Amphetamine, Amphetamine dl-aspartate and Dextroamphetamine

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.

• Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 12 years of age is 30 mg once daily. • Adults: 20 mg once daily in the morning. • Pediatric patients (ages 6 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. • Adults with severe renal impairment: 15 mg once daily in the morning. • Patients with end stage renal disease (ESRD): Not recommended.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsule administration is contraindicated in patients: • known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products.

Boxed warning (abuse, misuse, and addiction): Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. • Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. • Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse at appropriate intervals. • Psychiatric Adverse Reactions: Prior to initiating dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, screen patients for risk factors for developing a manic episode.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Abuse, Misuse, and Addiction • Risks to Patients with Serious Cardiac Disease • Increased Blood Pressure and Heart Rate • Psychiatric Adverse Reactions • Long-Term Suppression of Growth in Pediatric Patients • Seizures • Peripheral Vasculopathy, including Raynaud’s Phenomenon • Serotonin Syndrome • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome • Pediatric patients ages 6 to 12: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. • Pediatric patients ages 13 to 17: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.

• Alkalinizing agents (GI antacids and urinary): These agents increase blood levels of amphetamine. • Acidifying agents (GI and urinary): These agents reduce blood levels of amphetamine.

Store at room temperature, 20°C to 25°C (68°F to 77°F).