DOCSLIB.ORG

Addressing the Unique Issues of Student Athletes with ADHD

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Addressing the Unique Issues of Student Athletes with ADHD Online Exclusive Adam E. Perrin, MD; Vijay M. Jotwani, MD Addressing the unique issues Department of Family Medicine, University of Connecticut School of of student athletes with ADHD Medicine, Farmington (Dr. Perrin); Methodist Hospital Center for Sports The impact of ADHD depends on an individual’s Medicine, Houston, Texas symptoms and chosen sport, which, along with specific (Dr. Jotwani) aperrin@stfranciscare. medication recommendations and cautions, help direct org treatment choices. The authors reported no potential conflict of interest relevant to this article. he symptoms typical of attention-deficit/hyperactiv- PrActicE ity disorder (ADHD)—inability to focus concentration rEcommendations and maintain attention span, and associated hyper- › T Schedule twice-monthly activity—impair normal daily functioning and cause distress visits when prescribing a for affected individuals.1 For the student athlete with ADHD, psychostimulant to assess sports are a natural outlet, fulfilling the need to be active. In the symptom control, review case of a developing child with ADHD, involvement in sports adverse effects, and record often is a haven from negative feedback that can occur in the blood pressure, pulse, height, and weight in determining classroom and an environment in which to experience success. the optimal dose. C Symptoms of ADHD also may offer an advantage in sports. Impulsivity, or the ability to act without reflection, en- › Keep in mind that using ables quick decision-making and the spontaneity required of a a psychostimulant can put quarterback or point guard.2 Well-known athletes with ADHD endurance athletes at risk for heat-related injury. C have said that while tasks requiring long stretches of concen- tration are difficult, aspects of their sport involving instanta- › Advise college-bound neous reactions help them to succeed. Evidence also shows athletes that the NCAA a statistically significant decrease in markers of anxiety and requires a therapeutic use exemption for those who take depression among ADHD subjects with higher levels of sports 3 psychostimulant participation. medications. C Given the positive experience sports can provide, children and adolescents with ADHD are likely to continue participat- strength of recommendation (SOR) ing and be as large a segment of youth athletes as they are of the A Good-quality patient-oriented 2,4 evidence general population. Primary care providers often treat student B Inconsistent or limited-quality athletes, and in this article we discuss the need for accurate di- patient-oriented evidence agnosis through comprehensive clinical evaluation, proper use C Consensus, usual practice, opinion, disease-oriented of psychostimulant medication and other available treatments, evidence, case series and special health concerns for athletes who have ADHD. Diagnosis: the need for awareness and accurate evaluation The worldwide prevalence of ADHD is 5.3%.5 In the United 6,7 States, it is 8.7% among adolescents and 4.4% among adults. conTinued jfponline.com Vol 63, no 5 | mAY 2014 | The journAl of FamilY prAcTice E1 tABlE 1 Differential diagnosis for inattention and hyperactivity1,3,4,6 psychiatric conditions Systemic medical conditions environmental factors neurologic conditions major depression hyperthyroidism Abuse or neglect hearing deficits Generalized anxiety disorder lead or other toxicities disruptive environment petit mal and partial complex seizures obsessive-compulsive disorder hepatic disease Giftedness or cultural factors post-concussion syndrome Substance abuse Sleep apnea learning disability conduct disorders Tourette syndrome personality disorders pervasive developmental disorders (eg, autism) One study of NFL athletes found that 14 of the student athlete with a legitimate need for 159 players studied had either ADHD or a treatment from one who is fine and merely learning disability for a combined prevalence looking for a performance enhancer.9 More- of 8.8%.8 ADHD is diagnosed 3 times more over, having a comprehensive assessment often in males than females9; however, stud- with diagnostic confirmation already in place ies have shown no gender effect on ADHD, when an individual enters college greatly fa- and referral patterns contribute to the higher cilitates completion of National Collegiate prevalence pattern for males.10 Athletic Association (NCAA) medical exemp- ADHD usually is diagnosed in child- tion documentation. hood, but increasingly, it is not established z Essential diagnostic steps. The until adolescence or adulthood.2,9 Although core clinical evaluation should cover the there is no age limit for the diagnosis, the following: Diagnostic and Statistical Manual of Mental • Ensure that DSM-5 criteria are met. Disorders (DSM-5) calls for the presence of • Obtain objective reports to confirm some symptoms before age 12, and symp- the presence of symptoms in multiple toms must cause impairment of function- settings. Commonly applied symptom ing in multiple settings.1 While hyperactivity assessment scales include the Brown, symptoms may decrease over time, a signifi- Vanderbilt, and Connors question- cant number of children and adolescents will naires administered to parents, teach- experience inattention symptoms into adult- ers, and adolescent patients mature hood.11 In fact, the disorder may not become enough to complete a self-evaluation. evident until college entry, when academic • Determine whether comorbid condi- demands overwhelm an individual’s usual tions are present. coping strategies.2 • Rule out medical conditions that can z Multiple reasons for an accurate di- mimic ADHD (eg, lead toxicity or thy- agnosis. Initiate evaluation for ADHD for roid disorder). any child 4 to 18 years of age who exhibits symptoms of inattention, hyperactivity, or No neurocognitive or laboratory test for impulsivity to such a degree that it causes ADHD has sufficient sensitivity and speci- distress or impairment at home, at school, or ficity to qualify as a standard diagnostic on the sports field.12 Making an accurate di- test.2,13 In the future, advanced neuroimaging agnosis of ADHD is vital in student athletes may provide a means of diagnosing ADHD. given that treatment, or lack thereof, may put Functional magnetic resonance imaging has their health at risk and adversely impact their shown characteristic patterns of reduced ac- academic and athletic performances. Diag- tivation in the basal ganglia, frontal lobe, and nostic accuracy also aids in distinguishing parietal lobes in patients with ADHD.14 E2 The journAl of FamilY prAcTice | mAY 2014 | Vol 63, no 5 STUDENT ATHLETES with adhd z The differential diagnosis for symp- that has shown benefit is behavior therapy, toms of inattention and hyperactivity is which includes a broad set of specific inter- large (tABlE 1).1,3,4,6 Once underlying medical ventions that modify physical and social en- conditions have been ruled out, screen the vironments to change behavior.19 Behavioral patient for mental disorders, including de- training, which primary care providers can pression and mood disorders, anxiety, and introduce to parents, teachers, and coaches, conduct disorders, before concluding that involves the simple principles of reinforcing symptoms are likely due to ADHD. When desired behavior through reward and ignor- compared with mood disorders, a patient ing undesired behavior to reduce or elimi- with ADHD will have a persistent course of nate it. Consistent application of rewards or symptoms rather than periods of recurring unresponsiveness helps patients increase and remitting symptoms.2 ADHD is a chron- attention to instructions, comply with rules, ic condition that raises special health care improve productivity, and decrease disrup- concerns for children and adolescents.12 As tive behavior.20 many as two-thirds of children with ADHD The athlete with ADHD will benefit from have at least one coexisting neuropsychi- a structured environment and, depending on atric condition, and symptoms may over- age and level of maturity, can be educated lap, making for a significant diagnostic and by coaches on self-management strategies management challenge.9 Difficult cases may such as time management, effective planning necessitate consulting a specialist (psychia- and organization, and avoidance of distrac- Accurate trist, neurologist, or neuropsychologist) for tions.20 Exercise may help relieve subjective diagnosis is guidance. Additionally, in ADHD youth the symptoms of ADHD and comorbid mood needed to overall risk of developing a substance use disorders, but evidence is insufficient to de- distinguish a disorder is twice that of children who do not termine its direct impact on ADHD. legitimate need have ADHD.2,15 for treatment Pharmacologic treatment from an Of the many available medications used to unwarranted treatment: More than medication treat ADHD (tABlE 2),9,12,16,18,20,21 psychostim- request for Effective treatment for ADHD improves qual- ulants are most effective for reducing core a stimulant. ity of life, decreases the rate of substance symptoms of the disorder.22 It is estimated abuse, reduces errors when driving vehicles, that 56% of patients with ADHD receive drug and decreases the prevalence of comorbid therapy, and most of these drugs are psycho- psychological disorders.16,17 Pharmacologic stimulants.16 These agents increase dopa- and nonpharmacologic options are avail- mine and norepinephrine concentrations in able. With athletes, it’s important to be aware the brainstem, midbrain, and frontal cortex,
Load more

Recommended publications
  • Are Prescription Stimulants “Smart Pills”?
    University of Pennsylvania ScholarlyCommons Neuroethics Publications Center for Neuroscience & Society 9-2011 Are Prescription Stimulants “Smart Pills”? M. Elizabeth Smith University of Pennsylvania Martha J. Farah University of Pennsylvania, [email protected] Follow this and additional works at: https://repository.upenn.edu/neuroethics_pubs Part of the Bioethics and Medical Ethics Commons, Neuroscience and Neurobiology Commons, Neurosciences Commons, and the Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Smith, M., & Farah, M. J. (2011). Are Prescription Stimulants “Smart Pills”?. Psychological Bullentin, 137 (5), 717-741. http://dx.doi.org/10.1037/a0023825 This paper is posted at ScholarlyCommons. https://repository.upenn.edu/neuroethics_pubs/96 For more information, please contact [email protected]. Are Prescription Stimulants “Smart Pills”? Abstract Use of prescription stimulants by normal healthy individuals to enhance cognition is said to be on the rise. Who is using these medications for cognitive enhancement, and how prevalent is this practice? Do prescription stimulants in fact enhance cognition for normal healthy people? We review the epidemiological and cognitive neuroscience literatures in search of answers to these questions. Epidemiological issues addressed include the prevalence of nonmedical stimulant use, user demographics, methods by which users obtain prescription stimulants, and motivations for use. Cognitive neuroscience issues addressed include the effects of prescription stimulants on learning and executive function, as well as the task and individual variables associated with these effects. Little is known about the prevalence of prescription stimulant use for cognitive enhancement outside of student populations. Among college students, estimates of use vary widely but, taken together, suggest that the practice is commonplace.
    [Show full text]
  • Total Force Fitness for Endurance Events
    TOTAL FORCE FITNESS FOR ENDURANCE EVENTS 30 October 2019 CONTENTS INTRODUCTION 3 SECTION 1 : TRAINING 4 CHAPTER 1: THE SUPPORT YOU NEED TO CROSS THE FINISH LINE 5 CHAPTER 2: STRESS-FRACTURE PREVENTION: ENDURANCE-TRAINING EDITION 7 CHAPTER 3: HEAT-ILLNESS PREVENTION 8 CHAPTER 4: WHEN “RUBBING DIRT IN IT” ISN’T THE ANSWER 9 CHAPTER 5: EVERYDAY PERFORMANCE NUTRITION 11 CHAPTER 6: ENDURANCE-TRAINING WORKOUT PLANNING 16 WORKSHEET: TRAINING GOALS PLANNER 17 WORKSHEET: CARDIO PLANNER 19 WORKSHEET: WEIGHT-TRAINING PLANNER 21 CHAPTER 7: IMAGINE YOUR WAY TO BETTER PERFORMANCE 22 WORKSHEET: BUILD AN IMAGERY SCRIPT 23 CHAPTER 8: TRAINING NUTRITION 28 CHAPTER 9: THE RUNNER’S CORNER 33 SECTION 2: EVENT 37 CHAPTER 10: CHECKLIST FOR ENDURANCE ATHLETES 38 CHAPTER 11: CHECKLIST FOR FAMILY AND FRIENDS OF ATHLETES 40 CHAPTER 12: OPTIMIZE PERFORMANCE THROUGH POSITIVE SELF-TALK 42 CHAPTER 13: GOT ANXIETY? GET EXCITED INSTEAD! 44 CHAPTER 14: PRE-EVENT AND EVENT-DAY NUTRITION STRATEGIES 45 SECTION 3: RECOVERY 47 CHAPTER 15: FINISH STRONG: RECOVERY NUTRITION 48 CHAPTER 16: ACTIVE AND PASSIVE RECOVERY 49 CHAPTER 17: ENDURANCE EVENT AFTER-ACTION REVIEW (AAR) 52 2 TOTAL FORCE FITNESS FOR ENDURANCE EVENTS INTRODUCTION Optimal performance requires more than just physical prowess. Many other factors play a role in your endurance performance. This Human Performance Resources by CHAMP Total Force Fitness for Endurance Events guide contains hundreds of evidence-based tips to help you maximize your training and recov- ery for peak performance on race day. It brings the concept of Total Force Fitness for Military Service Members to the arena of athletic endurance.
    [Show full text]
  • Physical Education Fitness Plan Study Guide
    Physical Education Fitness Plan Study Guide The following topics will be covered on the assessment: • Components of health-related fitness (flexibility, body composition, cardiorespiratory endurance, muscular strength, and muscular endurance) • FITT Principle • Training Principles • Components of skill-related fitness (agility, balance, coordination, power, reaction time, and speed) • Careers in health and fitness • Fitness assessments(e.g., Presidential Fitness Challenge) • Fitness logs and goal setting throughout life • Health and Fitness Plans • Safety Principles • R.I.C.E • Warm up/Cool down This packet includes the following documents to help you study: 1. Lake Washington School District Fitness Power Standards that will be covered on the assessment 2. Lake Washington School District Proficiency Scales for the standards that will be covered on the assessment 3. Information to help you study for the assessment Addition information can be found at: • Careers in health and fitness: https://www.shapeamerica.org/career/fields/ • Fitness assessments: https://www.hhs.gov/fitness/index.html • Fitness and changes of life http://www.apa.org/pi/aging/resources/guides/older.aspx 9/2021| Curriculum and Assessment documents by Lake Washington School District are licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. 1 Fitness Level II | Power Standards 3. Understands the components of health-related fitness and interprets information from feedback, evaluation, and self-assessment in order to improve performance. 4. Understands the components of skill-related fitness and interprets information from feedback, evaluation, and self-assessment in order to improve performance. 5. Develops and monitors a fitness plan. Please note: Power standards 1 and 2 are movement standards so will not be assessed on the Fitness Knowledge Assessment.
    [Show full text]
  • Fitness, Dance, and Health
    Commentary Fitness, Dance, and Health Karen S. Clippinger, M.S.P.E. t first glance, past dance study cardiovascular fitness, but also in their to fitness: results have been somewhat implications for energy expenditure 1.A shift from emphasizing cardio- A disappointing from a cardio- and body composition. For example, respiratory fitness or athletic fitness respiratory fitness perspective. For an elite distance runner could readily toward health-related fitness; example, various studies have shown burn 600 kcal in an hour of running, 2.A shift in emphasis toward encour- that dance, or at least ballet and mod- resulting in approximately 6,000 kcal aging frequent more moderate exercise ern dance, only provide a moderate burned from 10 hours of running in with a greater variety of forms and stimulus for cardiovascular develop- a week. In contrast, an elite female formats; and ment. Although there appears to be ballet dancer is likely to burn only 3.A focus on encouraging involve- some variability between differing 200 kcal from a one hour advanced/ ment of more people in regular physi- dance styles and levels,1 studies have professional ballet class,3 resulting in cal activity, particularly groups that shown that professional and university approximately 2,000 versus 6,000 have been less responsive to the fitness ballet and modern female dancers kcal burned from 10 hours of train- movement — females, elderly, less af- ° generally have VO2 max values in the ing. Due to this contrasting energy fluent individuals, and non-Caucasian low to mid 40s (mean values of eight expenditure, it is easy to see why ethnic groups.
    [Show full text]
  • Effects of Indigenous Aerobic Dance Music on the Physiological Variables of Female Workers in Lagos Metropolis Grace O
    Effects of Indigenous Aerobic Dance Music on the Physiological Variables of Female Workers in Lagos Metropolis Grace O. Otinwa*, Ph.D. (corresponding author) Aerobic dance allows for maintenance and connection to everyday [email protected] life because it gives a feeling of enjoyment and promotes social +234 805 515 7540 interaction, physical fitness and a sense of community appreciation Department of Human Kinetics and Health Education of aesthetics. Aerobic dance is a form of physical activity that University of Lagos, Akoka Lagos, Nigeria is more likely to be adopted as part of exercise program for the middle aged than other forms of activities (Justin, Keogh, Philippa, Jane S. Akinyemi, M.Sc. (Ed.) Linda & Dawn). Aerobic dance as a symbol of quest for fitness, [email protected] hinges on the use of large muscle groups in a continuous rhythmic +234 802 311 4062 movement at an intensity and duration sufficient to stress the Department of Human Kinetics and Health Education cardiovascular and respiratory system at 50% to 80% of maximum University of Lagos, Akoka Lagos, Nigeria oxygen consumption. Aerobic dance is also a combination of dance step patterns and other whole body movements including Abstract walking, jogging, hopping, skipping, jumping and kicking Nigeria has a diversified culture with huge cultural resources accompanied with rhythmic beat of popular music that is drawn for entertainment which includes rich songs composed for various from various dance forms such as rock, blues, jazz, juju or high social and religious functions. Even though dance movement life (Awopetu, 2007). Aerobic dance exercise is engaged by the is involved, traditional music and dance are not structured for beat of the music carefully selected to match the tempo or pace physical fitness.
    [Show full text]
  • Planning for Physical Fitness
    Lesson 6: Planning for Physical Fitness Introduction In this lesson students review the basics of physical fitness, including definitions of physical fitness health- and skill-related fitness components principles of fitness development the FITT principle resistance training At the completion of this lesson students develop and implement an exercise routine as part of their personal physical activity practicum (see Module A). ________________________________________________________________________________ Specific Learning Outcomes 11.FM.4 Demonstrate an understanding of the concepts and principles related to the development and implementation of a personal physical activity plan. Examples: cardiorespiratory endurance/aerobic fitness, musculoskeletal fitness, training principles, FITT (frequency, intensity, time, type) principle 11.FM.5 Design, implement, evaluate, and revise an exercise routine that contributes to the health-related fitness components. Examples: resistance training, walking, running programs ________________________________________________________________________________ Key Understandings Physical fitness is a complex concept related to the effects of physical activity on the human body. Physical fitness comprises health- and skill-related components. The development of physical fitness is governed by the FITT principle. Planning is important for successful physical fitness development. ________________________________________________________________________________ _____________________________________________________________________________
    [Show full text]
  • Training for Cardiovascular Fitness, Continued
    Training for Cardiovascular Fitness, Continued UNIVERSITY SPORTS MEDICINE Training for Cardiovascular Fitness What’s in it for me? Cardiovascular (aerobic) exercise: • increases your energy and stamina • helps control blood pressure • improves your blood lipid profile (cholesterol) • helps you burn extra calories to maintain an ideal weight. Aerobic power helps an athlete sustain a challenging exercise pace over time. When you get tired, your movements are no longer fluid and efficient. You are more likely to make mistakes or get injured. Even though you can expect benefits from engaging in cardiovascular exercise, not all exercises are suitable or safe for everyone. You should, therefore, consult with your doctor before beginning any exercise program. The information provided in this handout should not substitute for medical counseling specific to you. What kind of exercise will most improve my cardiovascular fitness? Cardiovascular exercise is any activity that: • involves the large muscles of the body (especially the legs) • is rhythmic and continuous in nature (as opposed to stop-and-start) • challenges your heart and lungs to work harder. Activities like walking, jogging, running, cycling, swimming, aerobics, rowing, stair climbing, hiking, cross country skiing and many types of dancing are “pure” aerobic activities. Sports such as soccer, basketball, squash and tennis may also improve your cardiovascular fitness. However, endurance training could improve performance in these sports. Athletes typically use three training methods to improve their cardiovascular fitness: • slow to moderate-intensity distance training • moderate to high-intensity interval training • high-intensity continuous exercise. What’s the best type of cardiovascular exercise? The best type is any exercise you enjoy and will continue to do! Select an activity that matches your personal preferences and health and fitness status.
    [Show full text]
  • Strength and Endurance
    Week 4: Managing Energy Strength and Endurance What are Strength and Endurance? Strength training—also known as resistance training—refers to exercise that causes muscles to contract against resistance. This helps to build muscle strength, mass, and tone. Strength training also helps increase muscular endurance—the capacity of a muscle or muscle group to engage in physical activities for longer periods of time before fatigue sets in. Endurance is essential for any activity, whether it be a sport or cleaning your home. If your muscles can work longer, you will have a greater ability to sustain the activities of everyday life, including your fitness program. Developing a Strength Training Program Three things need to be considered as you put together a weight-training program that will help build strength and endurance: • Repetitions and Sets: Repetitions are the number of times you lift a weight, or one complete cycle of an exercise. You should perform 8-15 reps of 8-10 different exercises that, together, target all the major muscle groups. With a set, you will perform an exercise for a given number of repetitions, rest for a period of time, then repeat the exercise. The number of repetitions per set and sets for each exercise depend on your specific goals. Two to three sets of each exercise are usually recommended. Be sure to include one to two minute rest periods between sets of each exercise, or long enough to catch your breath. • Resistance: Many things can be used as resistance in strength training exercises, such as your own body weight against gravity, free weights, weight machines, resistance bands, and medicine balls.
    [Show full text]
  • Understanding and Enhancing Crew Endurance
    Understanding and Enhancing Crew Endurance Megan L. Moundalexis, Jennifer A. B. McKneely, William B. Fitzpatrick, and Cory C. Sheffer arfighters possess steadfast dedication while conduct- ing operations to maintain national security. Regardless of their motivation, however, working long hours in extreme conditions can compromise alertness and performance. Certain factors, such as sched- ules, sleep needs, lighting, nutrition, diet, and exercise, can be managed to support crew endurance. Several U.S. service branches have adopted crew endurance manage- ment (CEM) programs to decrease operational risk and increase mission readiness by educating and training personnel on endurance risks and management strategies. APL is currently investigating how performance stressors impact operations and how these stressors can be managed. A holistic approach involving management strategies, edu- cation, and training is recommended to enhance crew endurance. Continued research is needed to develop appropriate monitoring and management tools and strategies. This article describes the state of research on CEM as well as work APL is currently undertaking in this arena. INTRODUCTION Warfighters are essential to the security of our nation. ness (SA) to make good risk-based decisions.1, 2 Under- High standards are in place, requiring crews to perform standing how crews can safely maintain performance consistently at high levels in extreme conditions over while undergoing physical, environmental, physiologi- extended periods of time. Such performance often comes cal, and psychological challenges on the job is critical at a cost to the crew members’ stamina, which may lead to the support of our nation’s most valuable asset.3 This to operational risks. Sustained and continuous opera- ability has been termed crew endurance.
    [Show full text]
  • HPLC Determination of Amphetamine and Guanfacine
    HPLC Determination of Amphetamine and Guanfacine HonorsProject Infulfillmentof the Requirements for The EstherG. Maynor Honors College UniversityofNorthCarolinaat Pembroke By Kendra Dorn Department of Chemistry and Physics December 11, 2015 Name Date Honors College Scholar Name Date FacultyMentor Name Date MHC Se/ior Proj nator cr Abstract: Stimulant medications are most often prescribed for the treatment of attention deficit hyperactivity disorder (ADHD) and fetal alcohol syndrome (FAS). However, about 20% of the children taking stimulants do not have much symptom relief or they suffer from side effects. As a result, adjunctive therapy is often recommended. One approach is to prescribe Intuniv® (guanfacine) with an ADHD stimulant medication such as Adderall® (amphetamine). Many research studies report that Intuniv® given in combination with a stimulant leads to significant improvements in ADHD and impulsivity symptoms. Therefore, the purpose of this research is to develop an HPLC method to simultaneously determine the concentration of amphetamine and guanfacine in dosage form, which could then be used in the analysis of biological fluids. Introduction: The research being conducted in this project has not been the only kind done. There has been much research done on the basis of determination or identification of amphetamine and/or guanfacine in biological samples. Throughout all the research, there has been one common motive: develop a method of determination that is effective enough for guanfacine or amphetamine to be quantified in the biological samples. The various methods for determining guanfacine specifically include high-performance liquid chromatography1,2, spectrofluorimetric determination3, dried blood spot technology4, liquid chromatography-tandem mass spectrometry5, gas chromatography-mass spectrometry6, and spectrophotometry7.
    [Show full text]
  • 021303Orig1s005
    CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 021303Orig1s005 Trade Name: ADDERALL XR Generic or Proper Dextroamphetamine Saccharate , Amphetamine Name: Aspartate Monohydrate Dextroamphetamine Sulfate Amphetamine Sulfate Sponsor: Shire Approval Date: 08/11/2004 Indication: ADDERALL XR™ is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). CENTER FOR DRUG EVALUATION AND RESEARCH 021303Orig1s005 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters X Labeling X REMS Summary Review X Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review(s) X Chemistry Review(s) X Environmental Assessment Pharmacology Review(s) Statistical Review(s) X Microbiology / Virology Review(s) Clinical Pharmacology/Biopharmaceutics Review(s) X Other Reviews X Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s) X CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 021303Orig1s005 APPROVAL LETTER NDA 21-303/S-005 Page 2 69009) and was effective June 8, 2004. For additional information, consult the following guidance for industry: Regulatory Submissions in Electronic Format – Content of Labeling (February 2004). Pediatric Research Equity Act (PREA) All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are waiving the pediatric study requirement for ages less than 6 years and deferring pediatric studies for ages 13 to 17 years for this application. Your deferred pediatric studies required under section 2 of the Pediatric Research Equity Act (PREA) are considered required postmarketing study commitments.
    [Show full text]
  • PE Fitness Components.Pdf
    The 5 Fitness Components 1. Cardiovascular (aerobic) – Cardiovascular fitness is how efficient the heart, lungs and blood vessels work during activity. 2. Muscular Endurance – How long you can sustain activities like: sit- ups, push-ups, rowing, running uphill and other muscle building exercises is muscular endurance. 3. Flexibility – The range of motion of your joints and muscles and your ability to stretch is flexibility. 4. Muscular strength – How much hard work your muscles can do and how explosive and quick you are is muscular strength 5. Body composition (fat to muscle ratio) – Your body should have a high percent of muscle and a low percent of fat to be healthy. CARDIOVASCULAR FITNESS - AEROBICS (means with oxygen) Aerobic exercise would be any large muscle movement done in a continuous and repetitive way for a long period of time. It is recommended that the exercises continue for at least 20 minutes at a pace, which raises the heart rate 60% to 80% of the maximum heart rate (MHR) and the increases respiration. The FIT (frequency, intensity, time) principle for an aerobic workout is: F (frequency) – exercise 3 to 5 times a week I (intensity) – keep your heart rate at about 60% - 80% of MHR T (time)– Exercise continuously for 20 minutes Cardiovascular exercise is the most important to maintain weight and health. DIFFERENT TYPES OF AEROBIC EXERCISE Aerobic exercises can be running or jogging, walking briskly, swimming laps, bicycling, dancing, rope jumping, stair climbing, playing handball, racket ball, squash, basketball, soccer, or interval training. TYPES OF AEROBIC CLASSES 1. High Impact – Doing large muscle movements with vigor.
    [Show full text]