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A 3:1 mixture of dextro-[[amphetamine]] to levo-[[amphetamine]] salts and is approved for the treatment of [[attention deficit hyperactivity disorder]]. The brand Adderall® is marketed by [http://www.shire.com/ Shire Pharmaceuticals]. | |||
[[Off-label indications]] include depression, especially in older adults who have not responded to [[second-generation antidepressant|second-generation]] and [[first-generation antidepressant]]s. | |||
Adderall also can be considered a [[nootropic]], a drug that improves mental functioning and alertness. | |||
==History== | ==History== | ||
In the [[United States]], the mixture was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) by the FDA in 1960.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=011522 Drugs@FDA]. U S Food and Drug Administration</ref> The extended release version was approved in 2001.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=021303 Drugs@FDA]. U S Food and Drug Administration</ref> A generic version (not extended release) was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2002.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=040422 Drugs@FDA]. U S Food and Drug Administration</ref> | In the [[United States of America]], the mixture was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) by the FDA in 1960.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=011522 Drugs@FDA]. U S Food and Drug Administration</ref> The extended release version was approved in 2001.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=021303 Drugs@FDA]. U S Food and Drug Administration</ref> A generic version (not extended release) was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2002.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=040422 Drugs@FDA]. U S Food and Drug Administration</ref> | ||
==Pharmacokinetics== | |||
The time to reach maximum plasma concentration is:<ref name="dailymed-adderallxr">[http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=5535 Adderall XR] (Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate) capsule, extended release [Shire US Inc.]</ref> | |||
* Adderall XR® is about 7 hours | |||
* Addreall 3 hours | |||
Adderall XR 20 mg one daily has similar pharmacokinetics to Adderall(immediate-release) 10 mg twice dialy administered 4 hours apart. <ref name="dailymed-adderallxr">[http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=5535 Adderall XR] (Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate) capsule, extended release [Shire US Inc.]</ref> | |||
The mean elimination half-life in adults for d-amphetamine is 10 hours and for the l-amphetamine is 13 hours<ref name="dailymed-adderallxr">[http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=5535 Adderall XR] (Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate) capsule, extended release [Shire US Inc.]</ref> | |||
==Drug abuse and control== | |||
As an [[amphetamine]], although somewhat less likely to be abused than those that reach a peak level more quickly, it is in the most tightly regulated group of prescription drugs. In the U.S., that is Schedule II of the [[Drug Enforcement Administration]]. | |||
==External links== | ==External links== | ||
{{CZMed}} | {{CZMed}} | ||
Latest revision as of 10:51, 2 February 2023
A 3:1 mixture of dextro-amphetamine to levo-amphetamine salts and is approved for the treatment of attention deficit hyperactivity disorder. The brand Adderall® is marketed by Shire Pharmaceuticals.
Off-label indications include depression, especially in older adults who have not responded to second-generation and first-generation antidepressants.
Adderall also can be considered a nootropic, a drug that improves mental functioning and alertness.
History
In the United States of America, the mixture was approved with a New Drug Application (NDA) by the FDA in 1960.[1] The extended release version was approved in 2001.[2] A generic version (not extended release) was approved with a Abbreviated New Drug Application (ANDA) in 2002.[3]
Pharmacokinetics
The time to reach maximum plasma concentration is:[4]
- Adderall XR® is about 7 hours
- Addreall 3 hours
Adderall XR 20 mg one daily has similar pharmacokinetics to Adderall(immediate-release) 10 mg twice dialy administered 4 hours apart. [4]
The mean elimination half-life in adults for d-amphetamine is 10 hours and for the l-amphetamine is 13 hours[4]
Drug abuse and control
As an amphetamine, although somewhat less likely to be abused than those that reach a peak level more quickly, it is in the most tightly regulated group of prescription drugs. In the U.S., that is Schedule II of the Drug Enforcement Administration.
External links
The most up-to-date information about Adderall and other drugs can be found at the following sites.
- Adderall - FDA approved drug information (drug label) from DailyMed (U.S. National Library of Medicine).
- Adderall - Drug information for consumers from MedlinePlus (U.S. National Library of Medicine).
- Adderall - Detailed information from DrugBank.
References
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ 4.0 4.1 4.2 Adderall XR (Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate) capsule, extended release [Shire US Inc.]