Vyvanse 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
Prodrug of Dextroamphetamine
Pregnancy Category
Not available
FDA Approved
Feb 2007
DEA Schedule
Schedule II
Overview
What is this medicine?
Vyvanse is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and moderate to severe Binge Eating Disorder (BED). It's a 'prodrug' which means your body converts it into an active form (dextroamphetamine) after you take it. This active form helps increase certain natural chemicals in your brain that are involved in attention and impulse control.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. To minimize sleep disturbances, avoid taking this medication late in the day.
When taking the capsule, swallow it whole without chewing, breaking, or crushing. However, if needed, you can open the capsule and mix the powder with water, orange juice, or yogurt. If the powder clumps together, you can use a spoon to gently break it apart. Mix well and swallow the mixture immediately. Do not store the mixed medication for later use.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. To ensure safety, store your medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area.
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. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs.
Missing 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. To minimize sleep disturbances, avoid taking this medication late in the day.
When taking the capsule, swallow it whole without chewing, breaking, or crushing. However, if needed, you can open the capsule and mix the powder with water, orange juice, or yogurt. If the powder clumps together, you can use a spoon to gently break it apart. Mix well and swallow the mixture immediately. Do not store the mixed medication for later use.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. To ensure safety, store your medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area.
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. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs.
Missing 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 the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Taking it in the afternoon or evening can cause sleep problems.
- Can be taken with or without food.
- Capsules can be swallowed whole, or opened and the entire contents mixed with yogurt, water, or orange juice. Consume immediately.
- Avoid alcohol, as it may affect how the medication works.
- Maintain a healthy diet and regular exercise, as appetite suppression and weight loss can occur.
- Report any new or worsening psychiatric symptoms (e.g., anxiety, agitation, hallucinations) or cardiovascular symptoms (e.g., chest pain, shortness of breath) to your doctor immediately.
- Do not share this medication with others, as it has a high potential for abuse.
Available Forms & Alternatives
Available Strengths:
- Vyvanse 70mg Capsules
- Vyvanse 50mg Capsules
- Vyvanse 30mg Capsules
- Vyvanse 60mg Capsules
- Vyvanse 40mg Capsules
- Vyvanse 20mg Capsules
- Vyvanse 10mg Capsules
- Vyvanse 10mg Chewable Tablets
- Vyvanse 20mg Chewable Tablets
- Vyvanse 30mg Chewable Tablets
- Vyvanse 40mg Chewable Tablets
- Vyvanse 50mg Chewable Tablets
- Vyvanse 60mg Chewable Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
30-70 mg once daily in the morning
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg once daily; titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
BED:
Initial 30 mg once daily; titrate in 20 mg increments weekly to a target dose of 50-70 mg/day. Max 70 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 30 mg once daily; titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Adolescent:
ADHD (13-17 years): Initial 30 mg once daily; titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min)
Moderate:
Max 50 mg/day (CrCl 30-50 mL/min)
Severe:
Max 30 mg/day (CrCl <30 mL/min)
Dialysis:
Consider alternative treatment or max 30 mg/day; supplemental dose not needed after dialysis.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that causes the release of norepinephrine and dopamine from presynaptic nerve terminals and blocks their reuptake into the presynaptic neuron. This increases the concentration of these neurotransmitters in the synaptic cleft, leading to central nervous system stimulation.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high.
Tmax:
Lisdexamfetamine: 3.5 hours; Dextroamphetamine: 4.5 hours (after oral administration of lisdexamfetamine)
FoodEffect:
Food does not affect the extent of absorption (AUC) or Cmax of dextroamphetamine, but it may prolong Tmax by approximately 1 hour.
Distribution:
Vd:
Not available (for lisdexamfetamine); Dextroamphetamine: 2.5-4.5 L/kg
ProteinBinding:
Not available (for lisdexamfetamine); Dextroamphetamine: Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as dextroamphetamine and its metabolites)
Unchanged:
Approximately 96% of lisdexamfetamine is converted to dextroamphetamine; approximately 50% of dextroamphetamine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for therapeutic effect of dextroamphetamine)
PeakEffect:
Approximately 3-4 hours (for dextroamphetamine concentration)
DurationOfAction:
Up to 14 hours
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES 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 Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
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 trouble passing urine
Important Heart-Related Warnings
If you have a pre-existing heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek 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
Throwing up
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness
If any of these side effects or other concerns 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 visit 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 help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
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 trouble passing urine
Important Heart-Related Warnings
If you have a pre-existing heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek 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
Throwing up
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness
If any of these side effects or other concerns 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 visit https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain
- Shortness of breath
- Fainting spells
- Palpitations (feeling your heart race or pound)
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening aggression or hostility
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening tics (uncontrolled movements or sounds)
- Severe headache
- Blurred vision
- Unexplained fever with muscle stiffness or confusion (Serotonin Syndrome symptoms)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
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 other activities that require alertness and 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 need 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 cause 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.
Before starting this medication, you may need to undergo certain heart tests. If you have any 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 OTC 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 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 signs 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 other activities that require alertness and 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 need 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 cause 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.
Before starting this medication, you may need to undergo certain heart tests. If you have any 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 OTC 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 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 signs 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
- Hyperpyrexia (very high fever)
- Rhabdomyolysis
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea
- Vomiting
- Diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensives (may reduce efficacy of antihypertensives)
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine levels and prolong half-life
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine levels and shorten half-life
- Proton Pump Inhibitors (PPIs) / H2 Blockers (may affect absorption of the capsule formulation if opened and mixed with acidic food/drink, but generally not clinically significant for overall absorption)
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
- Lithium - may antagonize stimulant effects
- Opioids (e.g., meperidine) - increased risk of serotonin syndrome
- Alcohol - may alter release of dextroamphetamine from the prodrug
Minor Interactions
- Not specifically listed as minor, but general caution with other CNS stimulants or depressants.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause dose-related increases in BP and HR.
Timing: Prior to initiation
Height and Weight
Rationale: Stimulants can cause growth suppression in pediatric patients and weight loss in all patients.
Timing: Prior to initiation
Psychiatric History (including family history of sudden death or ventricular arrhythmia)
Rationale: To identify pre-existing cardiac conditions or psychiatric disorders that may be exacerbated.
Timing: Prior to initiation
ECG (if clinically indicated based on history/exam)
Rationale: To screen for underlying cardiac abnormalities.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age/baseline
Action Threshold: Sustained elevation (e.g., >10-15 mmHg increase in BP, >15-20 bpm increase in HR) warrants evaluation and potential dose adjustment/discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric), annually (adults)
Target: Normal growth trajectory (pediatric), stable weight (adults)
Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential dose adjustment/drug holiday.
Psychiatric Symptoms (e.g., agitation, aggression, new-onset psychosis, mania)
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Emergence or worsening of severe psychiatric symptoms warrants immediate evaluation and discontinuation.
Abuse/Diversion Risk
Frequency: At each visit
Target: No signs of abuse or diversion
Action Threshold: Signs of abuse or diversion warrant intervention and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Dizziness
- Numbness/tingling in extremities (Raynaud's phenomenon)
- New or worsening aggression
- Hostility
- Psychotic symptoms (hallucinations, delusions)
- Manic symptoms (elevated mood, decreased need for sleep, racing thoughts)
- Anxiety
- Agitation
- Depression
- Tics or exacerbation of pre-existing tics
- Blurred vision
- Dry mouth
- Insomnia
- Anorexia/weight loss
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 adverse pregnancy outcomes, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting.
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 near term.
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 - Moderately safe, but potential for adverse effects; use with caution or consider alternatives)
Pediatric Use
Approved for ADHD in children 6 years and older. Growth suppression (weight and height) has been observed with long-term stimulant use; monitor growth parameters regularly. Safety and efficacy for BED not established in pediatric patients.
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 conversion to active dextroamphetamine occurs primarily in the blood, not the GI tract or liver. This reduces the potential for dose dumping if the capsule is crushed or dissolved, making it less prone to abuse via injection or snorting compared to immediate-release amphetamines.
- The onset of action is slower and duration longer than immediate-release amphetamines due to the prodrug conversion.
- Patients should be advised to take the medication in the morning to avoid insomnia.
- Monitor for signs of cardiovascular issues (BP, HR) and psychiatric symptoms (agitation, psychosis, mania) due to stimulant effects.
- Regular growth monitoring is crucial for pediatric patients on long-term therapy.
- The dose of 50mg is a common therapeutic dose, but titration is essential to find the optimal balance between efficacy and tolerability for each patient.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin, Focalin)
- Mixed amphetamine salts (e.g., Adderall, Mydayis)
- 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 Psychotherapy, Dialectical Behavior Therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $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 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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.