Lisdexamfetamine 30mg Chewable Tabs
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat binge eating disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System Stimulant
Pharmacologic Class
Prodrug of Dextroamphetamine; Sympathomimetic Amine
Pregnancy Category
Not available
FDA Approved
Feb 2007
DEA Schedule
Schedule II
Overview
What is this medicine?
Lisdexamfetamine is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children 6 years and older, and moderate to severe Binge Eating Disorder (BED) in adults. It is a stimulant that works by increasing certain natural substances in the brain that help with focus and impulse control. The chewable tablet should be chewed thoroughly before swallowing, or it can be dissolved in water.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day. Be sure to chew the medication thoroughly before swallowing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. When you're finished with your medication or it's expired, dispose of it properly. 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'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 a 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. Be sure to chew the medication thoroughly before swallowing.
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, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. When you're finished with your medication or it's expired, dispose of it properly. 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'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 a missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning to avoid sleep problems.
- Do not take more than the prescribed dose or take it more often.
- Do not stop taking this medication suddenly without talking to your doctor, as withdrawal symptoms may occur.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption while taking this medication.
- Monitor for changes in mood, behavior, or new physical symptoms and report them to your doctor.
- Maintain a healthy diet and regular exercise, especially for children, to support overall health and growth.
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 mg or 20 mg increments at weekly intervals.
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg once daily, maximum 70 mg/day.
Binge Eating Disorder (BED):
Initial 30 mg once daily, maximum 70 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 30 mg once daily, maximum 70 mg/day. Titrate in 10 mg or 20 mg increments at weekly intervals.
Adolescent:
ADHD (13-17 years): Initial 30 mg once daily, maximum 70 mg/day. Titrate in 10 mg or 20 mg increments at weekly intervals.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
Consider reducing maximum dose to 50 mg/day (CrCl 30 to <50 mL/min).
Severe:
Consider reducing maximum dose to 30 mg/day (CrCl <30 mL/min).
Dialysis:
Not recommended for patients with end-stage renal disease (ESRD) requiring dialysis.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to dextroamphetamine, which is a central nervous system (CNS) stimulant. Dextroamphetamine is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high.
Tmax:
Lisdexamfetamine: approximately 1 hour; Dextroamphetamine: approximately 3.5 hours (after oral administration of lisdexamfetamine).
FoodEffect:
Food does not affect the extent of absorption of dextroamphetamine, but may prolong Tmax by approximately 1 hour.
Distribution:
Vd:
Not available for lisdexamfetamine; Dextroamphetamine: 2.4-4.5 L/kg.
ProteinBinding:
Not available for lisdexamfetamine; Dextroamphetamine: approximately 15-20% (to albumin).
CnssPenetration:
Yes (dextroamphetamine)
Elimination:
HalfLife:
Lisdexamfetamine: less than 1 hour; Dextroamphetamine: approximately 10-13 hours (adults), 9-11 hours (children).
Clearance:
Not available for lisdexamfetamine; Dextroamphetamine: pH-dependent renal clearance.
ExcretionRoute:
Renal (primarily as dextroamphetamine and its metabolites).
Unchanged:
Approximately 50% of dextroamphetamine is excreted unchanged in urine at normal urinary pH.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for therapeutic effects of dextroamphetamine).
PeakEffect:
Approximately 3.5 hours (for dextroamphetamine plasma concentrations).
DurationOfAction:
Up to 14 hours.
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including lisdexamfetamine, have a high potential for abuse and dependence. Administration of CNS stimulants for prolonged periods of time may lead to drug dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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 feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
Important Heart-Related Warnings
If you have a heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or 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, upset stomach, or vomiting
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 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 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 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 feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
Important Heart-Related Warnings
If you have a heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or 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, upset stomach, or vomiting
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 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 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 agitation
- New or worsening tics (uncontrolled movements or sounds)
- Seeing or hearing things that are not real (psychosis)
- Feeling unusually suspicious or paranoid
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or slowed growth in children
- Severe headache or blurred vision
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Approved Use
This medication is not approved for weight loss. If you have any questions or concerns, discuss them with your doctor.
Safety Precautions
Avoid operating a vehicle or engaging in activities that require alertness and clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Additionally, long-term or regular use of this medication may result in dependence. Stopping the medication abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication may affect the results of certain laboratory tests. Inform all of your healthcare providers and laboratory 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 be permanent or even fatal. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
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. Discuss this with your doctor.
Use in Children
This medication is not approved for use in children under the age of 6. The risk of long-term weight loss is increased in children under 6 years old.
Pregnancy
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 crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Approved Use
This medication is not approved for weight loss. If you have any questions or concerns, discuss them with your doctor.
Safety Precautions
Avoid operating a vehicle or engaging in activities that require alertness and clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Additionally, long-term or regular use of this medication may result in dependence. Stopping the medication abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication may affect the results of certain laboratory tests. Inform all of your healthcare providers and laboratory 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 be permanent or even fatal. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
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. Discuss this with your doctor.
Use in Children
This medication is not approved for use in children under the age of 6. The risk of long-term weight loss is increased in children under 6 years old.
Pregnancy
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
- Convulsions
- Coma
What to Do:
Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management includes symptomatic treatment, gastric lavage, activated charcoal, and sedation for CNS overstimulation.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use) - risk of hypertensive crisis.
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensive drugs - may decrease the hypotensive effect of these drugs.
- Urinary acidifying agents (e.g., ammonium chloride, ascorbic acid) - increase urinary excretion of amphetamine, decreasing efficacy.
- Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - decrease urinary excretion of amphetamine, increasing efficacy and prolonging duration of action.
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may alter gastric pH, potentially affecting absorption (though less significant for lisdexamfetamine due to hydrolysis in blood).
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
- Antipsychotics - may antagonize the stimulant effects of amphetamines.
- Adrenergic blockers (e.g., beta-blockers) - may potentiate the pressor effect of amphetamines.
- Alcohol - may alter absorption or increase adverse effects.
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.
Cardiac History (e.g., family history of sudden death, structural heart abnormalities)
Rationale: Assess for pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiation of therapy.
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Assess for pre-existing psychiatric conditions that may be exacerbated by stimulants.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Persistent elevation above normal range; consider dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.
Psychiatric Status (e.g., emergence of new psychotic symptoms, mania, aggression, tics)
Frequency: At each visit.
Target: Stable mental health.
Action Threshold: New or worsening psychiatric symptoms; consider dose reduction or discontinuation.
Abuse/Diversion Potential
Frequency: At each visit.
Target: No signs of abuse or diversion.
Action Threshold: Signs of abuse or diversion; implement appropriate management strategies.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms
- Aggression or hostility
- New or worsening tics
- Unexplained weight loss
- Growth deceleration (in children)
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and inconsistent.
Second Trimester:
Risk of premature birth and low birth weight.
Third Trimester:
Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
Lactation
Lisdexamfetamine and its active metabolite, dextroamphetamine, are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), breastfeeding is not recommended during treatment.
Infant Risk:
High (L4 - Possibly hazardous)
Pediatric Use
Safety and efficacy established for ADHD in children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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, meaning it is inactive until converted in the body to dextroamphetamine. This conversion occurs primarily in the blood and is not affected by gastrointestinal pH, which may lead to more consistent absorption compared to immediate-release amphetamines.
- The chewable tablet can be chewed thoroughly and swallowed, or dissolved in water, orange juice, or yogurt and consumed immediately. Do not store the mixture.
- Due to its long duration of action (up to 14 hours), it is typically dosed once daily in the morning to avoid interference with sleep.
- Careful cardiovascular and psychiatric screening is essential before initiating therapy and throughout treatment.
- Patients should be educated on the potential for abuse and dependence, and the importance of taking the medication exactly as prescribed.
- Growth monitoring is crucial for pediatric patients on long-term therapy.
Alternative Therapies
- Other CNS Stimulants (e.g., Methylphenidate, Dextroamphetamine, Mixed Amphetamine Salts)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy and psychotherapy (especially for ADHD and BED)
Cost & Coverage
Average Cost:
$300 - $450 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand, or generic equivalent)
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, a patient fact sheet that provides crucial information. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.