Lisdexamfetamine 10mg 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; Sympathomimetic Amine
Pregnancy Category
Category C
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 inactive until your body converts it into an active form (dextroamphetamine). This active form works by affecting certain natural chemicals in the brain to help improve focus, attention, and control impulsive behavior.
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.
When taking your medication, swallow the capsule whole without chewing, breaking, or crushing 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, protected from light and moisture. Keep it in a dry place, away from the bathroom. To ensure safety, store your medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area 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, check with your pharmacist for guidance on the best way to dispose of unused or expired medication. You may also want to explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 the missed one.
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.
When taking your medication, swallow the capsule whole without chewing, breaking, or crushing 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, protected from light and moisture. Keep it in a dry place, away from the bathroom. To ensure safety, store your medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area 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, check with your pharmacist for guidance on the best way to dispose of unused or expired medication. You may also want to explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 the 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.
- Do not crush, chew, or open the capsule and sprinkle the contents on food or in liquid if not specifically instructed by your doctor, as this may alter its release and effect.
- Avoid alcohol, as it can increase the risk of side effects.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
- Store in a safe place to prevent misuse or 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 once daily in the morning. May be titrated in increments of 10 mg or 20 mg at approximately weekly intervals.
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg once daily, maximum 70 mg once daily.
BED:
Initial 30 mg once daily, maximum 70 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 30 mg once daily, maximum 70 mg once daily. Titrate in increments of 10 mg or 20 mg at approximately weekly intervals.
Adolescent:
ADHD (13-17 years): Initial 30 mg once daily, maximum 70 mg once daily. Titrate in increments of 10 mg or 20 mg at approximately weekly intervals.
Dose Adjustments
Renal Impairment:
Mild:
No dosage 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:
Not recommended for patients with end-stage renal disease (ESRD) as dialysis is not expected to remove lisdexamfetamine or dextroamphetamine to a clinically significant extent.
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 non-catecholamine sympathomimetic amine that causes the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also inhibits the reuptake of these monoamines into the presynaptic neuron.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine; high for dextroamphetamine.
Tmax:
Lisdexamfetamine: approximately 1 hour; Dextroamphetamine: approximately 3.5 hours.
FoodEffect:
Food does not significantly affect absorption or Tmax of dextroamphetamine.
Distribution:
Vd:
Dextroamphetamine: 2.5-4.5 L/kg
ProteinBinding:
Dextroamphetamine: Low (15-20%)
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance:
Not available (highly variable for dextroamphetamine due to pH-dependent renal excretion)
ExcretionRoute:
Renal (primarily)
Unchanged:
Lisdexamfetamine: <0.1%; Dextroamphetamine: 30-40% (pH-dependent)
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
Approximately 3.5 hours (for dextroamphetamine)
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
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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
If you have a history of heart problems or heart defects, inform your doctor, as sudden deaths have occurred in people with these conditions. 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, 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. 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
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 medical attention right away:
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
If you have a history of heart problems or heart defects, inform your doctor, as sudden deaths have occurred in people with these conditions. 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, 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. 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
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 (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
- Manic symptoms (e.g., feeling overly excited, restless, or having racing thoughts)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Blurred vision
- Severe headache
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 health issues, 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 first.
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 health issues, 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 first.
Precautions & Cautions
Important Warnings and 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, and if you have any questions or concerns, you should discuss them with your doctor.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision.
Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the drug may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication can cause dependence, and suddenly stopping it may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Heart-Related Precautions
You may need to undergo heart tests before starting this medication. Your doctor will monitor your blood pressure and heart rate, and you should report any changes or concerns. This medication may cause high blood pressure, so it is crucial to follow your doctor's instructions for monitoring your blood pressure and heart rate.
Interactions with Other Medications and Lab Tests
Inform all your healthcare providers and lab workers that you are taking this medication, as it may affect certain lab tests. Before using over-the-counter (OTC) 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, or certain natural products or aids, consult your doctor.
Severe Skin Reaction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. 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.
Behavior and Mood Changes
This medication may 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. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, and you should discuss this with your doctor.
Use in Children and Pregnancy
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. If you are pregnant or plan to become pregnant, you should discuss the benefits and risks of using this medication with your doctor.
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, and if you have any questions or concerns, you should discuss them with your doctor.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision.
Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the drug may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication can cause dependence, and suddenly stopping it may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Heart-Related Precautions
You may need to undergo heart tests before starting this medication. Your doctor will monitor your blood pressure and heart rate, and you should report any changes or concerns. This medication may cause high blood pressure, so it is crucial to follow your doctor's instructions for monitoring your blood pressure and heart rate.
Interactions with Other Medications and Lab Tests
Inform all your healthcare providers and lab workers that you are taking this medication, as it may affect certain lab tests. Before using over-the-counter (OTC) 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, or certain natural products or aids, consult your doctor.
Severe Skin Reaction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. 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.
Behavior and Mood Changes
This medication may 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. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, and you should discuss this with your doctor.
Use in Children and Pregnancy
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. If you are pregnant or plan to become pregnant, you should discuss the benefits and risks of using this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- 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.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI use (risk of hypertensive crisis, serotonin syndrome)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, some antacids) - increase plasma levels and prolong half-life of dextroamphetamine
- Acidifying agents (e.g., ascorbic acid, ammonium chloride, fruit juices) - decrease plasma levels and shorten half-life of dextroamphetamine
- Antihypertensives - may reduce the hypotensive effect of these drugs
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines
- Alcohol - may increase risk of adverse cardiovascular events
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: CNS stimulants can cause increases in BP and HR.
Timing: Prior to initiation of therapy.
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation of therapy.
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new psychotic/manic symptoms.
Timing: Prior to initiation of therapy.
Cardiovascular History (e.g., structural cardiac abnormalities, cardiomyopathy, arrhythmias)
Rationale: Risk of sudden death in patients with pre-existing serious structural cardiac abnormalities or other serious heart problems.
Timing: Prior to initiation of therapy; consider ECG if indicated.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly (e.g., at each visit or every 3-6 months)
Target: Within normal limits for age/individual
Action Threshold: Persistent elevation requiring intervention or discontinuation.
Height and Weight
Frequency: Regularly (e.g., every 3-6 months for children, annually for adults)
Target: Normal growth trajectory for children; stable weight for adults
Action Threshold: Significant growth deceleration or weight loss.
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 requiring dose adjustment or discontinuation.
ADHD/BED Symptom Control
Frequency: At each visit
Target: Improved symptom control with minimal side effects
Action Threshold: Lack of efficacy or intolerable side effects.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- Tics or dyskinesias
- Numbness, coolness, or pain in digits (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Severe headache
- Blurred vision
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 adverse pregnancy outcomes, 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 limited and inconsistent.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress) if used near term.
Lactation
Dextroamphetamine is excreted into human milk. Breastfeeding is not recommended during treatment with lisdexamfetamine due to the potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss). If breastfeeding is chosen, monitor the infant closely.
Infant Risk:
L3 - Moderately safe; however, significant amounts of amphetamine are excreted into breast milk. Monitor infant for irritability, sleep disturbances, poor feeding, and weight loss.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, 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 that requires enzymatic hydrolysis in the blood to become active dextroamphetamine, which contributes to its smoother, longer-lasting effect and potentially lower abuse liability compared to immediate-release amphetamines.
- The 10mg capsule strength is typically used for dose titration or for patients who require a very low maintenance dose, rather than as a standard starting dose.
- Patients should be advised to take the medication in the morning to avoid sleep disturbances.
- The medication can be taken with or without food. The capsule can be swallowed whole, or opened and the entire contents mixed with water, yogurt, or orange juice and consumed immediately.
- Careful cardiovascular and psychiatric screening is essential before initiating therapy and throughout treatment.
Alternative Therapies
- Other CNS Stimulants (e.g., Methylphenidate, Mixed Amphetamine Salts, Dextroamphetamine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine extended-release, Clonidine extended-release)
- Behavioral therapy (for ADHD)
- Cognitive Behavioral Therapy (CBT) (for BED)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 or 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 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.