Amphetamine

Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets 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. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

May be taken with or without food. Allow tablet to disintegrate in saliva then swallow. Pediatric patients (ages 6 to 17 years): Starting dose is 6.3 mg once daily in the morning. Maximum dose is 18.8 mg once daily for patients 6 to 12 years, and 12.5 mg once daily for patients 13 to 17 years. Adults: 12.5 mg once daily in the morning. To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

Amphetamine extended-release orally disintegrating tablets is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of amphetamine extended-release orally disintegrating tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products. Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.

Boxed warning (abuse, misuse and addiction): Amphetamine extended-release orally disintegrating tablets has 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 heart arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. Psychiatric Adverse Reactions: Prior to initiating amphetamine extended-release orally disintegrating tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing amphetamine extended-release orally disintegrating tablets.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction Hypersensitivity to amphetamine, or other components of amphetamine extended-release orally disintegrating tablets Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors Risks to Patients with Serious Cardiac Disease Increased Blood Pressure and Heart Rate Psychiatric Adverse Reactions Long-Term Suppression of Growth in Pediatric Patients Peripheral Vasculopathy, including Raynaud’s phenomenon Serotonin Syndrome Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Pediatric patients ages 6 to 12 years: 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.

Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents can increase amphetamine blood levels. Adjust amphetamine extended-release orally disintegrating tablets dosage accordingly.

Storage Store at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) Store amphetamine extended-release orally disintegrating tablets bottle packaging in a cool, dry place at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) Store amphetamine extended-release orally disintegrating tablets blister packages in the rigid, plastic travel case provided after removal from the carton.