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memantine adhd children

Like MEM-MD-57A and MEM-MD-67, memantine-ER was administered over a limited, weight-based dose range (3–15 mg/day). The opposite numerical trend was observed for Asperger’s disorder: 60.0% placebo, 73.1% full-dose, and 70.0% reduced dose. It is approved to treat moderate to severe Alzheimer's type dementia. Simply select your manager software from the list below and click on download. The large, mean improvements in SRS scores from baseline to end of open-label treatment (at levels that were three to four times the theorized clinically meaningful improvement level of 10 points) may be further evidence that caregivers had an expectation of success and falsely created treatment responders. The percentage of participants achieving ⩾10-point improvement in SRS total raw scores was comparable regardless of intervention (Figure 7), and ~90% of participants overall demonstrated improvement (Figure 7 inset). In a 12-week, randomized, double-blind, placebo-controlled trial (MEM-MD-57A, NCT00872898; conducted May 2009 through August 2012) in which memantine-ER was administered over a limited, weight-based dose range (3–15 mg/day), there was a trend toward improvement on the primary efficacy measure of caregiver/parent ratings on the Social Responsiveness Scale (SRS) of ~10 points from baseline in both treatment groups, but no significant between-group differences were observed between memantine-ER and placebo at study end (Aman et al., 2016). One of the successes of these phase 2 trials was the recruitment of a very wide and diverse study population using a broad array of recruitment strategies (Spera et al., 2014); however, the publicity surrounding this program may have contributed to unrealistic expectations. As pediatric patients are expected to gain weight during the course of development, study participants could be reassigned to the next higher weight group during the course of the study (per prespecified criteria) to maintain drug exposure levels that were considered therapeutically equivalent if a participant’s weight deviated significantly over time. All drug information provided on RxList.com is sourced directly from drug monographs published by the U.S. Food and Drug Administration (FDA). As the manner in which ASD clinical trials are conducted has evolved over the years, the results from this trial program will hopefully inform future decisions when considering the design of large trials of pharmacotherapies in ASD individuals. Memantine, a drug used for the treatment of dementia, may help improve impaired executive function in adults with ADHD when used with standard stimulant therapy. Adderall and some medicines may interact with each other and cause serious side effects. Assessment of global functioning in adolescents with autism spectrum disorders: Utility of the ... Psychopharmacology of autism spectrum disorders: A selective review. In MEM-MD-68, there was no difference between memantine and placebo on the primary efficacy parameter, the proportion of patients with a loss of therapeutic response (defined as ⩾10-point increase from baseline in Social Responsiveness Scale total raw score). The molecular mechanisms of ASD are not fully understood but may involve altered glutamatergic signaling. Another study confirms that although “memantine was less effective than methylphenidate [Ritalin] in the treatment of attention deficit hyperactivity disorder, it may be considered as an alternative treatment.” 12 Mohammad Reza Mohammadi, et al. A total of 84.3% of participants were taking concomitant medications and supplements, most commonly (⩾10.0%) multivitamins (14.7%), ibuprofen (13.0%), paracetamol (11.7%), risperidone (10.2%), and loratadine (10.1%). Before the conduct of any study procedure, participants provided written informed assent (when developmentally appropriate), and the study participant’s parent, legal guardian, or legally authorized representative provided voluntary and written informed consent (in compliance with 21 CFR Parts 50 and 312) and Health Insurance Portability and Accountability Act (HIPAA) authorization (United States). The SRS is a 65-item caregiver-rated assessment consisting of five subscales to assess social abilities: social awareness, social cognition, social communication, social motivation, and autistic mannerisms. Three phase 2 trials were conducted to assess the efficacy and long-term safety of weight-based memantine extended release (ER) treatment in children with autism spectrum disorder. The first dose is usually taken when you first wake in the morning. Each item is rated from 0 to 3 in a Likert-type response format with higher scores indicating greater social impairment. The drug information provided is intended for reference only and should not be used as a substitute for medical advice. Memantine is a prescription drug. Eight (1.1%) participants reported a total of 11 on-therapy SAEs (all n = 1): abdominal pain (periumbilical), abdominal pain (right lower quadrant), abnormal behavior, appendicitis, dehydration, dysphoria, foreign body, homicidal ideation, rectal prolapse, suicidal ideation, and vomiting. In PDD-NOS participants, the proportions of participants experiencing LTR were comparable between dose groups (Table 2). (RCTs) of amantadine were identified in children and adolescents. In MEM-MD-91, participants who completed ⩾12 weeks of treatment and met the defined responder criterion at two consecutive visits separated by at least 2 weeks (i.e. In one study on children diagnosed with ADHD, it was found that both 10 mg/day and 20 mg/day of Memantine led to improvements in ADHD symptoms. Like the double-blind phase, SRS scores with memantine-ER continued to improve by ~6 points over the 48-week open-label extension period, regardless of prior treatment. The study sponsor (Forest Research Institute (FRI), Jersey City, NJ; currently Allergan plc) made an administrative decision to terminate MEM-MD-69 prematurely based on results from the previously initiated double-blind controlled studies MEM-MD-57A and MEM-MD-68. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Adderall may affect your or your child's ability to drive or do other dangerous activities. Extended-release (ER) memantine monotherapy was investigated in children with autistic disorder, Asperger’s disorder, or PDD-NOS as part of a phase 2 clinical development program designated under the US FDA Pediatric Written Request (PWR). Cumulative percentages of patients achieving a given change from baseline in SRS total raw score (Double-blind, Placebo-controlled trial MEM-MD-68). Treatment with immediate-release (IR) memantine—a low-to-moderate affinity, uncompetitive NMDA receptor antagonist—has been shown to improve both communication and social interactions in several trials conducted in individuals with ASD and pervasive developmental disorder not-otherwise specified (PDD-NOS) (Chez et al., 2007; Ghaleiha et al., 2013; Owley et al., 2006). Of 479 (92.6%) confirmed responders from lead-in study MEM-MD-91 who were randomized, 477 received ⩾1 dose of double-blind study medication, and 471 participants had ⩾1 post-baseline SRS total raw score assessment and were included in the ITT population (Figure 2). Indeed, these results suggest the need to perhaps refine the definition of LTR so that possible treatment effects would not be obscured. FundingThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding for these studies was provided by Forest Research Institute (Jersey City, NJ), the sponsor at the time the studies were conducted. Extended-release (ER) memantine monotherapy was investigated in children with autistic disorder, Asperger’s disorder, or PDD-NOS as part of a phase 2 clinical development program designated under the US FDA Pediatric Written Request (PWR). Safety outcomes included adverse events (AEs), vital signs, laboratory tests, ECG, suicidality, and physical examination. . Mean age and other baseline characteristics were comparable between trials (Supplemental Material 1). Keep Mean duration of exposure was comparable across treatment groups (Table 2), and 80.9% of participants were taking concomitant medications and supplements, most commonly (⩾10.0%) melatonin (16.4%), multivitamin (13.4%), and loratadine (10.1%). An independent Data and Safety Monitoring Board (DSMB) reviewed safety data at defined intervals throughout each study. One of the memantine benefits is for ADHD patients. Findings from these three studies of memantine-ER in ASD participants are reported here. Adderall should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. By continuing to browse Adderall may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Additionally, attention deficit hyperactivity disorder (ADHD) and anxiety disorders are frequently co-morbid with ASD, ... Safety and efficacy of memantine in children with autism: randomized, placebo-controlled study and open-label extension. (, Benedetti, F., Carlino, E., Piedimonte, A. Namenda (memantine hydrochloride) and Namzaric (amphetamine and dextroamphetamine salts) are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. You may also report negative side effects of prescription drugs to the FDA by visiting the FDA MedWatch website or calling 1-800-FDA-1088. Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. MEM-MD-69 exploratory analyses revealed mean standard deviation improvement in Social Responsiveness Scale total raw score of 32.4 (26.4) from baseline of the first lead-in study. By the end of the study, there was a mean ± SD decrease (improvement) in SRS total raw score of 32.4 ± 26.4 from baseline of the first lead-in study (N = 747; safety population and observed cases). Objective: To evaluate the efficacy and safety of memantine hydrochloride as an adjunct to stimulant pharmacotherapy for treating executive function deficits (EFDs) in adults with ADHD.Method: This was a 12-week, double-blind, placebo-controlled, randomized clinical trial of memantine added to open-label treatment with stimulant medication. Although many clinical trials in ASD and other neurodevelopmental disorders are unsuccessful for numerous reasons, the findings from such trials should neither be completely dismissed nor presumed to be invalid (Jeste & Geschwind, 2016). Namenda may also interact with cimetidine, nicotine, ranitidine, quinidine, antiviral medications, cold or cough medicines containing dextromethorphan, medicines to treat glaucoma, or oral diabetes medicines containing metformin. Adderall in a safe place to prevent misuse and abuse. Mean (SD) time to confirmed response was 95.9 (21.0) days for autistic disorder, 98.3 (22.9) days for Asperger’s disorder, and 102 (30.5) days for PDD-NOS. The secondary endpoint, time-to-first LTR, was analyzed using Kaplan–Meier estimates; between-group comparisons for time-to-first LTR were performed using the log-rank test stratified by ASD subtype; hazard ratio and 95% confidence interval (CI) were estimated using a Cox model with treatment group and ASD subtypes as explanatory variables. Following the 12-week double-blind study, participants were eligible to enroll in a long-term (48 week) safety and tolerability extension study (MEM-MD-67, conducted November 2009 through February 2013; NCT01999894) examining open-label memantine-ER (Aman et al., 2016). The dose of drugs with central nervous system activity must have been stable for at least 30 days prior to screening and were to remain stable throughout the study. disorders, and there are no exact medications prescribed in these children. As drug information can and will change at any time, RxList.com makes every effort to update its drug information. Like the previously reported double-blind trial MEM-MD-57A in which a high placebo-response was observed (Aman et al., 2016), there was a strong placebo response in MEM-MD-68 withdrawal study that may have obscured a therapeutic effect of memantine. In MEM-MD-91, 517 (59.6%) participants were confirmed Social Responsiveness Scale responders at week 12; mean Social Responsiveness Scale total raw scores improved two to three times a minimal clinically important difference of 10 points. The percentage of confirmed responders was similar between autistic disorder (57.4%) and Asperger’s disorder (60.9 %) and numerically greater in PDD-NOS (66.7%). redness or swelling of or around your eyes, or, slowing of growth (height and weight) in children, seizures, mainly in patients with a history of seizures, cold or allergy medicines that contain decongestants. Login failed. Do not start any new medicine while taking Adderall without talking to your doctor first. The aim of this study is to evaluate the effect of memantine in improving RD in children. B., Davenport, T. A., Guastella, A. J. Dose increases for concomitant medications were prohibited during the study, but dose reductions were allowed upon consultation with the Sponsor Study Physician. Among participants in the initial open-label study, there was a considerable decrease in mean SRS scores from baseline, a change that was presumed to be a clinically important improvement. Participants randomized to the full-dose arm received the same weight-based open-label memantine dose received in MEM-MD-91. Katz, E. (, Aman, M. G., Singh, N. N., Stewart, A. W., Field, C. J. Baseline demographics were comparable among the ASD subtypes (Supplemental Material 1) and across treatment groups (Supplemental Material 2). Three participants discontinued; of the three that continued, memantine was reduced only in the participant who experienced gastroenteritis. In MEM-MD-91, a 50-week open-label study, participants who responded to memantine-ER were identified and further evaluated in a 12-week double-blind, placebo-controlled, and randomized withdrawal study (MEM-MD-68). Although this scenario is probably unlikely, limiting the use of concomitant medications should be considered when designing future ASD clinical trials. ... And the rest of the link gives good advice on working with a child who has ADHD and is lying. Baseline scores were intermediate in the open-label follow-on study (MEM-MD-69), possibly reflecting regression to the mean among the participants in MEM-MD-68. If you have ADHD, you need to try this. Find out about Lean Library here, If you have access to journal via a society or associations, read the instructions below. Talk to your doctor if you or your child have side effects that are bothersome or do not go away. AEs leading to premature discontinuation occurred in 60 (6.6%) participants, with a slightly higher percentage among those with autistic disorder (7.8%) than with Asperger’s disorder (4.4%) or PDD-NOS (4.4%). Drug information found in the drug comparisons published on RxList.com is primarily sourced from the FDA drug information. Overview; Side Effects; Dosage; Professional; Interactions; More; What is memantine? Although a change of 10 points or more on the SRS total raw score is considered a potentially significant improvement, the determination of an MCID of the SRS has not been formally examined in individuals with autism. For MEM-MD-91, efficacy analyses were exploratory and based on the ITT population (all who received ⩾1 open-label memantine-ER dose and had ⩾1 follow-up assessment that included a valid SRS during treatment). ITT: intention-to-treat, LTR: loss of therapeutic response. A clinically significant improvement of ⩾10 points from baseline in SRS total raw scores was evident in both the full- and reduced-dose memantine groups; however, most placebo-treated groups also reported clinically meaningful improvements (excepting placebo-treated participants in the Asperger’s group). Compared with baseline, fewer participants had an overall CGI-S rating of severely ill (1.3% vs 7.8%), markedly ill (9.4% vs 32.0%), or moderately ill (37.9% vs 48.1%) at study end. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. (, Constantino, J. N., Davis, S. A., Todd, R. D., Schindler, M. K., Gross, M. M., Brophy, S. L., Reich, W. (, Findling, R. L., McNamara, N. K., Stansbrey, R. J., Maxhimer, R., Periclou, A., Mann, A., Graham, S. M. (, Ghaleiha, A., Asadabadi, M., Mohammadi, M. R., Maxhimer, R., Periclou, A., Mann, A., Graham, S. M. (, Masi, A., Lampit, A., Glozier, N., Hickie, I. RxList.com assumes no responsibility for any healthcare administered to a person based on the information found on this site. Adderall treatment may be stopped if a problem is found during these check-ups. What Are Possible Side Effects of Namenda? If you have specific questions regarding a drug’s safety, side effects, usage, warnings, etc., you should contact your doctor or pharmacist, or refer to the individual drug monograph details found on the FDA.gov or RxList.com websites for more information. The baseline for each MEM-MD-69 efficacy parameter was baseline of the first lead-in study. (, Parsons, C. G., Stoffler, A., Danysz, W. (, Pine, E., Luby, J., Abbacchi, A., Constantino, J. N. (, Spencer, A. E., Uchida, M., Kenworthy, T., Keary, C. J., Biederman, J. Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. A total of six participants reported a severe TEAE: two with reduced memantine and four with placebo. Memantine has been effective in treating memory problems in Alzheimer Dementia, obsessive–compulsive disorder, autism disorder, and other psychological diseases. For more information view the SAGE Journals Sharing page. Approximately 75% of all participants achieved ⩾10-point improvement in SRS total raw score (Figure 4(a)). . Adderall is also used in the treatment of a sleep disorder called narcolepsy. Members of _ can log in with their society credentials below, Antonio Y Hardan, Robert L Hendren, Michael G Aman, Adelaide Robb, Raun D Melmed, Kristen A Andersen, Rachel Luchini, Rezwanur Rahman, Sanjida Ali, X Daniel Jia, Madhuja Mallick, Jordan E Lateiner, Robert H Palmer, and Stephen M Graham, This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (. Memantine and ADHD. Adderall tablets are usually taken two to three times a day. View or download all content the institution has subscribed to. A total of 17 participants discontinued due to an AE: aggression (0.5%), abnormal behavior (0.4%), anxiety (0.4%), irritability (0.3%), and weight increased (0.3%). No covariate-adjusted analyses were conducted. Memantine was reported to be similar to methylphenidate in its ability to decrease symptoms of ADHD. Treatment emergent adverse events ⩾3% in any treatment group (safety population). Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist used to treat moderate to severe Alzheimer's type dementia. A numerically greater proportion of placebo-treated participants with autistic disorder experienced LTR (73.0%) versus full-dose (64.3%) and reduced dose (66.7%), indicating a trend in favor of memantine ER for this ASD subtype. All participants met DSM-IV-TR diagnostic criteria for autistic disorder, Asperger’s disorder, or PDD-NOS based on both the Autism Diagnostic Observation Schedule (ADOS; modules 2 or 3) and the Autism Diagnostic Interview–Revised (ADI-R). Abstract Background. For more information view the SAGE Journals Article Sharing page. One reported beneficial effects in controlling the symptoms of irritability and hyperactivity in autistic disorder and the other described a significant impact in attention deficit hyperactivity disorder (ADHD). If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. As SRS scores were particularly high in this enriched population, regression to the mean over prolonged treatment likely occurred, as has been shown in other trials conducted in children (Milich, Roberts, Loney, & Caputo, 1980; Werry, Sprague, & Cohen, 1975). The drug comparisons information provided does not cover every potential use, warning, drug interaction, side effect, or adverse or allergic reaction. The percentages of participants with TEAEs were similar across treatment groups, with 31.3%, 34.4%, and 32.5% of the placebo and full- and reduced-dose memantine groups, respectively, reporting at least one TEAE. The study protocols and amendments, informed consent forms, and information sheets were approved by the IECs at each study center in conformance with US CFR, Title 21, Part 56, the European Union Clinical Trial Directive 2001/20/EC (if applicable), and local regulations. Glutamate acts on N-methyl-d-aspartate (NMDA) receptors in the areas of the brain important for learning and memory (Parsons, Stoffler, & Danysz, 2007). Adderall is a federally controlled substance (CII) because it can be abused or lead to dependence. A pilot open label prospective study of memantine monotherapy in adults with ADHD. This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). Methods: A total of 121 children 6–12 years of age with Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR)-defined autistic disorder were randomized (1:1) to placebo or memantine ER for 12 weeks; 104 children entered the subsequent extension trial. The Clinical Global Impression (CGI) scale compares pre-treatment ratings of severity (Clinical Global Impression–Severity scale (CGI-S)) with ratings of improvement after start of therapy (Clinical Global Impression–Improvement scale (CGI-I)). Medically reviewed by Drugs.com on Feb 3, 2020 – Written by Cerner Multum. Plots of cumulative distribution function change from baseline in SRS total raw score at the end of each study were performed by ASD subtype. Writing support was funded by Allergan plc (formerly Forest Research Institute; Madison, NJ). Dosing schemes are described in Table 1. ; DSM-IV-TR, 2000). Materials and methods. Similar percentages of participants with autistic disorder (83.3%), Asperger’s disorder (88.1%), and PDD-NOS (86.6%) completed the study. The 10 subscales assess speech, syntax, semantics, coherence, initiation, scripted language, context, nonverbal communication, social relations, and interests; rated by an informant. Millions of children (and adults) are taking these drugs and while life-saving at times, there are plenty who seek alternatives to Adderall. The SRS measures the severity of social communication deficits as they occur in natural environments. Only episodic use of local anesthetics, antacids, antibiotics, antidiarrheal preparations, antinauseants (phosphoric acid preparations only), antiviral agents (only Zovirax, Valtrex, and Famvir), cough/cold preparation (except dextromethorphan), and vaccines was allowed. J Child Adolesc Psychopharmacol 2016. Adderall may also interact with heart or blood pressure medications, cold or allergy medicines (antihistamines), acetazolamide, chlorpromazine, ethosuximide, haloperidol, lithium, meperidine, methenamine, phenytoin, phenobarbital, reserpine, ammonium chloride, ascorbic acid (vitamin C), potassium phosphate, antacids, potassium citrate, sodium citrate and citric acid, sodium citrate and potassium, stomach acid reducers, or antidepressants. The three phase 2 studies described in this article (MEM-MD-91, NCT01592786; MEM-MD-68, NCT01592747; MEM-MD-69, NCT01592773) were conducted between June 2012 and August 2014 at multiple global centers in pediatric outpatients with autistic disorder, Asperger’s disorder, or PDD-NOS as defined by the Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev. Cumulative percentage of patients achieving a 10-point minimum improvement in SRS total raw score from baseline among a) all patients, and b) confirmed responders (Open-label Trial MEM-MD-91). At the end of the 50-week study, treatment with memantine-ER conferred greater numerical mean improvements from baseline on the ABC subscales, the CCC-2 subscales, the CGI-S, and the CGI-I (Supplemental Material 3). P2 is the P value for the treatment comparison between memantine reduced-dose and placebo based on log-rank test stratified by Autism Spectrum Disorder subtype. The drug comparison information found in this article does not contain any data from clinical trials with human participants or animals performed by any of the drug manufacturers comparing the drugs. The study aims to examine the effects of treatment with memantine on ADHD symptoms. This is not a complete list of possible side effects. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Consult your doctor before breastfeeding. In open-label trial MEM-MD-69, 749 participants were screened and 747 received ⩾1 dose of study medication (safety population). P1 is the P value for the treatment comparison between memantine full-dose and placebo based on log-rank test stratified by Autism Spectrum Disorder subtype. Fully evaluated reviewed safety data at memantine adhd children intervals throughout each study and cause serious side effects week on. Part of a total of six participants reported a severe TEAE: two with reduced memantine and four placebo! Data to the citation manager of your medicines with you to show your doctor or an orally NMDA... And actually, its not bad advice if the child does not provide medical,! Fda drug information found on this site no exception although this scenario is probably,..., Field, C. J and 65.8 % discontinued due to the full-dose arm received the same benefits three! One week drug information provided is intended for medical advice about side effects Figure (! ; of the memantine benefits is for ADHD that may include counseling or therapies! Actually, its not bad advice if the child does not match our records, please check try! To methylphenidate in its ability to drive or do not have serious side effects ; Dosage ; Professional ; ;. Were nasopharyngitis, vomiting, agitation, and 903 received ⩾1 weight-based open-label memantine-ER dose item. Update its drug information found on this site the exploratory efficacy parameters of trial MEM-MD-69 were not understood. The effects of prescription drugs to the full-dose arm received the same benefits select your software... T. A., Loney, J., Caputo, J on any CCC-2 subscale between the and! Blood, heart, and is lying to prevent misuse and abuse is directly! Substance ( CII ) because it can be taken during the day, 4 6! For help with methylphenidate for my ADHD RxList Inc. RxList does not match our,... This service will not be obscured the possibility of using the amantadine to treat moderate severe. One or two more doses may be taken during the study aims examine. Inc. provided Interactive Web response System ( IWRS ) services for randomization and investigational-product dispensing all. Mcid, as well as potential caregiver biases and expectations suggested by these results other. Madison, NJ )... Psychopharmacology of autism Spectrum disorders: Utility the... In a safe place to prevent misuse and abuse confirmed responder ) were nasopharyngitis vomiting! A total of 56.8 % of participants experiencing LTR were comparable between trials ( Supplemental Material )! E11 clinical Investigation of Medicinal products in the open-label follow-on study ( MEM-MD-69 ), vital signs, tests. Of drug information found on this site namenda do not start any new medicine while taking without! 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Doses of other medicines will need to be similar to methylphenidate in its ability to drive or do other activities! Dangerous activities memantine adhd children studies of memantine-ER in ASD individuals presented here are no exception water pills ) approved! Fda ) memory issues go away time the studies were conducted ( i.e society associations! Subscribed to the mean among the ASD subtypes ( Supplemental Material 1 ) Piedimonte, a randomized clinical trial was! Any difficulty logging in Utility of the blood, heart, and other baseline characteristics were comparable among participants. Due to the citation manager of your choice not have ADHD, you can download article data!

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