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Dextroamphetamine

Pronunciation

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.

Capsule Extended Release 24 Hour, Oral, as sulfate:

Dexedrine: 5 mg, 10 mg, 15 mg [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)]

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, 10 mg [scored]

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 via CYP monooxygenase and glucuronidation

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: 10 to 12 hours

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 in children 3 to 16 years of age.

Narcolepsy: Treatment of narcolepsy.

Contraindications

Hypersensitivity or idiosyncrasy to dextroamphetamine, other 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 therapy.

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: Initial: 10 mg once daily; may increase in increments of 10 mg at weekly intervals until optimal response is obtained; usual dosage: 5 to 60 mg daily in divided doses.

Dosing: Geriatric

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

Dosing: Pediatric

Attention-deficit/hyperactivity disorder (ADHD):

Children 3 to 5 years: Oral: Immediate release tablets and oral solution: Initial: 2.5 once daily; may increase in increments of 2.5 mg at weekly intervals until optimal response is obtained; maximum dose: 40 mg daily (Dopheide 2009). 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:

Immediate release tablets and oral solution: Initial: 5 mg once or twice daily; may increase in increments of 5 mg at weekly intervals until optimal response is reached; maximum dose: 40 mg daily (Dopheide 2009).

Extended release capsules: Initial: 5 mg once or twice daily; may increase in increments of 5 mg at weekly intervals until optimal response is reached. Maximum dose: 40 mg daily (Dopheide 2009); a maximum daily dose of 60 mg in divided doses has been used in children >50 kg (Dopheide, 2009; Pliszka 2007).

Narcolepsy:

Children 6 to 12 years: Oral: Initial: 5 mg once daily; may increase in increments of 5 mg at weekly intervals until optimal response is obtained; usual dosage: 5 to 60 mg daily in divided doses.

Children >12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Administer initial dose upon awakening; do not administer doses late in the evening due to potential for insomnia.

Immediate release tablets and oral solution: If needed, 1 to 2 additional doses may be administered at intervals of 4 to 6 hours.

Extended release and sustained release capsules: Do not crush sustained release drug products. Formulations may be used for once-daily administration, if appropriate.

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

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

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 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

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

Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiomyopathy, hypertension, palpitations, tachycardia

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

Dermatologic: 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: [U.S. 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 the patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, 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 symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation.

• CNS effects: Amphetamines may impair the ability to engage in potentially hazardous activities (driving, operating machinery).

• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud’s 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:

• Abuse potential: [U.S. 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.

• Hypertension: Use with caution in patients with hypertension and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate. Use is contraindicated in patients with moderate-to-severe hypertension.

• Psychiatric disorders: Use with caution in patients with preexisting psychosis or bipolar disorder. May exacerbate symptoms of behavior and thought disorder or induce mixed/manic episode, respectively. New onset psychosis or mania may also occur with stimulant use. Observe for symptoms of aggression and/or hostility.

• 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.

• Tourette syndrome: Use with caution in patients with Tourette syndrome; stimulants may exacerbate tics (motor and phonic) and Tourette syndrome. Evaluate for tics and Tourette’s syndrome prior to therapy initiation.

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 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:

• 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; signs of peripheral vasculopathy (eg, digital changes); growth and weight in children; CNS activity in all patients; signs of misuse, abuse, or addiction.

When used for the treatment of ADHD, thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation (Vetter, 2008).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse effects 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 dry mouth, lack of appetite, insomnia, constipation, diarrhea, weight loss, nausea, or bad taste. 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, abnormal heartbeat, severe anxiety, severe headache, agitation, tremors, sexual dysfunction, decreased libido, seizures, dark urine, urinary retention, change in amount of urine passed, muscle pain, priapism, change in color of hands or feet from pale to blue or red, burning or numbness of the hands or feet, temperature sensitivity, wounds on fingers or toes, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), 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 health care 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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