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Dextroamphetamine and Amphetamine

Pronunciation

Pronunciation

(deks troe am FET a meen & am FET a meen)

Index Terms

  • Amphet Asp/Amphet/D-Amphet
  • Amphetamine and Dextroamphetamine
  • Dextroamphetam/Amphetam(Base)
  • Dextroamphetamine/Amphetamine
  • Mydayis

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, extended release, oral:

Adderall XR:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.1 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.5 mg)]

25 mg [dextroamphetamine sulfate 6.25 mg, dextroamphetamine saccharate 6.25 mg, amphetamine aspartate monohydrate 6.25 mg, amphetamine sulfate 6.25 mg (equivalent to amphetamine base 15.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Generic:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.1 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.5 mg)]

25 mg [dextroamphetamine sulfate 6.25 mg, dextroamphetamine saccharate 6.25 mg, amphetamine aspartate monohydrate 6.25 mg, amphetamine sulfate 6.25 mg (equivalent to amphetamine base 15.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Tablet, oral:

Adderall:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.13 mg)]

7.5 mg [dextroamphetamine sulfate 1.875 mg, dextroamphetamine saccharate 1.875 mg, amphetamine aspartate monohydrate 1.875 mg, amphetamine sulfate 1.875 mg (equivalent to amphetamine base 4.7 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

12.5 mg [dextroamphetamine sulfate 3.125 mg, dextroamphetamine saccharate 3.125 mg, amphetamine aspartate monohydrate 3.125 mg, amphetamine sulfate 3.125 mg (equivalent to amphetamine base 7.8 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Generic:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.13 mg)]

7.5 mg [dextroamphetamine sulfate 1.875 mg, dextroamphetamine saccharate 1.875 mg, amphetamine aspartate monohydrate 1.875 mg, amphetamine sulfate 1.875 mg (equivalent to amphetamine base 4.7 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

12.5 mg [dextroamphetamine sulfate 3.125 mg, dextroamphetamine saccharate 3.125 mg, amphetamine aspartate monohydrate 3.125 mg, amphetamine sulfate 3.125 mg (equivalent to amphetamine base 7.8 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Brand Names: U.S.

  • Adderall
  • Adderall XR

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.

Absorption

Extended release: Food does not affect absorption but prolongs Tmax by 2 to 3 hours.

Metabolism

Hepatic oxidation via cytochrome P450 to 4-hydroxyamphetamine (active) norephedrine (active), and alpha-hydroxy-amphetamine with both active metabolites subsequently oxidized to 4-hydroxy-norephedrine. Cytochrome P450 2D6 is primarily responsible for the formation of 4-hydroxy-amphetamine.

Excretion

Urine (highly dependent on urinary pH); excreted as unchanged amphetamine (30% to 40%, may range from ~1% in alkaline urine to ~75% in acidic urine), and derivatives of alpha-hydroxyamphetamine (50%)

Time to Peak

Immediate release: 3 hours; Extended release: 7 hours

Duration of Action

Tablet: 4 to 6 hours (Dopheide 2009)

Half-Life Elimination

Children 6 to 12 years: d-amphetamine: 9 hours; l-amphetamine: 11 hours

Adolescents 13 to 17 years: d-amphetamine: 11 hours; l-amphetamine: 13 to 14 hours

Adults: d-amphetamine: 10 hours; l-amphetamine: 13 hours

Special Populations: Children

Children eliminated amphetamine faster than adults. The elimination half-life is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. However, children had higher systemic exposure to amphetamine (Cmax and AUC) than adults for a given dose of ER capsules, which was attributed to the higher dose administered to children on a mg/kg basis compared with adults. Upon dose normalization on a mg/kg basis, children showed 30% less systemic exposure compared with adults.

Special Populations Note

Weight: Weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic exposure measured by AUC and Cmax decreased with increases in body weight, while apparent oral volume of distribution, apparent oral clearance, and elimination half-life increased with increases in body weight.

Use: Labeled Indications

Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder (ADHD) as part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect.

Narcolepsy (immediate release only): Treatment of narcolepsy.

Contraindications

Hypersensitivity (eg, angioedema, anaphylaxis) or idiosyncrasy to amphetamine, sympathomimetic amines or any component of the formulation; advanced arteriosclerosis; symptomatic cardiovascular disease; moderate-to-severe hypertension; hyperthyroidism; glaucoma; agitated states; patients with a history of drug abuse; during or within 14 days following MAO inhibitor (including linezolid or 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

Note: Use lowest effective individualized dose; administer first dose as soon as awake.

ADHD: Oral:

Note: Interrupt therapy occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Immediate release: Initial: 5 mg once or twice daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 40 mg/day in 1 to 3 divided doses.

Extended release: Initial: 20 mg once daily in the morning; higher doses (up to 60 mg/day) have been evaluated; however, there is not adequate evidence that higher doses afforded additional benefit. The Canadian labeling recommends a maximum dose of 30 mg/day.

Narcolepsy: Immediate release: Oral: Initial: 10 mg once daily in the morning; may increase daily dose in 10 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 60 mg/day in 1 to 3 divided doses.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Use lowest effective individualized dose; administer first dose as soon as awake.

ADHD: Oral:

Note: Interrupt therapy occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Children <3 years: Use is not recommended.

Children 3 to 5 years: Immediate release: Initial 2.5 mg once daily in the morning; may increase daily dose in 2.5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 2.5 to 40 mg/day in 1 to 3 divided doses.

Children ≥6 years:

Immediate release: Refer to adult dosing.

Extended release: 5 to 10 mg once daily in the morning; may increase daily dose in 5 to 10 mg increments at weekly intervals until optimal response is obtained; maximum: 30 mg/day.

Adolescents:

Immediate release: Refer to adult dosing.

Extended release: 10 mg once daily in the morning; may increase to 20 mg daily after 1 week if needed; higher doses (up to 60 mg/day) have been evaluated; however, there is not adequate evidence that higher doses afforded additional benefit. The Canadian labeling recommends a maximum dose of 30 mg/day.

Narcolepsy: Immediate release: Oral:

Children ≥6 years: Initial: 5 mg daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage: 5 to 60 mg/day in 1 to 3 divided doses.

Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

US labeling: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Canadian labeling:

Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: (GFR 15 to <30 mL/minute/1.73 m2): Maximum dose: 20 mg/day.

Hemodialysis: There are no specific dosage adjustments provided in the manufacturer’s labeling; however, the manufacturer recommends considering further dosage reductions (compared to that recommended for severe impairment). Dextroamphetamine is not dialyzable.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Extemporaneously Prepared

A 1 mg/mL oral suspension may be made with tablets. Crush ten 10 mg tablets in a mortar and reduce to a fine powder. Add small portions of Ora-Sweet and mix to a uniform paste; mix while adding the vehicle in equal proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add sufficient quantity of vehicle to make 100 mL. Label "shake well". Stable 30 days at room temperature.

Justice J, Kupiec TC, Matthews P, et al, "Stability of Adderall in Extemporaneously Compounded Oral Liquids," Am J Health Syst Pharm, 2001, 58(15):1418-21.11494787

Administration

Administer with or without food.

Immediate release: Administer in 1 to 3 divided doses per day with intervals of 4 to 6 hours between doses. To avoid insomnia, late evening doses should be avoided.

Extended release: To avoid insomnia, afternoon doses should be avoided. Capsule may be swallowed whole or it may be opened and the contents sprinkled on applesauce. Applesauce should be consumed immediately without chewing. Do not divide the contents of the capsule. Do not take less than one capsule per day; a single capsule should not be divided.

Storage

Immediate release tablets: Store at 20°C to 25°C (68°F to 77°F).

Extended release capsules: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

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

Alkalinizing Agents: May decrease the excretion of Amphetamines. Consider therapy modification

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

Analgesics (Opioid): Amphetamines may enhance the analgesic effect of Analgesics (Opioid). 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

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

Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Exceptions: Brinzolamide; Dorzolamide. Monitor therapy

Cocaine: 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

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

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. 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

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Lithium: May diminish the stimulatory effect of Amphetamines. Monitor therapy

MAO 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. Exceptions: Linezolid; Tedizolid. Avoid combination

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

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

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 Amphetamine. 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

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 stimulatory effect of Amphetamines. Tricyclic Antidepressants may also potentiate the cardiovascular effects of Amphetamines. Monitor therapy

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

Test Interactions

May cause a significant elevation in plasma corticosteroid levels; may interfere with urinary steroid testing

Adverse Reactions

Frequency not always defined.

Cardiovascular: Systolic hypertension (extended release; adolescents: 12% to 35%; dose related; transient), tachycardia (extended release; adults: ≤6%), palpitations (extended release: 2% to 4%), increased blood pressure, myocardial infarction, Raynaud's phenomenon

Central nervous system: Insomnia (extended release: 12% to 27%), headache (extended release; adults: ≤26%), emotional lability (extended release: 2% to 9%), anxiety (extended release; adults: 8%), agitation (extended release; adults: ≤8%), dizziness (extended release: 2% to 7%), nervousness (extended release: 6%), fatigue (extended release: 2% to 6%), drowsiness (extended release: 2% to 4%), speech disturbance (extended release: 2% to 4%), twitching (extended release: 2% to 4%), aggressive behavior, depression, dysphoria, euphoria, exacerbation of vocal tics, formication, irritability, outbursts of anger, overstimulation, paresthesia, psychosis, restlessness, talkativeness

Dermatologic: Diaphoresis (extended release: 2% to 4%), skin photosensitivity (extended release: 2% to 4%), alopecia, dermatillomania, skin rash, urticaria

Endocrine & metabolic: Weight loss (extended release: 4% to 10%), decreased libido (extended release: 2% to 4%), dysmenorrhea (extended release: 2% to 4%)

Gastrointestinal: Decreased appetite (extended release: 22% to 36%), xerostomia (extended release: 2% to 35%), abdominal pain (extended release: 11% to 14%), nausea (extended release: 2% to 8%), vomiting (extended release: 2% to 7%), diarrhea (extended release: 2% to 6%), constipation (extended release: 2% to 4%), dyspepsia (extended release: 2% to 4%), teeth clenching (extended release: ≤4%), tooth infection (extended release: ≤4%), anorexia (extended release: 2%), bruxism, unpleasant taste

Genitourinary: Urinary tract infection (extended release: 5%), impotence (extended release: 2% to 4%), frequent erections, prolonged erections

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Infection: Infection (extended release: 2% to 4%)

Neuromuscular & skeletal: Dyskinesia, rhabdomyolysis, tremor

Ophthalmic: Blurred vision, mydriasis

Respiratory: Dyspnea (extended release: 2% to 4%)

Miscellaneous: Fever (extended release: 5%)

<1% (Limited to important or life-threatening): Cardiomyopathy, cerebrovascular accident, Gilles de la Tourette's syndrome (exacerbation), peripheral vascular disease, seizure, toxic epidermal necrolysis

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. Particular attention should be paid to the possibility of persons obtaining amphetamines for nontherapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

Cardiovascular events:

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

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). These products should be avoided in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease or other serious cardiac problems that could increase the risk of sudden death. Patients should be carefully evaluated for cardiac disease prior to initiation of therapy. Patients who develop exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation. CNS stimulants may increase heart rate (mean increase: 3 to 6 bpm) and blood pressure (mean increase: 2 to 4 mm Hg). Use with caution in patients with cardiovascular conditions that may be exacerbated by increases in blood pressure or heart rate (eg, hypertension, heart failure, recent myocardial infarction, ventricular arrhythmia).

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

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, and urticaria have been observed.

• 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. 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:

• Hepatic impairment: Use with caution in patients with hepatic impairment; elimination is reduced.

• Psychiatric disorders: Use with caution in patients with preexisting psychosis or bipolar disorder. May exacerbate symptoms of behavior and thought disorder in psychotic patients; new onset psychosis or mania may occur with stimulant use; consider discontinuation if such 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. Screen patients with comorbid depressive symptoms prior to initiating treatment to determine if they are at risk for bipolar disorder.

• Renal impairment: Use with caution in patients with renal impairment; elimination is reduced.

• Seizure disorder: Limited information exists regarding amphetamine use in seizure disorder (Cortese 2013). The manufacturer recommends use with caution in patients with a history of seizure disorder; may lower seizure threshold leading to new onset or breakthrough seizure activity. If seizures occur, discontinue therapy.

• 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:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) may occur when dextroamphetamine/amphetamine 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/amphetamine. Concomitant use with monoamine oxidase inhibitors is contraindicated. If concomitant use of dextroamphetamine/amphetamine with serotonergic drugs or CYP2D6 inhibitors is indicated, initiate dextroamphetamine/amphetamine at a low dose and monitor patient closely for signs and symptoms of SS. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

Special populations:

• Elderly: Use caution in this age group due to CNS stimulant adverse effects.

• Pediatric: Appetite suppression may occur; particularly in children. Use of stimulants has been associated with weight loss and slowing 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.

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Has high potential for abuse. Administration for prolonged periods may lead to drug dependence and must be avoided. Particular attention should be paid to the possibility of subjects obtaining dextroamphetamine/amphetamine for nontherapeutic use or distribution to others, and the drug should be prescribed or dispensed sparingly. Use with caution 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.

• 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 on any patient who develops exertional chest pain, unexplained syncope, and any symptom of cardiac disease during treatment with stimulants; behavioral changes; CNS activity; height, weight and growth parameters in children; signs of peripheral vasculopathy (eg, digital changes). Assess for risk of abuse prior to prescribing and signs of misuse, abuse, or addiction throughout treatment.

When used for the treatment of ADHD, perform a targeted cardiac history (eg, patient history of previously detected cardiac disease, palpitations, syncope, or seizures; family history of sudden death in children or young adults; hypertrophic cardiomyopathy; long QT syndrome) and physician examination including cardiac examination. Monitor heart rate and blood pressure (baseline; follow-up within 1 to 3 months and routinely at 6 to 12 month intervals thereafter unless clinically indicated with dose titration and weaning of therapy) Consider obtaining ECG prior to initiation (Perrin 2008; Vetter 2008).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. 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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, lack of appetite, insomnia, constipation, diarrhea, dry mouth, bad taste, or weight loss. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, shortness of breath, severe dizziness, passing out, tachycardia, severe anxiety, severe headache, sexual dysfunction, decreased libido, abnormal heartbeat, seizures, abnormal movements, agitation, vision changes, priapism, change in color of hands or feet from pale to blue or red, burning or numbness of hands or feet, cold sensation, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), wounds on fingers or toes, dark urine, change in amount of urine passed, muscle pain, muscle weakness, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), mood changes, hallucinations, or behavioral changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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