Aspartate

• Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.ICD-10: F90.9, G47.419

• CONTAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see ADVERSE REACTIONS ].contraindicated

Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained. In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy. Prior to treating patients with DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE ANDAMPHETAMINE SULFATE TABLETS assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS].

Abuse, Misuse, and Addiction DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS has a high potential for abuse and misuse. which can lead to the development of a substance use disorder, including addiction. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS can be diverted for non-medical use into illicit channels or distribution [see DRUG ABUSE and DEPENDENCE: Abuse]. Misuse and abuse of CNS stimulants, including DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS, can result in overdose and death [see OVERDOSAGE], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS to anyone else.

Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania. Eye Disorders Vision blurred, mydriasis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido, frequent or prolonged erections. Skin Alopecia. Musculoskeletal Rhabdomyolysis.

Pregnancey Teratogenic Effects Pregnancy Category C Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m 2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m 2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. There are no adequate and well-controlled studies in pregnant women.

Metabolism

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine.

Clinical effects of overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop Overdose management Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations .

• Oct 11, 2001NDANDA021303Takeda Pharms Usa
• Feb 11, 2002ANDAANDA040422Barr
• Jun 14, 2002ANDAANDA040439Sandoz
• Jun 19, 2002ANDAANDA040444Epic Pharma Llc
• Sep 9, 2003ANDAANDA040480Sun Pharm Industries
• Oct 7, 2003ANDAANDA040440Specgx Llc
• Jun 22, 2012ANDAANDA077302Actavis Elizabeth
• Jun 20, 2017NDANDA022063Takeda Pharms Usa

1. 1Drug Ineffective4,79112%
2. 2Fatigue3,2097.8%
3. 3Nausea2,8857.0%
4. 4Headache2,6806.5%
5. 5Anxiety2,5036.1%
6. 6Depression2,1235.2%
7. 7Feeling Abnormal2,0204.9%
8. 8Pain1,7614.3%
9. 9Dizziness1,7454.2%
10. 10Somnolence1,7184.2%
11. 11Insomnia1,6404.0%
12. 12Off Label Use1,4823.6%
13. 13Vomiting1,2793.1%
14. 14Malaise1,1842.9%
15. 15Condition Aggravated1,1632.8%

Recent PubMed references pinned to Aspartate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Fueling the fire: aspartate deficiency primes and fuels STING activation.
  The Journal of clinical investigation · 2026 · Jiang H, Wang W, Fu YX, et al.
  PMID 42222881DOI 10.1172/JCI206431
• Aspartate deficiency amplifies cGAS-STING signaling in antitumor immunity.
  The Journal of clinical investigation · 2026 · Liao Y, Wang H, Liu H, et al.
  PMID 42222880DOI 10.1172/JCI199716
• Aspartate-Glutamate Carrier 1 (SLC25A12) Deficiency: Malate-Aspartate Shuttle Failure, Neurodevelopmental Epileptic Encephalopathy, and Ketone-Based Metabolic Therapy.
  International journal of molecular sciences · 2026 · Murano M, Iaconisi GN, Monné M, et al.
  PMID 42196434DOI 10.3390/ijms27104455
• Performance of Forensic Age Estimation by Aspartic Acid Racemization and DNA Methylation: A Systematic Review.
  F1000Research · 2024 · Prastyo E, Auerkari EI, Suhartono AW, et al.
  PMID 42182984DOI 10.12688/f1000research.147348.3
• Total N-acetylaspartate: A potential early biomarker of depression?
  Journal of affective disorders · 2026 · Hudhud L, Haney M, Petrovic P, et al.
  PMID 42066849DOI 10.1016/j.jad.2026.121896
• Dmpic as an Orthogonal Protecting Group for Aspartic Acid Side Chains: Facilitating the Synthesis of Lactam-Cyclized Peptides.
  The Journal of organic chemistry · 2026 · Liu B, Bai H, Ye F, et al.
  PMID 42059347DOI 10.1021/acs.joc.6c00442
• [Therapeutic efficacy of ASS1 combined with LOLA in the treatment of hyperammonemia in mice].
  Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2025 · Luo T, Ming Z, Zou Z, et al.
  PMID 42032990DOI 10.11817/j.issn.1672-7347.2025.250577
• Advanced NMR Characterization and Sensitive Detection of Isoaspartate in Proteins.
  Analytical chemistry · 2026 · Julien M, Zinn-Justin S, Theillet FX, et al.
  PMID 42011539DOI 10.1021/acs.analchem.5c07290

The 10 most recently updated of 306 ClinicalTrials.gov registrations naming Aspartate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis
  Active not recruiting · Interventional · 239 enrolled · Rennes University Hospital
  NCT04779593updated 2026-06-12
• Neurobiology of Suicide
  Recruiting · Phase 2 · Interventional · 325 enrolled · National Institute of Mental Health (NIMH)
  NCT02543983updated 2026-06-12
• The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study
  Completed · Observational · 715 enrolled · Tongji Hospital
  NCT07639294updated 2026-06-10
• Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
  Recruiting · Phase 3 · Interventional · 200 enrolled · The First People's Hospital of Changzhou
  NCT06867991updated 2026-06-09
• A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis
  Recruiting · Phase 3 · Interventional · 120 enrolled · Hoffmann-La Roche
  NCT05503264updated 2026-06-08
• Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
  Recruiting · Phase 1 · Interventional · 150 enrolled · National Institute of Mental Health (NIMH)
  NCT03065335updated 2026-06-08
• Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
  Active not recruiting · Phase 3 · Interventional · 669 enrolled · National Cancer Institute (NCI)
  NCT02101853updated 2026-06-03
• Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
  Completed · Phase 3 · Interventional · 1,645 enrolled · National Cancer Institute (NCI)
  NCT01371981updated 2026-06-02
• Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
  Recruiting · Phase 1 · Interventional · 27 enrolled · Taiho Oncology, Inc.
  NCT04953910updated 2026-05-28
• Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
  Recruiting · Phase 2 · Interventional · 164 enrolled · Syndeio Biosciences, Inc
  NCT06547489updated 2026-05-28

Frequently asked questions

What is Aspartate used for?

According to FDA labeling, Aspartate carries indications including: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Aspartate?

Aspartate is marketed under brand names including Aminosyn II 10 %, Aminosyn II 15%, Aminosyn II 8.5 % with Electrolytes, Sulfite-Free, Aminosyn II 8.5 %, Sulfite-Free, Aminosyn-PF 10 %, Sulfite-Free, Aminosyn-PF 7%, Clinisol 15, Plenamine.

What are the contraindications for Aspartate?

Aspartate labeling lists contraindications including: CONTAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see ADVERSE REACTIONS ].. Always consult the full prescribing information and a clinician.