amphetamine (Rx)

Brand and Other Names:Adzenys XR-ODT, Dyanavel XR, more...Evekeo, Adzenys ER, Evekeo ODT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Evekeo): Schedule II

  • 5mg
  • 10mg

oral disintegrating tablet (Evekeo ODT): Schedule II

  • 5mg
  • 10mg
  • 15mg
  • 20mg

extended-release oral suspension (Dyanavel XR): Schedule II

  • 2.5mg/mL

extended-release oral disintegrating tablet (Adzenys XR-ODT): Schedule II

  • 3.1mg
  • 6.3mg
  • 9.4mg
  • 12.5mg
  • 15.7mg
  • 18.8mg

extended-release oral suspension (Adzenys ER): Schedule II

  • 1.25 mg/mL

Narcolepsy

5-60 mg/day PO in divided doses depending on the individual patient response

Administer at the lowest effective dose; individually adjust dosage

Obesity

Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy (eg, repeated diets, group programs, and other drugs)

Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals

Administer at the lowest effective dose; individually adjust dosage

Attention Deficit Hyperactivity Disorder

Indicated for attention deficit hyperactivity disorder (ADHD) in adolescents and adults

Adzenys XR-ODT: 12.5 mg PO qAM

Adzenys ER: 12.5 mg PO qAM

Dyanavel XR: 2.5-5 mg PO qAM; may increase by 2.5 -10 mg/day q4-7days; not to exceed 20 mg/day

Evekeo: 5 mg PO qDay or q12hr; may increase by 5 mg qWeek until optimal response is obtained; not to exceed 40 mg/day

Dosage Modifications

Equivalent doses of Adzenys ER or Adzenys XR-ODT and Adderall XR

  • Adzenys ER/XR-ODT 3.1 mg (2.5 mL): Adderall XR 5 mg
  • Adzenys ER/XR-ODT 6.3 mg (5 mL): Adderall XR 10 mg
  • Adzenys ER/XR-ODT 9.4 mg (7.5mL): Adderall XR 15 mg
  • Adzenys ER/XR-ODT 12.5 mg (10 mL): Adderall XR 20 mg
  • Adzenys ER/XR-ODT 15.7 mg (12.5 mL): Adderall XR 25 mg
  • Adzenys ER/XR-ODT 18.8 mg (15 mL): Adderall XR 30 mg

Concomitant use of extended-release amphetamines with other medications

  • Do not administer concomitantly or within 14 days after discontinuing MAO inhibitors
  • Coadministration of and gastrointestinal alkalinizing agents should be avoided
  • See Warnings

Dosing Considerations

Do not substitute for other amphetamine products on a mg-per-mg basis, because of different amphetamine base compositions and differing pharmacokinetic profiles

Dosage Forms & Strengths

tablet (Evekeo): Schedule II

  • 5mg
  • 10mg

oral disintegrating tablet (Evekeo ODT): Schedule II

  • 5mg
  • 10mg
  • 15mg
  • 20mg

extended-release oral suspension (Dyanavel XR): Schedule II

  • 2.5mg/mL

extended-release oral disintegrating tablet (Adzenys XR-ODT): Schedule II

  • 3.1mg
  • 6.3mg
  • 9.4mg
  • 12.5mg
  • 15.7mg
  • 18.8mg

extended-release oral suspension (Adzenys ER): Schedule II

  • 1.25 mg/mL

Attention Deficit Hyperactivity Disorder

Evekeo

  • <3 years: Safety and efficacy not established
  • 3-5 years: 2.5 mg PO qDay initially; may increase daily dose by 2.5-mg increments at weekly intervals until optimal response is obtained
  • ≥6 years: 5 mg PO qDay initially; may increase daily dose by 5-mg increments at weekly intervals until optimal response is obtained; only in rare cases will it be necessary to exceed 40 mg/day
  • If necessary, administer additional doses (1-2) at intervals of 4-6 hr

Evekeo ODT

  • <6 years: Safety and efficacy not established
  • ≥6 years
    • 5 mg PO qDay initially; may increase daily dose by 5-mg increments at weekly intervals until optimal response is obtained; only in rare cases will it be necessary to exceed 40 mg/day
    • If necessary, administer an additional dose after 4-6 hr

Dyanavel XR

  • <6 years: Safety and efficacy not established
  • ≥6 years: Initial: 2.5-5 mg PO qAM
  • May increase dose in increments of 2.5-10 mg/day q4-7 days; not to exceed dose of 20 mg/day

Adzenys XR-ODT or Adzenys ER

  • <6 years: Safety and efficacy not established
  • 6-17 years (initial dose): 6.3 mg PO qDay in AM; not to exceed 18.8 mg/day (6-12 years); 12.5 mg/day (13-17 years)

Narcolepsy (Evekeo)

Seldom occurs in children younger than 12 yr; however, when it does, amphetamine may be prescribed

6-12 years: 5 mg/day PO initially; daily dose may be increased by 5-mg increments at weekly intervals until optimal response obtained

≥12 years: 10 mg/day PO initially; daily dose may increase by 10-mg increments at weekly intervals until optimal response is obtained

Administer in divided doses according to individual response

Administer first dose on awakening; give additional doses (5-10 mg) at intervals of 4-6 hr

Obesity (Evekeo)

Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy (eg, repeated diets, group programs, and other drugs)

<12 years: Safety and efficacy not established

≥12 years: Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals

Dosage Modifications

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine

Acidifying agents (eg, ascorbic acid) decrease blood levels, while alkalinizing agents (eg, sodium bicarbonate) increase blood levels; adjust dosage accordingly

Dosing Considerations

Assess for presence of cardiac disease (eg, family history of sudden death or ventricular arrhythmia, physical exam)

Switching From Other Amphetamine Products

  • Do not substitute for other amphetamine products on a mg-per-mg basis, because of different amphetamine base compositions and differing pharmacokinetic profiles
  • Switching from Evekeo to Evekeo ODT can done on a milligram-per-milligram basis
  • Switching from other amphetamine products to Evekeo ODT, discontinue treatment and titrate with Evekeo ODT using the titration schedule above
  • Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine salt compositions and differing pharmacokinetic profiles
  • Avoid late evening doses because of insomnia
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Interactions

Interaction Checker

and amphetamine

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            Adverse Effects

            >10% (Evekeo)

            Decreased appetite (28%)

            Infections (22%)

            Abdominal pain (15%)

            Irritability (14%)

            Headache (13%)

            >10% (Adzenys ER)

            Appetite loss (22-36%)

            Dry mouth (1.6-35%)

            Headache (1.6-26%)

            Insomnia (5.2-17%)

            Abdominal pain (11-14%)

            1-10% (Evekeo)

            Insomnia (10%)

            Fatigue (10%)

            Affect lability, includes mood swings (9%)

            Tachycardia (9%)

            Nausea (6%)

            Vomiting (6%)

            Dry mouth (6%)

            Decreased appetite (4%)

            Insomnia (4%)

            Abdominal pain (3%)

            Affect lability (3%)

            Injury (3%)

            1-10% (Dyanavel XR)

            Epistaxis (3.8%)

            Rhinitis allergic (3.8%)

            Upper abdominal pain (3.8%)

            1-10% (Adzenys ER)

            Weight loss (4-9%)

            Emotional lability (9%)

            Nausea (5-8%)

            Agitation (8%)

            Anxiety (2.1-8%)

            Dizziness (2-7%)

            Vomiting (7%)

            Diarrhea (6%)

            Nervousness (6%)

            Urinary tract infection (5%)

            Fever (5%)

            Infection (4%)

            Accidental injury (3%)

            Asthenia (1-2%)

            Dyspepsia (2%)

            Nervousness (1.6%)

            Tachycardia (1.6%)

            Postmarketing Reports

            Cardiovascular: Palpitations, tachycardia, sudden death, myocardial infarction; elevation of blood pressure; isolated reports of cardiomyopathy associated with chronic use

            Central nervous system: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, depression, aggression, anger, logorrhea, and paresthesia (including formication). euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette’s syndrome

            Gastrointestinal: Dry mouth, unpleasant taste, diarrhea, constipation; anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect

            Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported

            Endocrine: Impotence, changes in libido, and frequent or prolonged erections

            Skin: Alopecia

            Eye Disorders: Vision blurred, mydriasis

            Vascular disorders: Raynaud phenomenon

            Musculoskeletal: Rhabdomyolysis

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            Warnings

            Black Box Warnings

            Abuse and dependence

            • CNS stimulants, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence
            • Assess risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy

            Contraindications

            Advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate-to-severe hypertension

            In patients known to be hypersensitive to amphetamine, or other components

            Patients with a history of drug abuse

            During or within 14 days following the administration of MAOIs (hypertensive crises may result)

            Cautions

            Sudden death reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems

            May cause a modest increase in average blood pressure (~2-4 mmHg) and heart rate (~3-6 bpm); caution with hypertension and other cardiovascular conditions

            May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder CNS stimulants may induce a mixed or manic episode in patients with bipolar disorder; before initiating treatment, screen for risk factors for developing a manic episode (eg, comorbid or has a history of depressive symptoms or a family history of suicide, bipolar disorder, and depression)

            Treatment emergent psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses

            Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD; monitor for the worsening of aggressive behavior or hostility

            Monitor childhood growth during treatment; patients who are not growing or gaining height or weight as expected may need to interrupt their treatment May lower seizure threshold in patients with prior history of seizures

            Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon

            Visual disturbances reported (eg, difficulties with accommodation, blurred vision)

            Medication errors, including substitution and dispensing errors, between amphetamine products could occur, leading to possible overdosage; avoid substitution errors and overdosage, do not substitute for other amphetamine products on a mg-per-mg basis because of different amphetamine salt compositions and differing pharmacokinetic profile

            Drug interactions overview

            • Amphetamines can cause a significant elevation in plasma corticosteroid levels (greatest increase in the evening); may interfere with urinary steroid determinations
            • Concomitant use of amphetamines with alkalizing agents (eg, proton pump inhibitors) may increase exposure to amphetamine and exacerbate the action of amphetamine
            • Coadministration with acidifying agents (eg, ascorbic acid) may lower blood levels and efficacy of amphetamines
            • Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort
            • Amphetamines are metabolized by CYP2D6 and minor iCYP2D6 inhibitors; coadministration with CYP2D6 inhibitors may increase exposure to amphetamines; consider alternative non-serotonergic drug or alternative drug that does not inhibit CYP2D6
            • If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome
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            Pregnancy & Lactation

            Pregnancy

            Pregnancy exposure registry monitors pregnancy outcomes in women exposed to amphetamines during pregnancy

            Encourage patients to register by calling the National Pregnancy Registry for Psychostimulants at 1-866- 961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications

            Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage

            Adverse pregnancy outcomes, including premature delivery and low birth weight, were seen in infants born to mothers taking amphetamines during pregnancy

            Dextroamphetamine sulfate shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses ~41 times the maximum human dose

            Clinical considerations

            • Amphetamines cause vasoconstriction and thereby decrease placental perfusion
            • Also, may stimulate uterine contractions, increasing the risk of premature delivery
            • Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight; monitor infants born to mothers taking amphetamines for symptoms of withdrawal (eg, feeding difficulties, irritability, agitation, excessive drowsiness)

            Lactation

            Based on limited published case reports, amphetamine (d- or d1) is present in human milk at relative infant doses of 2-13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9and 7.5

            No reports of adverse effects on the breastfed infantLong-term neurodevelopmental effects on infants from amphetamine exposure are unknown

            Owing to the potential for serious adverse reactions in nursing infants, breast feeding is not recommended during treatment

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Noncatecholamine, sympathomimetic amine that elicits CNS stimulant activity

            Peripheral actions include increased systolic and diastolic blood pressures, and weak bronchodilator and respiratory stimulant action

            Absorption

            Adzenys XR-ODT

            • Peak plasma time, d-amphetamine: 5 hr (fasted); 7 hr (fed)
            • Peak plasma concentration, d-amphetamine: 44.9 ng/mL (fasted); 36.3 ng/mL (fed)
            • AUC, d-amphetamine: 876.9 hr·ng/mL (fasted); 856.3 hr·ng/mL (fed)
            • Coadministration of Adzenys XR-ODT and food prolonged peak plasma time by ~2 hr (d-amphetamine); 2.5 hr (l-amphetamine)

            Adzenys ER

            • Peak plasma time: 5 hr
            • Increase in amphetamine release occurred in the presence of 40% alcohol

            Dyanavel XR

            • Peak plasma time: 4 hr
            • Bioavailability of Dyanavel XR compared to an equal dose of mixed amphetamine salts IR tablets is 106% (d-amphetamine) and 111% (l-amphetamine)

            Evekeo ODT

            • Peak plasma time (Evekeo ODT [d- and l-amphetamine]): ~3.5 hr (with water) and 3 hr (without water)

            Metabolism

            Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated

            In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites

            Elimination

            Adzenys ER

            • Half-life, d-amphetamine: 11.4 hr (adults); 12.7 hr (6-12 years)
            • Half-life, l-amphetamine: 14.1 hr (adults); 15.3 hr (6-12 years)
            • Excretion: Urine (30-40%)

            Adzenys XR-ODT

            • Half-life, d-amphetamine: 11 hr (adults); 9-10 hr (6-12 years)
            • Half-life, l-amphetamine: 14 hr (adults); 10-11 hr (6-12 years)
            • Excretion: Urine (30-40%)

            Dyanavel XR

            • Half-life, d-amphetamine: 12.36 hr (adults)
            • Half-life, l-amphetamine: 15.12 hr (adults)
            • Excretion: Urine (30-40%)

            Evekeo ODT

            • Half-life (Evekeo ODT): 10 hr (d-amphetamine); 11.7 hr (l-amphetamine)
            • Renally eliminated in a pH-dependent mannerRenal excretion rate of unchanged amphetamine at a urine pH= 6.6 averages 70% versus 17%; - 43% at urine pH of >6.7
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            Administration

            Oral Administration

            Avoid late evening doses because of insomnia

            Tablet

            • Take 30-60 minutes before meals
            • Administer first dose on awakening; 1-2 additional doses at 4-6 hr intervals

            Oral suspension

            • Shake suspension well before measuring dose with a calibrated measuring device
            • Take with or without meals

            Oral disintegrating tablet

            • May be taken with or without food
            • Once blister is opened, remove tablet and place on patient’s tongue
            • Place whole tablet on the tongue and allow tablet to disintegrate in saliva then swallow

            Storage

            Evekeo: Store at 20-25°C (68-77°F); dispense in a well closed container

            Evekeo ODT: Store at 20-25°C (68- 77°F); excursions permitted from 15-30ºC (59-86ºF); store blister packages in the provided plastic sleeve

            Dyanavel XR: Dispense in a tight container with child resistant closure; store at 20-25°C (68- 77°F); excursions permitted from 15-30ºC (59-86ºF)

            Adzenys XR-ODT: Store blister packages in the rigid, plastic travel case provided after removal from the carton; store at 20-25°C (68- 77°F); excursions permitted from 15-30ºC (59-86ºF)

            Adzenys ER: Dispense in a tight container with child-resistant closure; store at 20-25°C (68- 77°F); excursions permitted from 15-30ºC (59-86ºF)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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