Evekeo ODT

AMPHETAMINE SULFATE

Manufacturer: Azurity Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

Evekeo ODT is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. The recommended starting dosage is 5 mg once or twice daily, with a maximum daily dose of 40 mg. The drug has a high potential for abuse and misuse, and patients should be assessed for their risk of abuse, misuse, and addiction before prescribing. Common adverse reactions include decreased appetite, insomnia, abdominal pain, irritability, and headache. Special considerations are needed for pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age
Central nervous system stimulant
High potential for abuse and misuse

Important Safety Information

Warning

Evekeo ODT 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 EVEKEO ODT
Receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI

Adverse Reactions

Decreased appetite
Insomnia
Abdominal pain
Irritability
Headache

Dosing Recommendations

General Guidance

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

ADHD

Adult Dose

Not applicable

Pediatric Dose

5 mg once or twice daily, with a maximum daily dose of 40 mg

Special Population Considerations

Pregnancy

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
Monitor infants born to mothers taking amphetamines for symptoms of withdrawal

Nursing Mothers

Not specified in the provided information

Pediatric Use

The safety and effectiveness of EVEKEO ODT have been established in pediatric patients 6 years and older
Long-term growth suppression is a potential risk in pediatric patients