Lisdexamfetamine 50mg 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 Stimulant
Pharmacologic Class
Amphetamine Prodrug
Pregnancy Category
Not available
FDA Approved
Feb 2007
DEA Schedule
Schedule II
Overview
What is this medicine?
Lisdexamfetamine is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children 6 years and older, and moderate to severe Binge Eating Disorder (BED) in adults. It is a prodrug, meaning it's inactive until your body converts it into an active form (dextroamphetamine). This active form works by affecting certain chemicals in your brain to help improve focus, attention, and control over impulsive behaviors.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day.
You can take your medication with or without food.
To avoid sleep problems, try to take your medication earlier in the day, rather than late in the evening.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can open it 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 well and swallow the mixture right away. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store your medication at room temperature, away from light and moisture.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in the bathroom.
Keep your medication out of the reach of children and pets, and store it in a secure location where others cannot access it. A locked box or cabinet can help keep your medication safe.
Dispose of unused or expired medication 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 how to dispose of your medication, and ask about any medication take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and take your next dose at the regular time.
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 these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day.
You can take your medication with or without food.
To avoid sleep problems, try to take your medication earlier in the day, rather than late in the evening.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can open it 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 well and swallow the mixture right away. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store your medication at room temperature, away from light and moisture.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in the bathroom.
Keep your medication out of the reach of children and pets, and store it in a secure location where others cannot access it. A locked box or cabinet can help keep your medication safe.
Dispose of unused or expired medication 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 how to dispose of your medication, and ask about any medication take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and take your next dose at the regular time.
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, with or without food.
- Do not take in the afternoon or evening as it may cause sleep problems.
- Do not crush, chew, or open the capsule and sprinkle contents on food or in liquid unless specifically instructed by your doctor (e.g., for oral suspension).
- Store at room temperature away from moisture and heat.
- Avoid alcohol consumption, as it may worsen side effects.
- Maintain a healthy diet and regular exercise, as appetite suppression and weight loss can occur.
- 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:
ADHD: Initial 30 mg once daily in the morning; titrate by 10-20 mg/day weekly to a maximum of 70 mg/day. BED: Initial 30 mg once daily in the morning; titrate by 20 mg/day weekly to a target dose of 50-70 mg/day.
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, target 50-70 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 30 mg once daily in the morning; titrate by 10-20 mg/day weekly to a maximum of 70 mg/day.
Adolescent:
ADHD (13-17 years): Initial 30 mg once daily in the morning; titrate by 10-20 mg/day weekly to a maximum of 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min).
Moderate:
Consider dose reduction to a maximum of 50 mg/day (CrCl 30-50 mL/min).
Severe:
Maximum dose 30 mg/day (CrCl <30 mL/min).
Dialysis:
Avoid use in end-stage renal disease (ESRD) as dialysis is not expected to remove significant amounts of dextroamphetamine.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed, but caution is advised due to potential for increased exposure to dextroamphetamine.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a central nervous system (CNS) stimulant that 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 (approx. 75-100%).
Tmax:
Lisdexamfetamine: approximately 3.5 hours; Dextroamphetamine: approximately 4.5 hours (after oral administration of lisdexamfetamine).
FoodEffect:
Food does not affect the extent of absorption (AUC) or peak plasma concentration (Cmax) of dextroamphetamine, but it may prolong Tmax by approximately 1 hour.
Distribution:
Vd:
Dextroamphetamine: 2.4-4.5 L/kg.
ProteinBinding:
Dextroamphetamine: approximately 15-20% to plasma proteins.
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: less than 1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children).
Clearance:
Not available for lisdexamfetamine; Dextroamphetamine: approximately 0.33-0.68 L/hr/kg.
ExcretionRoute:
Renal (primarily as dextroamphetamine and its metabolites).
Unchanged:
Approximately 50% of dextroamphetamine is excreted unchanged in urine, depending on urinary pH.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours for clinical effects.
PeakEffect:
Approximately 3-4 hours for clinical effects.
DurationOfAction:
Up to 14 hours.
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including lisdexamfetamine, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out or 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations 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. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. 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
Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Call your doctor right away if you experience:
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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Anxiety
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
* Dizziness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out or 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations 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. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. 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
Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Call your doctor right away if you experience:
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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Anxiety
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
* Dizziness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. 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 mental problems (e.g., hallucinations, paranoia, mania, aggression).
- Numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon).
- Unexplained muscle pain, tenderness, or weakness (rhabdomyolysis).
- Uncontrolled movements or tics.
- Blurred vision or other vision changes.
- Severe headache or dizziness.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine 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
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine 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
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, so if you have any questions or concerns, discuss them with your doctor.
To ensure your safety, avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Additionally, be aware that long-term or high-dose use of this drug can lead to tolerance, where the medication may not work as effectively, and you may require higher doses to achieve the same effect. If you experience a decrease in the drug's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Prolonged or regular use of this medication may result in dependence, and suddenly stopping it can lead to withdrawal symptoms. Before reducing the dose or discontinuing the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Prior to initiating this medication, you may need to undergo certain heart tests. If you have questions or concerns, discuss them with your doctor. This drug can cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.
Certain over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, can interact with this medication and increase blood pressure. Inform your doctor before using any of these products, and tell all your healthcare providers and laboratory personnel that you are taking this medication.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, permanent damage, or even death. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
This medication can also cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood disorders, 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, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
In some cases, this medication can affect growth in children and adolescents, and they may require regular growth checks. This medication is not approved for use in children under 6 years of age, as it can increase the risk of long-term weight loss in this age group.
If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.
To ensure your safety, avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Additionally, be aware that long-term or high-dose use of this drug can lead to tolerance, where the medication may not work as effectively, and you may require higher doses to achieve the same effect. If you experience a decrease in the drug's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Prolonged or regular use of this medication may result in dependence, and suddenly stopping it can lead to withdrawal symptoms. Before reducing the dose or discontinuing the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Prior to initiating this medication, you may need to undergo certain heart tests. If you have questions or concerns, discuss them with your doctor. This drug can cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.
Certain over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, can interact with this medication and increase blood pressure. Inform your doctor before using any of these products, and tell all your healthcare providers and laboratory personnel that you are taking this medication.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, permanent damage, or even death. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
This medication can also cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood disorders, 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, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
In some cases, this medication can affect growth in children and adolescents, and they may require regular growth checks. This medication is not approved for use in children under 6 years of age, as it can increase the risk of long-term weight loss in this age group.
If you are pregnant or plan to become pregnant, 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:
Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Overdose treatment is generally symptomatic and supportive.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensive agents - may decrease the hypotensive effect of these drugs.
- Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase dextroamphetamine blood levels and prolong half-life.
- Urinary acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine blood levels and shorten half-life.
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
- Adrenergic blockers (e.g., guanethidine) - amphetamines may antagonize the hypotensive effect.
- Phenothiazines - may inhibit the stimulant effect of amphetamines.
- Haloperidol - may inhibit the stimulant effect of amphetamines.
- Lithium carbonate - may inhibit the stimulant effect of amphetamines.
Minor Interactions
- Proton Pump Inhibitors (PPIs) / H2 blockers - generally no significant interaction, but theoretical impact on urinary pH could affect excretion.
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.
Cardiac history (e.g., structural cardiac abnormalities, cardiomyopathy, arrhythmias)
Rationale: Risk of sudden death in patients with pre-existing cardiac conditions.
Timing: Prior to initiation of therapy.
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.
Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months in pediatric patients.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.
Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania, tics)
Frequency: Regularly (e.g., at each visit).
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of symptoms; consider dose reduction or discontinuation.
Abuse potential/Diversion
Frequency: Regularly (e.g., at each visit).
Target: No signs of abuse or diversion.
Action Threshold: Signs of abuse or diversion; consider discontinuation and referral for substance use disorder treatment.
Clinical efficacy (ADHD/BED symptoms)
Frequency: Regularly (e.g., at each visit).
Target: Improvement in target symptoms.
Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- New or worsening tics
- Unexplained weight loss
- Anxiety
- Insomnia
- Dry mouth
- Anorexia
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit outweighs the potential risk to the fetus. Amphetamines can 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:
Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence) if used late in pregnancy.
Lactation
Dextroamphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), breastfeeding is not recommended during treatment with lisdexamfetamine.
Infant Risk:
High (L3 - Moderate risk)
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Psychiatric and cardiovascular monitoring is also crucial.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Lisdexamfetamine is a prodrug, meaning its effects are smoother and less prone to 'peaks and troughs' compared to immediate-release amphetamines, potentially reducing abuse liability and improving tolerability.
- The conversion of lisdexamfetamine to dextroamphetamine is not affected by gastrointestinal pH, unlike other amphetamines, which can be influenced by stomach acidity.
- It is crucial to take this medication in the morning to avoid insomnia, as its effects can last up to 14 hours.
- Patients should be advised against sharing or selling this medication due to its high abuse potential and Schedule II classification.
- For patients who have difficulty swallowing capsules, the capsule can be opened and the entire contents mixed with soft food (e.g., yogurt) or liquid (e.g., water, orange juice) and consumed immediately.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Amphetamine/dextroamphetamine (e.g., Adderall)
- 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 (e.g., Interpersonal Therapy, Dialectical Behavior Therapy)
Cost & Coverage
Average Cost:
Varies widely (e.g., $300-$400+) per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (brand), Tier 1 or 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. When you receive this medication, you will also get a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it occurred, to help healthcare professionals provide the best possible care.