Adzenys XR-ODT

AMPHETAMINE

Manufacturer: Neos Therapeutics Brands, LLC

Score: 145.0

Quick Summary

Adzenys XR-ODT (amphetamine) is a central nervous system stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. It has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. The recommended starting dosage is 6.3 mg once daily in the morning for pediatric patients, and 12.5 mg once daily for adults. Important safety information includes the risk of hypertensive crisis when used concomitantly with monoamine oxidase inhibitors, and the potential for serious adverse reactions such as serotonin syndrome, long-term suppression of growth in pediatric patients, and peripheral vasculopathy. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in 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

High potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Contraindications

Patients known to be hypersensitive to amphetamine, or other components of Adzenys XR-ODT
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs

Adverse Reactions

Loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever in pediatric patients
Dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections in adults

Dosing Recommendations

General Guidance

Adjust dosage according to the therapeutic needs and response of the patient

ADHD

Adult Dose

12.5 mg once daily in the morning

Pediatric Dose

6.3 mg once daily in the morning, with a maximum dose of 18.8 mg once daily for patients 6 to 12 years, and 12.5 mg once daily for patients 13 to 17 years

Special Population Considerations

Pregnancy

Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Nonteratogenic effects, such as vasoconstriction and premature delivery, have been reported

Nursing Mothers

Breastfeeding is not recommended during treatment with Adzenys XR-ODT
Amphetamine is present in human milk at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage

Pediatric Use

The safety and effectiveness of Adzenys XR-ODT have been established in pediatric patients with ADHD ages 6 to 17 years
Long-term growth suppression has been reported in pediatric patients

Geriatric Use

Adzenys XR-ODT has not been studied in the geriatric population

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Adzenys XR-ODT

Quick Summary

Key Clinical Findings and Indications

Important Safety Information

Warning

Contraindications

Adverse Reactions

Dosing Recommendations

General Guidance

ADHD

Adult Dose

Pediatric Dose

Special Population Considerations

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

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