Lisdexamfetamine 70mg Capsules
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
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 is a prodrug, meaning it is converted in your body to an active stimulant (dextroamphetamine) which helps improve focus, attention, and impulse control.
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 sleep disturbances, avoid taking your medication late in the day.
When taking your medication, swallow the capsule whole - do not chew, break, or crush it. However, if you need to, you can open the capsule and mix the powder with water, orange juice, or yogurt. If the powder clumps together, you can use a spoon to gently break it apart. Mix the powder well and swallow the mixture immediately. Do not store the mixed medication for later use.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from 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, keep your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to store your medication.
When disposing of your medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, throw away unused or expired medication. Check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available 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 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 sleep disturbances, avoid taking your medication late in the day.
When taking your medication, swallow the capsule whole - do not chew, break, or crush it. However, if you need to, you can open the capsule and mix the powder with water, orange juice, or yogurt. If the powder clumps together, you can use a spoon to gently break it apart. Mix the powder well and swallow the mixture immediately. Do not store the mixed medication for later use.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from 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, keep your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to store your medication.
When disposing of your medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, throw away unused or expired medication. Check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available 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 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. Do not take in the afternoon or evening to avoid sleep problems.
- Swallow capsules whole, or open and mix the entire contents with soft food (e.g., yogurt) or water/orange juice, and consume immediately. Do not crush, chew, or divide the capsule.
- Store securely to prevent misuse or diversion.
- Avoid alcohol, as it may increase the risk of side effects.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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 once daily in the morning. Titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg once daily in the morning. Titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Binge Eating Disorder (BED):
Initial 30 mg once daily in the morning. Titrate in 20 mg increments weekly to a maximum of 50-70 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For ADHD (6-12 years): Initial 30 mg once daily in the morning. Titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Adolescent:
For ADHD (13-17 years): Initial 30 mg once daily in the morning. Titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl 50-80 mL/min).
Moderate:
Maximum dose 50 mg/day (CrCl 30-50 mL/min).
Severe:
Maximum dose 30 mg/day (CrCl < 30 mL/min).
Dialysis:
Maximum dose 30 mg/day. Administer after dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effect by blocking the reuptake of norepinephrine and dopamine into the presynaptic neuron and increasing the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine; dextroamphetamine bioavailability is high.
Tmax:
Lisdexamfetamine: ~1 hour; Dextroamphetamine: ~3.5 hours (after oral lisdexamfetamine).
FoodEffect:
Food does not affect absorption but may prolong Tmax by approximately 1 hour.
Distribution:
Vd:
Dextroamphetamine: ~3.5-4.5 L/kg.
ProteinBinding:
Dextroamphetamine: ~15-20%.
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children).
Clearance:
Dextroamphetamine: ~0.7 L/hr/kg.
ExcretionRoute:
Renal (dextroamphetamine and its metabolites).
Unchanged:
Lisdexamfetamine is minimally excreted unchanged. Dextroamphetamine is excreted unchanged (30-40% in adults, 50% in children).
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 dimesylate, other amphetamine-containing products, and methylphenidate, 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 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
+ Making loud noises
Changes in skin color, including:
+ Pale
+ Blue
+ Gray
+ Purple
+ Red
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Warnings
If you have a pre-existing heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or 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. Call your doctor right away if you experience any of the following symptoms:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Throwing up
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness
If any of these side effects or other symptoms bother you or do not go away, 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
+ Making loud noises
Changes in skin color, including:
+ Pale
+ Blue
+ Gray
+ Purple
+ Red
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Warnings
If you have a pre-existing heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or 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. Call your doctor right away if you experience any of the following symptoms:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Throwing up
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness
If any of these side effects or other symptoms bother you or do not go away, 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 (signs of heart problems)
- Unexplained weakness or numbness (signs of stroke)
- Vision changes
- New or worsening aggressive behavior, hostility, or agitation
- Hallucinations (seeing or hearing things that are not real)
- Paranoia or new psychotic symptoms
- Mania (unusual excitement, overactivity, or uninhibited behavior)
- Seizures
- Unexplained fever, muscle rigidity, or severe 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 conditions to ensure safe treatment:
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 family 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
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ 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 treatments 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 conditions to ensure safe treatment:
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 family 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
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ 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 treatments 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 drug is not intended for weight loss, so if you have any questions or concerns, be sure to discuss them with your doctor.
Caution When Performing Daily Activities
Until you are aware of how this medication affects you, avoid driving and other tasks that require alertness and clear vision. This will help prevent any potential accidents or injuries.
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 drug may not work as effectively. In such cases, you may need higher doses to achieve the same effect. However, do not take more than the prescribed amount. If you find that the medication is no longer working well, contact your doctor. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring Your Health
Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss the details with you. It is also essential to monitor your blood pressure and heart rate as directed by your doctor, as this medication can cause high blood pressure.
Interactions with Other Medications and Lab Tests
This medication may affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab workers that you are taking this medication. Additionally, before using any over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, consult your doctor, as these may increase your blood pressure.
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. 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.
Mental Health and Mood 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 hallucinations, changes in behavior, or mood changes such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
Effects on Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Additionally, this medication is not approved for use in children under the age of 6, as it may 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. You will need to discuss the benefits and risks of taking 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 drug is not intended for weight loss, so if you have any questions or concerns, be sure to discuss them with your doctor.
Caution When Performing Daily Activities
Until you are aware of how this medication affects you, avoid driving and other tasks that require alertness and clear vision. This will help prevent any potential accidents or injuries.
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 drug may not work as effectively. In such cases, you may need higher doses to achieve the same effect. However, do not take more than the prescribed amount. If you find that the medication is no longer working well, contact your doctor. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring Your Health
Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss the details with you. It is also essential to monitor your blood pressure and heart rate as directed by your doctor, as this medication can cause high blood pressure.
Interactions with Other Medications and Lab Tests
This medication may affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab workers that you are taking this medication. Additionally, before using any over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, consult your doctor, as these may increase your blood pressure.
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. 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.
Mental Health and Mood 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 hallucinations, changes in behavior, or mood changes such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
Effects on Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Additionally, this medication is not approved for use in children under the age of 6, as it may 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. You will need to discuss the benefits and risks of taking this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia (overactive reflexes)
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Convulsions
- Coma
- Arrhythmias (irregular heartbeats)
- Hypertension or hypotension (high or low blood pressure)
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
What to Do:
Seek immediate medical attention. Call 911 or your local Poison Control Center (e.g., 1-800-222-1222 in the U.S.).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation.
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensives - may counteract the blood pressure lowering effects.
Moderate Interactions
- Urinary acidifiers (e.g., ascorbic acid, ammonium chloride) - increase renal excretion of amphetamine, decreasing efficacy.
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - decrease renal excretion of amphetamine, increasing efficacy/toxicity.
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR, ECG if clinically indicated)
Rationale: To assess for pre-existing cardiovascular conditions and risk of sudden death/serious cardiovascular events.
Timing: Prior to initiation of therapy.
Psychiatric history (e.g., bipolar disorder, psychosis, tics)
Rationale: To identify risk factors for exacerbation of psychiatric conditions or emergence of new symptoms.
Timing: Prior to initiation of therapy.
Height and weight (pediatric patients)
Rationale: To establish baseline for monitoring growth suppression.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure and heart rate
Frequency: At each visit or every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Persistent elevation; consider dose reduction or discontinuation.
Height and weight (pediatric patients)
Frequency: Every 3-6 months.
Target: Consistent growth curve.
Action Threshold: Growth deceleration; consider drug holiday or alternative treatment.
Psychiatric symptoms (e.g., agitation, aggression, psychosis, mania, tics)
Frequency: At each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of symptoms; consider discontinuation.
Efficacy (ADHD/BED symptoms)
Frequency: Regularly, as clinically indicated.
Target: Symptom improvement.
Action Threshold: Lack of efficacy; consider dose adjustment or alternative.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting
- Unexplained weakness or numbness
- Vision changes
- New or worsening aggressive behavior
- Hallucinations
- Paranoia
- Mania
- Seizures
- Unexplained fever
- Muscle rigidity
- Severe agitation
Special Patient Groups
Pregnancy
Based on animal data, lisdexamfetamine may cause fetal harm. Human data are limited but suggest potential for adverse pregnancy outcomes (e.g., preterm birth, low birth weight) and neonatal withdrawal symptoms. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; generally avoid stimulants if possible.
Second Trimester:
Limited human data.
Third Trimester:
Risk of preterm birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia, somnolence, respiratory distress) if used during the third trimester.
Lactation
Dextroamphetamine is present in human milk. Breastfeeding is not recommended during treatment due to potential for serious adverse reactions in the infant (e.g., agitation, insomnia, anorexia, reduced weight gain).
Infant Risk:
High
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Safety and efficacy for BED have not been established in pediatric patients.
Geriatric Use
Not studied in patients over 65 years of age. Generally, use with caution due to increased risk of cardiovascular events and other comorbidities. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Lisdexamfetamine is a prodrug, which means it is inactive until converted in the body. This mechanism contributes to a smoother onset and longer duration of action compared to immediate-release amphetamines, and may reduce the potential for intravenous or intranasal abuse.
- The conversion of lisdexamfetamine to dextroamphetamine is not dependent on gastrointestinal pH, which can be an advantage over some other stimulants.
- Always screen patients for pre-existing cardiac conditions and psychiatric disorders before initiating therapy.
- Educate patients and caregivers about the high potential for abuse and dependence, and the importance of secure storage.
- Monitor for signs of growth suppression in pediatric patients and consider drug holidays if growth deceleration is observed.
Alternative Therapies
- Other CNS Stimulants for ADHD: Methylphenidate (e.g., Ritalin, Concerta), mixed amphetamine salts (e.g., Adderall), dextroamphetamine (e.g., Dexedrine).
- Non-stimulants for ADHD: Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree).
- Other treatments for BED: Topiramate, psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Psychotherapy).
Cost & Coverage
Average Cost:
Highly variable, typically $300-$500+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may vary by plan and generic availability)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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, don't hesitate to discuss them with 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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, don't hesitate to discuss them with 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.