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Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE

Manufacturer: Lannett Company, Inc.

Score: 144.0

Quick Summary

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules are a central nervous system stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. The drug has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. It is recommended to assess each patient's risk for abuse, misuse, and addiction before prescribing the drug. The recommended dosage for pediatric patients 6 to 12 years old is 10 mg once daily in the morning, while for adults it is 20 mg once daily in the morning.

Key Clinical Findings and Indications

  • Treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older
  • High potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Important Safety Information

Warning

The drug has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Contraindications

  • Known hypersensitivity to amphetamine or other components of the drug
  • Taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs

Adverse Reactions

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

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with severe renal impairment

ADHD

Adult Dose

20 mg once daily in the morning

Pediatric Dose

10 mg once daily in the morning for pediatric patients 6 to 12 years old

Special Population Considerations

Pregnancy

  • The drug can cause vasoconstriction and thereby may decrease placental perfusion
  • Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of the drug have been established in pediatric patients with ADHD 6 years of age and older
  • Long-term effects of amphetamines in pediatric patients have not been well established

Geriatric Use

  • The drug has not been studied in the geriatric population

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