Extension to fluoxetine substitution instrument Skip to main contentMain navigation Menu SearchYou are hereHome News and Community Safety alertsExtension to fluoxetine substitution instrumentPublished31 May 2024ListenPrintShare To address the ongoing shortage of Zactin Tabs (Fluoxetine 20mg dispersible tablets), we have extended the Therapeutic Goods (Serious Scarcity and Substitutable Medicine ) (Fluoxetine) Instrument 2023- external site (SSSI), which was initially due to expire on 31 May 2024. The extended Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Amendment Instrument 2024- external site will remain in effect until 30 September 2024, ensuring timely access for patients. This instrument allows pharmacists to substitute ZACTIN TABS 20mg dispersible tablet

Safety advisory: Fluoxetine Skip to main contentMain navigation Menu SearchYou are hereHome News and Community Safety alertsSafety advisory: Fluoxetine Information for consumers and health professionals about low levels of nitrosamine impurity in medicines containing fluoxetine. Published27 November 2023ListenPrintShareOn this page:What is N-nitrosofluoxetine?What should consumers do?What should health professionals do?What action we are takingReporting problemsRelated linksOn this pageWhat is N-nitrosofluoxetine?What should consumers do?What should health professionals do?What action we are takingReporting problemsRelated links We are investigating the presence of low levels of the nitrosamine impurity known as N‑nitrosofluoxetine in medicines containing fluoxetine. Fluoxetine

Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study To evaluate the efficacy and safety of vortioxetine in adolescents with major depressive disorder (MDD). After 4 weeks of single-blind lead-in treatment with a Brief Psychosocial Intervention (BPI) plus placebo, patients (aged 12-17 years) with MDD (DSM-5 ) who did not meet response criteria (Children's Depression Rating Scale-Revised [CDRS-R]; total score ≥40 plus <40% reduction and a Parent Global Assessment score >2) were randomized 1:1:1:1 to 8 weeks of BPI plus double-blind treatment with vortioxetine 10 mg, vortioxetine 20 mg, fluoxetine 20 mg, or placebo. The primary endpoint was change from randomization in CDRS-R total score at week 8

Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke

Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke: Results From EFFECTS, a Randomized Controlled Trial The EFFECTS (Efficacy of Fluoxetine—a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months . The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months

Fluoxetine You need to be logged in to see the full monograph.LoginUSE OF FLUOXETINE IN PREGNANCYDate of issue: June 2022, Version: 3A corresponding patient information leaflet on USE OF FLUOXETINE IN PREGNANCY is available.Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used in the treatment of depression, obsessive-compulsive disorder and bulimia nervosa.The available data regarding gestational use of fluoxetine are conflicting, with the majority of studies not demonstrating statistically significant increased risks of major malformation or of cardiac malformation specifically. It is therefore unclear whether the available findings concerning maternal fluoxetine use in pregnancy represent a risk with the individual drug, a class effect of SSRIs, or are produced due

Fluoxetine does not improve outcomes after stroke Fluoxetine does not improve outcomes after strokeFluoxetine does not improve outcomes after stroke Skip to content * Accessibility options: * * Search articles Evidence * About Us * Browse content * Brain and Nerves * Birth Conditions * Blood * Cancer * Heart and Circulation * Dementia * Detection, Screening and Diagnosis * Diabetes, Metabolics * Reproductive health and childbirth * Skin Conditions * Smoking and addiction * Social Care * Stomach and Digestion * Stroke * View all content * Become a reviewer * Newsletter Sign Up What’s the issue?What’s new?Why is this important?What’s next?You may be interested to readMenu * About Us * Browse content * Become a reviewer * Newsletter Sign Up * Contact us * Homepage * > * Alert * > * Fluoxetine does

Fluoxetine Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * FrançaisSearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs and health

Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months

Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT * Text only * * Home * Journals * * Other NIHR research * * For authors * For reviewers * About * * Accessibility * Journals report PDF * Download report documents * Download report documents * * Disclosure of interest * * * Download report XML * * Citation Tools * Print * * * * Responses to this report (0) * Permissions information View ProjectAmiloride, fluoxetine and riluzole were not effective in reducing the brain volume loss in people with secondary progressive

Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT * Text only * * Home * Journals * * Other NIHR research * * For authors * For reviewers * About * * Accessibility * Journals LibraryNHS NIHR - National Institute for Health Research Select EME HSDR HTA PGfAR PHR EME

Effect of Fluoxetine on Obsessive-Compulsive Behaviors in Children and Adolescents With Autism Spectrum Disorders: A Randomized Clinical Trial. Selective serotonin receptor inhibitors are prescribed to reduce the severity of core behaviors of autism spectrum disorders, but their efficacy remains uncertain. To determine the efficacy of fluoxetine for reducing the frequency and severity began November 2010 and ended April 2017. Follow-up ended August 2017. Participants were randomized to receive fluoxetine (n = 75) or placebo (n = 71). Study medication was commenced at 4 or 8 mg/d for the first week, depending on weight, and then titrated to a maximum dose of 20 or 30 mg/d over 4 weeks. Treatment duration was 16 weeks. The primary outcome was the total score on the CYBOCS-PDD (scores

Fluoxetine for adults who are overweight or obese. Fluoxetine is a serotonin reuptake inhibitor indicated for major depression. It is also thought to affect weight control: this seems to happen through appetite changes resulting in decreased food intake and normalisation of unusual eating behaviours. However, the benefit-risk ratio of this off-label medication is unclear. To assess the effects of fluoxetine for overweight or obese adults. We searched the Cochrane Library, MEDLINE, Embase, LILACS, the ICTRP Search Portal and ClinicalTrials.gov and World Health Organization (WHO) ICTRP Search Portal. The last date of the search was December 2018 for all databases, to which we applied no language restrictions . We included randomised controlled trials (RCTs) comparing the administration of fluoxetine

Does fluoxetine improve recovery after stroke? The studyFOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. 2019;393:256-74.The study was funded by the UK Stroke Association and the NIHR Health Technology Assessment Programme project number 13/04/30.To read the full NIHR Signal, go to: https

Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects. FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm

The efficacy comparison of citalopram, fluoxetine, and placebo on motor recovery after ischemic stroke: a double-blind placebo-controlled randomized controlled trial The present study aimed to assess the effectiveness of oral citalopram, compared with fluoxetine and a placebo, in patients with post-stroke motor disabilities. A randomized double-blind placebo-controlled clinical trial was conducted between January 2015 and January 2016. The neurology department of a university-affiliated urban hospital in Tehran, Iran. Ninety adult patients with acute ischemic stroke, hemiplegia, or hemiparesis and a Fugl-Meyer Motor Scale score of below 55 were included. Participants were randomly allocated to one of three groups: Group A received 20 mg PO of fluoxetine daily, Group B received 20 mg PO

Hypersexuality: fluoxetine Hypersexuality: fluoxetine Evidence summary Published: 21 July 2015 www.nice.org.uk/guidance/esuom46 pathwaysKey points from the evidence Key points from the evidence The content of this evidence summary was up-to-date in July 2015. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information . Summary Summary No randomised controlled trials (RCTs) which evaluate the use of fluoxetine in the treatment of hypersexuality were found, nor any studies that compared fluoxetine with any of the hormonal treatments licensed to treat hypersexuality. Limited evidence from 3 small, short-term observational studies suggests that fluoxetine may improve some measurements of hypersexuality and sexual

Continuation-phase cognitive therapy and fluoxetine are effective in reducing the risk of relapse/recurrence in major depression after incomplete remission

Fluoxetine USE OF FLUOXETINE IN PREGNANCY 0344 892 0909Public Health England USE OF FLUOXETINE IN PREGNANCYView printable version (Date of issue: June 2022, Version: 3) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.A corresponding patient information leaflet on fluoxetine use in pregnancy is available at www.medicinesinpregnancy.org.SummaryFluoxetine is a selective serotonin reuptake inhibitor (SSRI) used in the treatment of depression, obsessive-compulsive disorder and bulimia nervosa.The available data regarding gestational use of fluoxetine are conflicting

Fluoxetine and sertraline may be associated with lower risk of suicide death than paroxetine in adults with depression