Amphetamine / Amphetamine Aspartate / Dextroamphetamine / Dextroamphetamine Saccharate

Amphetamine mixed salts (combinations of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate) are CNS stimulants approved for the following uses, depending on the specific product and formulation:

• ADHD (attention deficit hyperactivity disorder) — approved across all formulations (tablets and extended-release capsules) in adults and children. Age eligibility varies by product: ADDERALL XR and similar extended-release capsules are approved for children 6 and older; Mydayis extended-release capsules and certain other extended-release products are approved only for patients 13 and older.
• Narcolepsy — approved for tablet formulations only (including Adderall tablets and other mixed amphetamine salt tablet products). Extended-release capsule products are not approved for narcolepsy.

Amphetamines work by blocking the reabsorption (reuptake) of norepinephrine and dopamine — two key brain chemicals — back into the nerve cell that released them. They also increase the release of these chemicals into the gap between nerve cells. This raises the available levels of these signaling chemicals in the brain, which is thought to help improve focus, attention, and impulse control. The exact reason this helps with ADHD symptoms is not fully known.

All forms are taken by mouth. Tablet formulations are taken as directed by your prescriber — timing and frequency depend on your specific product and condition. Extended-release capsule formulations are taken once daily in the morning upon waking, because their effects can last up to 16 hours and taking them later in the day may cause insomnia. Extended-release capsules can be taken with or without food, but you should be consistent — take them the same way every day. For those who have trouble swallowing capsules, some extended-release capsule products can be opened and the contents sprinkled onto applesauce.

• Never substitute one amphetamine product for another on a milligram-for-milligram basis without prescriber guidance — different products have different amphetamine compositions and release profiles.
• Patients with severe kidney disease need dose adjustments; use is not recommended at all in end-stage kidney disease.

The most commonly reported side effects vary somewhat by age group but include:

• Loss of appetite (very common)
• Trouble sleeping (insomnia)
• Stomach pain, nausea, or vomiting
• Dry mouth
• Headache
• Weight loss
• Increased heart rate (tachycardia)
• Anxiety, nervousness, or agitation
• Dizziness
• Emotional ups and downs (emotional lability)

Seek immediate medical attention for serious reactions such as chest pain, signs of psychosis or mania (hallucinations, paranoid thoughts), serotonin syndrome (fever, rapid heartbeat, muscle stiffness, confusion), seizures, or circulation changes in the fingers and toes (color changes, pain, or sores).

• Abuse, misuse, and addiction: This is a Schedule II controlled substance with a high potential for abuse. Misuse, especially at higher doses or by unapproved routes (snorting, injecting), can lead to overdose and death. Store securely, dispose of leftovers properly, and never share.
• Heart risks: Sudden death has been reported in people with pre-existing structural heart problems. CNS stimulants raise blood pressure and heart rate. Avoid this medication if you have serious heart disease, abnormal heart rhythms, cardiomyopathy, or coronary artery disease.
• Psychiatric effects: May trigger or worsen psychosis, mania, or hallucinations — even in people without a prior psychiatric history. Screen for bipolar disorder before starting. Contact your doctor immediately if new psychiatric symptoms appear.
• Growth suppression in children: CNS stimulants can slow height and weight gain in pediatric patients. Height and weight should be monitored regularly during treatment.
• Serotonin syndrome: A potentially life-threatening reaction can occur if combined with other drugs that affect serotonin. Symptoms include fever, rapid heart rate, confusion, muscle twitching, and agitation.
• Circulation problems: Raynaud's phenomenon (reduced blood flow to fingers and toes, causing color changes or pain) has been reported. Report any finger or toe changes to your doctor.
• Seizures: May lower the seizure threshold. If a seizure occurs, stop the medication and seek medical care.

Several drugs and substances can interact significantly with amphetamine mixed salts:

• MAOIs (e.g., phenelzine, selegiline, linezolid, IV methylene blue): Combining with MAOIs can cause life-threatening high blood pressure (hypertensive crisis). Do not use within 14 days of an MAOI.
• Serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, lithium, St. John's Wort, buspirone, fentanyl, tryptophan, tricyclic antidepressants): Increases risk of serotonin syndrome — a dangerous reaction involving fever, confusion, and muscle problems.
• CYP2D6 inhibitors: Can raise amphetamine blood levels, increasing side effect risk and serotonin syndrome risk.
• Alkalinizing agents (antacids, sodium bicarbonate): Increase amphetamine absorption and blood levels — avoid combining.
• Acidifying agents (ammonium chloride): Lower amphetamine blood levels, potentially reducing effectiveness.
• Tricyclic antidepressants: May amplify cardiovascular effects of amphetamines.
• Proton pump inhibitors: May change how quickly amphetamine reaches peak levels in the blood.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not take if you are allergic to amphetamine or any ingredient in these products.
• Do not take if you are currently using or have recently used an MAOI — wait at least 14 days after stopping an MAOI before starting this medication.
• Tell your doctor about any personal or family history of heart problems, high blood pressure, irregular heartbeat, or sudden cardiac death.
• Tell your doctor if you have or have ever had bipolar disorder, depression, psychosis, or a family history of suicide.
• Tell your doctor if you or a family member has tics or Tourette's syndrome.
• Tell your doctor if you have a history of seizures.
• Tell your doctor if you have kidney disease — dose reductions are required for severe kidney impairment; not recommended in end-stage kidney disease.
• Pregnancy: May cause harm to the fetus based on animal data. Premature birth and low birth weight have been seen in infants born to amphetamine-dependent mothers. Discuss risks with your doctor.
• Breastfeeding: Not recommended. Amphetamine passes into breast milk and can cause serious reactions in nursing infants.
• Children under 6: Extended-release capsule products are not recommended for children younger than 6 due to higher drug exposure and greater risk of side effects in this age group.

Too much of this medication can cause a dangerous surge of stimulant effects, including rapid or irregular heartbeat, dangerously high or low blood pressure, extreme agitation, hallucinations, seizures, high body temperature (above 104°F), and in severe cases, coma or death. If you suspect an overdose, call the Poison Help line at 1-800-222-1222 or go to the nearest emergency room immediately.

Amphetamines block the reuptake of norepinephrine and dopamine into the nerve cell that released them, and also increase the release of these chemicals into the space between nerve cells. This results in higher concentrations of these signaling chemicals in the brain, leading to CNS stimulant effects. As a whole-body effect, CNS stimulants cause a measurable increase in blood pressure (average about 2–4 mmHg) and heart rate (average about 3–6 beats per minute), though some individuals may experience larger increases.

After taking the immediate-release tablet, amphetamine reaches peak blood levels in about 3 hours. The extended-release capsule reaches peak levels in about 7 hours — roughly 4 hours later — consistent with its prolonged-release design. Food does not change how much amphetamine is absorbed from extended-release capsules, but it does delay the time to peak levels by about 2–3 hours. Amphetamine is processed (metabolized) primarily in the liver, partly through the CYP2D6 enzyme, and is eliminated mainly through the urine. The time it takes for half the drug to leave the body (half-life) is approximately 9–10 hours in children, 11–14 hours in adolescents, and 10–13 hours in adults, varying by the specific amphetamine form (d- or l-).

Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20ºC to 25°C (68°F to 77ºF) .