Adderall: Difference between revisions
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==Performance-enhancing use== |
==Performance-enhancing use== |
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In individuals without ADHD, amphetamine has been shown to increase effortful behavior, improve the ability to detect errors, and reduce emotional reactions to frustration; however, an increased susceptibility to environmental distraction and the increased possibility of risky behavior may detract from the usefulness of amphetamine as a [[nootropic]] in the general population.<ref name="pmid23754970">{{cite journal | author = Advokat C, Scheithauer M | title = Attention-deficit hyperactivity disorder (ADHD) stimulant medications as cognitive enhancers | journal = Front Neurosci | volume = 7 | issue = | pages = 82 | year = 2013 | pmid = 23754970 | doi = 10.3389/fnins.2013.00082 |
In individuals without ADHD, amphetamine has been shown to increase effortful behavior, improve the ability to detect errors, and reduce emotional reactions to frustration; however, an increased susceptibility to environmental distraction and the increased possibility of risky behavior may detract from the usefulness of amphetamine as a [[nootropic]] in the general population.<ref name="pmid23754970">{{cite journal | author = Advokat C, Scheithauer M | title = Attention-deficit hyperactivity disorder (ADHD) stimulant medications as cognitive enhancers | journal = Front Neurosci | volume = 7 | issue = | pages = 82 | year = 2013 | pmid = 23754970 | doi = 10.3389/fnins.2013.00082 }}</ref> |
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At low to moderate therapeutic doses (10–40 mg), amphetamine has been shown to increase physical strength, stamina, and endurance in numerous studies; however, the presence and magnitude of associated increases appear to be sensitive to both the dosage and timing of administered amphetamine relative to the tests.<ref>{{cite journal |author=Chandler JV, Blair SN |title=The effect of amphetamines on selected physiological components related to athletic success |journal=Med Sci Sports Exerc |volume=12 |issue=1 |pages=65–9 |year=1980 |pmid=7392905 }}</ref><ref name="pmid5051458">{{cite journal | author = Borg G, Edström CG, Linderholm H, Marklund G | title = Changes in physical performance induced by amphetamine and amobarbital | journal = Psychopharmacologia | volume = 26 | issue = 1 | pages = 10–8 | year = 1972 | pmid = 5051458 | doi = }}</ref><ref name="pmid13653995">{{cite journal | author = Smith GM, Beecher HK | title = Amphetamine sulfate and athletic performance. I. Objective effects | journal = J Am Med Assoc | volume = 170 | issue = 5 | pages = 542–57 | year = 1959 | month = May | pmid = 13653995 | doi = | url = }}</ref> |
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==Abuse== |
==Abuse== |
Revision as of 11:32, 25 June 2013
Combination of | |
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amphetamine aspartate | psychostimulant |
amphetamine sulfate | psychostimulant |
dextroamphetamine saccharate | psychostimulant |
dextroamphetamine sulfate | psychostimulant |
Clinical data | |
Trade names | Adderall Adderall ER Adderall XR |
AHFS/Drugs.com | Monograph |
MedlinePlus | a601234 |
License data | |
Dependence liability | High |
Routes of administration | (Medical) Oral, (Recreational) Oral, Insufflated, Intravenous |
ATC code | |
Legal status | |
Legal status |
|
Identifiers | |
CAS Number | |
PubChem CID | |
DrugBank | |
ChemSpider | |
KEGG | |
ChEBI | |
ChEMBL | |
Chemical and physical data | |
3D model (JSmol) | |
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Amphetamine mixed salts (also known as amphetamine and dextroamphetamine mixed salts, amphetamine salt combo, or simply amphetamine salts, and sold under the brand name Adderall) is a pharmaceutical drug used in the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. The active ingredient contained in this medication is a mixture of the salts of amphetamine and dextroamphetamine, both of which act as stimulants. As of 2013, there is a single commercial formulation, which contains a 3:1 ratio of dextroamphetamine (the dextrorotary or "right-handed" enantiomer) to levoamphetamine (the levorotary or "left-handed" enantiomer[2]). Amphetamine mixed salts are available in immediate release and extended release formulations.
Medical use
Amphetamine mixed salts is generally used for the treatment of ADHD and narcolepsy. These are the only two conditions for which the United States Food and Drug Administration has approved its use.[3] However, it is sometimes prescribed off-label for other conditions such as depression. It has been used to treat obesity, but the American Society of Health-System Pharmacists does not recommend this use.[4] Nearly 14 million monthly prescriptions for the condition were written for Americans ages 20 to 39 in 2011, two and a half times the 5.6 million just four years before, according to the data company I.M.S. Health.[5]
Attention deficit hyperactivity disorder
The comparative effectiveness of treatment options for children with ADHD, including different amphetamine medications, has been studied by the US Agency for Health Care Research and Quality,[6] and summarized for parents.[7] Amphetamines may improve ADHD in symptoms in children over the age of six, but there is not enough evidence to be sure.[6] Use for younger children and use for longer than a year in particular require further study.[6]
Amphetamine mixed salts have also been shown to reduce ADHD in adults, but research is limited.[8]
Dosing and administration
Amphetamine mixed salts is available as immediate release form or extended-release form.[9] The extended release capsule is generally used in the morning.[10] Generic forms are available in some doses.[7]
The extended release formulation available under the brand Adderall XR is designed to provide therapeutic effect and plasma concentrations identical to taking two doses 4 hours apart.[11]
Adverse effects
Side effects of amphetamine salts include dry mouth, insomnia, tired feeling, drowsiness, dizziness, nervousness, headache and weight loss, diarrhea, as well as changes in heartbeat and blood pressure.
Chronic
A study on comparative effects between amphetamine mixed salts and methylphenidate in children who have been treated for a year or more have shown a temporary decrease in growth rate that does not affect final adult height. Change in weight was reported as slightly greater for amphetamine mixed salts and authors concluded that the result may be clinically insignificant.[12]
Studies on rats show long-term neurological and behavioral changes resulting from prenatal and early postnatal exposure to amphetamines.[13][14] Warnings from the Patient Medication Guide for Adderall include emergence of new psychotic or manic symptoms, aggression and blurred vision.[15][16] Recent studies by the FDA indicate that, in children, young adults, and adults, there is no association between serious adverse cardiovascular events (sudden death, myocardial infarction, and stroke) and the use of amphetamines or other ADHD stimulants.[17][18][19]
Contraindications, interactions, and precautions
- MAOIs (monoamine oxidase inhibitors, e.g., phenelzine, selegiline, iproniazid, etc.) —There is a high risk of a hypertensive crisis if amphetamine is administered within two weeks after last use of an MAOI type drug. Preliminary trials of low-dose amphetamine and MAOIs being administered together are in progress. However, this is to be done only under strict supervision of the prescribing parties.
- SSRIs (selective serotonin reuptake inhibitors, e.g., fluvoxamine, citalopram, paroxetine, etc.) — While a common combination, and although rare, the risk for serotonin syndrome exists. (Use only when directed)
- NRIs (norepinephrine reuptake inhibitors, e.g., atomoxetine, 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 — Both bupropion and amphetamine have noradrenergic and dopaminergic activity. Bupropion is a potent CYP2D6 inhibitor. Bupropion has pro-convulsant properties that may be enhanced or cumulatively potentiated by amphetamine.[20] (Use only when directed)
- Monoaminergic tricyclic antidepressant — See NRIs, SNRIs, and SSRIs. Possible potentiation of serotonin-, dopamine-, and/or norepinephrine-related drug effects. The combination of monoaminergic tricyclics and amphetamine compounds has been associated with increased sympathomimetic effects. The exceptions to this class (i.e. non-monoaminergic tricyclic antidepressants) include the glutamatergic tricyclic tianeptine and sigmaergic tricyclic opipramol.
- CYP2D6 (liver enzyme) inhibitors, e.g., Bupropion and most SSRIs such as fluoxetine, citalopram, paroxetine, etc. Some anti-psychotics such as thioridazine, haloperidol, and levomepromazine, as well as cocaine, the opioid agonist methadone, and others. It is important to determine if any medication or drug taken is a CYP2D6 inhibitor. Taking a CYP2D6-inhibiting drug along with amphetamine will lead to an elevated level of amphetamine in the system, resulting in the drug's remaining in the body for a longer period, which can lead to undesirable and possibly serious side effects.
- Individuals with pre-existing cardiac conditions or mental illnesses.
- Individuals with a history of drug abuse
Pregnancy
Amphetamine mixed salts is in FDA pregnancy category C.[3] Drugs assigned category C have been demonstrated to have adverse effect on fetus in animal studies, but no adequate studies on human are available.[21]
Prolonged use and withdrawal
Prolonged use of amphetamines can lead to dependence.[22] Chronic abuse of amphetamines can result in the manifestation of amphetamine psychosis;[13] occasionally this psychosis can occur at therapeutic doses during chronic therapy as a treatment emergent side effect.[23]
Most longterm users of amphetamines will experience severe, time-limited withdrawal symptoms within 24 hours of their last dose.[22] Symptoms can include dysphoric mood, irritability, anxiety, agitation, vivid or unpleasant dreams, hypersomnia or fatigue, cravings and more.[22] Thoughts of suicide have been reported.[22] This initial "crash" can last up to a week, followed generally by about two weeks of less acute withdrawal symptoms.[22] Antidepressant drugs have been studied to ease amphetamine withdrawal, but more research on their effects is needed.[22]
Commercial formulations
Historical
Rexar, a pharmaceutical company, reformulated another drug, branded as Obetrol, to exclude methamphetamine and continued to sell this new formulation under the same brand name. This new unapproved formulation was later rebranded and sold as Adderall by Richwood after it acquired Rexar resulting in FDA warning in 1994. Richwood submitted this formulation as NDA 11-522 and Adderall gained FDA approval for the treatment of attention-deficit/hyperactivity disorder therapy on February 13, 1996.[24]
Current
Amphetamine mixed salts is a psychostimulant medication used primarily for the treatment of ADHD and narcolepsy.[4]
It is a mixture of amphetamine salts consisting of equal amounts by mass of:[11]
- amphetamine aspartate monohydrate (racemic)
- amphetamine sulfate (racemic)
- dextroamphetamine sulfate
- dextroamphetamine saccharate
This mixture is a dopamine releasing agent, a norepinephrine releasing agent, and can be mildly serotonergic.[13]
Amphetamine mixed salts are available in immediate release and extended release formulations. The immediate release formulation is indicated for use in ADHD and narcolepsy,.[9] The extended release formulation only approved for the treatment of ADHD.[13]
Mechanism of action
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Amphetamine's pharmacological activity is due mainly to the release of dopamine and norepinephrine. It can also increase serotonin release, although it is disputed whether this is pharmacologically significant at therapeutic doses.[25][26][27] Dextroamphetamine (the dextrorotary enantiomer) and levoamphetamine (the levorotary enantiomer) have different pharmacological properties.[28] Dextroamphetamine is several times more potent in the central nervous system than levoamphetamine), but the two isomers have comparable activity in the peripheral nervous system.[29] The overall greater potency of dextroamphetamine to central actions suggests that this form may have a higher potential for abuse.[30]
Levoamphetamine provides mixed amphetamine salts quicker onset and longer-lasting effects than dextroamphetamine alone.[31] It has been reported that certain children have a better clinical response to levoamphetamine.[32]
Pharmacokinetics
"The mean elimination half-life 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 l-amphetamine, the mean elimination half-life in adults is 13 hours; 13 to 14 hours in adolescents; and 11 hours in children aged 6 to 12 years. On a mg/kg body weight basis children have a higher clearance than adolescents or adults."[11]
Urinary and stomach pH levels influence amphetamine excretion and absorption.[33] An acidic stomach and GI pH will decrease the absorption of amphetamine salts.[34] Plasma half life of amphetamine sulfate, a constituent of amphetamine mixed salts is dependent on pH of urinary system. For each unit of pH increase, plasma half life of amphetamine sulfate is increased by 7 hours.[35]
Detection of use
Techniques such as immunoassay may cross-react with a number of sympathomimetics drugs, so chromatographic methods specific for amphetamine should be employed to prevent false-positive results. Chiral techniques may be employed to help distinguish the source of the drug, whether obtained legally (by prescription) or illegally or possibly as a result of formation from a prodrug such as lisdexamfetamine or selegiline. Chiral separation can be used to differentiate amphetamine mixed salts use from use of another prescription form of amphetamine or from use of illicit amphetamine[36][37][38]
Performance-enhancing use
In individuals without ADHD, amphetamine has been shown to increase effortful behavior, improve the ability to detect errors, and reduce emotional reactions to frustration; however, an increased susceptibility to environmental distraction and the increased possibility of risky behavior may detract from the usefulness of amphetamine as a nootropic in the general population.[39]
Abuse
Amphetamine is considered to have a high potential for misuse and a high liability for dependence and listed as Schedule II in the US,[40][41] Schedule II in the UN Convention of Psychotropic Substances and Schedule I in Canada (CSA).[42] Amphetamine mixed salts is a drug of abuse.[43] Amphetamine salts can be crushed, and snorted or dissolved in water and injected.[44] Injection into the bloodstream can be dangerous because insoluble fillers within the tablets can block small blood vessels.[44]
Recreational use of amphetamines is exceedingly dangerous, especially when used at very high doses. Research has shown that amphetamine binges in lab animals cause neurotoxicity in dopaminergic pathways, resulting in permanent but not irreversible cognitive impairments.[45] Moreover, extremely high doses of amphetamine can induce rapid muscle breakdown, repetitive or stereotyped behaviors, catecholaminergic/adrenergic storm, and coma.[46]
History
Adderall is available as an instant-release (IR) and an extended-release (XR) drug. Adderall instant-release is manufactured today by Teva and Barr Pharmaceuticals. Shire Pharmaceuticals, the creator of Adderall IR, no longer produces it. However, Shire does continue to manufacture the extended-release version of Adderall ("Adderall XR"). Richwood Pharmaceuticals (later merged with Shire) 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 Pharmaceuticals[47] DuraMed Pharmaceuticals was acquired by Teva Pharmaceuticals in 2008 when Teva completed its acquisition of Barr Pharmaceuticals (including Barr's Duramed division).[48] Therefore, following its acquisition of Duramed, Teva is in the somewhat unusual position of manufacturing both a generic formulation of Adderall instant-release (under its Barr Division) as well as "brand name" Adderall (under its DuraMed division.)
In 2001, Shire introduced an extended-release preparation of these ingredients in a variety of dosages under the brand name "Adderall XR," on which Shire retains exclusive patent rights until the patent expires, expected in 2018.[49] Shire was unable to extend patents by evergreening and generic version of Adderall XR became available in 2009.[50] In 2009, Barr and Shire reached a settlement agreement permitting Barr to offer a generic form of the drug beginning April 1, 2009.[51]
Patent disputes
Manufacturer's claims of instant release have been disputed. A US patent granted for Adderall[52] was a pharmaceutical composition patent listing a rapid immediate-release oral dosage form. No claim of increased or smooth drug delivery was made. A study by James and colleague as published In the November 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry, placebo-controlled crossover study conducted among 35 children ages 5–12 indicated that patients behaved similarly to those having taken other immediate-release amphetamines. The authors found that sustained-release dexamphetamine (the main isomeric-amphetamine component of Adderall) had a longer duration of action, however D-amphetamine was less effective in the first few hours.[53]
Legal status
- United Nations: Schedule II of CSA[54]
- Canada: Prescription only, Schedule I[55]
- New Zealand: International travelers with valid prescriptions must declare them, the drugs will be taken, and the patient must go to a dispensary daily to receive their medications.[citation needed]
- Japan:prohibited[56]
- South Korea: prohibited [57]
- Thailand: Amphetamines are classified as Type 1 Narcotics.[58]
- United States: Prescription only, Schedule II controlled substance.[59][60][61]
References
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- ^ Enantiomers are molecules that are "mirror images" of one another; they are structurally identical but of the opposite orientation, like left and right hands
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suggested) (help) [dead link] - ^ US patent 6384020, Flanner HH, Chang R-K, Pinkett JE, Wassink SE, White LR, "A pharmaceutical composition comprising lactitol and one or more amphetamine salts in a rapid-release formulation", issued 2002-05-07, assigned to Shire Lab Inc.
- ^ Buck ML (2002). "Amphetamines in the Treatment of Attention-Deficit/Hyperactivity Disorder" (PDF). Pediatric Pharmacotherapy. 8 (3).
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ignored (help) - ^ United Nations Office on Drugs and Crime (2007). Preventing Amphetamine-type Stimulant Use Among Young People: A Policy and Programming Guide (PDF). New York: United Nations. ISBN 92-1-148223-2.
- ^ The Minister and Attorney General. "Controlled Drugs and Substances Act". Justice Laws Website. Government of Canada.
- ^ kouseikyoku.mhlw.go.jp
- ^ "Thailand Law" (PDF). Government of Thailand. Retrieved 2013-05-23.
- ^ 21 U.S.C. § 829
- ^ "Lists of: Scheduling Actions, Controlled Substances, Regulated Chemicals" (PDF). DEA Listing of Controlled Substances.
- ^ "Issuance of Multiple Prescriptions for Schedule II Controlled Substances". Retrieved 2012-12-16.