Indicated for:

Attention Deficit Hyperactivity Disorder (ADHD):

The effectiveness of Adderall for long-term use has not been systematically evaluated in controlled trials.Therefore, the physician who elects to use Adderall for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder.

Narcolepsy:

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily)

The effectiveness of Adderall for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Adderall for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Adderall has not been studied in the geriatric population.

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. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions. 

Sudden death has been reported with usual doses of CNS stimulants in children and adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial infarction have been reported in adults taking CNS stimulants at usual doses. Stimulant drugs should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.

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.

Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases.

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Treatment-emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without 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.

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 MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort.

Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted. 

Stimulants, including Adderall, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures.

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore, clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of stimulant medications.

Adderall is contraindicated in patients with:

• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate to severe hypertension
• Hyperthyroidism
• Glaucoma
• Agitated states
• History of drug abuse
• During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis

Use with acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts) lower blood levels and efficacy of amphetamines.

Adrenergic blockers are inhibited by amphetamines.

Use with tricyclic antidepressants (e.g.,desipramine, protriptyline) may enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Use with alkalinizing agents (e.g, sodium bicarbonate, acetazolamide, some thiazides) increase blood levels and potentiate the action of amphetamine.

The concomitant use of Adderall and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, serotonergic drugs, quinidine, ritonavir) may increase the exposure of Adderall.

The concomitant use of Adderall and serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort) increases the risk of serotonin syndrome.

Concomitant use of MAOIs (e.g., selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue) and CNS stimulants can cause hypertensive crisis.

Amphetamines may antagonize the hypotensive effects of antihypertensives.

Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.

The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Amphetamines potentiate the analgesic effect of meperidine.

Amphetamines enhance the adrenergic effect of norepinephrine.

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy.

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

GoToSource    

• Adderall use in children under 3 years of age. GoToSource

• Cognition enhancement. GoToSource

• Weight loss. GoToSource

• Depression. GoToSource

• Use with SSRIS or SNRIS in the treatment of adult ADHD patients with generalized anxiety. GoToSource

• Fibromyalgia syndrome and chronic fatigue syndrome. GoToSource

• Obsessive compulsive disorder. GoToSource

• Cocaine dependence. GoToSource

• Cognitive impairment associated with multiple sclerosis. GoToSource

Heart attacks. GoToSource

Takotsubo cardiomyopathy (sudden temporary weakening of heart muscle). GoToSource  

Cardiomyopathy with heart failure. GoToSource

Addiction. GoToSource

Growth suppression, anorexia (eating disorder), psychosis and exacerbation of tics and tourette syndrome. GoToSource

Acute, sustained chorea (movement disorder). GoToSource

Elevated blood pressure, increased heart rate and sudden cardiac death. GoToSource

Hallucinations and delusions. GoToSource

Peripheral vasculopathy including raynaud’s phenomenon (progressive circulation disorder caused by narrowing, blockage or spasms in a blood vessel). GoToSource

Seizures. GoToSource

Serotonin syndrome (life-threatening drug reaction). GoToSource

Bruxism (grinding of teeth). GoToSource

Priapism (frequent or prolonged erections). GoToSource

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (movement disorder), hypomania, mania and insomnia. GoToSource

Tremor, choreoathetosis (involuntary movements), dystonia (feeling unwell or unhappy) dyskinesias (movement disorder), gait disturbance, ischemic infarction, intracerebral hemorrhage, depression and palpitations. GoToSource

Trichotillomania (hair pulling). GoToSource

Liver injury. GoToSource

Lawsuits filed for heart attacks, kidney failure, sudden death and addiction.