Mixed Salts of a Single-Entity Amphetamine Product

Warning

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 medication
• Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor

Adverse Reactions

• Insomnia
• Decreased appetite
• Decreased weight
• Irritability
• Nausea
• Increased heart rate
• Anxiety

General Guidance

Dose adjustments may be necessary in patients with renal impairment

Pregnancy

• The limited available data from published literature and postmarketing reports on use of amphetamine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage
• Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines

Nursing Mothers

• Caution should be exercised when administering Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules to nursing mothers

Pediatric Use

• The safety and effectiveness of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules in pediatric patients with ADHD ages 13 to 17 years have been established
• Growth suppression has been reported in pediatric patients taking stimulants, including Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules

Geriatric Use

• Clinical studies of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
• Dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy