lisdexamfetamine

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1 hr	24 hr

Contraindicated in:

Hypersensitivity to lisdexamfetamine or other sympathomimetic amines;
Advanced arteriosclerosis;
Serious structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease (may ↑ risk of sudden death);
Moderate to severe hypertension;
Glaucoma;
Agitation;
Concurrent use or use within 14 days of MAO inhibitors or MAO-like drugs (linezolid or methylene blue);
Lactation: Lactation.

Use Cautiously in:

History of pre-existing psychosis, bipolar disorder, aggression, or seizures (may exacerbate condition);
Tics or family history/diagnosis of Tourette syndrome (may worsen condition);
History of substance abuse
;
Continual use (may result in psychological or physical dependence)
;
Severe renal impairment (↓ maximum daily dose);
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Pedi: Children <6 yr (safety and effectiveness not established); growth suppression may occur in children with long-term use.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, tachycardia, Raynaud phenomenon, SUDDEN DEATH

Derm: alopecia, rash

EENT: blurred vision, poor accommodation

GI: ↓appetite, abdominal pain, dry mouth, intestinal ischemia, nausea, vomiting, weight loss (especially with prolonged use)

GU: ↓libido, priapism

Metab: growth suppression (especially with prolonged use)

MS: RHABDOMYOLYSIS

Neuro: behavioral disturbances, dizziness, hallucinations, insomnia, irritability, mania, paresthesia, psychomotor hyperactivity, thought disorder, tics, Tourette syndrome

Misc: physical dependence, psychological dependence, SEROTONIN SYNDROME

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with MAO inhibitors or MAO-inhibitor-like drugs, such as linezolid or methylene blue, may result in serious, potentially fatal reactions; wait ≥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, may ↑ risk of serotonin syndrome.
Sympathomimetic amines may result in additive effects and ↑ risk of adverse reactions.
Urinary acidifying agents, including sodium acid phosphate, ↑ excretion and ↓ levels and may result in ↓ effectiveness.
May ↓ effectiveness of adrenergic blockers.
↑risk of adverse cardiovascular reactions with tricyclic antidepressants.
May ↓ sedating effects of antihistamines.
May ↓ effectiveness of antihypertensives.
Effects may be ↓ by haloperidol, lithium, or chlorpromazine.
May ↓ absorption of phenobarbital or phenytoin.

Route/Dosage ⬆ ⬇

Attention-Deficit Hyperactivity Disorder

PO (Adults and Children ≥6 yr): 30 mg once daily; may ↑ by 10–20 mg/day at weekly intervals, up to 70 mg/day.

Renal Impairment

PO (Adults and Children ≥6 yr): CCr 15–29 mL/min: Do not exceed 50 mg/day; CCr <15 mL/min: Do not exceed 30 mg/day.

Binge Eating Disorder

PO (Adults ): 30 mg once daily; may ↑ by 20 mg/day at weekly intervals, up to target dose of 50–70 mg/day.

Availability ⬆ ⬇

(Generic available)

Capsules: 10 mg; 20 mg; 30 mg; 40 mg; 50 mg; 60 mg; 70 mg
Chewable tablets: 10 mg; 20 mg; 30 mg; 40 mg; 50 mg; 60 mg
Oral solution (Arynta): 10 mg/mL

Assessment ⬆ ⬇

Monitor BP, HR, and respiratory rate before administering 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 and treat promptly.
- Assess for risk of abuse, misuse, or addiction prior to starting therapy and during therapy. Has high dependence and abuse or misuse potential. Misuse and abuse of CNS stimulants can result in overdose and death; this risk is ↑ with higher doses or unapproved methods of administration, such as snorting or injection. Tolerance to medication occurs rapidly; do not ↑ dose.
- Screen patients with bipolar disorder for risk of manic episode (comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression) prior to starting therapy.
- Monitor growth, both height and weight, in children on long-term therapy. May need to interrupt therapy in patients who are not growing or gaining height or weight as expected.
- Monitor closely for behavior change.
Assess for signs/symptoms of serotonin syndrome (mental changes [agitation, hallucinations, coma], autonomic instability [tachycardia, labile BP, hyperthermia], neuromuscular aberrations [hyperreflexia, incoordination], or GI symptoms [nausea, vomiting, diarrhea]), especially in patients taking other serotonergic drugs (SSRIs, SNRIs, triptans).
ADHD: 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.
Binge Eating Disorder: Monitor frequency and amount of binge eating.

Lab Test Considerations:

May cause ↑ plasma corticosteroid levels interfering with urinary steroid determinations.

Implementation ⬆ ⬇

PO: Administer in the morning without regard to meals. Avoid afternoon doses due to potential for insomnia. Capsules may be swallowed whole or opened and the entire contents dissolved in yogurt, water, or orange juice. If solution method is used, consume immediately; do not store for future use. Do not divide capsules or take less than one capsule per day. Chewable tablets must be chewed thoroughly. Tablets and chewable tablets can be substituted on a unit per unit/mg per mg basis.
- For oral solution, use oral dosing syringe and adapter provided with the bottle. Ensure that the bottle adapter is firmly inserted into the bottle before 1st use and keep the adapter in place for as long as bottle is used. Discard any remaining solution 30 days after initially opening the bottle.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed. Advise patient and caregivers to read Patient Information before therapy and with each renewal of Rx refill. If more than prescribed amount is taken, notify health care provider immediately. Instruct patient not to alter dose without consulting health care provider. Emphasize the importance of routine follow-up exams to monitor progress.
- Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
- Advise caregivers to notify school nurse of medication regimen.
- Advise patient that lisdexamfetamine is a drug with known potential for abuse, misuse, or addiction. Store in safe place, protect it from theft, and never give to anyone other than the individual for whom it was prescribed.
- Advise patient to store in a safe place, preferably locked, and not to share this medication with anyone.
- Advise patient to check weight 2–3 times weekly and report weight loss to health care provider. If ↓ appetite and weight loss are a problem, advise parents to provide high-calorie meals when drug levels are low (at breakfast and or bedtime).
- Inform patients starting therapy of risk of peripheral vasculopathy. Instruct patients to notify health care provider 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. May require rheumatology consultation.
- Advise caregivers to notify health care provider immediately if child has signs of heart problems (chest pain, shortness of breath, fainting) or if new or worsening mental symptoms or problems, especially seeing or hearing things that are not real or believing things that are not real or are suspicious, occur.
- May cause dizziness or blurred vision. Caution patient to avoid driving or activities requiring alertness until response to medication is known.
- Advise patient to notify health care provider if nervousness, restlessness, insomnia, dizziness, anorexia, or dry mouth becomes severe.
- Inform patient that health care provider may order periodic holidays from the drug to assess progress and to ↓ dependence.
- May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected and to avoid breastfeeding. May cause premature delivery. Monitor infants born to mothers taking lisdexamfetamine for symptoms of withdrawal (feeding difficulties, irritability, agitation, excessive drowsiness). Inform pregnant patient of registry that monitors outcomes in women exposed to ADHD medications during pregnancy. Register patient by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/adhdmedications/.

Evaluation/Desired Outcomes ⬆ ⬇

Improved attention span, decreased impulsiveness and hyperactivity in ADHD.
Reduction in number of binge eating days per wk.

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Pill Image

Code ⬆

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-6854- Lisdexamfetamine Dimesylate
  - 0378-6854-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6854-77)

0378- Mylan Pharmaceuticals Inc.
- 0378-6855- Lisdexamfetamine Dimesylate
  - 0378-6855-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6855-77)

0378- Mylan Pharmaceuticals Inc.
- 0378-6856- Lisdexamfetamine Dimesylate
  - 0378-6856-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6856-77)

0378- Mylan Pharmaceuticals Inc.
- 0378-6857- Lisdexamfetamine Dimesylate
  - 0378-6857-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6857-77)

0378- Mylan Pharmaceuticals Inc.
- 0378-6858- Lisdexamfetamine Dimesylate
  - 0378-6858-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6858-77)

0378- Mylan Pharmaceuticals Inc.
- 0378-6859- Lisdexamfetamine Dimesylate
  - 0378-6859-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6859-77)

0378- Mylan Pharmaceuticals Inc.
- 0378-6860- Lisdexamfetamine Dimesylate
  - 0378-6860-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6860-77)

42291- AvKARE
- 42291-036- Lisdexamfetamine Dimesylate
  - 42291-036-90- 90 CAPSULE in 1 BOTTLE (42291-036-90)

42291- AvKARE
- 42291-037- Lisdexamfetamine Dimesylate
  - 42291-037-90- 90 CAPSULE in 1 BOTTLE (42291-037-90)

42291- AvKARE
- 42291-038- Lisdexamfetamine Dimesylate
  - 42291-038-90- 90 CAPSULE in 1 BOTTLE (42291-038-90)

42291- AvKARE
- 42291-039- Lisdexamfetamine Dimesylate
  - 42291-039-90- 90 CAPSULE in 1 BOTTLE (42291-039-90)

42291- AvKARE
- 42291-040- Lisdexamfetamine Dimesylate
  - 42291-040-90- 90 CAPSULE in 1 BOTTLE (42291-040-90)

42291- AvKARE
- 42291-041- Lisdexamfetamine Dimesylate
  - 42291-041-90- 90 CAPSULE in 1 BOTTLE (42291-041-90)

65162- Amneal Pharmaceuticals LLC
- 65162-023- Lisdexamfetamine Dimesylate
  - 65162-023-09- 90 CAPSULE in 1 BOTTLE (65162-023-09)

65162- Amneal Pharmaceuticals LLC
- 65162-024- Lisdexamfetamine Dimesylate
  - 65162-024-09- 90 CAPSULE in 1 BOTTLE (65162-024-09)

65162- Amneal Pharmaceuticals LLC
- 65162-025- Lisdexamfetamine Dimesylate
  - 65162-025-09- 90 CAPSULE in 1 BOTTLE (65162-025-09)

65162- Amneal Pharmaceuticals LLC
- 65162-026- Lisdexamfetamine Dimesylate
  - 65162-026-09- 90 CAPSULE in 1 BOTTLE (65162-026-09)

65162- Amneal Pharmaceuticals LLC
- 65162-027- Lisdexamfetamine Dimesylate
  - 65162-027-09- 90 CAPSULE in 1 BOTTLE (65162-027-09)

65162- Amneal Pharmaceuticals LLC
- 65162-028- Lisdexamfetamine Dimesylate
  - 65162-028-09- 90 CAPSULE in 1 BOTTLE (65162-028-09)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇