Home About

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Manufacturer: Granules Pharmaceuticals Inc.

Score: 144.0

Quick Summary

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules are a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The drug has a high potential for abuse and dependence, and its use is contraindicated in patients with certain conditions such as advanced arteriosclerosis, symptomatic cardiovascular disease, and moderate to severe hypertension. The recommended dosage varies by age and condition, with adults typically starting at 20mg once daily and children starting at 10mg once daily. Special considerations are needed for patients with renal impairment, pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults
  • High potential for abuse and dependence
  • Contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, and other conditions

Important Safety Information

Warning

CNS stimulants, including Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, have a high potential for abuse and dependence

Contraindications

  • Advanced arteriosclerosis
  • Symptomatic cardiovascular disease
  • Moderate to severe hypertension
  • Hyperthyroidism
  • Glaucoma
  • Agitated states
  • History of drug abuse

Adverse Reactions

  • Loss of appetite
  • Insomnia
  • Abdominal pain
  • Emotional lability
  • Nervousness
  • Dry mouth
  • Weight loss
  • Anxiety
  • Agitation
  • Dizziness
  • Tachycardia
  • Diarrhea
  • Asthenia
  • Urinary tract infections

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with renal impairment

ADHD

Adult Dose

20mg once daily

Pediatric Dose

10mg once daily for children 6-12 years old, 10mg once daily for adolescents 13-17 years old

Special Population Considerations

Pregnancy

  • Pregnancy Exposure Registry available
  • Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage

Nursing Mothers

  • Caution should be exercised when administering Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate to nursing mothers

Pediatric Use

  • Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate are indicated for use in children 6 years of age and older
  • Long-term effects of amphetamines in children have not been well established

Geriatric Use

  • Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate have not been studied in the geriatric population