Amphetamine mixed salts (medication)

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"Adderall" redirects here. For amphetamine base, see amphetamine.
amphetamine mixed salts
Combination of
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
Licence data US Daily Med:link
Pregnancy cat. C (US)
Legal status Schedule I (CA) Schedule II (US)
Dependence liability High
Routes (Medical) Oral, (Recreational) Oral, Insufflated, Intravenous
Identifiers
CAS number 51-64-9 YesY 300-62-9
ATC code N06BA02 N06BA01
PubChem CID 44149306
DrugBank DB01576
ChemSpider 13852819 YesY
KEGG D03740 YesY
ChEBI CHEBI:2679 YesY
ChEMBL CHEMBL405 YesY
 N (what is this?)  (verify)

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[1]). Amphetamine mixed salts are available in immediate release and extended release formulations.

Contents

Medical use[edit]

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.[2] 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.[3]

Attention deficit hyperactivity disorder[edit]

Amphetamine mixed salts has shown to significantly reduce symptoms associated with ADHD and reportedly presents minimal side-effects.[4] Compared to alternate medication methylphenidate, some studies have suggested that amphetamine mixed salts is slightly more potent and has a longer period of efficacy, especially at lower doses.[5] For patients who experience adverse side effects or do not find methylphenidate effective, amphetamine mixed salts is often recommended as a substitute.[6][7]

United States[edit]

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.[8]

Dosing and administration[edit]

Amphetamine mixed salts is available as immediate release form or extended-release form.[9]

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.[10]

Adverse effects[edit]

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[edit]

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.[11]

Studies on rats show long-term neurological and behavioral changes resulting from prenatal and early postnatal exposure to amphetamines.[12][13] Warnings from the Patient Medication Guide for Adderall include emergence of new psychotic or manic symptoms, aggression and blurred vision.[14][15] 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.[16][17][18]

Contraindications, interactions, and precautions[edit]

  • 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.[19] (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[edit]

Amphetamine mixed salts is in FDA pregnancy category C.[2] Drugs assigned category C have been demonstrated to have adverse effect on fetus in animal studies, but no adequate studies on human are available.[20]

Prolonged use[edit]

Prolonged high doses of amphetamines followed by an abrupt cessation can result in extreme fatigue, insomnia, irritability, weight gain, mental depression, urination problems (sometimes mistaken for a urinary tract infection), and bloody stools. Chronic abuse of amphetamines can result in the manifestation of amphetamine psychosis;[12] occasionally this psychosis can occur at therapeutic doses during chronic therapy as a treatment emergent side effect.[21]

Commercial formulations[edit]

Historical[edit]

In the Unites States, a formula of amphetamine mixed salts was approved by the U.S. Food and Drug Administration (FDA) on January 19, 1960 under the name Obetrol.[22] between 1965 and 1973, this formula was offered in 10 mg and 20 mg strength through Obetrol Pharmaceuticals division of an American pharmaceutical company Rexar under the trade name Obetrol. Its indication was for exogenous obesity.[23]

The formulation for the 1965-1973 Obetrol 10 mg strength:[23]

  • Methamphetamine saccharate 2.5 mg
  • Methamphetamine hydrochloride 2.5 mg
  • Amphetamine sulfate 2.5 mg
  • Dextroamphetamine sulfate 2.5 mg

Obetrol was withdrawn from the market in 1973 under DESI statute.[24]

Rexar reformulated and continued to sell the unapproved formulation of Obetrol. This formulation was sold as Adderall by Richwood after it acquired Rexar resulting in FDA warning in 1994. Richwood submitted this formulation as NDA 11-522 and gained approval.[24]

Current[edit]

Amphetamine mixed salts is a psychostimulant medication used primarily for the treatment of ADHD and narcolepsy.[3]

It is a mixture of amphetamine salts consisting of equal amounts by mass of:[10]

This mixture is a dopamine releasing agent, a norepinephrine releasing agent, and can be mildly serotonergic.[12]

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.[12]

Mechanism of action[edit]

Main article: Amphetamine#Pharmacology
Main article: Dextroamphetamine mechanism of action
[icon] This section requires expansion. (May 2013)

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[edit]

"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."[10]

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[edit]

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]

Abuse[edit]

 This section needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. (November 2012)

Amphetamines are considered to have a high potential for misuse and a high liability for dependence and listed as Schedule II in the US[39][40] Schedule II in the UN and Schedule I in Canada (CSA)[citation needed]

United States[edit]

Performance Enhancer[edit]

Survey results published in 2006 found that amphetamine salts like Adderall were used three times more on college campuses than methylphenidate (commonly known as Ritalin). White and Hispanic students used amphetamine salts far more often than black and Asian students.[41]

The NCAA has banned the use of stimulants such as amphetamines for its collegiate athletes without a prescription and adequate records of evaluation and diagnosis of ADHD.[42]

Amphetamine mixed salts are a drug of abuse along with other forms of amphetamines[43] Amphetamine salts can be crushed, and snorted or dissolved in water and injected. Injection into the bloodstream can be dangerous because insoluble fillers within the tablets can block small blood vessels.[44]

Prescription amphetamines such as amphetamine mixed salts are often obtained by those with a prescription and diverted and sold to those who do not have a prescription.[citation needed]

History[edit]

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[45] DuraMed Pharmaceuticals was acquired by Teva Pharmaceuticals in 2008 when Teva completed its acquisition of Barr Pharmaceuticals (including Barr's Duramed division).[46] 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.[47] Shire was unable to extend patents by evergreening and generic version of Adderall XR became available in 2009.[48] In 2009, Barr and Shire reached a settlement agreement permitting Barr to offer a generic form of the drug beginning April 1, 2009.[49]

Patent disputes[edit]

Manufacturer's claims of instant release have been disputed. A US patent granted for Adderall[50] 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.[51]

Legal status[edit]

References[edit]

  1. ^ 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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Phenethylamines
Amphetamines
Phenylisopropylamines
Phentermines
Cathinones
Phenylisobutylamines
Phenylalkylpyrrolidines
Catecholamines
(and close relatives)
Miscellaneous
Psychostimulants, agents used for ADHD, and nootropics (N06B)
Centrally acting sympathomimetics
Xanthine derivatives
Glutamate receptor
Eugeroics / Benzhydryl compounds
Histamine H3 receptor antagonists
GABAA α5 inverse agonists
Dopamine D1 receptor agonists
α7 nicotinic agonists / PAMs
Prolyl endopeptidase inhibitors
Alpha-adrenergic agonists
Plants
Antioxidants
Other psychostimulants and nootropics

M: PSO/PSI

dsrd (o, p, m, p, a, d, s), sysi/epon, spvo

proc (eval/thrp), drug (N5A/5B/5C/6A/6B/6D)
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