Lisdexamfetamine 20mg Chewable Tabs
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat binge eating disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Prodrug of dextroamphetamine; sympathomimetic amine
Pregnancy Category
Not available
FDA Approved
Feb 2007
DEA Schedule
Schedule II
Overview
What is this medicine?
Lisdexamfetamine is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children 6 years and older, and moderate to severe Binge Eating Disorder (BED) in adults. It's a 'prodrug,' meaning your body converts it into an active form (dextroamphetamine) after you take it. This active form helps improve focus, attention, and control over impulsive behavior by affecting certain chemicals in your brain.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day. Be sure to chew the medication thoroughly before swallowing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from direct light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication safe. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on proper disposal methods, which may include drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day. Be sure to chew the medication thoroughly before swallowing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from direct light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication safe. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on proper disposal methods, which may include drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning to avoid sleep problems.
- Do not take more than prescribed or share your medication.
- Swallow the chewable tablet whole or chew thoroughly before swallowing. It can also be dissolved in water, orange juice, or yogurt.
- Avoid alcohol, as it can increase side effects.
- Maintain a healthy diet and monitor weight, especially in children.
- Report any new or worsening heart problems, mental health changes, or circulation issues in fingers/toes.
Available Forms & Alternatives
Available Strengths:
- Lisdexamfetamine 50mg Chewable Tabs
- Lisdexamfetamine 30mg Chewable Tabs
- Lisdexamfetamine 40mg Chewable Tabs
- Lisdexamfetamine 10mg Chewable Tabs
- Lisdexamfetamine 60mg Chewable Tabs
- Lisdexamfetamine 10mg Capsules
- Lisdexamfetamine 20mg Chewable Tabs
- Lisdexamfetamine 70mg Capsules
- Lisdexamfetamine 60mg Capsules
- Lisdexamfetamine 30mg Capsules
- Lisdexamfetamine 50mg Capsules
- Lisdexamfetamine 40mg Capsules
- Lisdexamfetamine 20mg Capsules
- Lisdexamfetamine 20mg Capsules
- Lisdexamfetamine 60mg Capsules
- Lisdexamfetamine 50mg Capsules
- Lisdexamfetamine 70mg Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 30 mg orally once daily in the morning; titrate in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg/day.
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg, target 30-70 mg/day
BED:
Initial 30 mg, target 50-70 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 30 mg orally once daily in the morning; titrate in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg/day.
Adolescent:
ADHD (13-17 years): Initial 30 mg orally once daily in the morning; titrate in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl 50-80 mL/min).
Moderate:
Consider reducing maximum dose to 50 mg/day (CrCl 30 to <50 mL/min).
Severe:
Consider reducing maximum dose to 30 mg/day (CrCl <30 mL/min).
Dialysis:
Maximum dose 30 mg/day. Administer after dialysis.
Hepatic Impairment:
Mild:
No dosage adjustment needed.
Moderate:
No dosage adjustment needed.
Severe:
No dosage adjustment needed.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a central nervous system (CNS) stimulant that is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine due to prodrug nature; dextroamphetamine bioavailability is high.
Tmax:
Lisdexamfetamine: ~1 hour; Dextroamphetamine: ~3.5-4.5 hours (after oral lisdexamfetamine)
FoodEffect:
Food does not affect the extent of absorption (AUC) or the maximum plasma concentration (Cmax) of dextroamphetamine, but it may prolong Tmax by approximately 1 hour.
Distribution:
Vd:
Dextroamphetamine: 0.8-1.2 L/kg
ProteinBinding:
Dextroamphetamine: Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance:
Dextroamphetamine: Approximately 0.33-0.62 L/hr/kg
ExcretionRoute:
Renal (primarily as dextroamphetamine and its metabolites)
Unchanged:
Lisdexamfetamine: Negligible; Dextroamphetamine: Approximately 50% (dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Approximately 3-4 hours (for dextroamphetamine plasma levels)
DurationOfAction:
Up to 14 hours
Safety & Warnings
BLACK BOX WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
Important Heart-Related Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Serotonin Syndrome: A Potentially Life-Threatening Condition
Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. If you experience any of the following symptoms, contact your doctor right away:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have minor ones, it's essential to be aware of the following potential side effects:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness
If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
Important Heart-Related Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Serotonin Syndrome: A Potentially Life-Threatening Condition
Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. If you experience any of the following symptoms, contact your doctor right away:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have minor ones, it's essential to be aware of the following potential side effects:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness
If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, fainting
- New or worsening aggression, hostility, or agitation
- Hallucinations, delusions, or paranoia
- Unexplained numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Severe headache, blurred vision
- Unexplained weight loss or lack of growth (in children)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is not intended for weight loss, so if you have any questions or concerns, discuss them with your doctor.
To ensure your safety, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. If you have been taking this drug for an extended period or at high doses, you may develop tolerance, which means it may not work as well, and you may need higher doses to achieve the same effect. If you notice this medication is no longer effective, contact your doctor. Do not exceed the prescribed dose.
Long-term or regular use of this medication can lead to dependence, and suddenly stopping it may cause withdrawal symptoms. Before reducing the dose or stopping this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor.
Before starting this medication, you may need to undergo certain heart tests. If you have any questions, discuss them with your doctor. This drug can cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.
Additionally, this medication may affect the results of certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Before using over-the-counter products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult your doctor.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems that may be permanent or even fatal. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
This medication can also cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
In some cases, this medication can affect growth in children and teenagers, and they may require regular growth checks. Discuss this with your doctor. This medication is not approved for use in children under 6 years of age, as it may increase the risk of long-term weight loss in this age group.
If you are pregnant or plan to become pregnant, inform your doctor, and discuss the benefits and risks of using this medication during pregnancy.
To ensure your safety, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. If you have been taking this drug for an extended period or at high doses, you may develop tolerance, which means it may not work as well, and you may need higher doses to achieve the same effect. If you notice this medication is no longer effective, contact your doctor. Do not exceed the prescribed dose.
Long-term or regular use of this medication can lead to dependence, and suddenly stopping it may cause withdrawal symptoms. Before reducing the dose or stopping this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor.
Before starting this medication, you may need to undergo certain heart tests. If you have any questions, discuss them with your doctor. This drug can cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.
Additionally, this medication may affect the results of certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Before using over-the-counter products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult your doctor.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems that may be permanent or even fatal. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
This medication can also cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
In some cases, this medication can affect growth in children and teenagers, and they may require regular growth checks. Discuss this with your doctor. This medication is not approved for use in children under 6 years of age, as it may increase the risk of long-term weight loss in this age group.
If you are pregnant or plan to become pregnant, inform your doctor, and discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness, tremor, hyperreflexia, rapid breathing
- Confusion, assaultiveness, hallucinations, panic states
- High fever, rhabdomyolysis
- Cardiac arrhythmias, hypertension or hypotension, circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Convulsions, coma, death
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI use (risk of hypertensive crisis)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensives - may reduce the hypotensive effect of these drugs
- Urinary acidifiers (e.g., ammonium chloride, sodium acid phosphate) - increase renal excretion of amphetamine, decreasing efficacy
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion of amphetamine, increasing efficacy and prolonging duration
Moderate Interactions
- Proton pump inhibitors (PPIs) and H2 blockers - may alter gastric pH, potentially affecting absorption (though less significant for lisdexamfetamine due to prodrug nature)
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects
- Antidepressants (e.g., TCAs) - may increase cardiovascular effects of amphetamines
- Adrenergic blockers (e.g., guanethidine) - amphetamines may inhibit the hypotensive effect
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR)
Rationale: To identify pre-existing cardiovascular conditions and establish baseline for potential stimulant-induced changes.
Timing: Prior to initiation
Height and Weight (especially pediatric)
Rationale: To monitor for growth suppression, a known side effect in children.
Timing: Prior to initiation
Psychiatric history and symptoms
Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure and Heart Rate
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age/individual
Action Threshold: Sustained elevation (e.g., >10-20 mmHg increase in BP, >10-20 bpm increase in HR) warrants investigation/dose adjustment/discontinuation.
Height and Weight (pediatric)
Frequency: Every 3-6 months
Target: Consistent growth trajectory
Action Threshold: Significant deviation from growth curve or weight loss warrants intervention (e.g., drug holiday, dose reduction, alternative therapy).
Psychiatric symptoms (e.g., agitation, anxiety, psychosis, mania)
Frequency: At each visit
Target: Absence or control of symptoms
Action Threshold: Emergence or worsening of symptoms warrants immediate evaluation and potential discontinuation.
Effectiveness of therapy (ADHD/BED symptoms)
Frequency: At each visit
Target: Improvement in target symptoms
Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or change in therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression/hostility
- New or worsening psychotic or manic symptoms (e.g., hallucinations, delusions, paranoia)
- Severe anxiety or agitation
- Unexplained weight loss
- Growth deceleration (in children)
- Peripheral vasculopathy (e.g., Raynaud's phenomenon - numbness, coolness, pain, or color change in digits)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm. Risks include premature delivery and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia, respiratory distress).
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations (e.g., cardiac defects, oral clefts) based on some studies, though data are conflicting.
Second Trimester:
Potential for growth restriction and preterm birth.
Third Trimester:
Risk of preterm birth, low birth weight, and neonatal withdrawal symptoms.
Lactation
Dextroamphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, weight loss, cardiovascular effects), breastfeeding is not recommended during treatment with lisdexamfetamine.
Infant Risk:
Moderate to High (L3-L4)
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Long-term safety and efficacy in children under 6 years have not been established.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Lisdexamfetamine is a prodrug, meaning it is inactive until converted in the body to dextroamphetamine. This conversion process is thought to contribute to its smoother pharmacokinetic profile and potentially lower abuse liability compared to immediate-release amphetamines.
- The chewable tablet can be chewed thoroughly or dissolved in water, orange juice, or yogurt, offering flexibility for patients who have difficulty swallowing capsules.
- Patients should be advised to take the medication in the morning to avoid insomnia.
- Careful cardiovascular and psychiatric screening is essential before initiating treatment and during therapy due to potential serious adverse effects.
- Growth monitoring is crucial for pediatric patients on long-term therapy.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Mixed amphetamine salts (e.g., Adderall, Mydayis)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)
- Cognitive Behavioral Therapy (CBT) for ADHD and BED
Cost & Coverage
Average Cost:
Varies widely, typically $300-$400+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand name), Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.