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16-September-2008 16:15:15 - Adderall Adderall XR 15 mg capsule Adderall XR 15 mg capsule Adderall is a brand-name pharmaceutical psychostimulant or sympathomimetic amine composed of mixed amphetamine salts. The drug is used primarily to treat attention-deficit hyperactivity disorder and narcolepsy. These are its only two approved indications. The Extended release formulation is not approved to treat narcolepsy.1 Contents 1 Other Uses 2 History 3 Chemistry 4 Dosing and administration 5 Use as treatment for attention-deficit/hyperactivity disorder ADHD 6 Generic equivalents/alternatives 7 Mechanism of action 8 Side effects 8.1 In children 8.2 In adults 8.3 From overdose 9 Adderall abuse 9.1 Contraindications, interactions, and precautions 10 Performance-enhancing use 11 Government warnings 12 Notes and references 13 Further reading Other Uses Adderall has also been used successfully to manage severe cases of treatment-resistant depression. Individuals who show little or no response to typical antidepressants--such as the SSRIs and tricyclics--are more likely to respond to psychostimulant therapy. These patients, however, are the exception, rather than the norm among those with depression and this is not an approved indication. Other recognized uses include2: Idiopathic Central Nervous System Hypersomnia established by recognized diagnostic criteria Drug-induced brain dysfunction Epilepsy Depression shown to be refractory to other therapeutic modalities Senile apathetic behavior. These above uses are not necessarily licensed in any particular country; for example they are not FDA approved in the USA. History Shire Pharmaceuticals introduced the Adderall brand in 1996 in the form of a multi-dose, instant-release tablet derived from an original formula of the weight management drug Obetrol. In 2006, Shire agreed to sell rights to the Adderall name for this instant-release medication to Duramed Pharmaceuticals3 and this instant-release medication has since become available in a generic formulation of mixed amphetamine salts4. The active ingredients of Adderall include a combination of dextroamphetamine and racemic DL-amphetamine salts.4 In 2001, Shire Pharmaceuticals introduced an extended-release preparation of these ingredients in a variety of dosages under the brand name Adderall XR extended release, on which Shire retains exclusive patent rights until the patent expires, expected in 2009. Chemistry Specifically, Adderall XR is composed of the following proportions of active ingredients5: 1/4 dextroamphetamine saccharate 1/4 dextroamphetamine sulfate 1/4 racemic dextro/levo-amphetamine aspartate monohydrate 1/4 racemic dextro/levo-amphetamine sulfate These four salts are metabolized at different rates and possess diverse half lives, therefore resulting in a less dramatic onset and termination of therapeutic action; as compared to single-salt amphetamine preparations.4 The average elimination half-life in adults for dextroamphetamine and levoamphetamine is 10 hours and 13 hours respectively. Breakdown rates are affected by many factors including urinary and stomach pH, weight, gender, other medications being taken, and age. Urinary and stomach pH levels can have the strongest effect on DL-amphetamine excretion and absorption. Co-administration of acidic substances e.g. citric acid causes an accelerated excretion of DL-amphetamine while co-administration of alkaline agents e.g. antacids causes a marked increase in both retention and absorption of amphetamines potentially resulting in dangerously high serum amphetamine levels. Adderall's effects are similar to other CNS stimulants of the same class and preparation see amphetamine for details. Dosing and administration Adderall is marketed as either an immediate-release tablet, Adderall, or an extended-release capsule, Adderall XR Extended Release. Doses for both Adderall XR and Adderall are 5, 10, 15, 20, and 30 milligram strengths with instant-release Adderall having two extra ones, 7.5 and 12.5 milligrams, and Adderall XR having a 25 milligram dose.citation needed Adderall XR utilizes the Microtrol extended-release delivery system, incorporating two types of beads. The first dissolves immediately, releasing half of the medication, while the second type dissolves much more slowly releasing the remaining medication four hours later. Maximum plasma concentration is achieved in seven hours, compared to instant-release Adderall, which reaches maximum plasma concentration within three hours. As a result of its high bioavailability, Adderall XR's effectiveness is not altered by food absorption in the gastrointestinal tract. However, mean plasma concentration is prolonged by 2.5 hours using a 900 calorie standard high-fat meal as the control. Medications that alter urinary pH will cause variations in amount and method of excretion and usage should be monitored when taken concurrently with Adderall.citation needed Manufacturer's claims of instant release have been disputed. A US patent granted for Adderall6 was a pharmaceutical composition patent listing a rapid immediate release oral dosage form. No claim of increased or smooth drug delivery was made. A recent double-blind, placebo-controlled crossover study, conducted among children, indicated that patients behaved similarly to other immediate release amphetamines. The authors found that sustained-release dexamphetamine the main isomeric-amphetamine component of Adderall had a longer duration of action, though D-amphetamine was less effective in the first few hours.7 Use as treatment for attention-deficit/hyperactivity disorder ADHD Adderall has been commonly prescribed for many years as a treatment for children and adults with attention deficit/hyperactive disorder ADHD, a disorder that prevents children and adults from being able to focus on tasks for extended periods of time, a particularly detrimental condition for school performance. After administration of Adderall students have been shown to give higher teacher ratings and perform better in mathematics within 1.5 hours of initial dose. Depending on dosage, these beneficial effects can also last several hours allowing improved performance throughout the day.89 Other studies comparing Adderall with other similar medications have shown that Adderall is also more potent than Ritalin methylphenidate and has a longer period of efficaciousness. For many this means it is likely preferable as a medication for ADHD, and certainly a substitute for children who have adverse side effects to Ritalin, or for whom Ritalin has become ineffective.1011 There are also other reasons for taking Adderall aside from just alleviating the symptoms of ADHD. Untreated ADHD has been linked to an increased risk of psychoactive substance abuse later in life.12Fortunately, the likelihood of a drug abuse disorder can be approximately halved by proper treatment during childhood. For many, these stimulant medications used to treat ADHD actually provide protection against developing other drug dependencies in this increased risk population. This contradicts the commonly held misconception that use of drugs like Adderall or Ritalin can cause increased drug dependency later in life.13 However, specialists also stress the need for ADHD treatments not to solely rely on drugs like Adderall. They advise a comprehensive treatment plan that includes ADHD education, coaching and support groups; regular visits to your doctor; therapy or counseling regarding ADHD; involvement in recovery programs, and family and relationship counseling when appropriate.14 Generic equivalents/alternatives Until recently, the closest generic equivalent to Adderall which uses racemic mixed amphetamine salts was dextroamphetamine sulfate also known as Dexedrine and available in a sustained release form called Dexedrine ER. As of 2008, mixed amphetamine salts are available as a generic formulation15. It should be noted that Dexedrine is a single salt form of D-amphetamine, therefore Dexedrine and Dexedrine ER are not strict generic equivalents for Adderall and Adderall XR, though they may, in terms of physiological and psychological effects, be a de facto generic alternative. The savings between Adderall XR and generic Dexedrine ER are significant: 90 dextroamphetamine extended-release capsules cost $20 at a retail pharmacy in the United States, while the equivalent 90 Adderall XR capsules cost $270. The difference is because Adderall XR has been protected under patent in the United States. Until this patent expires, generic versions of Adderall XR will not become available. The generic formulation of Adderall, however, marketed as mixed amphetamine salts or d-amphetamine salt combo, carry a significant savings over that of branded Adderall. On average, Adderall runs about $330 per 100 doses or $3.30 per dose, whereas the generic mixed amphetamine salts are about one third as expensive - running about $120 per 100 doses or a little more than $1 per dose.15 Vyvanse is another alternative which is actually a prodrug precursor of Dextroamphetamine. It behaves differently in the body than other formulations of amphetamines because in its parent form is not directly biologically active as an amphetamine see Dextroamphetamine at Formulations. Pharmaceutical companies use strategies such as this in order to patent allegedly improved products that are similar to previous agents yet cannot be produced generically for the time being or offer some other benefit. Mechanism of action Main article: Dextroamphetamine#Mixed_amphetamine_salts Adderall's inclusion of levoamphetamine provides the pharmaceutical with a quicker onset and longer clinical effect compared to pharmaceuticals exclusively formulated of dextroamphetamine.16 Although it seems that where the human brain has a preference for dextroamphetamine over levoamphetamine, it has been reported that certain children have a better clinical response to levoamphetamine.17 Side effects In children Decreased appetite5 Difficulty falling asleep5 Stomach ache5 Emotional lability5 Premature puberty5 Kidney Failure5 In adults Dry mouth5 Loss of appetite5 Difficulty falling asleep5 Weight losscitation needed Symptoms of depression/anxietycitation needed Skin Peelingcitation needed From overdose These symptoms require immediate medical assistance: Symptoms of tourettism5 Seizures or abnormal EEGs5 High blood pressure5 Tachycardia Swelling of hands/feet/ankles for example, numbing of the fingertips Hyperactivity Delusions Hallucinations Sweating Vomiting Intense Dehydration Muscle Pain Lower abdominal pain Adderall abuse Tolerance, extreme psychological dependence, and severe social disability can occur when amphetamines are abused. The manufacturer warns against exceeding the prescribed dosage, injecting the drug, or insufflation of the drug. Prolonged high doses of amphetamines followed by an abrupt cessation can result in extreme fatigue and mental depression. Chronic abuse of amphetamines can result in the manifestation of amphetamine psychosis.5 Contraindications, interactions, and precautions The following provides only general guidelines and is not comprehensive. Please refer to a more comprehensive list for further information regarding co-administration of amphetamine with other substances. SSRIs selective serotonin reuptake inhibitors, e.g., Fluoxetine, Citalopram, Paroxetine, etc. - While rare, the possibility for serotonin syndrome exists with this combination. Use only when it is directed. NRIs norepinephrine reuptake inhibitors, e.g., Atomoxetine, Strattera, etc. - NRI medications and amphetamine both enhance noradrenergic activity. Possible augmentation/potentiation of effects. Use only when directed. SNRIs selective serotonin-norepinephrine reuptake inhibitors - See SSRIs and NRIs. Bupropion Zyban, Wellbutrin IR, ~SR, ~XL, etc. - Both bupropion and amphetamine have noradrengic and dopaminergic activity. Possible augmentation/potentiation of effects. Bupropion has pro-convulsant properties that may be enhanced or cumulatively potentiated by amphetamine. Use only when directed. MAOIs monoamine oxidase inhibitors, e.g., Phenelzine, Nardil, Selegiline, Emsam, Iproniazid, Iprozid, etc. - Do not administer amphetamines for a minimum of two weeks after last use of MAOI type drug. Possible hypertensive crises, dangerously elevated amphetamine levels. Preliminary trials of low dose amphetamine and MAOIs being administered together are in progress. However, this is to only be done under strict supervision of the prescribing parties. Tricyclics and related compounds tricyclic antidepressants, e.g., Imipramine, Tofranil, Janamine; as well as related compounds including Cyclobenzaprine - See SNRIs and SSRIs. Possible potentiation of 5htp serotonin, dopamine and norepinephrine related drug effects. The combination of tricyclic and amphetamine compounds / other direct acting sympathomimetics has been associated with increased sympathetic action. Adjustments to dose may be required. Concurrent use not generally recommended due to interaction between direct acting sympathomimetics such as amphetamines and tricyclics. Indirect acting sympathomimetics may have decreased efficacy when combined with tricyclics tricyclic blockade may inhibit the action of some indirect acting sympathomimetics. Performance-enhancing use Due to side effects including appetite suppression and weight loss, Adderall has also been used as an off-label drug for obesity.18 Adderall is also reportedly widely used as a study drug at many American universities. Adderall is reported to help focus energy and concentration to a much higher level than normal. It enables the user to focus and stay awake.19 Stories of students writing papers for an unusual number of continuous hours e.g., 14 hours, or cramming all night for an exam with no loss of energy or concentrations are common. However, the user reportedly can suffer from drastic side effects the following day if Adderall was used to avoid a normal sleep pattern. These reported side effects include temporary loss of vision, sleeping over 14 hours, muscle spasms, vomiting, mental confusion, etc. William Frankenberger, psychology professor at University of Wisconsin at Eau Claire, led at a study at the university in 2004 that reported 14% of the campus had abused some form of ADHD drug, including Adderall.19. College campuses known to be highly competitive or have a high rate of binge drinking had up to 25% of students who misused an ADHD medication within one year, a survey of students at 119 colleges across the country concluded.19. Government warnings On February 9, 2005, Health Canada suspended all sales of Adderall XR after data collected by manufacturer Shire Pharmaceuticals linked the drug to 12 sudden deaths in American children.20 Further research found data suggesting use of Adderall resulted in an increased risk of cardiac defect. Given the more than 37,000,000 prescriptions for Adderall filled during the four years, the U.S. Food and Drug Administration could find no increased risk of sudden death among Adderall users beyond the normal rate of the general population.2122 In August 2005, Health Canada followed the committee report of three independent physicians and lifted the ban on Adderall XR.2324 Given that persons with ADHD are more likely to engage in risky or dangerous behavior, it has been suggested that stimulant medications for persons with ADHD may actually result in lower incidence of premature death.25 The use of Adderall is generally not advised in those persons with pre-existing cardiac or mental illnesses. It is also not advised in persons who have a history of drug abuse.26 Although FDA safety advisors voted 8 to 7 to issue a black box warning, the FDA's pediatric advisory committee refused to give the drug its most severe black box warning in March 2006.27 A Black Box Warning regarding amphetamine abuse potential is in place, however. Notes and references ^ Shire US Inc., Prescribing Information sheet PDF for Adderall XR, March, 2007. Accessed May 1, 2008 ^ Narcotic Prescription Changes for Chronic Pain ^ Press Release: Barr and Shire Sign Three Agreements, August 14, 2006, Accessed May 1, 2008. ^ a b c Adderall Amphetamine Mixed Salts drug description - FDA approved labeling for prescription drugs and medications at RxList ^ a b c d e f g h i j k l m n Shire US Inc., Prescribing Information sheet PDF for Adderall XR, March, 2007. Accessed May 1, 2008 ^ US6,384,020 PDF version 2002-05-07 Flanner, Henry H., et al. A pharmaceutical composition comprising lactitol and one or more amphetamine salts in a rapid release formulation ^ http://www.healthsystem.virginia.edu/internet/pediatrics/pharma-news/v8n3.pdf ^ Swanson, et al., Analog Classroom Assessment of AdderallR in Children With ADHD, Journal of the American Academy of Child Adolescent Psychiatry. 375:519-526, May 1998. ^ Biederman, et al., A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SLI381 Adderall XR in Children With Attention-Deficit/Hyperactivity Disorder, PEDIATRICS Vol. 110 No. 2 August 2002, pp. 258-266 ^ Pelham, et al., A Comparison of Ritalin and Adderall: Efficacy and Time-course in Children With Attention-deficit/Hyperactivity Disorder, PEDIATRICS Vol. 103 No. 4 April 1999, p. e43 ^ Pliszka, et al., A Double-Blind, Placebo-Controlled Study of Adderall and Methylphenidate in the Treatment of Attention-Deficit/Hyperactivity Disorder, Journal of the American Academy of Child Adolescent Psychiatry. 395:619-626, May 2000. ^ Biederman, et al., Is ADHD a Risk Factor for Psychoactive Substance Use Disorders? Finding From a Four-Year Prospective Follow-Up Study, FOCUS 1:196-204 2003 ^ Wilens, et al., Does Stimulant Therapy of Attention-Deficit/Hyperactivity Disorder Beget Later Substance Abuse? A Meta-analytic Review of the Literature, PEDIATRICS Vol. 111 No. 1 January 2003, pp. 179-185 ^ Richardson, AD/HD and Stimulant Medication Abuse, adapted from The Link Between ADD Addiction, Getting the Help You Deserve, 1997 Piñon Press, and When Too Much Isn't Enough, Ending The Destructive Cycle of AD/HD and Addictive Behavior, released in January 2005 Piñon Press ^ a b Drugstore.com Brand and Generic Prices for Adderall ^ Glaser, et al. 2005. Differential Effects of Amphetamine Isomers on Dopamine in the Rat Striatum and Nucleus Accumbens Core. Psychopharmacology 178: 250-258 Pages: 255,256. doi:10.1007/s00213-004-2012-6. ^ Arnold 2000. Methylphenidate vs Amphetamine: Comparative Review. Journal of Attention Disorders 3 4: 200-211. doi:10.1177/108705470000300403. ^ Quick-fix diet drugs: Effective or harmful? - Eating Well - MSNBC.com ^ a b c Twohey, Megan. Pills become an addictive study aid: At colleges, students take a deadly risk by abusing ADHD drug. Knight Rider Tribune Business News. 26 March 2006: 1. ^ Public Health Advisory for Adderall and Adderall XR ^ Ibid. ^ Sudden Death in 12 Kids on ADHD Drug Adderall ^ Report of the Adderall XR New Drug Committee ^ Canada Reverses Ban On ADHD Medication - Rosack 40 19: 2 - Psychiatr News ^ Resources for Information about ADD/ADHD and Related Disorders ^ Patient Information Sheet for Adderall ^ Dire Warning Not Urged for ADHD Drugs - washingtonpost.com Further reading Hanna, Mohab Making the Connection: A Parent's Guide to Medication in ADHD Ladner-Drysdale 2006 v d e Stimulants Alkylamines Cyclopentamine Geranamine Isometheptene Octodrine Propylhexedrine Tuamine Alphapyrrolidinylalkiophenones α-PPP MDPPP MDPV MPBP MPHP MPPP MOPPP Pyrovalerone Cholinergics ABT-089 ABT-418 Anabasine Arecoline Cotinine Cytisine Dianicline Epibatidine Epiboxidine GTS-21 Ispronicline Nicotine Rivanicline Tebanicline Varenicline Convulsants Bicuculline DMCM Gabazine Pentetrazol Picrotoxin Strychnine Thujone Eugeroics Adrafinil Armodafinil Carphedon Modafinil Phenethylamines 4-Bromomethcathinone 4-Fluoroamphetamine 4-Fluoromethamphetamine 4-Fluoromethcathinone 4-Methylmethcathinone 4-MTA Aletamine Amfepentorex Amphechloral Amphetamine Dextroamphetamine, Adderall Amphetaminil Benzphetamine Bupropion Cathinone Chlorphentermine Clenbuterol Clobenzorex Clortermine Diethylpropion Dimethoxyamphetamine Dimethylamphetamine Dimethylcathinone Ephedrine Epinephrine Ethcathinone Ethylamphetamine Fenethylline Fenfluramine Fenproporex Fludorex Furfenorex Levomethamphetamine Lisdexamfetamine MDMA Mefenorex Methamphetamine Methcathinone Methoxyphedrine Methylone Octopamine Ortetamine Parahydroxyamphetamine PCA PIA PMA PMEA PMMA PPAP Phendimetrazine Phenmetrazine Phentermine Phenylephrine Phenylpropanolamine Propylamphetamine Pseudoephedrine Selegiline Synephrine Tiflorex Xylopropamine Phenylaminooxazoles 4-Methyl-aminorex Aminorex Clominorex Fenozolone Fluminorex Pemoline Thozalinone Piperazines 2C-B-BZP BZP GBR-12783 GBR-12935 GBR-13069 GBR-13098 GBR-13119 MeOPP MBZP Vanoxerine Piperidines 2-Benzylpiperidine Desoxypipradrol Diphemethoxidine Ethylphenidate HDMP-28 --Methyl-1-methyl-4β-2-naphthylpiperidine-3β-carboxylate Methylphenidate Dexmethylphenidate Nocaine Phacetoperane Pipradrol Tropanes 3α-Bis-4-fluorophenylmethoxytropane 3α-4-Chlorophenylphenylmethoxytropane 3-Pseudotropyl-4-fluorobenzoate Altropane IACFT Brasofensine CFT WIN 35,428 β-CIT RTI-55 Cocaethylene Cocaine β-CPPIT Dichloropane RTI-111 Difluoropine FE-β-CPPIT FP-β-CPPIT PIT PTT RTI-31 RTI-32 RTI-51 RTI-112 RTI-113 RTI-121 IPCIT RTI-126 RTI-150 RTI-171 RTI-177 RTI-336 Tesofensine Troparil β-CPT, WIN 35,065-2 WF-23 WF-33 WF-60 Xanthines Aminophylline Caffeine Dimethazan Paraxanthine Theobromine Theophylline Others Amineptine Bemegride Benzydamine BPAP Bromantane BTQ Clofenciclan Cypenamine Cyprodenate Diclofensine Dimethocaine Diphenyl prolinol Ethamivan Fencamfamine Feprosidnine Gilutensin GYKI-52895 Hexacyclonate Indanorex Indatraline LR-5182 Mazindol Mesocarb Naphthylisopropylamine Nikethamide Nomifensine Phthalimidopropiophenone Prolintane Sibutramine Yohimbine Zylofuramine See also Sympathomimetic amines Retrieved from http://en..org/wiki/Adderall Categories: Amphetamines | Sulfates | NootropicsHidden categories: All articles with statements | Articles with statements since May 2008 | Articles with statements since June 2008 Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page Languages Polski Türkçe This page was last modified on 13 August 2008, at 22:14
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