Lisdexamfetamine 10mg 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 Stimulant
Pharmacologic Class
Prodrug of Dextroamphetamine
Pregnancy Category
Not available
FDA Approved
Jan 2015
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 is a 'prodrug,' meaning it's inactive until your body converts it into an active form (dextroamphetamine). This conversion happens slowly, providing a smooth and long-lasting effect throughout the day to help improve focus, attention, and control over impulsive behaviors.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. To minimize sleep disturbances, avoid taking it 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, protected from light and moisture. Keep it in a dry place, away from the bathroom. Store it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. 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. Instead, check with your pharmacist for guidance on proper disposal or participate in a drug take-back program in your area.
Missing 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 one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. To minimize sleep disturbances, avoid taking it 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, protected from light and moisture. Keep it in a dry place, away from the bathroom. Store it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. 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. Instead, check with your pharmacist for guidance on proper disposal or participate in a drug take-back program in your area.
Missing 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 one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Taking it in the afternoon or evening may cause sleep problems.
- Can be taken with or without food.
- Chew the tablet thoroughly before swallowing. Do not swallow whole.
- Avoid alcohol, as it can increase the risk of side effects.
- Maintain a healthy diet and regular exercise routine.
- Report any new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania) or cardiovascular symptoms (e.g., chest pain, shortness of breath, fainting) to your doctor immediately.
- Do not share this medication with others, as it has a high potential for abuse.
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. Max: 70 mg/day.
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial: 30 mg orally once daily. Max: 70 mg/day.
Binge Eating Disorder (BED):
Initial: 30 mg orally once daily. Max: 70 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial: 30 mg orally once daily. Max: 70 mg/day.
Adolescent:
ADHD (13-17 years): Initial: 30 mg orally once daily. Max: 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl 50-80 mL/min).
Moderate:
No dose adjustment needed (CrCl 30-50 mL/min).
Severe:
Max 50 mg/day (CrCl <30 mL/min).
Dialysis:
Max 30 mg/day. Administer after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug of dextroamphetamine. After oral administration, lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and hydrolyzed to dextroamphetamine and L-lysine, primarily by enzymes in the blood. Dextroamphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effect by releasing norepinephrine and dopamine from nerve terminals in the brain, thereby increasing the levels of these neurotransmitters in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high (approx. 75-100%).
Tmax:
Lisdexamfetamine: approx. 1 hour; Dextroamphetamine: approx. 3.5 hours (after oral administration of 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: 2.4-4.5 L/kg.
ProteinBinding:
Dextroamphetamine: 15-20% (to albumin).
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-12 hours (adults), 9-11 hours (children).
Clearance:
Not available
ExcretionRoute:
Renal (primarily as dextroamphetamine and its metabolites).
Unchanged:
Approximately 50% of dextroamphetamine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for therapeutic effect of dextroamphetamine).
PeakEffect:
Approximately 3.5 hours (for dextroamphetamine plasma concentration).
DurationOfAction:
Up to 14 hours.
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including lisdexamfetamine, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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 medical attention immediately:
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
Uncontrollable 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 feeling 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, such as:
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. Contact your doctor immediately if you experience any of the following symptoms:
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 only have mild side effects, 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 medical attention immediately:
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
Uncontrollable 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 feeling 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, such as:
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. Contact your doctor immediately if you experience any of the following symptoms:
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 only have mild side effects, 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, or fainting (syncope)
- New or worsening aggression or hostility
- Seeing or hearing things that are not real (psychosis)
- Feeling overly excited, irritable, or having racing thoughts (mania)
- Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or growth problems in children
- Muscle rigidity, high fever, sweating, confusion, or agitation (signs of serotonin syndrome, especially if taking other serotonergic drugs)
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
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (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 the safety of taking 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
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (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 the safety of taking 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
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Approved Use
This medication is not approved for weight loss. If you have any questions or concerns about your treatment, be sure to discuss them with your doctor.
Safety Precautions
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Long-Term Use and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as well as it initially did. In this case, you may need to take higher doses to achieve the same effect. However, do not take more than the prescribed dose. Long-term or regular use of this medication can also lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this can cause withdrawal symptoms. Instead, talk to your doctor, who will provide guidance on how to safely taper off the medication.
Monitoring and Follow-Up
Before starting this medication, you may need to undergo certain heart tests. Your doctor will determine if these tests are necessary and will discuss the results with you. Additionally, this medication can cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication can affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab personnel that you are taking this medication. Furthermore, some over-the-counter (OTC) products, 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, can raise blood pressure. Before taking any of these products, talk to your doctor to ensure they are safe for you to use.
Rare but Serious Side Effects
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. If you experience any 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, seek medical attention immediately.
Mental Health and Behavioral Changes
This medication can cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. If you experience any symptoms such as hallucinations, changes in behavior, or mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life, contact your doctor right away.
Use in Children and Adolescents
This medication can affect growth in children and adolescents. If you are a parent or caregiver, be sure to discuss this with your child's doctor, who may recommend regular growth checks. Additionally, this medication is not approved for use in children under the age of 6, as it can increase the risk of long-term weight loss in this age group.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor, who will discuss the benefits and risks of using this medication during pregnancy.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Approved Use
This medication is not approved for weight loss. If you have any questions or concerns about your treatment, be sure to discuss them with your doctor.
Safety Precautions
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Long-Term Use and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as well as it initially did. In this case, you may need to take higher doses to achieve the same effect. However, do not take more than the prescribed dose. Long-term or regular use of this medication can also lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this can cause withdrawal symptoms. Instead, talk to your doctor, who will provide guidance on how to safely taper off the medication.
Monitoring and Follow-Up
Before starting this medication, you may need to undergo certain heart tests. Your doctor will determine if these tests are necessary and will discuss the results with you. Additionally, this medication can cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication can affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab personnel that you are taking this medication. Furthermore, some over-the-counter (OTC) products, 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, can raise blood pressure. Before taking any of these products, talk to your doctor to ensure they are safe for you to use.
Rare but Serious Side Effects
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. If you experience any 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, seek medical attention immediately.
Mental Health and Behavioral Changes
This medication can cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. If you experience any symptoms such as hallucinations, changes in behavior, or mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life, contact your doctor right away.
Use in Children and Adolescents
This medication can affect growth in children and adolescents. If you are a parent or caregiver, be sure to discuss this with your child's doctor, who may recommend regular growth checks. Additionally, this medication is not approved for use in children under the age of 6, as it can increase the risk of long-term weight loss in this age group.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor, who will 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
- Hyperpyrexia (very high fever)
- Rhabdomyolysis
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea
- Abdominal cramps
- Convulsions
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic treatment, gastric lavage, and sedation for CNS overstimulation.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis).
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensives (may reduce hypotensive effect).
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life.
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine blood levels and shorten half-life.
Moderate Interactions
- Adrenergic blockers (e.g., guanethidine) - may inhibit adrenergic neuron blocking effects.
- Antacids (e.g., magnesium hydroxide, aluminum hydroxide) - may increase absorption.
- Proton pump inhibitors (PPIs) - may increase absorption.
- Phenothiazines (e.g., chlorpromazine) - may inhibit stimulant effects.
- Haloperidol - may inhibit stimulant effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Cardiovascular assessment (heart rate, blood pressure, ECG if indicated)
Rationale: To identify pre-existing cardiac conditions that may contraindicate stimulant use or require close monitoring.
Timing: Prior to initiation of therapy.
Psychiatric history (personal and family history of bipolar disorder, psychosis, tics/Tourette's syndrome)
Rationale: To assess risk of psychiatric adverse events or exacerbation of underlying conditions.
Timing: Prior to initiation of therapy.
Height and weight
Rationale: To establish baseline for growth monitoring, especially in pediatric patients.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure and heart rate
Frequency: At each dose adjustment and at least every 3-6 months thereafter.
Target: Within normal limits for age/patient.
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm heart rate) warrant evaluation and potential dose adjustment or discontinuation.
Weight and height (pediatric patients)
Frequency: Every 3-6 months.
Target: Consistent growth trajectory.
Action Threshold: Significant growth deceleration or weight loss may require dose adjustment or drug holiday.
Mental status (mood, anxiety, agitation, psychotic symptoms, tics)
Frequency: Regularly, at each visit.
Target: Stable, improved symptoms of ADHD/BED without emergence of new psychiatric symptoms.
Action Threshold: Emergence of new or worsening psychiatric symptoms (e.g., hallucinations, mania, severe anxiety, tics) requires immediate evaluation and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression/hostility
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- Severe anxiety or agitation
- Unexplained weight loss
- Growth deceleration (in children)
- New onset or worsening tics
- Serotonin syndrome symptoms (e.g., agitation, hallucinations, rapid heart rate, fever, muscle rigidity, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence) if exposed late in pregnancy.
Lactation
Dextroamphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), advise mothers not to breastfeed during treatment with lisdexamfetamine.
Infant Risk:
Moderate risk (L3). Potential for irritability, poor feeding, insomnia, and weight loss in the infant. Long-term neurodevelopmental effects are unknown.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can be associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.
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. Avoid use in patients with pre-existing cardiovascular disease.
Clinical Information
Clinical Pearls
- Lisdexamfetamine is a prodrug, meaning its effects are smoother and longer-lasting compared to immediate-release amphetamines, reducing the potential for 'crashes' and abuse liability.
- The chewable tablet formulation offers an alternative for patients who have difficulty swallowing capsules.
- Ensure patients understand the importance of taking the medication in the morning to avoid sleep disturbances.
- Always assess for a history of substance abuse, cardiovascular disease, and psychiatric disorders before initiating therapy.
- Educate patients and caregivers about the signs of serotonin syndrome, especially if other serotonergic drugs are co-administered.
- Regularly monitor blood pressure, heart rate, and growth parameters (in children) throughout treatment.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Amphetamine/dextroamphetamine (e.g., Adderall)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin) - off-label for ADHD
- Cognitive Behavioral Therapy (CBT) for ADHD and BED
- Other psychotherapies for BED (e.g., Interpersonal Therapy, Dialectical Behavior Therapy)
Cost & Coverage
Average Cost:
Varies, typically $300-$400+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 or Tier 2 (for 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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.