Evekeo

— THERAPEUTIC DISORDERS TREATED —
  • ADHD
  • Obesity
  • Sleep-wake disorders

Evekeo Generic Name & Formulations

General Description

Amphetamine sulfate 5mg, 10mg; tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Tabs—100

Storage

Store at 20° to 25°C (68° to 77°F).

Generic Availability

NO

Evekeo Indications

Indications

Attention deficit hyperactivity disorder.

Evekeo Dosage and Administration

Adults and Children

<3yrs: not recommended. Avoid late evening doses; give first dose upon awakening and additional doses at 4–6hr intervals. Individualize. 3–5yrs: initially 2.5mg daily, may increase by 2.5mg/day at weekly intervals. ≥6yrs: initially 5mg once or twice daily; may increase by 5mg/day at weekly intervals; max 40mg/day.

Evekeo Contraindications

Contraindications

Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate-to-severe hypertension. Hyperthyroidism. History of drug abuse. Agitation. During or within 14 days of MAOIs. Hypersensitivity to sympathomimetics.

Evekeo Boxed Warnings

Boxed Warning

Amphetamines have a high potential for abuse; administration for long periods of time may lead to dependence and must be avoided.

Misuse may cause sudden death and serious cardiovascular adverse events.

Evekeo Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease: not recommended. Hypertension. Heart failure. Recent MI. Arrhythmias. Assess cardiovascular status. Psychosis. Bipolar disorder. Depression. Monitor for worsening of aggressive behavior or hostility. Seizure disorders; discontinue if occur. Evaluate for tics or Tourette's syndrome prior to therapy. Peripheral vasculopathy including Raynaud's phenomenon; monitor for digital changes. Monitor HR, BP, growth in children. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy (Cat.C). Nursing mothers: not recommended.

Warnings/Precautions

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

  • Children/adolescents: sudden death has been reported with CNS stimulant use in patients with structural cardiac abnormalities or other serious heart problems.
  • Adults: sudden deaths, stroke, and myocardial infarction have been reported with stimulant use at usual doses for ADHD.

Hypertension/Other Cardiovascular Conditions

  • Increases in blood pressure (about 2-4 mmHg) and heart rate (about 3-6 bpm) have been observed with stimulant medication use.
  • Patients should be monitored for larger changes.
  • Use caution in patients whose underlying medical conditions might be compromised by increases in BP or heart rate (eg, pre-existing hypertension, heart failure, recent MI, or ventricular arrhythmia).

Assessing Cardiovascular Status

  • Assess patient history and perform physical exam to exclude cardiac disease.
  • Patients should undergo prompt cardiac evaluation if exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment develop.

Psychiatric Adverse Events

  • Stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorders.
  • Comorbid bipolar disorder: caution with use of stimulants to treat ADHD because of concern for possible induction of a mixed/manic episode. Screen patients prior to initiating stimulant treatment.
  • Emergent psychotic or manic symptoms in patients without history of psychotic illness can be caused by stimulants at usual doses.
  • Patient beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Growth Suppression

  • Growth should be monitored during treatment with stimulants; therapy may need to be interrupted if children are not growing as expected. 

Seizures

  • Stimulants may lower the convulsive threshold in patients with convulsive disorders or a history of seizures, as well as in patients without a history of seizure disorders.
  • Discontinue treatment in the presence of seizures.

Peripheral Vasculopathy 

  • Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud phenomenon.
  • Signs/symptoms generally improve after dose reduction or discontinuation.
  • Careful observation for digital changes is necessary during treatment.

Visual Disturbance

  • Stimulant treatment has been associated with difficulties with accomodation and blurring of vision.

Drug Abuse and Dependence

  • Amphetamines have been extensively abused.
  • Tolerance, extreme psychological dependence, and severe social disability have occurred.

Pregnancy Considerations

No adequate and well-controlled studies in pregnant women. Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Infants may also experience symptoms of withdrawal.

Nursing Mother Considerations

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

Pediatric Considerations

Amphetamines are not recommended for use as anorectic agents in children under 12 years of age, or in children under 3 years of age with ADHD. 

Long-term effects have not been well established. Growth should be monitored during treatment.

Evekeo Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal.

Evekeo Interactions

Interactions

See Contraindications. Avoid concomitant antacids. Potentiated by alkalinizers (eg, sodium bicarbonate, acetazolamide, some thiazides), propoxyphene. Antagonized by acidifiers, chlorpromazine, haloperidol, lithium. May antagonize effects of adrenergic blockers, antihistamines, veratrum alkaloids, antihypertensives. May potentiate effects of tricyclic antidepressants, meperidine, norepinephrine. May delay absorption of phenytoin, phenobarbital, ethosuximide. Monitor effects when concomitant PPIs. Convulsions with propoxyphene overdose and amphetamines. May interfere with urinary steroid tests.

Interactions

Monoamine Oxidase Inhibitors (MAOIs)

  • Concomitant use of Evekeo with MAOIs is contraindicated.
  • MAOI antidepressants, as well as a metabolic of furazolidone, can potentiate  amphetamines, thereby increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings, leading to headaches and other signs of hypertensive crisis.

Serotonergic Drugs/CYP2D6 Inhibitors

  • Serotonin syndrome may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. 
  • Consider an alternative nonserotonergic drug or an alternative drug that does not inhibit CYP2D6; coadministration of CYP2D6 inhibitors may increase the risk with increased exposure to Evekeo. If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Evekeo at a lower dose and monitor.
  • Discontinue treatment with Evekeo and any concomitant serotonergic agents immediately if serotonin syndrome symptoms occur, and initiate supportive symptomatic treatment.

Acidifying Agents

  • Gastrointestinal acidifying agents (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices) lower absorption of amphetamines.
  • Urinary acidifying agents (eg, ammonium chloride, sodium acid phosphate) increase concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion.

Adrenergic Blockers

  • Adrenergic blockers are inhibited by amphetamines.

Alkalinizing Agents

  • Gastrointestinal alkalinizing agents (eg, sodium bicarbonate) increase absorption of amphetamines. 
  • Urinary alkalinizing agents (eg, acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion.

Tricyclic Antidepressants

  • Amphetamines may enhance the activity of tricyclic or sympathomimetic agents.
  • D-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Antihistamines

  • Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives

  • Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine

  • Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine.
  • Can be used to treat amphetamine poisoning.

Ethosuximide

  • Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol

  • Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate 

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

Meperidine 

  • Amphetamines potentiate the analgesic effect of meperidine.

Methenamine Therapy

  • Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy.

Norepinephrine 

  • Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital/Phenytoin

  • Amphetamines may delay intestinal absorption of phenobarbital and phenytoin. 
  • Coadministration may produce a synergistic anticonvulsant action.

Propoxyphene 

  • In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum Alkaloids

  • Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

  • Amphetamines can cause a significant elevation in plasma corticosteroid levels. 
  • Amphetamines may interfere with urinary steroid determinations.

Evekeo Adverse Reactions

Adverse Reactions

Palpitations, tachycardia, BP increase, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, motor/phonic tics, Tourette's syndrome, dry mouth, unpleasant taste, diarrhea, constipation, anorexia, weight loss, urticaria, impotence, libido change, prolonged erection, rhabdomyolysis; serious cardiovascular events, visual disturbances.

Evekeo Clinical Trials

See Literature

Evekeo Note

Not Applicable

Evekeo Patient Counseling

Patient Counseling

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicle.

Instruct patients to report any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes or if unexplained wounds appear on fingers or toes.

Cost Savings Program

Evekeo savings card available here.

Evekeo Generic Name & Formulations

General Description

Amphetamine sulfate 5mg, 10mg; tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Tabs—100

Storage

Store at 20° to 25°C (68° to 77°F).

Generic Availability

NO

Evekeo Indications

Indications

Short-term adjunct in managing exogenous obesity.

Evekeo Dosage and Administration

Adult

Take 30–60 mins before meals. Usually up to 30mg/day in divided doses of 5–10mg.

Children

Not recommended.

Evekeo Contraindications

Contraindications

Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate-to-severe hypertension. Hyperthyroidism. History of drug abuse. Agitation. During or within 14 days of MAOIs. Hypersensitivity to sympathomimetics.

Evekeo Boxed Warnings

Boxed Warning

Amphetamines have a high potential for abuse; administration for long periods of time may lead to dependence and must be avoided.

Misuse may cause sudden death and serious cardiovascular adverse events.

Evekeo Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease: not recommended. Hypertension. Heart failure. Recent MI. Arrhythmias. Assess cardiovascular status. Psychosis. Bipolar disorder. Depression. Monitor for worsening of aggressive behavior or hostility. Seizure disorders; discontinue if occur. Evaluate for tics or Tourette's syndrome prior to therapy. Peripheral vasculopathy including Raynaud's phenomenon; monitor for digital changes. Monitor HR, BP, growth in children. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy (Cat.C). Nursing mothers: not recommended.

Warnings/Precautions

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

  • Children/adolescents: sudden death has been reported with CNS stimulant use in patients with structural cardiac abnormalities or other serious heart problems.
  • Adults: sudden deaths, stroke, and myocardial infarction have been reported with stimulant use at usual doses for ADHD.

Hypertension/Other Cardiovascular Conditions

  • Increases in blood pressure (about 2-4 mmHg) and heart rate (about 3-6 bpm) have been observed with stimulant medication use.
  • Patients should be monitored for larger changes.
  • Use caution in patients whose underlying medical conditions might be compromised by increases in BP or heart rate (eg, pre-existing hypertension, heart failure, recent MI, or ventricular arrhythmia).

Assessing Cardiovascular Status

  • Assess patient history and perform physical exam to exclude cardiac disease.
  • Patients should undergo prompt cardiac evaluation if exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment develop.

Psychiatric Adverse Events

  • Stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorders.
  • Comorbid bipolar disorder: caution with use of stimulants to treat ADHD because of concern for possible induction of a mixed/manic episode. Screen patients prior to initiating stimulant treatment.
  • Emergent psychotic or manic symptoms in patients without history of psychotic illness can be caused by stimulants at usual doses.
  • Patient beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Growth Suppression

  • Growth should be monitored during treatment with stimulants; therapy may need to be interrupted if children are not growing as expected. 

Seizures

  • Stimulants may lower the convulsive threshold in patients with convulsive disorders or a history of seizures, as well as in patients without a history of seizure disorders.
  • Discontinue treatment in the presence of seizures.

Peripheral Vasculopathy 

  • Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud phenomenon.
  • Signs/symptoms generally improve after dose reduction or discontinuation.
  • Careful observation for digital changes is necessary during treatment.

Visual Disturbance

  • Stimulant treatment has been associated with difficulties with accomodation and blurring of vision.

Drug Abuse and Dependence

  • Amphetamines have been extensively abused.
  • Tolerance, extreme psychological dependence, and severe social disability have occurred.

Pregnancy Considerations

No adequate and well-controlled studies in pregnant women. Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Infants may also experience symptoms of withdrawal.

Nursing Mother Considerations

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

Pediatric Considerations

Amphetamines are not recommended for use as anorectic agents in children under 12 years of age, or in children under 3 years of age with ADHD. 

Long-term effects have not been well established. Growth should be monitored during treatment.

Evekeo Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal.

Evekeo Interactions

Interactions

See Contraindications. Avoid concomitant antacids. Potentiated by alkalinizers (eg, sodium bicarbonate, acetazolamide, some thiazides), propoxyphene. Antagonized by acidifiers, chlorpromazine, haloperidol, lithium. May antagonize effects of adrenergic blockers, antihistamines, veratrum alkaloids, antihypertensives. May potentiate effects of tricyclic antidepressants, meperidine, norepinephrine. May delay absorption of phenytoin, phenobarbital, ethosuximide. Monitor effects when concomitant PPIs. Convulsions with propoxyphene overdose and amphetamines. May interfere with urinary steroid tests.

Interactions

Monoamine Oxidase Inhibitors (MAOIs)

  • Concomitant use of Evekeo with MAOIs is contraindicated.
  • MAOI antidepressants, as well as a metabolic of furazolidone, can potentiate  amphetamines, thereby increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings, leading to headaches and other signs of hypertensive crisis.

Serotonergic Drugs/CYP2D6 Inhibitors

  • Serotonin syndrome may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. 
  • Consider an alternative nonserotonergic drug or an alternative drug that does not inhibit CYP2D6; coadministration of CYP2D6 inhibitors may increase the risk with increased exposure to Evekeo. If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Evekeo at a lower dose and monitor.
  • Discontinue treatment with Evekeo and any concomitant serotonergic agents immediately if serotonin syndrome symptoms occur, and initiate supportive symptomatic treatment.

Acidifying Agents

  • Gastrointestinal acidifying agents (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices) lower absorption of amphetamines.
  • Urinary acidifying agents (eg, ammonium chloride, sodium acid phosphate) increase concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion.

Adrenergic Blockers

  • Adrenergic blockers are inhibited by amphetamines.

Alkalinizing Agents

  • Gastrointestinal alkalinizing agents (eg, sodium bicarbonate) increase absorption of amphetamines. 
  • Urinary alkalinizing agents (eg, acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion.

Tricyclic Antidepressants

  • Amphetamines may enhance the activity of tricyclic or sympathomimetic agents.
  • D-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Antihistamines

  • Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives

  • Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine

  • Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine.
  • Can be used to treat amphetamine poisoning.

Ethosuximide

  • Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol

  • Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate 

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

Meperidine 

  • Amphetamines potentiate the analgesic effect of meperidine.

Methenamine Therapy

  • Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy.

Norepinephrine 

  • Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital/Phenytoin

  • Amphetamines may delay intestinal absorption of phenobarbital and phenytoin. 
  • Coadministration may produce a synergistic anticonvulsant action.

Propoxyphene 

  • In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum Alkaloids

  • Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

  • Amphetamines can cause a significant elevation in plasma corticosteroid levels. 
  • Amphetamines may interfere with urinary steroid determinations.

Evekeo Adverse Reactions

Adverse Reactions

Palpitations, tachycardia, BP increase, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, motor/phonic tics, Tourette's syndrome, dry mouth, unpleasant taste, diarrhea, constipation, anorexia, weight loss, urticaria, impotence, libido change, prolonged erection, rhabdomyolysis; serious cardiovascular events, visual disturbances.

Evekeo Clinical Trials

Clinical Trials

Adult obese patients instructed in dietary management and treated with anorectic drugs lose more weight on average than those receiving placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo patients and tends to decrease in succeeding weeks.

The total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Evekeo Note

Not Applicable

Evekeo Patient Counseling

Patient Counseling

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicle.

Instruct patients to report any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes or if unexplained wounds appear on fingers or toes.

Cost Savings Program

Evekeo savings card available here.

Evekeo Generic Name & Formulations

General Description

Amphetamine sulfate 5mg, 10mg; tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Tabs—100

Storage

Store at 20° to 25°C (68° to 77°F).

Generic Availability

NO

Evekeo Indications

Indications

Narcolepsy.

Evekeo Dosage and Administration

Adults and Children

Give first dose upon awakening and additional doses at 4–6hr intervals. Usual range 5–60mg/day. <6yrs: not recommended. 6–12yrs: initially 5mg daily, may increase by 5mg/day at weekly intervals. ≥12yrs: initially 10mg daily; may increase by 10mg/day at weekly intervals.

Evekeo Contraindications

Contraindications

Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate-to-severe hypertension. Hyperthyroidism. History of drug abuse. Agitation. During or within 14 days of MAOIs. Hypersensitivity to sympathomimetics.

Evekeo Boxed Warnings

Boxed Warning

Amphetamines have a high potential for abuse; administration for long periods of time may lead to dependence and must be avoided.

Misuse may cause sudden death and serious cardiovascular adverse events.

Evekeo Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease: not recommended. Hypertension. Heart failure. Recent MI. Arrhythmias. Assess cardiovascular status. Psychosis. Bipolar disorder. Depression. Monitor for worsening of aggressive behavior or hostility. Seizure disorders; discontinue if occur. Evaluate for tics or Tourette's syndrome prior to therapy. Peripheral vasculopathy including Raynaud's phenomenon; monitor for digital changes. Monitor HR, BP, growth in children. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy (Cat.C). Nursing mothers: not recommended.

Warnings/Precautions

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

  • Children/adolescents: sudden death has been reported with CNS stimulant use in patients with structural cardiac abnormalities or other serious heart problems.
  • Adults: sudden deaths, stroke, and myocardial infarction have been reported with stimulant use at usual doses for ADHD.

Hypertension/Other Cardiovascular Conditions

  • Increases in blood pressure (about 2-4 mmHg) and heart rate (about 3-6 bpm) have been observed with stimulant medication use.
  • Patients should be monitored for larger changes.
  • Use caution in patients whose underlying medical conditions might be compromised by increases in BP or heart rate (eg, pre-existing hypertension, heart failure, recent MI, or ventricular arrhythmia).

Assessing Cardiovascular Status

  • Assess patient history and perform physical exam to exclude cardiac disease.
  • Patients should undergo prompt cardiac evaluation if exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment develop.

Psychiatric Adverse Events

  • Stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorders.
  • Comorbid bipolar disorder: caution with use of stimulants to treat ADHD because of concern for possible induction of a mixed/manic episode. Screen patients prior to initiating stimulant treatment.
  • Emergent psychotic or manic symptoms in patients without history of psychotic illness can be caused by stimulants at usual doses.
  • Patient beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Growth Suppression

  • Growth should be monitored during treatment with stimulants; therapy may need to be interrupted if children are not growing as expected. 

Seizures

  • Stimulants may lower the convulsive threshold in patients with convulsive disorders or a history of seizures, as well as in patients without a history of seizure disorders.
  • Discontinue treatment in the presence of seizures.

Peripheral Vasculopathy 

  • Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud phenomenon.
  • Signs/symptoms generally improve after dose reduction or discontinuation.
  • Careful observation for digital changes is necessary during treatment.

Visual Disturbance

  • Stimulant treatment has been associated with difficulties with accomodation and blurring of vision.

Drug Abuse and Dependence

  • Amphetamines have been extensively abused.
  • Tolerance, extreme psychological dependence, and severe social disability have occurred.

Pregnancy Considerations

No adequate and well-controlled studies in pregnant women. Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Infants may also experience symptoms of withdrawal.

Nursing Mother Considerations

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

Pediatric Considerations

Amphetamines are not recommended for use as anorectic agents in children under 12 years of age, or in children under 3 years of age with ADHD. 

Long-term effects have not been well established. Growth should be monitored during treatment.

Evekeo Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal.

Evekeo Interactions

Interactions

See Contraindications. Avoid concomitant antacids. Potentiated by alkalinizers (eg, sodium bicarbonate, acetazolamide, some thiazides), propoxyphene. Antagonized by acidifiers, chlorpromazine, haloperidol, lithium. May antagonize effects of adrenergic blockers, antihistamines, veratrum alkaloids, antihypertensives. May potentiate effects of tricyclic antidepressants, meperidine, norepinephrine. May delay absorption of phenytoin, phenobarbital, ethosuximide. Monitor effects when concomitant PPIs. Convulsions with propoxyphene overdose and amphetamines. May interfere with urinary steroid tests.

Interactions

Monoamine Oxidase Inhibitors (MAOIs)

  • Concomitant use of Evekeo with MAOIs is contraindicated.
  • MAOI antidepressants, as well as a metabolic of furazolidone, can potentiate  amphetamines, thereby increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings, leading to headaches and other signs of hypertensive crisis.

Serotonergic Drugs/CYP2D6 Inhibitors

  • Serotonin syndrome may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. 
  • Consider an alternative nonserotonergic drug or an alternative drug that does not inhibit CYP2D6; coadministration of CYP2D6 inhibitors may increase the risk with increased exposure to Evekeo. If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Evekeo at a lower dose and monitor.
  • Discontinue treatment with Evekeo and any concomitant serotonergic agents immediately if serotonin syndrome symptoms occur, and initiate supportive symptomatic treatment.

Acidifying Agents

  • Gastrointestinal acidifying agents (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices) lower absorption of amphetamines.
  • Urinary acidifying agents (eg, ammonium chloride, sodium acid phosphate) increase concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion.

Adrenergic Blockers

  • Adrenergic blockers are inhibited by amphetamines.

Alkalinizing Agents

  • Gastrointestinal alkalinizing agents (eg, sodium bicarbonate) increase absorption of amphetamines. 
  • Urinary alkalinizing agents (eg, acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion.

Tricyclic Antidepressants

  • Amphetamines may enhance the activity of tricyclic or sympathomimetic agents.
  • D-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Antihistamines

  • Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives

  • Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine

  • Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine.
  • Can be used to treat amphetamine poisoning.

Ethosuximide

  • Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol

  • Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate 

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

Meperidine 

  • Amphetamines potentiate the analgesic effect of meperidine.

Methenamine Therapy

  • Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy.

Norepinephrine 

  • Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital/Phenytoin

  • Amphetamines may delay intestinal absorption of phenobarbital and phenytoin. 
  • Coadministration may produce a synergistic anticonvulsant action.

Propoxyphene 

  • In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum Alkaloids

  • Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

  • Amphetamines can cause a significant elevation in plasma corticosteroid levels. 
  • Amphetamines may interfere with urinary steroid determinations.

Evekeo Adverse Reactions

Adverse Reactions

Palpitations, tachycardia, BP increase, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, motor/phonic tics, Tourette's syndrome, dry mouth, unpleasant taste, diarrhea, constipation, anorexia, weight loss, urticaria, impotence, libido change, prolonged erection, rhabdomyolysis; serious cardiovascular events, visual disturbances.

Evekeo Clinical Trials

See Literature

Evekeo Note

Not Applicable

Evekeo Patient Counseling

Patient Counseling

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicle.

Instruct patients to report any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes or if unexplained wounds appear on fingers or toes.

Cost Savings Program

Evekeo savings card available here.