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Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

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

Manufacturer: Sun Pharmaceutical Industries, Inc.

Score: 144.0

Quick Summary

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. The drug has a high potential for abuse and misuse, and its use can lead to the development of a substance use disorder, including addiction. It is essential to assess each patient's risk for abuse, misuse, and addiction before prescribing the drug. The recommended dosage varies depending on the condition being treated and the patient's age, with careful monitoring required for signs and symptoms of abuse, misuse, and addiction, as well as other potential adverse reactions.

Key Clinical Findings and Indications

  • Used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy
  • Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity
  • The mode of therapeutic action in ADHD is not known

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

  • Hypersensitivity to amphetamine or other components of the drug
  • Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs

Adverse Reactions

  • Cardiovascular: palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction
  • Central Nervous System: psychotic episodes, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal or hepatic impairment, and in patients taking other medications that interact with the drug

ADHD

Adult Dose

Start with 5 mg once or twice daily, with daily dosage 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, and 5 mg once or twice daily for children 6 years of age and older

Narcolepsy

Adult Dose

Start with 10 mg daily, with daily dosage raised in increments of 10 mg at weekly intervals until optimal response is obtained

Pediatric Dose

Start with 5 mg daily for children aged 6 to 12, with daily dosage raised in increments of 5 mg at weekly intervals until optimal response is obtained

Special Population Considerations

Pregnancy

  • The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • There is a risk of premature delivery and low birth weight in infants born to mothers dependent on amphetamines

Nursing Mothers

  • Amphetamines are excreted in human milk, and mothers taking the drug should be advised to refrain from nursing

Pediatric Use

  • The drug is not recommended for use in children under 3 years of age with ADHD
  • Long-term effects of amphetamines in children have not been well established

Geriatric Use

  • The drug has not been studied in the geriatric population

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