- Adderall XR
central nervous system stimulants
Controlled Substance Schedule: II
Causes release of norepinephrine from nerve endings. Pharmacologic effects are:
- CNS and respiratory stimulation,
- Mydriasis (pupillary dilation).
- Increased motor activity, mental alertness, and decreased fatigue in narcoleptic patients.
- Increased attention span in ADHD.
Absorption: Well absorbed after oral administration.
Distribution: Widely distributed in body tissues, with high concentrations in the brain and CSF. Crosses placenta and enters breast milk.
Metabolism and Excretion: Some metabolism by the liver. Urinary excretion is pH-dependent. Alkaline urine promotes reabsorption and prolongs action.
Half-life: Children 6–12 yrs: 9–11 hr; Adults: 10–13 hr (depends on urine pH).
TIME/ACTION PROFILE (CNS stimulation)
|PO||tablet: 0.5–1 hr||tablet: 3 hr capsule: 7 hr||4–6 hr|
- Hyperexcitable states including hyperthyroidism;
- Psychotic personalities;
- Concurrent use or use within 14 days of MAO inhibitors or MAO-like drugs (linezolid or methylene blue);
- Suicidal or homicidal tendencies;
- Chemical dependence;
- Structural cardiac abnormalities (may ↑ the risk of sudden death);
- End-stage renal disease;
Use Cautiously in:
- Cardiovascular disease (sudden death has occurred in children with structural cardiac abnormalities or other serious heart problems);
- History of substance use disorder (misuse may result in serious cardiovascular events/sudden death);
- Diabetes mellitus;
- Tourette's syndrome (may exacerbate tics);
- Severe renal impairment (↓ dose);
- OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; may lead to premature delivery and low birth weight infants;
- Geri: Older adults may be more susceptible to side effects.
Adverse Reactions/Side Effects
CV: SUDDEN DEATH, palpitations, tachycardia, cardiomyopathy (increased with prolonged use, high doses), hypertension, hypotension, peripheral vasculopathy
Derm: alopecia, urticaria
Endo: growth inhibition (with long term use in children)
EENT: blurred vision, mydriasis
GI: anorexia, constipation, cramps, diarrhea, dry mouth, metallic taste, nausea, vomiting
GU: erectile dysfunction, libido changes, priapism
Neuro: paresthesia, hyperactivity, insomnia, restlessness, tremor, aggression, anger, behavioral disturbances, dizziness, hallucinations, headache, mania, irritability, skin picking, talkativeness, thought disorder, tics
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), psychological dependence
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- Concurrent use with MAO inhibitors or MAO-inhibitor-like drugs, such as linezolid or methylene blue may result in serious, potentially fatal reactions; wait at least 14 days following discontinuation of MAO inhibitor before initiation of amphetamine mixtures.
- Drugs that affect serotonergic neurotransmitter systems, including MAO inhibitors, tricyclic antidepressants, SSRIs, SNRIs, fentanyl, buspirone, tramadol, lithium, and triptans ↑ risk of serotonin syndrome.
- ↑ adrenergic effects with other adrenergics or thyroid preparations.
- Drugs that alkalinize urine ( sodium bicarbonate, acetazolamide ) ↓ excretion, ↑ effects.
- Drugs that acidify urine (large doses of ascorbic acid ) ↑ excretion, ↓ effects.
- ↑ risk of hypertension and bradycardia with beta blockers.
- ↑ risk of arrhythmias with digoxin.
- Tricyclic antidepressants may ↑ effect of amphetamine but may ↑ risk of arrhythmias, hypertension, or hyperpyrexia.
- Proton pump inhibitors may ↑ effects.
Use with St. John's wort may ↑ risk of serotonin syndrome.
Foods that alkalinize the urine (fruit juices) can ↑ effect of amphetamine.
Dose is expressed in total amphetamine content (amphetamine + dextroamphetamine)
PO (Adults): Immediate-release tablets– 5 mg 1–2 times daily; may ↑ daily dose in 5–mg increments at weekly intervals; usual dose range = 5–40 mg/day in 1–3 divided doses. Extended-release capsules (Adderall XR)– 20 mg once daily; Extended-release capsules (Mydayis)– 12.5–25 mg once daily in the morning upon awakening; may ↑ daily dose in 12.5–mg increments at weekly intervals. (maximum dose = 50 mg/day).
PO (Children ≥13 yr): Immediate-release tablets– 5 mg 1–2 times daily; may ↑ daily dose in 5–mg increments at weekly intervals; usual dose range = 5–40 mg/day in 1–3 divided doses. Extended-release capsules (Adderall XR)– 10 mg once daily in the morning; may ↑ to 20 mg once daily in the morning after 1 wk; Extended-release capsules (Mydayis)– 12.5 mg once daily in the morning upon awakening; may ↑ daily dose in 12.5–mg increments at weekly intervals (maximum dose = 25 mg/day).
PO (Children 6–12 yr): Immediate-release tablets– 5 mg 1–2 times daily; may ↑ daily dose in 5–mg increments at weekly intervals; usual dose range = 5–40 mg/day in 1–3 divided doses. Extended-release capsules (Adderall XR)– 5–10 mg once daily in the morning; may ↑ daily dose in 5–10–mg increments at weekly intervals (maximum dose = 30 mg/day).
PO (Children 3–5 yr): Immediate-release tablets– 2.5 mg once daily in the morning; may ↑ daily dose in 2.5–mg increments at weekly intervals; usual dose range = 2.5–40 mg/day in 1–3 divided doses.
PO (Adults): GFR 15–29 mL/min/1.73 m2 – Extended-release capsules (Adderall XR)–15 mg once daily in the morning; Extended–release capsules (Mydayis)–12.5 mg once daily in the morning upon awakening; may ↑ daily dose in 12.5–mg increments at weekly intervals (maximum dose = 25 mg/day).
(Children ≥13 yr): GFR 15–29 mL/min/1.73 m2 – Extended–release capsules (Mydayis)–12.5 mg once daily in the morning upon awakening (maximum dose = 12.5 mg/day).
(Children ≥6 yr): GFR 15–29 mL/min/1.73 m2 – Extended–release capsules (Adderall XR)–5 mg once daily in the morning (maximum dose = 20 mg/day in children 6–12 yrs).
PO (Adults and Children ≥13 yr): Immediate-release tablets– 10 mg once daily in the morning; may ↑ daily dose in 10–mg increments at weekly intervals; usual dosage range = 5–60 mg/day in 1–3 divided doses.
PO (Children 6–12 yr): Immediate-release tablets– 5 mg once daily; may ↑ daily dose in 5–mg increments at weekly intervals; usual dose range = 5–60 mg/day in 1–3 divided doses.
Availability (generic available)
Amount is expressed in total amphetamine content (amphetamine + dextroamphetamine)
Extended-release capsules (Adderall XR): 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
Generic: All strengths $613.15/100
Extended-release capsules (Mydayis): 12.5 mg, 25 mg, 37.5 mg, 50 mg
Tablets: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg
Generic: All strengths $171.40/100
- Monitor BP, pulse, and respiration before and periodically during therapy. Obtain a history (including assessment of family history of sudden death or ventricular arrhythmia), physical exam to assess for cardiac disease, and further evaluation (ECG and echocardiogram), if indicated. If exertional chest pain, unexplained syncope, or other cardiac symptoms occur, evaluate promptly.
- May produce a false sense of euphoria and well-being. Provide frequent rest periods and observe patient for rebound depression after the effects of the medication have worn off.
- Monitor closely for behavior change during therapy.
- Assess for risk of abuse before starting therapy. Monitor for signs and symptoms of abuse (increased heart rate, respiratory rate, blood pressure, sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, abdominal pain, anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation) during therapy. Has high dependence and abuse potential. Tolerance to medication occurs rapidly; do not increase dose.
- Assess infants born to mothers taking amphetamines for symptoms of withdrawal (feeding difficulties, irritability, agitation, excessive drowsiness).
- ADHD: Monitor weight biweekly and height periodically and inform health care professional of significant loss.
- Assess child's attention span, impulse control, and interactions with others. Therapy may be interrupted at intervals to determine whether symptoms are sufficient to continue therapy.
- Narcolepsy: Observe and document frequency of narcoleptic episodes.
Lab Test Considerations:
May interfere with urinary steroid determinations.
- May cause ↑ plasma corticosteroid concentrations; greatest in evening.
Administer in the morning to prevent insomnia. May be taken without regard to food. Individualize dose to therapeutic needs and response of patient. Use the lowest effective dose.
- Administer short acting doses 4–6 hrs apart.
- Extended-release capsules may be swallowed whole or opened and sprinkled on applesauce; swallow contents without chewing. Applesauce should be swallowed immediately; do not store. Do not divide contents of capsule; entire contents of capsule should be taken.
- ADHD: Pedi: When symptoms are controlled, dose reduction or interruption of therapy may be possible during summer mo or may be given on each of the 5 school days, with medication-free weekends and holidays.
- Instruct patient to take medication once in the early morning as directed. With extended release capsule, avoid afternoon doses to prevent insomnia. Omit missed doses and resume schedule next day. Do not double doses. Discuss safe use, risks, and proper storage and disposal of amphetamines with patients and caregivers with each Rx. Advise patient and parents to read the Medication Guide prior to starting therapy and with each Rx refill in case of changes. Instruct patient not to alter dose without consulting health care professional. Abrupt cessation of high doses may cause extreme fatigue and mental depression.
- Advise patient that amphetamine mixtures are drugs with known abuse potential. Protect them from theft, and never give to anyone other than the individual for whom they were prescribed. Store out of sight and reach of children, and in a location not accessible by others. Amphetamine mixtures is are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away amphetamines may harm others, and is against the law.
- Caution patients to inform health care professional if they have ever abused or been dependent on alcohol or drugs, or if they are now abusing or dependent on alcohol or drugs.
- Inform patient that the effects of drug-induced dry mouth can be minimized by rinsing frequently with water or chewing sugarless gum or candies.
- Advise patient to limit intake of foods that alkalinize the urine (fruit juices).
- May impair judgment. Advise patient to use caution when driving or during other activities requiring alertness until response to medication is known.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
- Inform patient that periodic holidays from the drug may be used to assess progress and decrease dependence. Pedi: Children should be given a drug-free holiday each yr to reassess symptoms and treatment. Doses will change as children age due to pharmacokinetic changes such as slower hepatic metabolism.
- Advise patient and/or parents to notify health care professional of behavioral changes (new or worse behavior and thought problems, bipolar illness, or aggressive behavior or hostility; new psychotic symptoms such as hearing voices, believing things that are not true, are suspicious, or new manic symptoms).
- Advise patient to notify health care professional if symptoms of heart problems (chest pain, shortness of breath, fainting), nervousness, restlessness, insomnia, dizziness, anorexia, or dry mouth becomes severe. Pedi: If reduced appetite and weight loss occur, advise parents to provide high calorie meals when drug levels are low (at breakfast and or bedtime).
- Inform patients of risk of peripheral vasculopathy. Instruct patients to notify health care professional of any new numbness; pain; skin color change from pale, to blue, to red; or coolness or sensitivity to temperature in fingers or toes, and call if unexplained wounds appear on fingers or toes.
- Rep: Advise patient to notify health care professional if pregnancy is planned or suspected, and to avoid breast feeding. May cause birth complications. Enroll women exposed to amphetamine mixtures during pregnancy by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyreg.... Monitor infants born to mothers taking amphetamines for symptoms of withdrawal (feeding difficulties, irritability, agitation, excessive drowsiness).
- Emphasize the importance of routine follow-up exams to monitor progress.
- Home Care Issues: Advise parents to notify school nurse of medication regimen.
- Improved attention span in patients with ADHD.
- Increased motor activity, mental alertness, and decreased fatigue in patients with narcolepsy.
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