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Dextroamphetamine

Medically reviewed by Drugs.com. Last updated on Sep 8, 2020.

Pronunciation

(deks troe am FET a meen)

Index Terms

  • Dextroamphetamine Sulfate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Extended Release 24 Hour, Oral, as sulfate:

Dexedrine: 5 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c blue #1 aluminum lake, fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Dexedrine: 5 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Dexedrine: 10 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c blue #1 aluminum lake, fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Dexedrine: 10 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Dexedrine: 15 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c blue #1 aluminum lake, fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Dexedrine: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Generic: 5 mg, 10 mg, 15 mg

Solution, Oral, as sulfate:

ProCentra: 5 mg/5 mL (473 mL) [contains benzoic acid, saccharin sodium; bubble-gum flavor]

Generic: 5 mg/5 mL (473 mL)

Tablet, Oral, as sulfate:

Dexedrine: 5 mg [DSC], 10 mg [DSC]

Zenzedi: 2.5 mg

Zenzedi: 5 mg [scored; contains fd&c yellow #6 (sunset yellow)]

Zenzedi: 7.5 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Zenzedi: 10 mg [scored; contains fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Zenzedi: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c blue #2 (indigotine), fd&c red #40]

Zenzedi: 20 mg [contains brilliant blue fcf (fd&c blue #1)]

Zenzedi: 30 mg [contains fd&c yellow #10 (quinoline yellow)]

Generic: 5 mg, 10 mg

Brand Names: U.S.

  • Dexedrine
  • ProCentra
  • Zenzedi

Pharmacologic Category

  • Central Nervous System Stimulant

Pharmacology

Amphetamines are noncatecholamine, sympathomimetic amines that promote release of catecholamines (primarily dopamine and norepinephrine) from their storage sites in the presynaptic nerve terminals. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition.

Metabolism

Hepatic to some degree by CYP2D6

Excretion

Urine; urinary excretion is pH dependent and is increased with acid urine (low pH)

Time to Peak

Serum: Immediate release: ~3 hours; Sustained release: ~8 hours

Duration of Action

Immediate release: 4 to 6 hours; extended release: 8 hours (Dopheide 2009)

Half-Life Elimination

Adults: ~12 hours

Use: Labeled Indications

Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder as part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients 3 to 16 years (IR tablet, oral solution) or 6 to 16 years (ER capsule).

Narcolepsy: Treatment of narcolepsy.

Contraindications

Hypersensitivity (eg, angioedema, anaphylaxis) or idiosyncrasy to amphetamine, dextroamphetamine, other sympathomimetic amines, or any component of the formulation; advanced arteriosclerosis, symptomatic cardiovascular disease, moderate-to-severe hypertension; hyperthyroidism; glaucoma; agitated states; history of drug abuse; during or within 14 days of stopping monoamine oxidase inhibitor (MAOI) therapy (including MAOIs such as linezolid or intravenous methylene blue).

Documentation of allergenic cross-reactivity for amphetamines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Narcolepsy: Oral:

Extended release (capsule): Initial: 10 mg once daily; may increase dose based on response and tolerability in 10 mg increments at intervals ≥1 week; usual dosage: 5 to 60 mg/day once daily or in divided doses.

Immediate release (solution, tablet): Initial: 10 mg once daily; may increase dose based on response and tolerability in 10 mg increments at intervals ≥1 week; usual dosage: 5 to 60 mg/day in 2 to 3 divided doses; use intervals of 4 to 6 hours between doses.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing; start at lowest dose. Use with caution.

Dosing: Pediatric

Note: Use lowest effective individualized dose; administer first dose as soon as awake; avoid late evening doses.

Attention-deficit/hyperactivity disorder:

Immediate-release tablets; oral solution (eg, ProCentra, Zenzedi):

Children 3 to 5 years: Oral: Initial: 2.5 mg once daily in the morning; increase daily dose by 2.5 mg increments at weekly intervals until optimal response is obtained; maximum daily dose: 40 mg/day in 2 to 3 divided doses; use intervals of 4 to 6 hours between doses. Note: Although FDA approved, current guidelines do not recommend use in children ≤5 years due to insufficient evidence (AAP 2011).

Children ≥6 years and Adolescents: Oral: Initial: 5 mg once or twice daily with first dose in the morning; increase daily dose by 5 mg increments at weekly intervals until optimal response is obtained, usual range 5 to 20 mg/day; maximum daily dose: 40 mg/day in 2 to 3 divided doses; use intervals of 4 to 6 hours between doses.

Extended-/sustained-release capsules (eg, Dexedrine Spansules): Children ≥6 years and Adolescents: Oral: Initial: 5 mg once or twice daily with first dose in the morning; increase daily dose by 5 mg increments at weekly intervals until optimal response is obtained, usual range: 5 to 20 mg/day; maximum daily dose: 40 mg/day in 1 to 2 divided doses; use intervals of 6 to 8 hours between doses; in patients >50 kg, a maximum daily dose of 60 mg/day in divided doses has been used (AACAP [Pliszka 2007]; Dopheide 2009).

Narcolepsy (hypersomnia): Note: Stimulants are recommended for management of daytime sleepiness associated with hypersomnia; alternative therapy is recommended for management of cataplexy if present (Kotagal 2018).

Immediate-release tablets, oral solution:

Children 6 to 12 years: Oral: Initial: 5 mg daily; may increase at 5 mg increments at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day in 1 to 3 divided doses: use intervals of 4 to 6 hours between doses (Kotagal 2018; manufacturer's labeling).

Adolescents: Oral: Initial: 10 mg daily; may increase at 10 mg increments at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day in 1 to 3 divided doses; use intervals of 4 to 6 hours between doses (Kotagal 2018; manufacturer's labeling).

Extended-/sustained-release capsules:

Children 6 to 12 years: Oral: Initial: 5 mg daily; may increase at 5 mg increments at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day in 1 to 2 divided doses; use intervals of 6 to 8 hours between doses (Kotagal 2018; manufacturer's labeling).

Adolescents: Oral: Initial: 10 mg daily; may increase at 10 mg increments at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day in 1 to 2 divided doses; use intervals of 6 to 8 hours between doses (Kotagal 2018; manufacturer's labeling).

Obesity secondary to hypothalamic-pituitary dysfunction: Limited data available (Bereket 2012): Immediate-release tablet; oral solution: Children ≥6 years and Adolescents: Oral: Initial: 5 mg once daily in the morning; may increase daily dose at 2.5 mg increments at weekly intervals until optimal response is obtained; additional daily doses may be given before lunch and dinner if necessary; maximum single dose reported: 7.5 mg/dose; maximum daily dose: 20 mg/day in divided doses; dosing based on experience in pediatric patients (n=17) following postsurgical resection for management of craniopharyngioma reported in 2 open-labeled trials and a case series (n=7); weight stabilization was reported in all 3 groups with some patients reporting moderate to significant weight loss (Denzer 2019; Ismail 2006; Mason 2002)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

Oral: Administer initial dose upon awakening; do not administer doses late in the evening due to potential for insomnia. Do not crush or chew ER formulations.

Bariatric surgery: Capsule, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. ER capsule cannot be opened due to biphasic release mechanism. Switch to IR formulation (tablet or oral solution).

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Drug Interactions

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy

Alkalinizing Agents: May decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects. Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy

Ammonium Chloride: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Monitor therapy

Antacids: May decrease the excretion of Amphetamines. Monitor therapy

Antihistamines: Amphetamines may diminish the sedative effect of Antihistamines. Monitor therapy

Antihypertensive Agents: Amphetamines may diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Antipsychotic Agents: May diminish the stimulatory effect of Amphetamines. Monitor therapy

Ascorbic Acid: May decrease the serum concentration of Amphetamines. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Monitor therapy

Cobicistat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a moderate CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a strong CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs. Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Monitor therapy

Ethosuximide: Amphetamines may diminish the therapeutic effect of Ethosuximide. Amphetamines may decrease the serum concentration of Ethosuximide. Monitor therapy

Gastrointestinal Acidifying Agents: May decrease the serum concentration of Amphetamines. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Iobenguane Radiopharmaceutical Products: Amphetamines may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination

Iobenguane Radiopharmaceutical Products: CNS Stimulants may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination

Ioflupane I 123: Amphetamines may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy

Methenamine: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Amphetamines. While linezolid and tedizolid may interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Avoid combination

Multivitamins/Fluoride (with ADE): May decrease the serum concentration of Amphetamines. More specifically, the ascorbic acid (vitamin C) in many multivitamins may decrease amphetamine concentrations. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Amphetamines. Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Amphetamines. Specifically, vitamin C may impair absorption of amphetamines. Monitor therapy

Opioid Agonists: Amphetamines may enhance the analgesic effect of Opioid Agonists. Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy

PHENobarbital: Amphetamines may decrease the serum concentration of PHENobarbital. Monitor therapy

Phenytoin: Amphetamines may decrease the serum concentration of Phenytoin. Monitor therapy

Proton Pump Inhibitors: May increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Monitor therapy

Quinolones: Amphetamines may enhance the cardiotoxic effect of Quinolones. Monitor therapy

Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Amphetamines may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities, including serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability). Initiate amphetamines at lower doses, monitor frequently, and adjust dose as needed. Monitor therapy

Serotonergic Agents (High Risk): Amphetamines may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability). Initiate amphetamines at lower doses, monitor frequently, and adjust doses as needed. Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Amphetamines. Tricyclic Antidepressants may potentiate the cardiovascular effects of Amphetamines. Amphetamines may enhance the serotonergic effect of Tricyclic Antidepressants. This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) and increased cardiovascular effects when these agents are combined. Monitor therapy

Urinary Acidifying Agents: May decrease the serum concentration of Amphetamines. Monitor therapy

Test Interactions

Amphetamines may elevate plasma corticosteroid levels; may interfere with urinary steroid determinations.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Cardiomyopathy, hypertension, palpitations, tachycardia

Central nervous system: Aggressive behavior, dizziness, dysphoria, euphoria, exacerbation of tics, Gilles de la Tourette syndrome, headache, insomnia, mania, overstimulation, psychosis, restlessness

Dermatologic: Alopecia, urticaria

Endocrine & metabolic: Change in libido, weight loss

Gastrointestinal: Anorexia, constipation, diarrhea, unpleasant taste, xerostomia

Genitourinary: Frequent erections, impotence, prolonged erection

Neuromuscular & skeletal: Dyskinesia, rhabdomyolysis, tremor

Ophthalmic: Accommodation disturbances, blurred vision

ALERT: U.S. Boxed Warning

Abuse potential:

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided. Pay particular attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others; prescribe and dispense the drugs sparingly.

Cardiovascular events:

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

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular events: [US Boxed Warning]: Use has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems (sudden death in children and adolescents; sudden death, stroke and MI in adults). Consistent with other studies, a large retrospective cohort study involving 1,200,438 children, adolescents, and young adults (aged 2 to 24 years) prescribed methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine found no evidence that current use of an ADHD medication increased risk for sudden cardiac death, acute MI, or stroke (Cooper 2011). Stimulants should be avoided in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, Marfan syndrome, or other serious cardiac problems. Some products are contraindicated in patients with moderate or severe hypertension. Prior to initiating stimulant, assess medical history and family history of sudden death or ventricular arrhythmia; conduct a physical exam to assess for cardiac disease; patients should receive further evaluation if findings suggest cardiac disease, such as ECG and echocardiogram. Promptly conduct cardiac evaluation in patients who develop exertional chest pain, unexplained syncope, or any other symptoms of cardiac disease during stimulant treatment.

• CNS effects: Amphetamines may impair the ability to engage in potentially hazardous activities; patients must be cautioned about performing tasks that require mental alertness (eg, driving, operating machinery).

• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs/symptoms are usually mild and intermittent, and generally improve with dose reduction or discontinuation. Peripheral vasculopathy effects have been observed at different times, at therapeutic doses, and in all age groups. Digital ulceration and/or soft tissue breakdown have been observed rarely; monitor for digital changes during therapy and seek further evaluation (eg, rheumatology) if necessary.

• Visual disturbance: Difficulty in accommodation and blurred vision has been reported with the use of stimulants.

Disease-related concerns:

• Abuse potential: [US Boxed Warning]: Potential for drug dependency exists; prolonged use may lead to drug dependency. Use is contraindicated in patients with history of ethanol or drug abuse. Prescriptions should be written for the smallest quantity consistent with good patient care to minimize possibility of overdose.

• Cardiovascular disease: CNS stimulants may increase heart rate and blood pressure; in pediatric patients, the observed mean increase in heart rate was 3 to 6 bpm and blood pressure was 2 to 4 mm Hg. Use with caution in patients with hypertension, heart failure, recent MI, ventricular arrhythmia, and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate. Some products are contraindicated in patients with moderate to severe hypertension or hyperthyroidism.

• Psychiatric disorders: Use with caution in patients with preexisting psychosis (may exacerbate symptoms of behavior and thought disorder) or bipolar disorder (may induce mixed/manic episode). New-onset psychosis or mania may occur with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing a manic episode prior to treatment; consider discontinuation if psychotic or manic symptoms (eg, delusional thinking, hallucinations, mania) occur. May be associated with aggressive behavior or hostility (causal relationship not established); monitor for development or worsening of these behaviors.

• Renal impairment: Use with caution in patients with renal impairment; elimination of amphetamines may be reduced.

• Seizure disorder: Limited information exists regarding stimulant use in seizure disorder. Whereas patients with ADHD are at an increased risk for seizure activity compared to the general population, a retrospective study using drug claims data showed that the use of stimulant medications was associated with a lower risk (Cortese 2013; Wiggs 2018). Manufacturers of some stimulants recommend discontinuing therapy if seizures occur.

• Tourette syndrome/tics: Use with caution in patients with Tourette syndrome or other tic disorders. Stimulants may exacerbate tics (motor and phonic) and Tourette syndrome; however, evidence demonstrating increased tics is limited. Evaluate for tics and Tourette syndrome prior to therapy initiation (AACAP [Murphy 2013, Pliszka 2007]).

Concurrent drug therapy issues:

• Serotonin syndrome: Potentially life-threatening serotonin syndrome may occur when dextroamphetamine is used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's wort, tryptophan), agents that impair metabolism of serotonin (eg, monoamine oxidase inhibitors), or CYP2D6 inhibitors that impair metabolism of dextroamphetamine. Concomitant use with monoamine oxidase inhibitors is contraindicated. If concomitant use of dextroamphetamine with serotonergic drugs or CYP2D6 inhibitors is indicated, initiate dextroamphetamine at a low dose and monitor patient closely for signs and symptoms of serotonin syndrome. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

Special populations:

• Pediatric: Appetite suppression may occur, particularly in children. Use of stimulants has been associated with weight loss and slowing of growth rate; monitor growth rate and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• ADHD treatment: Appropriate use: Recommended to be used as part of a comprehensive treatment program for attention-deficit disorders.

• Discontinuation of therapy: Abrupt discontinuation following high doses or for prolonged periods may result in symptoms for withdrawal.

Monitoring Parameters

Cardiac evaluation should be completed at baseline and on any patient who develops exertional chest pain, unexplained syncope, and any symptom of cardiac disease during treatment with stimulants. Monitor blood pressure and heart rate (baseline, following dose increases and periodically during treatment); growth rate (height and weight) and appetite in children; weight in adults; signs of peripheral vasculopathy (eg, digital changes); sleep and behavioral changes. Assess for risk of abuse prior to prescribing and signs of misuse, abuse, or addiction throughout treatment (NICE 2018).

Pregnancy Considerations

The majority of human data is based on illicit amphetamine/methamphetamine exposure and not from therapeutic maternal use (Golub 2005). Use of amphetamines during pregnancy may lead to an increased risk of premature birth and low birth weight; newborns may experience symptoms of withdrawal. Behavioral problems may also occur later in childhood (LaGasse 2012).

Patient Education

What is this drug used for?

• It is used to treat attention deficit problems with hyperactivity.

• It is used to treat narcolepsy.

• It may be given for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry mouth

• Lack of appetite

• Trouble sleeping

• Constipation

• Diarrhea

• Weight loss

• Nausea

• Bad taste

• Anxiety

• Hair loss

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Heart attack like chest pain; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting

• Vision changes

• Severe dizziness

• Passing out

• Slow heartbeat

• Fast heartbeat

• Abnormal heartbeat

• Severe headache

• Restlessness

• Tremors

• Abnormal movements

• Sexual dysfunction

• Sex drive changes

• Seizures

• Dark urine

• Unable to pass urine

• Muscle pain

• Muscle weakness

• Erection that lasts more than 4 hours

• Change in color of hands or feet from pale to blue or red

• Burning or numbness of the hands or feet

• Cold sensation of extremities

• Painful extremities

• Serotonin syndrome like dizziness, severe headache, agitation, sensing things that seem real but are not, fast heartbeat, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea

• Wounds on fingers or toes

• Depression like thoughts of suicide, anxiety, emotional instability, agitation, irritability, panic attacks, mood changes, behavioral changes, or confusion

• Sensing things that seem real but are not

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions