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The text emphasizes high abuse potential and risks including drug dependence, non-therapeutic use or distribution concerns, misuse-associated sudden death, and serious cardiovascular adverse events. It describes composition across 5–30 mg strengths, inactive ingredients, pharmacodynamics involving norepinephrine and dopamine reuptake and release, and pharmacokinetics showing delayed Tmax (~7 hours) and linear kinetics with food effects on Tmax.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/adderall-xr-drug-safety-warnings-and-pharmacology-nda-21-303s-010-page-3-5/564665/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/adderall-xr-drug-safety-warnings-and-pharmacology-nda-21-303s-010-page-3-5/564665.png","ImageObject",442,249,{"name":88,"@type":89},"mieayamfan","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-11-01","2026-10-12",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",8,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What safety risks does the document highlight for amphetamines in ADDERALL XR?","Question",{"text":109,"@type":110},"It warns that amphetamines have a high potential for abuse and that prolonged administration may lead to drug dependence. It also emphasizes risks related to misuse, including sudden death and serious cardiovascular adverse events.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How does ADDERALL XR® delivery differ from immediate-release ADDERALL®?",{"text":114,"@type":110},"ADDERALL XR® is an extended-release, once-daily product with a double-pulsed delivery design intended to prolong amphetamine release compared with the conventional immediate-release tablet formulation.",{"name":116,"@type":107,"acceptedAnswer":117},"What pharmacokinetic effect is reported for ADDERALL XR® compared with immediate-release?",{"text":118,"@type":110},"The time to reach maximum plasma concentration (Tmax) for ADDERALL XR® is about 7 hours, roughly 4 hours longer than immediate-release.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},564665,1792171142,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":47},962090893677,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","NDA 21-303/S-010 Page 3  \nADDERALL® XR CAPSULES CII Rx Only  \nAMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC 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  \nADDERALL XR® is a once daily extended-release, single-entity amphetamine product. ADDERALL XR® combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR® capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from ADDERALL XR® compared to the conventional ADDERALL® (immediaterelease) tablet formulation.  \nEACH CAPSULE CONTAINS:  5 mg 10 mg 15 mg 20 mg 25 mg 30 mg  \nDextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg  \nAmphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg  \nAmphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg  \nTotal amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg  \nInactive Ingredients and Colors: The inactive ingredients in ADDERALL XR® capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue \\#2 . The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.  \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  \nPharmacokinetic studies of ADDERALL XR® have been conducted in healthy adult and pediatric (6-12 yrs) subjects, and adolescent (13-17 yrs) and pediatric patients with ADHD. Both ADDERALL® (immediaterelease) tablets and ADDERALL XR® capsules contain d-amphetamine and l-amphetamine salts in the ratio of 3:1 . Following administration of ADDERALL® (immediate-release), the peak plasma concentrations occurred in about 3 hours for both d-amphetamine and l-amphetamine.  \nThe time to reach maximum plasma concentration (Tmax) for ADDERALL XR® is about 7 hours, which isabout 4 hours longer compared to ADDERALL® (immediate-release) . This is consistent with the extendedrelease nature of the product.  \nNDA 21-303/S-010 Page 4  \nMEAN PLASMA CONCENTRATIONS OF DEXTRO AND LEVOAMPHETAMINE (ng/mL)  \n30  \n25  \n20  \n15  \n10  \n5  \n0  \nDEXTROAMPHETAMINE ADDERALL XR® 20 mg qd ADDERALL® 10 mg bid  \nLEVOAMPHETAMINE ADDERALL XR® 20 mg qd ADDERALL® 10 mg bid  \n0 4 8 12 16 20 24  \nTIME (HOURS)  \nFigure 1 Mean d-amphetamine and l-amphetamine plasma concentrations following administration of ADDERALL XR® 20 mg (8am) and ADDERALL® (immediate-release) 10 mg bid (8am and 12 noon) in the fed state.  \nA single dose of ADDERALL XR® 20 mg capsules provided comparable plasma concentration profiles of both d-amphetamine and l-amphetamine to ADDERALL® (immediate-release) 10 mg bid administered 4 hours apart.  \nThe mean elimination half-live for d-amphetamine is 10 hours in adults; 11 hours in adolescents aged 13-17 years and weighing less than or equal to 75 kg/165 lbs; and 9 hours in children aged 6 to 12 years. For the lamphetamine, the mean elimin","cbCaiq9QKFrET8o8","https://ap.wps.com/l/cbCaiq9QKFrET8o8","pdf",380395,13,"English","# NDA 21-303/S-010 - Page 3\n## Description\n## Clinical Pharmacology\n### Pharmacodynamics\n### Pharmacokinetics\n# NDA 21-303/S-010 - Page 4\n## Mean plasma concentrations\n## Dose comparability and half-life\n## Linear pharmacokinetics and food effect\n# NDA 21-303/S-010 - Page 5\n## Metabolism and Excretion","[{\"question\":\"What safety risks does the document highlight for amphetamines in ADDERALL XR?\",\"answer\":\"It warns that amphetamines have a high potential for abuse and that prolonged administration may lead to drug dependence. It also emphasizes risks related to misuse, including sudden death and serious cardiovascular adverse events.\"},{\"question\":\"How does ADDERALL XR® delivery differ from immediate-release ADDERALL®?\",\"answer\":\"ADDERALL XR® is an extended-release, once-daily product with a double-pulsed delivery design intended to prolong amphetamine release compared with the conventional immediate-release tablet formulation.\"},{\"question\":\"What pharmacokinetic effect is reported for ADDERALL XR® compared with immediate-release?\",\"answer\":\"The time to reach maximum plasma concentration (Tmax) for ADDERALL XR® is about 7 hours, roughly 4 hours longer than immediate-release.\"}]","ADDERALL XR - Drug Safety Warnings and Pharmacology (NDA 21-303/S-010) - Page 3-5 | PDF",1791843581]