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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Manufacturer: Oryza Pharmaceuticals Inc.

Score: 144.0

Quick Summary

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. The drug has a high potential for abuse and may lead to drug dependence. It is essential to monitor patients for signs of serotonin syndrome, particularly when used in combination with other serotonergic drugs. The recommended dosage varies depending on the condition being treated, and special considerations should be taken for pregnant women, nursing mothers, pediatric, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
  • Treatment of Narcolepsy
  • Non-catecholamine sympathomimetic amines with CNS stimulant activity

Important Safety Information

Warning

Amphetamines have a high potential for abuse and may lead to drug dependence. Administration of amphetamines for prolonged periods may lead to drug dependence and should be avoided.

Contraindications

  • Advanced arteriosclerosis
  • Symptomatic cardiovascular disease
  • Moderate to severe hypertension
  • Hyperthyroidism
  • Known hypersensitivity or idiosyncrasy to the sympathomimetic amines
  • Glaucoma
  • Agitated states
  • Patients with a history of drug abuse

Adverse Reactions

  • Cardiovascular palpitations
  • Tachycardia
  • Elevation of blood pressure
  • Sudden death
  • Myocardial infarction
  • Psychotic episodes
  • Overstimulation
  • Restlessness
  • Irritability
  • Euphoria
  • Dyskinesia
  • Dysphoria
  • Depression
  • Tremor
  • Tics
  • Aggression
  • Anger
  • Logorrhea
  • Dermatillomania

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on individual patient response and tolerability

Attention Deficit Hyperactivity Disorder (ADHD)

Adult Dose

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

Pediatric Dose

Start with 2.5 mg daily for children from 3 to 5 years of age; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained

Narcolepsy

Adult Dose

Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response

Pediatric Dose

Start with 5 mg daily for patients aged 6 to 12; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained

Special Population Considerations

Pregnancy

  • Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight

Nursing Mothers

  • Amphetamines are excreted in human milk
  • Mothers taking amphetamines should be advised to refrain from nursing

Pediatric Use

  • Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder
  • Long-term effects of amphetamines in children have not been well established

Geriatric Use

  • Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets have not been studied in the geriatric population

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