Vyvanse 40mg Chewable Tablets
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 is a prodrug, meaning it's inactive until your body converts it into an active form (dextroamphetamine). This conversion happens slowly, providing a smooth and long-lasting effect throughout the day. It works by affecting certain chemicals in the brain to help improve focus, attention, and control over impulsive behaviors.
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. Be sure to chew the medication thoroughly before swallowing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. 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 to store your medication. 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 with your pharmacist for guidance on proper disposal. You may also want to check if there are drug take-back programs available in your area.
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 a missed dose.
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. Be sure to chew the medication thoroughly before swallowing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. 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 to store your medication. 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 with your pharmacist for guidance on proper disposal. You may also want to check if there are drug take-back programs available in your area.
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 a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning.
- Can be taken with or without food.
- Chewable tablets should be chewed thoroughly before swallowing.
- Do not take in the afternoon or evening to avoid sleep problems.
- Avoid alcohol consumption.
- Maintain a healthy diet and regular exercise.
- Report any new or worsening psychiatric symptoms or cardiovascular symptoms to your doctor immediately.
- Store securely to prevent misuse or diversion.
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:
Initial 30 mg once daily in the morning, titrated weekly by 10 mg or 20 mg increments.
Dose Range:
30 - 70 mg
Condition-Specific Dosing:
ADHD:
Initial 30 mg once daily, maximum 70 mg/day.
Binge Eating Disorder (BED):
Initial 30 mg once daily, maximum 70 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 30 mg once daily, maximum 70 mg/day.
Adolescent:
13-17 years: Initial 30 mg once daily, maximum 70 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary (CrCl 50-80 mL/min).
Moderate:
Consider reducing maximum dose to 50 mg/day (CrCl 30-50 mL/min).
Severe:
Consider reducing maximum dose to 30 mg/day (CrCl <30 mL/min).
Dialysis:
Not recommended for patients with end-stage renal disease (ESRD) on dialysis.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Pharmacology
Mechanism of Action
Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that is believed to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high.
Tmax:
Lisdexamfetamine: approximately 1 hour; Dextroamphetamine: approximately 3.5 hours (after oral administration of lisdexamfetamine).
FoodEffect:
Food does not affect the extent of absorption of lisdexamfetamine or dextroamphetamine, but may prolong Tmax by approximately 1 hour.
Distribution:
Vd:
Dextroamphetamine: 2.6-4.8 L/kg (in adults).
ProteinBinding:
Dextroamphetamine: approximately 15-20% (to albumin).
CnssPenetration:
Yes (dextroamphetamine readily crosses the blood-brain barrier).
Elimination:
HalfLife:
Lisdexamfetamine: less than 1 hour; Dextroamphetamine: approximately 10-13 hours (adults), 9-11 hours (children).
Clearance:
Not specifically reported for lisdexamfetamine; Dextroamphetamine clearance is primarily renal.
ExcretionRoute:
Renal (dextroamphetamine and its metabolites).
Unchanged:
Approximately 50% of dextroamphetamine is excreted unchanged in urine, dependent on urinary pH.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for therapeutic effect of dextroamphetamine).
PeakEffect:
Approximately 3.5 hours (for dextroamphetamine plasma concentrations).
DurationOfAction:
Up to 14 hours.
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 Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
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 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
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
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. If any of these symptoms bother you or persist, contact your doctor or seek medical attention:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
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 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
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
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. If any of these symptoms bother you or persist, contact your doctor or seek medical attention:
Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
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 (signs of heart problems)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- New or worsening aggression, hostility, or irritability
- New or worsening tics (uncontrolled movements or sounds)
- Seeing or hearing things that are not real (psychosis)
- Believing things that are not true (delusions)
- Feeling unusually excited or manic
- 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 medical history, 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 increase the risk of 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 to ensure safe use. Do not initiate, stop, or modify the dosage 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 you experienced, including the symptoms that occurred.
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 medical history, 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 increase the risk of 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 to ensure safe use. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Approved Use
This medication is not approved for weight loss. If you have any questions or concerns, be sure to discuss them with your doctor.
Safety Precautions
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Tolerance and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need to take higher doses to achieve the same effect. However, do not take more than the prescribed dose. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this can cause withdrawal symptoms. Instead, talk to your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring and Testing
Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss the details with you. Additionally, this medication can cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication can affect the results of certain laboratory tests. Be sure to inform all of your healthcare providers and laboratory personnel that you are taking this medication. Furthermore, some 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 certain natural products or aids, can increase blood pressure. Before using any of these products, talk to your doctor.
Rare but Serious Side Effects
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems, including death. If you experience any of the following symptoms, seek medical attention immediately: red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
Behavioral 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. If you experience any of the following symptoms, contact your doctor right away: 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 Children and Teens
This medication can affect growth in children and teens. If you are a parent or guardian, be sure to discuss this with your child's doctor, who may recommend regular growth checks. Additionally, this medication is not approved for use in children under the age of 6, as it can increase the risk of long-term weight loss in this age group.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor, who will discuss the benefits and risks of using this medication during pregnancy.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Approved Use
This medication is not approved for weight loss. If you have any questions or concerns, be sure to discuss them with your doctor.
Safety Precautions
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Tolerance and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need to take higher doses to achieve the same effect. However, do not take more than the prescribed dose. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this can cause withdrawal symptoms. Instead, talk to your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring and Testing
Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss the details with you. Additionally, this medication can cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.
Interactions with Other Medications
This medication can affect the results of certain laboratory tests. Be sure to inform all of your healthcare providers and laboratory personnel that you are taking this medication. Furthermore, some 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 certain natural products or aids, can increase blood pressure. Before using any of these products, talk to your doctor.
Rare but Serious Side Effects
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems, including death. If you experience any of the following symptoms, seek medical attention immediately: red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
Behavioral 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. If you experience any of the following symptoms, contact your doctor right away: 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 Children and Teens
This medication can affect growth in children and teens. If you are a parent or guardian, be sure to discuss this with your child's doctor, who may recommend regular growth checks. Additionally, this medication is not approved for use in children under the age of 6, as it can increase the risk of long-term weight loss in this age group.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor, who will discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis
- Tachycardia
- 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. Management includes symptomatic treatment, gastric lavage, activated charcoal, and acidification of the urine to increase excretion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensives (may reduce hypotensive effect).
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life.
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine blood levels and shorten half-life.
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects.
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects.
- Proton Pump Inhibitors (PPIs) / H2 Blockers - no significant interaction with lisdexamfetamine conversion, but may affect absorption of other drugs.
- Alcohol - may alter absorption or increase adverse effects.
Minor Interactions
- Not specifically listed for minor interactions, but general caution with other CNS stimulants or depressants.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause increases in BP and HR.
Timing: Prior to initiation.
Height and Weight
Rationale: Stimulants can cause growth suppression in pediatric patients.
Timing: Prior to initiation (pediatric patients).
Psychiatric history (e.g., bipolar disorder, psychosis, tics)
Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new ones.
Timing: Prior to initiation.
Cardiac history (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmias)
Rationale: Risk of sudden death in patients with pre-existing cardiac conditions.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly (e.g., at each visit or every 3-6 months).
Target: Within normal limits for age.
Action Threshold: Persistent elevation requiring intervention or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric symptoms (e.g., agitation, aggression, new-onset psychosis, mania, tics)
Frequency: Regularly (e.g., at each visit).
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of symptoms requiring intervention.
Abuse potential
Frequency: Regularly (e.g., at each visit).
Target: No signs of misuse or diversion.
Action Threshold: Signs of abuse or diversion.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Tics
- Numbness, coolness, or pain in digits (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations (limited data, but generally avoided).
Second Trimester:
Risk of premature birth and low birth weight.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
Lactation
Dextroamphetamine is excreted into human milk. Breastfeeding is not recommended during treatment with lisdexamfetamine due to potential for serious adverse reactions in the infant (e.g., irritability, poor feeding, sleep disturbances, weight loss).
Infant Risk:
L3 (Moderate risk) - Potential for irritability, poor feeding, sleep disturbances, weight loss, and other stimulant effects in the infant.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Long-term safety and efficacy in children under 6 years have not been established. Risk of growth suppression.
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, which contributes to its smoother onset and longer duration of action compared to immediate-release amphetamines, and may reduce abuse potential by preventing rapid 'rush' from crushing/snorting.
- The chewable tablet can be chewed thoroughly or dissolved in water, orange juice, or yogurt and consumed immediately.
- Patients should be advised to avoid taking the dose in the afternoon or evening to prevent insomnia.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers about the signs of serious cardiovascular and psychiatric adverse events.
- Due to its Schedule II classification, strict prescribing and dispensing regulations apply.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Amphetamine/dextroamphetamine (e.g., Adderall, Mydayis)
- Dexmethylphenidate (e.g., Focalin)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin) - off-label for ADHD
Cost & Coverage
Average Cost:
Check current pricing (varies widely) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (depends on insurance plan and generic availability)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by 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 receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, seek immediate medical attention or call your local poison control center. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to help healthcare professionals provide the best possible care.
This medication is accompanied by 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 receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, seek immediate medical attention or call your local poison control center. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to help healthcare professionals provide the best possible care.