- 1 DEA status
- 2 Rx status
- 3 Potential for abuse
- 4 Indications (use)
- 5 Mechanism of action
- 6 Pharmacokinetics
- 7 Half life
- 8 Contra-indications (when not to use)
- 9 Side effects
- 10 Emergency/overdose
- 11 Brand names
- 12 Warnings and precautions
- 13 Information for Patients
- 14 Pregnancy category
- 15 Pediatric Use
It is a prescription only controlled substance.
Potential for abuse
Amphetamines have a high potential for abuse. Administration of Amphetamines for prolonged periods of time may lead to drug dependence and must be avoided. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
- The combination of dextroamphetamine and amphetamine (common brand names:adderall, adderall xr, mydayis) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (adhd; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age).
- Adderall is used to treat adhd in adults and children 3 years of age and older. Adderall xr is used to treat adhd in adults and children 6 years of age and older.
- Mydayis is used to treat adhd in adults and children 13 years of age and older.
- Dextroamphetamine and amphetamine (adderall) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep) in adults and children 12 years of age and older.
Mechanism of action
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (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.
Adderall® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of Adderall® to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and lamphetamine.
The mean elimination half life (t1/2) for d-amphetamine was shorter than the t1/2 of the lisomer (9.77 to 11 hours vs. 11.5 to 13.8 hours).
Contra-indications (when not to use)
- Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
- Agitated states.
- Known hypersensitivity or idiosyncrasy to amphetamine.
- Patients with a history of drug abuse.
- In patients known to be hypersensitive to amphetamine, or other components of Adderall®.
- 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.
Dextroamphetamine and amphetamine may cause side effects.
Tell your doctor if any of these symptoms are severe or do not go away:
- changes in sex drive or ability
- painful menstrual cramps
- dry mouth
- weight loss
More serious side effects
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- slow or difficult speech
- weakness or numbness of an arm or leg
- motor or verbal tics
- teeth grinding
- believing things that are not true
- feeling unusually suspicious of others
- hallucinating (seeing things or hearing voices that do not exist)
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
- mania (frenzied or abnormally excited mood)
- changes in vision or blurred vision
- paleness or blue color of fingers or toes
- pain, numbness, burning, or tingling in the hands or feet
- unexplained wounds appearing on fingers or toes
- blistering or peeling skin
- swelling of the eyes, face, tongue, or throat
- difficulty breathing or swallowing
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Poison Help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
- aggressive behavior
- feelings of panic
- hallucination (seeing things or hearing voices that do not exist)
- fast breathing
- uncontrollable shaking of a part of the body
- dark red or cola-colored urine
- muscle weakness or aching
- tiredness or weakness
- fast or irregular heartbeat
- blurred vision
- upset stomach
- coma (loss of consciousness for a period of time)
- Mydayis® (as a combination product containing Amphetamine, Dextroamphetamine)
- Brand names of combination products
- Adderall® (containing Amphetamine, Dextroamphetamine)
- Adderall® XR (containing Amphetamine, Dextroamphetamine)
- Biphetamine® (containing Amphetamine, Dextroamphetamine)
Warnings and precautions
Children and Adolescents Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug
- Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy,
- serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs
- Hypertension and Other Cardiovascular Conditions
- Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see ADVERSE REACTIONS], and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.
- Assessing Cardiovascular Status in Patients Being Treated With stimulant medications
- 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, and should receive further
- cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Psychiatric Adverse Events
Preexisting Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.
Information for Patients
Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder