Amphetamine

Amphetamine is a prescription medications that is indicated for the treatment of:

• Narcolepsy
• Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, mental, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Non-localizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted.
• Exogenous Obesity 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. The limited usefulness of amphetamines should be weighed against possible risks inherent in use of the drug.

Amphetamine is available under the following different brand names: Adzenys XR-ODT, Dyanavel XR, and Evekeo.

Amphetamine belongs to a class of medications called stimulants.

Stimulant medications work by increasing dopamine levels in the brain.

Dopamine is a neurotransmitter (brain chemical) that is associated with pleasure, movement, and attention.

Amphetamine is closely related to other stimulant medicines such as:

• Adderall
• Adderall XR
• Concerta
• Focalin, and
• Vyvanse

People taking this medication should read the drug information leaflet that accompanies the prescription as well as every time the prescription is refilled. There may be new health information.

This medication is available by prescription only.

Addiction potential for stimulant is very high.

People taking this medicine must be closely monitored.

This drug must be used with extreme caution.

Tablet: Schedule II

• 5 mg
• 10 mg

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 (Dyanavel XR): Schedule II (pediatric only)

• 2.5 mg

Amphetamines have a high potential for abuse.

Administration for prolonged periods of time may lead to drug dependence and must be avoided.

Narcolepsy

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

• Pediatric
  • Narcolepsy 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 older: 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 first dose on awakening; give additional doses (5-10 mg) at intervals of 4-6 hours

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 adult 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
• Children under 12 years: Safety and efficacy not established
• Children 12 years and older: Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals

Attention Deficit Hyperactivity Disorder

• Adult
  • CNS stimulant indicated for ADHD
  • Adzenys XR-ODT: 12.5 mg orally once/day in AM

• Pediatric
  • Evekeo
    • Children under 3 years: Safety and efficacy not established
    • Children 3-5 years: 2.5 mg orally once/day initially; may increase daily dose by 2.5-mg increments at weekly intervals until optimal response is obtained
    • Children 6 years and older: 5 mg orally once/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
    • Administer first dose on awakening; give additional doses (1 to 2) at intervals of 4-6 hours
  • Dyanavel XR
    • Children under 6 years: Safety and efficacy not established
    • Children 6 years and older: Initial: 2.5-5 mg once/day in AM
    • May increase dose in increments of 2.5-10 mg/day every 4-7 days; not to exceed dose of 20 mg/day
    • Shake suspension well before measuring dose with a calibrated measuring device
    • Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine base compositions and differing pharmacokinetic profiles
  • Adzenys XR-ODT
    • Children under 6 years: Safety and efficacy not established
    • Children 6-17 years (initial dose): 6.3 mg orally once/day in AM

    Maximum dose

    • • Children 6-12 years: 18.8 mg once/day
      • Children 13-17 years: 12.5 mg once/day

Common amphetamine side effects may include:

• Palpitations
• Fast heart rate
• Elevation of blood pressure
• Heart muscle disease (cardiomyopathy) (isolated reports associated with chronic use)
• Psychotic episodes at recommended doses (rare)
• Mental overstimulation
• Restlessness
• Dizziness
• Insomnia
• Euphoria
• Abnormal and uncontrolled movements
• Feeling uneasy
• Tremor
• Headache pain
• Worsening of motor and phonic tics and Tourette's syndrome
• Dry mouth
• Unpleasant taste
• Diarrhea
• Constipation
• Loss of appetite
• Weight loss
• Hives
• Impotence
• Changes in sex drive
• Frequent or prolonged erections

Postmarketing side effects of amphetamine reported include:

• Muscle wasting (rhabdomyolysis)
• Serotonin syndrome

This document does not contain all possible side effects and other serious side effects (such as heart attack) may occur. Check with your physician for additional health information and medical advice about side effects.

If your doctor has directed you to use this medication for diabetes, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of amphetamine include:

• None

Serious Interactions of amphetamine include:

• isocarboxazid
• phenelzine
• tranylcypromine

Amphetamine has moderate interactions with at least 163 different drugs.

Mild Interactions of amphetamine include:

None

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• Amphetamines have a high potential for abuse.
• Administration for prolonged periods of time may lead to drug dependence and must be avoided.
• Pay attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others.
• Prescribe/dispense sparingly according to law.
• Misuse may cause sudden death and serious cardiovascular adverse events.
• This medication contains amphetamine. Do not take this dug if you are allergic to amphetamine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate-to-severe hypertension
• Hyperthyroidism
• Known hypersensitivity or idiosyncrasy to the sympathomimetic amines
• Agitated states
• Patients with a history of drug abuse
• During or within 14 days following the administration of MAOIs (hypertensive crises may result)

Effects of Drug Abuse

• Amphetamines have a high potential for abuse.
• Administration for prolonged periods of time may lead to amphetamine abuse or dependence.
• Potential for amphetamine addiction is high. Therefore, prolonged use must be avoided.
• Pay attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others.
• Prescribe/dispense sparingly according to law.
• Misuse may cause sudden death and serious cardiovascular adverse events.

Short-Term Effects

• See "What Are Side Effects Associated with Using Amphetamine?"

Long-Term Effects

• Administration for prolonged periods of time may lead to drug dependence and must be avoided.
• Heart muscle disease (cardiomyopathy) (isolated reports associated with chronic use)
• See "What Are Side Effects Associated with Using Amphetamine?"

Cautions

• Sudden death has been reported in association with central nervous system (CNS) stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
• Causes a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 beats per minute); caution with hypertension and other cardiovascular conditions.
• Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease.
• May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
• Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients.
• Treatment emergent psychotic or manic symptoms (e.g., hallucinations, delusional thinking, mania) in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses.
• Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD; although there is no systematic evidence that stimulants cause aggressive behavior or hostility, monitor for the appearance of or worsening of aggressive behavior or hostility.
• Childhood growth should be monitored during treatment; patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
• May lower seizure threshold in patients with prior history of seizures.
• Stimulants are associated with peripheral vasculopathy, including Raynaud's phenomenon.
• Visual disturbances reported (e.g., difficulties with accommodation, blurred vision).
• Drug interaction overview:
• Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort
• Amphetamines are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase risk with increased exposure to amphetamines; in these situations, consider alternative non-serotonergic drug or alternative drug that does not inhibit CYP2D6
• If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome

Pregnancy and Lactation

• Use amphetamine with caution during pregnancy if benefits outweigh risks. There are no adequate and well-controlled studies of amphetamine in pregnant women.
• Another stimulant (i.e., dextroamphetamine sulfate) has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose.
• Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose.
• Amphetamine is distributed in human breast milk; do not breastfeed.