Adderall (mixed amphetamine salts tablets)

Generic name: Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (mixed salts of a single-entity amphetamine product) · Brand names: Adderall (immediate-release tablets)

Quick facts

Drug class
It is a central nervous system stimulant.
Source text (exact source wording)
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. (Aurolife label, CLINICAL PHARMACOLOGY, Pharmacodynamics) / The combination of dextroamphetamine and amphetamine is in a class of medications called central nervous system stimulants. (MedlinePlus a601234)
Rx or otc
Rx (prescription). Source: label is a prescription drug label with DEA schedule field; label text 'Before prescribing...' in Boxed Warning.
Controlled schedule
Value
CII (Schedule II)
Source text (exact source wording)
DEA Schedule: CII (DailyMed product information field). / contain amphetamine, a Schedule II controlled substance. (DRUG ABUSE AND DEPENDENCE)
Forms and strengths
  • Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg (Description table 'EACH TABLET CONTAINS' columns, Aurolife label)
  • Other forms exist under other labels (Adderall XR and Mydayis extended-release capsules) and are NOT covered by this record
Generic available
Value
yes
Source
DailyMed lists many ANDA generic tablets, for example Aurolife (ANDA202424), Alvogen, Lannett, Granules, Northstar
Common use one line
Used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy.

What it is used for

This medicine is used to treat ADHD and narcolepsy. A doctor diagnoses ADHD when symptoms of being restless or impulsive, or having trouble paying attention, started before age 7 years, cause real problems, and show up in two or more places such as home and school or work.
Source text (exact source wording)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed salts of single entity amphetamine product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. (INDICATIONS AND USAGE)

How it works

It is a stimulant. The label says how it helps ADHD is not known. Amphetamines are thought to keep the brain chemicals norepinephrine and dopamine active longer and to release more of them.
Source text (exact source wording)
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 extra neuronal space. (CLINICAL PHARMACOLOGY, Pharmacodynamics)

Dosage: adults

The label says to use the lowest dose that works and adjust it to the person. For ADHD at age 6 years and older, the start is 5 mg once or twice a day, raised by 5 mg each week. It is rarely necessary to go over 40 mg per day. For narcolepsy the usual dose is 5 mg to 60 mg per day in divided doses; at 12 years and older the start is 10 mg a day, raised by 10 mg each week. The first dose is given on waking, with 1 or 2 more doses 4 to 6 hours apart. Late evening doses should be avoided because they cause insomnia.
Source text (exact source wording)
Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder: Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained. In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Prior to treating patients with Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS]. • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate [see WARNINGS]. Narcolepsy: Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response. 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; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. (DOSAGE AND ADMINISTRATION, full section; the label has no separate adult-only subsection)

Dosage: children

For ADHD, the label says this medicine is not recommended for children under 3 years of age. At ages 3 to 5 years the start is 2.5 mg daily, raised by 2.5 mg each week. At 6 years and older the start is 5 mg once or twice daily, raised by 5 mg each week. For narcolepsy, ages 6 to 12 start at 5 mg daily. The label says long-term effects in children have not been well established.
Source text (exact source wording)
Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder: Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained. In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Prior to treating patients with Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS]. • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate [see WARNINGS]. Narcolepsy: Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response. 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; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. (DOSAGE AND ADMINISTRATION, full section; the label has no separate adult-only subsection) 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 described under INDICATIONS AND USAGE. (PRECAUTIONS, Pediatric Use)

Dosage adjustments

Drug interaction caps
With serotonin-raising drugs or CYP2D6 inhibitors the label says to start with lower doses and watch for serotonin syndrome. Acid-making agents lower blood levels, and the label says to increase dose based on response. Alkalinizing agents raise blood levels and should be avoided.
Source text (exact source wording)
Serotonergic Drugs: The concomitant use of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets initiation or dosage increase. CYP2D6 Inhibitors: Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets initiation and after a dosage increase. Acidifyingagents: Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. AlkalinizingAgents: Increase blood levels and potentiate the action of amphetamine. Co-administration of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and gastrointestinal alkalinizing agents should be avoided. (PRECAUTIONS, Drug Interactions)
Elderly
The label says this medicine has not been studied in older adults.
Source text (exact source wording)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet has not been studied in the geriatric population. (PRECAUTIONS, Geriatric Use)

Missed dose

The tablet label has no missed-dose instructions. MedlinePlus gives instructions for the extended-release capsule only: skip the missed morning dose, take the next dose at the regular time the next day, do not take a dose later in the day and do not double up. Ask a pharmacist or doctor what to do for tablets.
Source text (exact source wording)
Label: NOT FOUND (no missed-dose statement in the immediate-release tablet label sections read). MedlinePlus a601234, 'What should I do if I forget a dose?' (written for the extended-release capsule): If you miss your dose of the extended-release capsule the morning, skip the missed dose and take your next dose at the regular time the next day. Do not take a dose later in the day. Do not take a double dose to make up for a missed one.

Overdose

An overdose can cause heart rhythm problems, blood pressure changes, agitation, confusion, hallucinations, seizures, coma and a dangerously high body temperature. If someone takes too much, call poison control at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Source text (exact source wording)
Clinical Effects of Overdose: Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management: Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. (OVERDOSAGE) Medication Guide: If you or your child take too much Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Storage

Store at room temperature, 20° to 25°C (68° to 77°F), in the container it came in, tightly closed and out of the reach of children. The label advises keeping it in a safe place, preferably locked, and not giving it to anyone else. Do not flush it; use a medicine take-back program.
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. (HOW SUPPLIED, Aurolife label; labeler-specific) Medication Guide, How should I store: Store Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets at room temperature, between 68 to 77°F (20 to 25°C). Protect Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets from light. Store Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets in a safe place, like a locked cabinet. Dispose of remaining, unused, or expired Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine sulfate Tablets by a medicine take back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. [MedlinePlus a601234: Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not flush this medication down the toilet. Use a medicine take-back program. (separate source)]

Boxed warning

This medicine has a high chance of being abused or misused, which can lead to addiction, overdose and death. The risk is higher with larger doses or with snorting or injecting it. Doctors should check each person's risk before prescribing and keep checking during treatment, and should teach patients about safe storage and disposal.
Source text (exact source wording)
WARNING: ABUSE, MISUSE, AND ADDICTION. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS and DRUG ABUSE AND DEPENDENCE). (Boxed Warning, Aurolife label, set ID a582d57f-d191-4ca5-b105-585b2d8a0e3e; copied verbatim from the printer-friendly DailyMed page)

Contraindications

Do not use if you are allergic to amphetamine or anything in the tablets.
Source text (exact source wording)
In patients known to be hypersensitive to amphetamine, or other components of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products. (CONTRAINDICATIONS)
Do not use with an MAOI, or within 14 days of stopping one, including linezolid or intravenous methylene blue, because of the risk of a hypertensive crisis.
Source text (exact source wording)
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. (CONTRAINDICATIONS)
Do not use if you have, or have had, pheochromocytoma.
Source text (exact source wording)
Patients with pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received an amphetamine product. (CONTRAINDICATIONS)

Warnings and precautions

The tablets can be misused and can lead to addiction, overdose and death. Keep them locked up, never share them, and dispose of unused tablets properly.
Heading
Abuse, Misuse, and Addiction
Source text (exact source wording)
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets has a high potential for abuse and misuse. The use of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE and DEPENDENCE: Abuse). Misuse and abuse of CNS stimulants, including Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to anyone else. Throughout Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. (WARNINGS)
Sudden death has been reported in people with serious heart problems who took stimulants. The label says to avoid use in people with known serious heart disease.
Heading
Risks to Patients with Serious Cardiac Disease
Source text (exact source wording)
Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulant treatment at the recommended ADHD dosages. Avoid Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. (WARNINGS)
Stimulants raise blood pressure (about 2 to 4 mm Hg on average) and heart rate (about 3 to 6 bpm on average). Some people have larger increases, so blood pressure and heart rate should be checked.
Heading
Increased Blood Pressure and Heart Rate
Source text (exact source wording)
CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases. Monitor all Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets -treated patients for potential tachycardia and hypertension. (WARNINGS)
Stimulants can make existing psychosis or bipolar disorder worse and can cause hallucinations, delusional thinking or mania even in people who never had them. In short studies this happened in approximately 0.1% of stimulant-treated patients compared with 0% on placebo. Stopping the medicine should be considered if it happens.
Heading
Psychiatric Adverse Reactions
Source text (exact source wording)
Exacerbation of Preexisting Psychosis: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms: CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consideration discontinuing Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. (WARNINGS)
Stimulants can cause weight loss and slow growth in children. Height and weight should be watched closely, and treatment may need to be paused if a child is not growing or gaining weight as expected.
Heading
Long-Term Suppression of Growth in Pediatric Patients
Source text (exact source wording)
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets treated pediatric patients treated with CNS stimulants. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted (see PRECAUTIONS, PEDIATRIC USE). (WARNINGS)
Stimulants may make seizures more likely, mostly in people with a past seizure or abnormal brain-wave test. If seizures occur, the drug should be stopped.
Heading
Seizures
Source text (exact source wording)
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. In the presence of seizures, the drug should be discontinued. (WARNINGS)
Stimulants can cause circulation problems in the fingers and toes, including Raynaud's phenomenon. Symptoms are usually mild and come and go, but sores can happen. They generally improved after a lower dose or stopping.
Heading
Peripheral Vasculopathy, Including Raynaud's Phenomenon
Source text (exact source wording)
Stimulants, including Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets treated patients who develop signs or symptoms of peripheral vasculopathy. (WARNINGS)
Serotonin syndrome is a potentially life-threatening reaction that can happen when amphetamines are taken with other drugs that affect serotonin. Symptoms can include agitation, hallucinations, fast heartbeat, tremor, stiff muscles, seizures, nausea, vomiting and diarrhea. Treatment and the other serotonin drugs should be stopped right away if it occurs.
Heading
Serotonin Syndrome
Source text (exact source wording)
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 [see DRUG INTERACTIONS]. The co-administration with cytochrome P450 (CYP2D6) inhibitors increase the risk with increased exposure to Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see DRUG INTERACTIONS]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, and hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, and incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Concomitant use of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets with MAOIs drugs is contraindicated [see CONTRAINDICATIONS]. Discontinue treatment with Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and any concomitant serotonergic agents immediately if the above symptoms occur and initiate supportive symptomatic treatment. If concomitant use Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome. (WARNINGS)
Stimulants can start or worsen tics and can worsen Tourette's syndrome. Family history and tics should be checked before starting and watched during treatment.
Heading
Motor and Verbal Tics, and Worsening of Tourette's Syndrome
Source text (exact source wording)
CNS stimulants, including amphetamine sulfate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, and discontinue treatment if clinically appropriate. (WARNINGS)

Pregnancy and breastfeeding

There are no adequate, well-controlled studies in pregnant women. The label says amphetamines should be used in pregnancy only if the potential benefit justifies the potential risk to the baby. Babies born to mothers dependent on amphetamines have an increased risk of early birth and low birth weight and may have withdrawal symptoms. Amphetamines pass into breast milk, and the label says mothers taking them should be advised to refrain from nursing.
Source text (exact source wording)
Pregnancy, Teratogenic Effects: Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal 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. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: 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. Usage in Nursing Mothers: Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing. (PRECAUTIONS)

Side effects

Common
The prescribing information gives no frequency list. The Medication Guide says the most common side effects include stomachache, decreased appetite and nervousness.
Source text (exact source wording)
Label ADVERSE REACTIONS: NOT FOUND (no most-common list or frequency threshold). Medication Guide (Aurolife label): The most common side effects of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets include stomachache decreased appetite nervousness (list exactly as it appears on the label page; the printer-friendly text runs it together with the preceding tics paragraph).
Serious
The label lists heart effects (including sudden death and heart attack), psychotic episodes, serious allergic reactions and serious skin rashes such as Stevens-Johnson syndrome, and rhabdomyolysis. MedlinePlus says to call a doctor right away or get emergency treatment for signs such as seizures, hallucinations, mania, swelling of the face or throat, trouble breathing, color changes in fingers or toes, or chest pain, shortness of breath or fainting.
Source text (exact source wording)
LABEL (ADVERSE REACTIONS and WARNINGS): Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, motor and verbal tics, aggression, anger, logorrhea, dermatillomania. Eye Disorders: Vision blurred, mydriasis. Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine: Impotence, changes in libido, frequent or prolonged erections. Skin: Alopecia. Musculoskeletal: Rhabdomyolysis. || MEDLINEPLUS a601234 (call your doctor immediately or get emergency medical treatment): slow or difficult speech; dizziness; weakness or numbness of an arm or leg; seizures; motor or verbal tics; teeth grinding; depression; believing things that are not true; feeling unusually suspicious of others; hallucinating; mania; 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; rash; hives; itching; swelling of the eyes, face, tongue, or throat; difficulty breathing or swallowing; hoarseness. Call your doctor right away if you or your child has any signs of heart problems while taking this medication including: chest pain, shortness of breath, or fainting.
Medwatch
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Interactions

Drugs
Do not take with an MAOI or within 14 days after stopping one. The combination can cause a hypertensive crisis with serious outcomes.
Name
MAO inhibitors
Section
DRUG INTERACTIONS
Source text (exact source wording)
Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets concomitantly or within 14 days after discontinuing MAOI [see CONTRAINDICATIONS and WARNINGS].
Taking it with serotonin-raising drugs raises the risk of serotonin syndrome. Start with lower doses and watch for symptoms.
Name
Serotonergic drugs
Section
DRUG INTERACTIONS
Source text (exact source wording)
The concomitant use of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and the concomitant serotonergic drug(s) [see WARNINGS and PRECAUTIONS].
CYP2D6 inhibitors can raise the amount of the medicine in the body and the risk of serotonin syndrome.
Name
CYP2D6 inhibitors
Section
DRUG INTERACTIONS
Source text (exact source wording)
The concomitant use of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and CYP2D6 inhibitors may increase the exposure of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and the CYP2D6 inhibitor [see WARNINGS, OVERDOSAGE].
Acidifying agents lower blood levels and effect of the medicine.
Name
Acidifying agents
Section
DRUG INTERACTIONS
Source text (exact source wording)
Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents and urinary acidifying agents.
Alkalinizing agents such as sodium bicarbonate raise blood levels and strengthen the effect; the label says to avoid using them together.
Name
Alkalinizing agents
Section
DRUG INTERACTIONS
Source text (exact source wording)
Increase blood levels and potentiate the action of amphetamine. Co-administration of Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents.
Can cause large, lasting increases of d-amphetamine in the brain and stronger heart effects. Needs frequent monitoring.
Name
Tricyclic antidepressants
Section
DRUG INTERACTIONS
Source text (exact source wording)
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. Monitor frequently and adjust or use alternative therapy based on clinical response.
Amphetamines inhibit adrenergic blockers.
Name
Adrenergic blockers
Section
DRUG INTERACTIONS
Source text (exact source wording)
Adrenergic blockers are inhibited by amphetamines.
Amphetamines may counteract the sleepy effect of antihistamines.
Name
Antihistamines
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines may counteract the sedative effect of antihistamines.
Amphetamines may work against blood pressure medicines.
Name
Antihypertensives
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine blocks the stimulant effects of amphetamines.
Name
Chlorpromazine
Section
DRUG INTERACTIONS
Source text (exact source wording)
Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.
Amphetamines may delay absorption of ethosuximide.
Name
Ethosuximide
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines may delay intestinal absorption of ethosuximide.
Haloperidol blocks the stimulant effects of amphetamines.
Name
Haloperidol
Section
DRUG INTERACTIONS
Source text (exact source wording)
Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.
Lithium carbonate may reduce the appetite-lowering and stimulating effects of amphetamines.
Name
Lithium carbonate
Section
DRUG INTERACTIONS
Source text (exact source wording)
The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Amphetamines increase the pain-relieving effect of meperidine.
Name
Meperidine
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines potentiate the analgesic effect of meperidine.
Acidifying agents used with methenamine increase urinary loss of amphetamines and reduce effect.
Name
Methenamine therapy
Section
DRUG INTERACTIONS
Source text (exact source wording)
Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.
Amphetamines boost the adrenergic effect of norepinephrine.
Name
Norepinephrine
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines enhance the adrenergic effect of norepinephrine.
May delay absorption of phenobarbital and may add to its anti-seizure action.
Name
Phenobarbital
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines may delay intestinal absorption of phenobarbital; coadministration of phenobarbital may produce a synergistic anticonvulsant action.
May delay absorption of phenytoin and may add to its anti-seizure action.
Name
Phenytoin
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines may delay intestinal absorption of phenytoin; coadministration of phenytoin may produce a synergistic anticonvulsant action.
In a propoxyphene overdose, amphetamine stimulation is increased and fatal convulsions can occur.
Name
Propoxyphene
Section
DRUG INTERACTIONS
Source text (exact source wording)
In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Amphetamine reaches its peak level sooner. Monitor for changes in effect.
Name
Proton pump inhibitors
Section
DRUG INTERACTIONS
Source text (exact source wording)
Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole.
Amphetamines reduce the blood-pressure-lowering effect of veratrum alkaloids.
Name
Veratrum alkaloids
Section
DRUG INTERACTIONS
Source text (exact source wording)
Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
Food and alcohol
Keep your normal diet unless told otherwise. The tablets can be taken with or without food.
Name
Diet
Section
MedlinePlus a601234, special dietary instructions
Source text (exact source wording)
Unless your doctor tells you otherwise, continue your normal diet. The tablet can be taken with or without food (Medication Guide: can be taken with or without food).
Name
Alcohol
Other
Tell your doctor about herbal products such as St. John's wort; the label lists St. John's wort as raising serotonin syndrome risk.
Name
St. John's wort and herbal products
Section
MedlinePlus a601234, Before taking; label WARNINGS (Serotonin Syndrome)
Source text (exact source wording)
the following nonprescription or herbal products may interact with dextroamphetamine and amphetamine (MedlinePlus). Label lists St. John's Wort among drugs that affect serotonergic systems.
MedlinePlus asks you to tell your doctor if you use antacids or other heartburn or ulcer medicines.
Name
Antacids and medicines for heartburn or ulcers
Section
MedlinePlus a601234, Before taking
Source text (exact source wording)
antacids and other medications for heartburn or ulcers

Patient tips

Label medication guide
Take it exactly as prescribed. The first dose is usually taken on waking, with or without food. Call right away or go to the emergency room for chest pain, shortness of breath or fainting, and call for any new or worsening mental symptoms. Do not drive or do dangerous activities until you know how it affects you. In an overdose, call poison control at 1-800-222-1222 or go to the nearest emergency room.
Source text (exact source wording)
Take Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets exactly as prescribed by your or your child's healthcare provider. Your healthcare provider may change the dose if needed The first dose of the day is usually taken when you first wake up. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets can be taken with or without food. Your healthcare provider may sometimes stop Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets treatment for a while to check ADHD symptoms. If you or your child take too much Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. (How should ... be taken?) Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets affect you. (What should I avoid) Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. Do not take Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets if you or your child: are allergic to amphetamine products or any of the ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. See the end of this Medication Guide for a complete list of ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. are taking or have taken within the past 14 days, an anti-depression medicine used to treat depression called a monoamine oxidase inhibitor or (MAOI), including the antibiotic linezolid or the intravenous medicine methylene blue. have a condition called pheochromocytoma (a rare tumor that usually grows in the adrenal glands which are above your kidneys). (Medication Guide)
Medlineplus
MedlinePlus says the tablet is usually taken 2 to 3 times daily, 4 to 6 hours apart, and should not be taken in the late afternoon or evening because it can make it hard to fall asleep. Do not stop without talking to your doctor.
Source text (exact source wording)
The immediate-release tablet (Adderall) is usually taken 2 to 3 times daily, 4 to 6 hours apart, with or without food. should not be taken in the late afternoon or evening because it may cause difficulty falling asleep. Your doctor may tell you to stop taking dextroamphetamine and amphetamine from time to time. Do not stop taking dextroamphetamine and amphetamine without talking to your doctor (IMPORTANT WARNING section). Unless your doctor tells you otherwise, continue your normal diet. In case of overdose, call the poison control helpline at 1-800-222-1222.

Alternatives

Indication source
Both indications (ADHD, narcolepsy) from the Aurolife label INDICATIONS AND USAGE; MedlinePlus a605027 says dextroamphetamine is used for ADHD symptoms and narcolepsy.
Candidates
Name
dextroamphetamine
Same class source
MedlinePlus a605027: 'Dextroamphetamine is in a class of medications called central nervous system stimulants.'
Name
methylphenidate

Frequently asked questions

Question
What is this medicine used for?
Answer
It is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy.
Source section
INDICATIONS AND USAGE
Source
Aurolife label, set ID a582d57f-d191-4ca5-b105-585b2d8a0e3e
Question
Can it be taken with food?
Answer
Yes. The Medication Guide says the tablets can be taken with or without food. The first dose of the day is usually taken when you first wake up.
Source section
Medication Guide, How should ... be taken
Source
Aurolife label
Question
What if I miss a dose?
Answer
The tablet label has no missed-dose instructions. MedlinePlus gives instructions only for the extended-release capsule: skip the missed morning dose and do not take a double dose. Ask your pharmacist or doctor what to do for tablets.
Source section
MedlinePlus: What should I do if I forget a dose?
Source
MedlinePlus a601234
Question
What are the common side effects?
Answer
The Medication Guide says the most common side effects include stomachache, decreased appetite and nervousness. The prescribing information gives no frequency list.
Source section
Medication Guide, possible side effects
Source
Aurolife label
Question
Is it addictive?
Answer
The boxed warning says it has a high potential for abuse and misuse, which can lead to a substance use disorder, including addiction, overdose and death. Keep it in a safe place, preferably locked, and do not give it to anyone else.
Source section
Boxed Warning; WARNINGS
Source
Aurolife label
Question
What should I not take with it?
Answer
Do not take it with an MAOI or within 14 days of stopping one, including linezolid or intravenous methylene blue. Tell your doctor about serotonin-raising drugs, CYP2D6 inhibitors, antacids and herbal products such as St. John's wort.
Source section
CONTRAINDICATIONS; DRUG INTERACTIONS
Source
Aurolife label; MedlinePlus a601234
Question
Is it safe during pregnancy or breastfeeding?
Answer
There are no adequate, well-controlled studies in pregnant women, and amphetamines should be used in pregnancy only if the potential benefit justifies the potential risk to the baby. Amphetamines pass into breast milk, and the label says mothers taking them should be advised to refrain from nursing.
Source section
PRECAUTIONS, Pregnancy and Nursing Mothers
Source
Aurolife label
Question
Can I take it late in the day?
Answer
The label says late evening doses should be avoided because of the resulting insomnia. MedlinePlus says it should not be taken in the late afternoon or evening.
Source section
DOSAGE AND ADMINISTRATION
Source
Aurolife label; MedlinePlus a601234

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug