Amphetamine: ADHD Uses, Warnings, Side Effects, Dosage

Generic Name: amphetamine

Brand Names: Adzenys XR-ODT, Dyanavel XR, Evekeo, Adzenys ER, Evekeo ODT

Drug Class: Stimulants; ADHD Agents

What is amphetamine, and what is it used for?

Amphetamine is a stimulant drug used in the treatment of attention deficit hyperactivity disorder (ADHD), narcolepsy, a chronic sleep disorder that causes daytime drowsiness, and for short-term treatment of obesity.

Amphetamine is a sympathomimetic amine drug that mimics the action of natural chemicals in the body that stimulate the sympathetic nervous system.

Amphetamine raises the levels of brain chemicals (neurotransmitters) that stimulate the central nervous system (CNS), including dopamine, norepinephrine, and to a lesser extent, serotonin. Amphetamine increases the neurotransmitter levels by stimulating their release from the nerve cells (neurons) and also blocking their reabsorption (reuptake), a natural process after the completion of neurotransmission. Amphetamine also inhibits monoamine oxidase, an enzyme that breaks down these neurotransmitters.

Dopamine, norepinephrine, and serotonin have multiple functions that include regulation of digestion, sleep-wake cycle, movement, attention, memory, motivation, and pleasure. An increase in the levels of these neurotransmitters improves concentration and reduces hyperactive and impulsive behaviors associated with ADHD. Amphetamine stimulates daytime wakefulness, which can improve the nighttime quality of sleep. Amphetamine also suppresses appetite, which is useful for short-term treatment of obesity, as an adjunct to calorie restriction.

Stimulants including amphetamine also increase heart rate, blood pressure, and blood glucose, and dilate the respiratory tract. Stimulants have a high potential for abuse, misuse, tolerance dependence, and addiction, and are used illegally as street drugs.

Warnings

• Do not use amphetamine in patients with the following conditions:
  • Known hypersensitivity to amphetamine or any of its components, or other sympathomimetic amines
  • Symptomatic cardiovascular disease
  • Moderate to severe hypertension
  • Advanced plaque formation in the arteries (arteriosclerosis)
  • Hyperthyroidism
  • Agitated states
  • History of drug abuse
• Do not administer amphetamine concurrently or within 14 days following the administration of monoamine oxidase inhibitor (MAOI) antidepressant drugs, it can lead to a hypertensive crisis.
• CNS stimulants, including amphetamine, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor the patient for signs of abuse and dependence while on therapy. Caution the patient, family, and caregivers.
• Do not administer amphetamine to patients with coronary artery disease, structural cardiac abnormalities or other heart diseases. Stroke, heart attack (myocardial infarction), and sudden death have been reported with even recommended doses.
• CNS stimulants increase blood pressure and heart rate, monitor patients for hypertension and tachycardia.
• Amphetamine may lower seizure threshold in patients with a history of seizures.
• Amphetamine may exacerbate existing psychotic disorders and induce mixed or manic episodes in patients with bipolar disorder. Assess the patient’s risk factors before initiating amphetamine therapy.
• Amphetamine may cause the new onset of psychotic or manic symptoms such as hallucinations and delusional thinking in patients without a history of psychiatric illness. Consider discontinuing amphetamine if such symptoms occur.
• Amphetamine may suppress growth in pediatric patients, closely monitor growth.
• Monitor children and adolescents with ADHD for development or worsening of aggressive behavior or hostility.
• Amphetamine is associated with peripheral vascular diseases such as Raynaud’s phenomenon.
• Amphetamine may cause blurry vision or difficulty focusing (accommodation disorder).
• Concurrent use with drugs that increase serotonin levels including selective serotonin reuptake inhibitors (SSRIs), MAOIs, and others can lead to serotonin syndrome, a potentially life-threatening reaction.
• Do not substitute amphetamine for other amphetamine products on mg-per-mg basis. Medication errors or substitutions can lead to overdose.

What are the side effects of amphetamine?

Common side effects of amphetamine include:

• Decreased appetite
• Loss of appetite (anorexia)
• Dry mouth (xerostomia)
• Abdominal pain
• Nausea
• Vomiting
• Weight loss
• Diarrhea
• Indigestion (dyspepsia)
• Infections
• Headache
• Sleeplessness (insomnia)
• Fatigue
• Dizziness
• Irritability
• Mood swings (emotional lability)
• Agitation
• Nervousness
• Anxiety
• Fever
• Urinary tract infection
• Allergic nasal inflammation (rhinitis)
• Nasal bleeding (epistaxis)
• Rapid heart rate (tachycardia)
• Accidental injury
• Weakness (asthenia)

Less common side effects of amphetamine include:

• Increase in blood pressure
• Palpitations
• Rapid heart rate (tachycardia)
• Heart attack (myocardial infarction)
• Sudden death
• Heart disease (cardiomyopathy) with chronic use
• Unpleasant taste
• Constipation
• Reduced blood flow (ischemia) to the intestines
• Overstimulation
• Restlessness
• Depression
• Aggression
• Anger
• Excessive talkativeness (logorrhea)
• Numbness, tingling and crawling skin sensations (paresthesia)
• Euphoria
• Movement disorder (dyskinesia)
• Feeling of unease (dysphoria)
• Tremor
• Exacerbation of motor and phonic tics (Tourette’s syndrome)
• Psychotic episodes at recommended doses (rare)
• Allergic skin reactions including:
  • Rash
  • Hives (urticaria)
  • Stevens-Johnson syndrome
  • Toxic epidermal necrolysis
• Hypersensitivity reactions including:
  • Swelling under the skin and mucous tissues (angioedema)
  • Severe allergic reaction (anaphylaxis)
• Hair loss (alopecia)
• Reduced blood supply to extremities (Raynaud’s phenomenon)
• Blurred vision
• Dilated pupils (mydriasis)
• Impotence
• Changes in libido
• Frequent and prolonged erections
• Breakdown of muscle tissue (rhabdomyolysis)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

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What are the dosages of amphetamine?

Tablet (Evekeo): Schedule II

• 5 mg
• 10 mg

Extended-Release Oral Tablets (Dyanavel XR): Schedule II

• 5 mg
• 10 mg
• 15 mg
• 20 mg

Extended-Release Oral Suspension (Dyanavel XR): Schedule II

• 2.5 mg/mL

Extended-Release Oral Disintegrating Tablet (Adzenys XR-ODT): Schedule II

• 3.1 mg
• 6.3 mg
• 9.4 mg
• 12.5 mg
• 15.7 mg
• 18.8 mg

Extended-Release Oral Suspension (Adzenys ER): Schedule II

• 1.25 mg/mL

Adult:

Narcolepsy

• 5-60 mg/day orally in divided doses depending on the individual patient response
• Administer at the lowest effective dose; individually adjust dosage

Obesity

• Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy (e.g., repeated diets, group programs, and other drugs)
• Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals
• Administer at the lowest effective dose; individually adjust dosage

Attention Deficit Hyperactivity Disorder

• Indicated for attention deficit hyperactivity disorder (ADHD) in adolescents and adults
• Adzenys XR-ODT: 12.5 mg orally every morning
• Adzenys ER: 12.5 mg orally every morning
• Dyanavel XR: 2.5-5 mg orally every morning; may increase by 2.5 -10 mg/day every 4-7days; not to exceed 20 mg/day
• Evekeo: 5 mg orally every day or every 12 hours; may increase by 5 mg every week until optimal response is obtained; not to exceed 40 mg/day

Dosage Modifications

Equivalent doses of Adzenys ER or Adzenys XR-ODT and Adderall XR

• Adzenys ER/XR-ODT 3.1 mg (2.5 mL): Adderall XR 5 mg
• Adzenys ER/XR-ODT 6.3 mg (5 mL): Adderall XR 10 mg
• Adzenys ER/XR-ODT 9.4 mg (7.5 mL): Adderall XR 15 mg
• Adzenys ER/XR-ODT 12.5 mg (10 mL): Adderall XR 20 mg
• Adzenys ER/XR-ODT 15.7 mg (12.5 mL): Adderall XR 25 mg
• Adzenys ER/XR-ODT 18.8 mg (15 mL): Adderall XR 30 mg

Concomitant use of extended-release amphetamines with other medications

• Do not administer concomitantly or within 14 days after discontinuing MAO inhibitors
• Coadministration of and gastrointestinal alkalinizing agents should be avoided
• See Warnings

Dosing Considerations

• Do not substitute for other amphetamine products on a mg-per-mg basis, because of different amphetamine base compositions and differing pharmacokinetic profiles

Before initiating

• Assess for presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)
• Assess risk of abuse before prescribing, and monitor for signs of abuse and dependence while on therapy; maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for use

Pediatric:

Attention Deficit Hyperactivity Disorder

Evekeo

• Children below 3 years: Safety and efficacy not established
• Children 3-5 years: 2.5 mg orally every day initially; may increase daily dose by 2.5-mg increments at weekly intervals until optimal response is obtained
• Children 6 years and above: 5 mg orally every day initially; may increase daily dose by 5-mg increments at weekly intervals until optimal response is obtained; only in rare cases will it be necessary to exceed 40 mg/day
• If necessary, administer additional doses (1-2) at intervals of 4-6 hours

Evekeo ODT

• Children below 3 years: Safety and efficacy not established
• Children 3-5 years: 2.5 mg orally every day; if needed, may increase daily dose at weekly intervals by 2.5 mg depending on response and tolerability
• Children 6-17 years: 5 mg orally every day; if needed, may increase daily dose at weekly intervals by 2.5-5 mg until optimal response obtained
• If necessary, administer an additional dose after 4-6 hours
• Only in rare cases will it be necessary to exceed 40 mg/day
• Where possible, interrupt drug administration occasionally to determine if behavioral symptoms recur and are sufficient to require continued therapy
• Administer at the lowest effective dose and individually adjust

Dyanavel XR

• Children below 6 years: Safety and efficacy not established
• Children 6 years and above: Initial: 2.5-5 mg orally every morning
• May increase dose in increments of 2.5-10 mg/day every 4-7 days; not to exceed dose of 20 mg/day

Adzenys XR-ODT or Adzenys ER

• Children below 6 years: Safety and efficacy not established
• Children 6-17 years (initial dose): 6.3 mg orally every day in the morning; not to exceed 18.8 mg/day (6-12 years); 12.5 mg/day (13-17 years)

Narcolepsy (Evekeo)

• Seldom occurs in children younger than 12 years; however, when it does, amphetamine may be prescribed
• Children 6-12 years: 5 mg/day orally initially; daily dose may be increased by 5-mg increments at weekly intervals until optimal response obtained
• Children 12 years and above: 10 mg/day orally initially; daily dose may increase by 10-mg increments at weekly intervals until optimal response is obtained
• Administer in divided doses according to individual response
• Administer the first dose on awakening; give additional doses (5-10 mg) at intervals of 4-6 hours

Obesity (Evekeo)

• Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy (e.g., repeated diets, group programs, and other drugs)
• Children below 12 years: Safety and efficacy not established
• Children 12 years and above: Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals

Dosage Modifications

• Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine
• Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels; adjust dosage accordingly

Dosing Considerations

Before initiating

• Assess for presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)
• Assess risk of abuse before prescribing, and monitor for signs of abuse and dependence while on therapy; maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for use

Switching From Other Amphetamine Products

• Do not substitute for other amphetamine products on a mg-per-mg basis, because of different amphetamine base compositions and differing pharmacokinetic profiles
• Switching from Evekeo to Evekeo ODT can be done on a mg-per-mg basis
• Switching from other amphetamine products to Evekeo ODT, discontinue treatment and titrate with Evekeo ODT using the titration schedule above
• May substitute Dyanavel XR extended-release oral suspension with Dyanavel XR extended-release tablets on a mg-per-mg basis
• Avoid late evening doses because of insomnia

Who is at greater risk for developing ADHD?
See Answer

Addiction/overdose

• Amphetamine has a high potential for abuse and misuse resulting in tolerance, dependence, and withdrawal symptoms such as fatigue and mental depression upon discontinuation. Misuse and abuse of amphetamine can lead to overdose and death.
• Acute amphetamine overdose symptoms include restlessness, tremor, overactive reflexes (hyperreflexia), rapid breathing, hallucination, confusion, panic, fatigue, high body temperature (hyperpyrexia), cardiovascular symptoms such as irregular heart rhythm, changes in blood pressure and circulatory collapse, and gastrointestinal symptoms such as nausea, vomiting, diarrhea and abdominal cramps. Severe overdose can cause convulsions, coma and death.
• Treatment for amphetamine overdose is symptomatic and supportive care. Undigested drug from the gastrointestinal tract may be eliminated with gastric lavage and administration of activated charcoal. Benzodiazepines may be used for sedation and to control seizures.
• Individual patient response to amphetamines varies widely. Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage.

What drugs interact with amphetamine?

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Amphetamine has no known severe interactions with other drugs.
• Serious Interactions of amphetamine include:
  • iobenguane I 131
  • ozanimod
• Moderate Interactions of amphetamine include:
  • benzhydrocodone/acetaminophen
  • buprenorphine, long-acting injection
  • epinephrine inhaled
  • esketamine intranasal
  • hydrocodone
  • sodium zirconium cyclosilicate
  • sufentanil SL
• Amphetamine has no known mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

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Pregnancy and breastfeeding

• There are no adequate and well-controlled studies of amphetamine use in pregnant women, however, animal reproductive studies indicate it can cause fetal harm. It may also cause premature delivery, low birth weight and withdrawal symptoms in the newborn.
• Use amphetamine during pregnancy only if potential benefits to the pregnant woman outweigh potential risks to the fetus. Monitor the infant for withdrawal symptoms such as agitation, irritability, excessive drowsiness, or feeding difficulties, in case of maternal use of amphetamine during pregnancy.
• Amphetamine is present in breast milk and is not recommended for nursing mothers.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to amphetamine during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications.

What else should I know about amphetamine?

• Amphetamine is a Schedule II controlled substance, diversion of Schedule II products is subject to criminal penalty.
• Take amphetamine exactly as prescribed, do not take larger or more frequent doses.
• Amphetamine has a high risk for abuse, addiction and dependency, and can lead to fatal overdose, exercise caution.
• Amphetamine can impair mental and physical ability. Avoid driving, operating heavy machinery or other potentially hazardous tasks.
• Avoid drinking alcohol while on amphetamine therapy, it can potentiate the drug effects.
• Use of amphetamine can increase heart rate, blood pressure and risk of serious cardiovascular events. Contact your healthcare immediately if you develop chest pain with exertion, unexplained fainting or other symptoms suggestive of cardiac disease.
• Store amphetamine safely out of reach of children and others. Dispose of remaining unused or expired medicine by a medicine take-back program.
• In case of overdose, immediately seek medical help or contact Poison Control.