[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-298048-105":59,"doc-detail-298048-en":131},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":124,"head_meta":126,"extra_data":128,"updated_unix":130},105,"en","adderall-nda-11-522s-040-medication-guides-and-clinical-pharmacology","ADDERALL® NDA 11-522/S-040 Medication Guides and Clinical Pharmacology","","Medication information for ADDERALL® (NDA 11-522/S-040, revised March 2007) emphasizes the high abuse potential of amphetamines and the need to avoid prolonged administration due to risk of drug dependence. It warns that misuse may cause sudden death and serious cardiovascular adverse events. The document provides formulation description, inactive ingredients and tablet color strengths, and details pharmacodynamics and pharmacokinetics including absorption timing, elimination half-life differences, dose proportionality, and metabolism and urinary recovery dependencies on pH and urine flow. It also states indications for ADHD and narcolepsy with DSM-IV criteria for ADHD.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/adderall-nda-11-522s-040-medication-guides-and-clinical-pharmacology/298048/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/adderall-nda-11-522s-040-medication-guides-and-clinical-pharmacology/298048.png","ImageObject",300,407,{"name":92,"@type":93},"Emma Mercer","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-22","2026-09-18",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What safety warnings are highlighted for amphetamines in this document?","Question",{"text":113,"@type":114},"It stresses that amphetamines have a high potential for abuse, that prolonged administration may lead to drug dependence, and that misuse may cause sudden death and serious cardiovascular adverse events.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"How are the ADDERALL® components described?",{"text":118,"@type":114},"The product is described as a single-entity amphetamine combination using neutral sulfate salts, including dextroamphetamine components and amphetamine components specified in the description section.",{"name":120,"@type":111,"acceptedAnswer":121},"What conditions and criteria are used for diagnosing ADHD in the indications section?",{"text":122,"@type":114},"The document states ADHD diagnosis implies hyperactive-impulsive or inattentive symptoms causing impairment before age 7, present in at least two settings, with clinically significant impairment and not better explained by another mental disorder; for the inattentive type, at least six symptoms must persist for at least 6 months.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},298048,1790072470,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146},962084925502,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","NDA 11-522/S-040 Page 3  \nADDERALL® (CII)  \n(MEDICATION GUIDES ATTACHED)  \nREVISED MARCH 2007  \n11001191  \nRX ONLY  \nAMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.  \nMISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.  \nDESCRIPTION:  \nA single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and  \namphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.  \nInactive Ingredients:  \nLACTITOL, MICROCRYSTALLINE CELLULOSE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, AND OTHER INGREDIENTS.  \nColors:  \nADDERALL® 5 MG IS A WHITE TO OFF-WHITE TABLET, WHICH CONTAINS NO COLOR ADDITIVES.  \nADDERALL® 7.5 MG AND 10 MG CONTAIN FD & C BLUE \\#1 .  \nADDERALL® 12.5 MG, 15 MG, 20 MG AND 30 MG CONTAIN FD & C YELLOW \\#6 AS A COLOR ADDITIVE.  \nNDA 11-522/S-040 Page 4  \nCLINICAL PHARMACOLOGY:  \nPharmacodynamics  \nAmphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.  \nPharmacokinetics  \nADDERALL® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1 . Following administration of a single dose 10 or 30 mg of ADDERALL® to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and lamphetamine. The mean elimination half-life (t 1/2) for d-amphetamine was shorter than the t 1/2 ofthe l-isomer (9.77-11 hours vs. 11.5-13.8 hours). The PK parameters (Cmax, AUC0-inf) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.  \nThe effect of food on the bioavailability of ADDERALL® has not been studied.  \nMetabolism and Excretion:  \nAmphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain a or ß carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.  \nAmphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.  \nWith normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30%-40% of the dose is recoverable in urine as amphetamine ","cbCaik8aet0QilAh","https://ap.wps.com/l/cbCaik8aet0QilAh","pdf",265044,15,"English","# Medication Guides\n## Abuse potential and safety warnings\n# Description and composition\n## Inactive ingredients and tablet colors\n# Clinical Pharmacology\n## Pharmacodynamics\n## Pharmacokinetics\n# Indications\n## Attention Deficit Hyperactivity Disorder (ADHD)\n## Narcolepsy","[{\"question\":\"What safety warnings are highlighted for amphetamines in this document?\",\"answer\":\"It stresses that amphetamines have a high potential for abuse, that prolonged administration may lead to drug dependence, and that misuse may cause sudden death and serious cardiovascular adverse events.\"},{\"question\":\"How are the ADDERALL® components described?\",\"answer\":\"The product is described as a single-entity amphetamine combination using neutral sulfate salts, including dextroamphetamine components and amphetamine components specified in the description section.\"},{\"question\":\"What conditions and criteria are used for diagnosing ADHD in the indications section?\",\"answer\":\"The document states ADHD diagnosis implies hyperactive-impulsive or inattentive symptoms causing impairment before age 7, present in at least two settings, with clinically significant impairment and not better explained by another mental disorder; for the inattentive type, at least six symptoms must persist for at least 6 months.\"}]","ADDERALL® NDA 11-522/S-040 Medication Guides and Clinical Pharmacology | PDF",1789750216,38]