets before you start taking them and each time you get a refill. If either is slowed, referral to a paediatrician should be considered. In U.S. Fluoxetine clinical trials, 0.2% of 10,782 patients reported convulsions. 3-Phenoxy-3-phenylpropylamine, a compound structurally similar to diphenhydramine, was taken as a starting point, and Molloy synthesized a series of dozens of its derivatives. This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with Fluoxetine and norFluoxetine following the discontinuation of Fluoxetine. Thus, the dose of TCAs may need to be reduced and plasma TCA concentrations may need to be monitored temporarily when Fluoxetine is co-administered or has been recently discontinued [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. However, it is clinical experience that uptitrating might be beneficial for some patients. -  Do not start Fluoxetine tablets  if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. In the second study, with intermittent luteal phase dosing (20mg daily for 14 days) for 3 cycles, improvement was observed in the primary efficacy parameter (Daily Record of Severity of Problems score). Hepatic Impairment—As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)]. Plasma concentrations of Fluoxetine were higher than those predicted by single-dose studies, because Fluoxetine’s metabolism is not proportional to dose. "Prozac" redirects here. Consider discontinuing Fluoxetine and obtaining a cardiac evaluation if patients develop signs or symptoms consistent with ventricular arrhythmia. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. The bioavailability is not affected by food intake. What are some common side effects of antidepressants? Mutagenicity—Fluoxetine and norFluoxetine have been shown to have no genotoxic effects based on the following assays: bacterial mutation assay, DNA repair assay in cultured rat hepatocytes, mouse lymphoma assay, and in vivo sister chromatid exchange assay in Chinese hamster bone marrow cells. Treatment of Pregnant Women—When treating pregnant women with Fluoxetine tablets, the physician should carefully consider the potential risks and potential benefits of treatment. It has not been established whether there is an effect on achieving normal adult height. 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. People who take Fluoxetine tablets close in time to an MAOI may have serious or even life-threatening side effects. U.S. Fluoxetine clinical trials included 687 patients ≥ 65 years of age and 93 patients ≥ 75 years of age. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes). All indications: The recommended dose may be increased or decreased. Avoid the concomitant use of drugs known to prolong the QT interval. [59], There is less data on fluoxetine than on antidepressants as a whole. Results of a number of published epidemiological studies assessing the risk of Fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results. Alternative, nonsaturable pathways (non-2D6) also contribute to the metabolism of Fluoxetine. Protect from light. Adjusted for gender. A major depressive episode may be the initial presentation of Bipolar Disorder. Mania: Antidepressants should be used with caution in patients with a history of mania/hypomania. Isolated cases of adverse events potentially indicating delayed sexual maturation or sexual dysfunction have been reported from paediatric clinical use. Phospholipid accumulation in animals has been observed with many cationic amphiphilic drugs, including fenfluramine, imipramine, and ranitidine. These long half-lives are responsible for persistence of the drug for 5-6 weeks after discontinuation. Fluoxetine tablets can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine tablets  and some medicines may interact with each other, may not work as well, or may cause serious side effects. Isolated cases of growth retardation have also been reported from clinical use. Fluoxetine tablets  can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. The patient should be monitored for symptoms of serotonin syndrome for 5 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. [46][47] Fluoxetine's longer half-life makes it less common to develop discontinuation syndrome following cessation of therapy, especially when compared to antidepressants with shorter half-lives such as paroxetine. 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 [see CONTRAINDICATIONS]. [27] Both the NICE and the Fournier analyses concluded that greater evidence is seen for the efficacy of antidepressants in the treatment of chronic mild depression (dysthymia) than in recent-onset mild depression. Do not use Fluoxetine tablets  for a condition for which they were not prescribed. Fluoxetine is secreted into breast milk. While early clinical trials suggested a relatively low rate of sexual dysfunction, more recent studies in which the investigator actively inquires about sexual problems suggest that the incidence is >70%. Thus, the net pharmacodynamic activities were essentially the same. Umbilical Arterial Line Catheter Placement, Recurrent hyperbilirubinemia in an infant. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. This may also apply if fluoxetine has been taken in the previous 5 weeks.”. Suicide-related behaviours (suicidal attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. In the controlled clinical trials of Fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20 mg, 40 mg, or 60 mg of Fluoxetine or placebo [see Clinical Studies (14.2)]. [4], There is also the potential for interaction with highly protein-bound drugs due to the potential for fluoxetine to displace said drugs from the plasma or vice versa hence increasing serum concentrations of either fluoxetine or the offending agent.

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