Lisdexamfetamine 60mg Chewable Tabs
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat binge eating disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Prodrug of dextroamphetamine; sympathomimetic amine
Pregnancy Category
Not available
FDA Approved
Feb 2007
DEA Schedule
Schedule II
Overview
What is this medicine?
Lisdexamfetamine is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and moderate to severe Binge Eating Disorder (BED). It is a 'prodrug,' meaning it's inactive until your body converts it into an active form (dextroamphetamine). This active form works by affecting certain natural chemicals in your brain, helping to improve focus, attention, and control over impulsive behaviors.
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 to you and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day. Be sure to chew the medication well 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 your medication in a secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to keep your medication safe. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day. Be sure to chew the medication well 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 your medication in a secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to keep your medication safe. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Taking it in the afternoon or evening may cause sleep problems.
- Can be taken with or without food.
- Chewable tablets should be chewed thoroughly before swallowing.
- Do not crush, chew (if capsule), or divide the dose of the capsule formulation.
- Store at room temperature, away from moisture and heat.
- Keep out of reach of children and pets.
- Avoid alcohol, as it may increase 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:
30 mg once daily in the morning, titrated up to 70 mg once daily
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial: 30 mg once daily. Titrate in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg once daily.
Binge Eating Disorder (BED):
Initial: 30 mg once daily. Titrate in 20 mg increments at approximately weekly intervals to a target dose of 50 mg to 70 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. Titrate in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg once daily.
Adolescent:
ADHD (13-17 years): Initial: 30 mg once daily. Titrate in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min)
Moderate:
Maximum dose 50 mg/day (CrCl 30 to <50 mL/min)
Severe:
Maximum dose 30 mg/day (CrCl <30 mL/min)
Dialysis:
Not recommended in patients with end-stage renal disease (ESRD) or on dialysis.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug of dextroamphetamine. After oral administration, lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and converted to dextroamphetamine and L-lysine, primarily by enzymatic hydrolysis in the blood. Dextroamphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effect by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking their reuptake into the presynaptic neuron. This leads to increased concentrations of these neurotransmitters in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high (approx. 75-90%)
Tmax:
Lisdexamfetamine: 1 hour; Dextroamphetamine (active metabolite): 3.5-4.5 hours
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: 2.5-4.5 L/kg
ProteinBinding:
Dextroamphetamine: Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: Less than 1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance:
Not available for lisdexamfetamine; Dextroamphetamine: Highly variable, primarily renal excretion.
ExcretionRoute:
Renal (primarily as dextroamphetamine and its metabolites)
Unchanged:
Lisdexamfetamine: Negligible; Dextroamphetamine: Approximately 50% (dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for dextroamphetamine effect)
PeakEffect:
Approximately 3.5-4.5 hours (for dextroamphetamine effect)
DurationOfAction:
Up to 14 hours
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including lisdexamfetamine, 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 while on 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
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation 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 medical help immediately 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, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following possible 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
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation 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 medical help immediately 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, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following possible 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 (seek immediate medical attention)
- New or worsening aggression, hostility, or agitation
- New or worsening anxiety, depression, or mood changes
- Seeing or hearing things that are not real (psychosis)
- Uncontrolled movements or tics
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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)
Existing health problems, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Use of other specific medications, such as:
+ Linezolid
+ Methylene blue
Breastfeeding status: do 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)
Existing health problems, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Use of other specific medications, such as:
+ Linezolid
+ Methylene blue
Breastfeeding status: do 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 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 understand 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 effectively, 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 sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have any questions, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication. 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, and certain natural products or aids, consult your doctor.
Severe Skin Reactions
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems that may not be reversible and can be life-threatening. 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 symptoms of mood changes, such as depression, thoughts of suicide, nervousness, emotional instability, 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. This medication is not approved for use in children under 6 years of age, as it may increase the risk of long-term weight loss in this age group.
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 using this medication during pregnancy.
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 understand 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 effectively, 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 sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have any questions, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication. 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, and certain natural products or aids, consult your doctor.
Severe Skin Reactions
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems that may not be reversible and can be life-threatening. 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 symptoms of mood changes, such as depression, thoughts of suicide, nervousness, emotional instability, 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. This medication is not approved for use in children under 6 years of age, as it may increase the risk of long-term weight loss in this age group.
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 using this medication during pregnancy.
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:
Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensive agents (may decrease hypotensive effect)
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels
- Acidifying agents (e.g., ascorbic acid, guanethidine) - decrease amphetamine levels
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
- Proton Pump Inhibitors (PPIs) / H2 Blockers - minimal effect on absorption, but monitor for altered response
- Alcohol - may alter absorption/release characteristics of some extended-release formulations (though less relevant for lisdexamfetamine's prodrug mechanism)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause increases in BP and HR.
Timing: Prior to initiation
Height and Weight (Pediatric)
Rationale: Stimulants can be associated with growth suppression.
Timing: Prior to initiation
Psychiatric history (e.g., bipolar disorder, psychosis, tics)
Rationale: Risk of exacerbation of pre-existing psychiatric conditions or emergence of new symptoms.
Timing: Prior to initiation
Cardiac 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
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: Significant or sustained elevation requiring intervention or dose adjustment.
Height and Weight (Pediatric)
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric symptoms (e.g., new or worsening aggression, hostility, anxiety, depression, mania, psychosis, tics)
Frequency: Regularly (e.g., at each visit)
Target: Absence of new or worsening symptoms
Action Threshold: Emergence or worsening of symptoms requiring dose adjustment or discontinuation.
Abuse/Diversion potential
Frequency: Regularly (e.g., at each visit)
Target: No signs of abuse or diversion
Action Threshold: Signs of abuse or diversion requiring intervention.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hostility
- Anxiety
- Depression
- Mania
- Psychotic symptoms (e.g., hallucinations, delusions)
- Motor or verbal tics
- Numbness, coolness, or pain in digits
- Unexplained wounds on fingers or toes
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. 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 (e.g., cardiac defects) based on some studies of amphetamine exposure, though data are conflicting.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia, somnolence, respiratory distress) if used near term.
Lactation
Dextroamphetamine is excreted into human milk. Because of the potential for serious adverse reactions in nursing infants (e.g., agitation, insomnia, anorexia, reduced weight gain), advise patients that breastfeeding is not recommended during treatment with lisdexamfetamine.
Infant Risk:
Risk level: L3 (Moderate Concern). Potential for irritability, poor feeding, insomnia, and reduced weight gain 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. Safety and efficacy for BED have not been established in pediatric patients. Not recommended for children under 6 years of age.
Geriatric Use
Clinical studies of lisdexamfetamine 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, which means it has a lower potential for abuse via injection or snorting compared to immediate-release amphetamines, as it requires enzymatic hydrolysis for activation.
- The prodrug mechanism provides a smoother, longer-lasting effect with less 'peak and crash' compared to some immediate-release stimulants.
- Chewable tablets must be chewed thoroughly before swallowing. They are not designed to be swallowed whole.
- Patients should be advised to take the medication in the morning to avoid insomnia.
- Careful cardiovascular assessment is crucial before initiating therapy, especially in patients with pre-existing heart conditions.
- Monitor for signs of stimulant-induced psychosis or mania, particularly in patients with a history of psychiatric disorders.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is essential.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Mixed amphetamine salts (e.g., Adderall, Mydayis)
- Dexmethylphenidate (e.g., Focalin)
- 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
Cost & Coverage
Average Cost:
$300 - $400 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization)
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.