Vyvanse 40mg Capsules
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat binge eating disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Prodrug of Dextroamphetamine; Sympathomimetic Amine
Pregnancy Category
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) in adults and children 6 years and older, and moderate to severe Binge Eating Disorder (BED) in adults. It is a 'prodrug' that gets converted in your body to dextroamphetamine, a stimulant that helps improve focus and reduce impulsivity.
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 sticks 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 it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep it out of 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 consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it 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 sticks 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 it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep it out of 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 consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it 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 Vyvanse once daily in the morning, with or without food. Taking it in the afternoon or evening can cause sleep problems.
- Do not take more than your prescribed dose.
- Swallow capsules whole, or open the capsule and mix the entire contents with water, yogurt, or orange juice. Consume immediately.
- Store at room temperature, away from moisture and heat.
- Keep out of reach of children and pets.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption while on this medication.
- Maintain a healthy diet and regular exercise routine.
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 mg once daily in the morning
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg once daily in the morning; titrate in increments of 10 mg or 20 mg at approximately weekly intervals to a maximum of 70 mg/day.
BED:
Initial 30 mg once daily in the morning; titrate in increments of 20 mg at approximately weekly intervals to a maximum of 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 in increments of 10 mg or 20 mg at approximately weekly intervals to a maximum of 70 mg/day.
Adolescent:
ADHD (13-17 years): Initial 30 mg once daily in the morning; titrate in increments of 10 mg or 20 mg at approximately weekly intervals to a maximum of 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl 50 to <80 mL/min).
Moderate:
Maximum dose 50 mg/day (CrCl 30 to <50 mL/min).
Severe:
Maximum dose 30 mg/day (CrCl <30 mL/min).
Dialysis:
Maximum dose 30 mg/day; administer after dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to L-lysine and dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine; dextroamphetamine bioavailability is high.
Tmax:
Lisdexamfetamine: ~1 hour; Dextroamphetamine: ~3.5 hours (after oral administration of lisdexamfetamine).
FoodEffect:
Food does not affect the extent of absorption but may delay Tmax by approximately 1 hour.
Distribution:
Vd:
Dextroamphetamine: ~3.5-4.5 L/kg
ProteinBinding:
Dextroamphetamine: Low (~15-20%)
CnssPenetration:
Yes
Elimination:
HalfLife:
Lisdexamfetamine: <1 hour; Dextroamphetamine: ~10-13 hours (adults), ~9-11 hours (children)
Clearance:
Not readily quantifiable for lisdexamfetamine due to rapid conversion; Dextroamphetamine clearance is primarily renal.
ExcretionRoute:
Renal (dextroamphetamine)
Unchanged:
Approximately 30-40% of dextroamphetamine is excreted unchanged in urine, depending on urine pH.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for therapeutic effect of dextroamphetamine)
PeakEffect:
Approximately 3-4 hours
DurationOfAction:
Up to 14 hours
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including Vyvanse, other amphetamine products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Difficulty 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
+ Fainting or changes in vision
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 urinating
If you have a history of heart problems or heart defects, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
A 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
Balance problems
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
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:
Anxiety
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Feeling jittery
Weight loss
Difficulty 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 immediately or seek emergency medical attention:
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
+ Difficulty 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
+ Fainting or changes in vision
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 urinating
If you have a history of heart problems or heart defects, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
A 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
Balance problems
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
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:
Anxiety
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Feeling jittery
Weight loss
Difficulty 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 psychiatric symptoms (e.g., hearing voices, believing things that are not true, becoming manic or agitated, aggression, hostility)
- Numbness, coolness, or pain in fingers or toes, or unexplained wounds on fingers/toes (Raynaud's phenomenon)
- Unexplained fever, muscle stiffness, or severe confusion (signs of serotonin syndrome)
- Blurred vision or other vision changes
- Severe headache
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, other drugs, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
A family history of certain health problems, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Current or recent medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as 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. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, other drugs, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
A family history of certain health problems, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Current or recent medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as 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. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is not intended for weight loss, and if you have any questions or concerns, you should discuss them with your doctor.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision.
Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the drug may not work as effectively, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. Your doctor will also monitor your blood pressure and heart rate, so it is essential to follow their instructions for checking these vital signs.
Interactions with Other Medications
This medication may interact with 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, which can increase blood pressure. Inform your doctor before using any OTC products, and tell all your healthcare providers and lab workers that you are taking this medication.
Severe Skin Reactions
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, including 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.
Behavior and Mood Changes
This medication can cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you.
Use in Children
This medication is not approved for use in children under 6 years of age, as it may increase the risk of long-term weight loss in this age group.
Pregnancy
If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the benefits and risks of using this medication during pregnancy.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is not intended for weight loss, and if you have any questions or concerns, you should discuss them with your doctor.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision.
Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the drug may not work as effectively, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. Your doctor will also monitor your blood pressure and heart rate, so it is essential to follow their instructions for checking these vital signs.
Interactions with Other Medications
This medication may interact with 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, which can increase blood pressure. Inform your doctor before using any OTC products, and tell all your healthcare providers and lab workers that you are taking this medication.
Severe Skin Reactions
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, including 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.
Behavior and Mood Changes
This medication can cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you.
Use in Children
This medication is not approved for use in children under 6 years of age, as it may increase the risk of long-term weight loss in this age group.
Pregnancy
If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid respiration
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Convulsions
- Coma
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea
- Vomiting
- Diarrhea
- Abdominal cramps
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI administration)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine blood levels and prolong half-life
- Acidifying agents (e.g., ascorbic acid, ammonium chloride, fruit juices) - decrease amphetamine blood levels and shorten half-life
- Antihypertensives (may reduce antihypertensive effect)
Moderate Interactions
- Atomoxetine, Guanfacine, Clonidine (additive CNS effects)
- Antipsychotics (may antagonize stimulant effects)
- Phenytoin, Phenobarbital (may alter metabolism)
- Tricyclic Antidepressants (TCAs) (may increase cardiovascular effects of amphetamines)
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 treatment.
Height and Weight
Rationale: Monitor for growth suppression, especially in pediatric patients.
Timing: Prior to initiation of treatment.
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 treatment.
Cardiovascular Assessment (e.g., ECG if indicated)
Rationale: Assess for pre-existing cardiac conditions that could be exacerbated by stimulant use.
Timing: Prior to initiation of treatment, especially if family history of sudden cardiac death or known cardiac abnormalities.
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 and clinical status.
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant further evaluation and potential dose adjustment or discontinuation.
Weight and Height (pediatric patients)
Frequency: Every 3-6 months.
Target: Consistent growth along growth curves.
Action Threshold: Significant growth deceleration or weight loss may require dose reduction, drug holiday, or alternative treatment.
Psychiatric Symptoms (e.g., agitation, anxiety, aggression, tics, psychosis, mood changes)
Frequency: At each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence of new psychotic or manic symptoms, severe agitation, or aggression warrants immediate evaluation and potential discontinuation.
Cardiovascular Symptoms (e.g., chest pain, syncope, dyspnea)
Frequency: At each visit.
Target: Absence of symptoms.
Action Threshold: Report of new or worsening cardiovascular symptoms requires immediate evaluation.
Symptom Monitoring
- Agitation
- Anxiety
- Psychosis (hallucinations, paranoia)
- Aggression
- Tics (new or worsening)
- Cardiovascular symptoms (palpitations, chest pain, shortness of breath, syncope)
- Growth suppression (in children)
- Peripheral vasculopathy (e.g., Raynaud's phenomenon, unexplained wounds on fingers/toes)
- Serotonin syndrome symptoms (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause adverse pregnancy outcomes, including preterm birth and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations not definitively established.
Second Trimester:
Potential for growth restriction and adverse neurodevelopmental outcomes.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia, somnolence, respiratory distress).
Lactation
Amphetamines are excreted into breast milk. There is a potential for serious adverse reactions in a breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss). A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Moderate risk (L3). Monitor infants for signs of adverse effects.
Pediatric Use
Safety and efficacy for ADHD established in children 6-17 years. Safety and efficacy for BED established in adults (18 years and older). Monitor growth (height and weight) in pediatric patients. Psychiatric and cardiovascular risks are similar to adults.
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 it is inactive until converted in the body to dextroamphetamine. This conversion occurs primarily in the blood, not the liver, and is thought to contribute to its lower abuse potential compared to immediate-release amphetamines.
- The onset of action is slower and duration longer than immediate-release amphetamines, providing a smoother effect profile.
- Capsules can be opened and mixed with water, yogurt, or orange juice for patients who have difficulty swallowing pills, without affecting absorption.
- Patients should be advised to take the medication in the morning to avoid insomnia.
- Regular monitoring of blood pressure, heart rate, and weight (especially in children) is crucial.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin XL - off-label for ADHD)
- Cognitive Behavioral Therapy (CBT) for ADHD and BED
Cost & Coverage
Average Cost:
Varies widely, typically $300-$400+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand name), Tier 1 or Tier 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, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.