Saccharate

• 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%

The 10 most recently updated of 12 ClinicalTrials.gov registrations naming Saccharate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
  Completed · Phase 4 · Interventional · 60 enrolled · CMH Multan Institute of Medical Sciences
  NCT06911034updated 2025-04-06
• Iron Administration Via Colonic TET Combined With WMT for ID
  Not yet recruiting · Phase 2 · Interventional · 60 enrolled · The Second Hospital of Nanjing Medical University
  NCT06487299updated 2024-07-22
• Safety of SPD465 in Treating Adults With ADHD.
  Completed · Phase 3 · Interventional · 505 enrolled · Shire
  NCT00152035updated 2021-08-23
• Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
  Completed · Phase 3 · Interventional · 412 enrolled · Shire
  NCT00152022updated 2021-07-13
• Efficacy and Safety of SPD465 in Adults With ADHD
  Completed · Phase 3 · Interventional · 240 enrolled · Shire
  NCT00150579updated 2021-06-30
• Safety and Efficacy of SPD465 in Adults With ADHD
  Completed · Phase 2 · Interventional · 72 enrolled · Shire
  NCT00202605updated 2021-06-24
• Safety, Tolerability and Pharmacokinetics of SHP465 in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
  Completed · Phase 1 · Interventional · 24 enrolled · Shire
  NCT03327402updated 2021-06-08
• Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients
  Completed · Phase 2 · Interventional · 64 enrolled · Ain Shams University
  NCT02335593updated 2020-01-22
• Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
  Completed · Phase 2 · Interventional · 100 enrolled · University of Washington
  NCT00416715updated 2017-07-11
• Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
  Unknown · Phase 2 · Interventional · 100 enrolled · Instituto do Cancer do Estado de São Paulo
  NCT01168505updated 2014-05-21

Frequently asked questions

What is Saccharate used for?

According to FDA labeling, Saccharate 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 contraindications for Saccharate?

Saccharate 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.