Lisdexamfetamine 40mg Capsules

Manufacturer MYLAN Active Ingredient Lisdexamfetamine Capsules(lis dex am FET a meen) Pronunciation liss-dex-am-FET-uh-meen
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.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Prodrug of dextroamphetamine; Norepinephrine and Dopamine Reuptake Inhibitor and Releaser
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Pregnancy Category
Not available
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FDA Approved
Feb 2007
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Lisdexamfetamine is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). It works by increasing certain natural substances in the brain that help with focus, attention, and impulse control. It's a 'prodrug,' meaning your body converts it into the active form (dextroamphetamine) after you take it.
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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 it 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. Ensure it is stored in a secure location where children and pets cannot access it, and consider using a locked box or area. Keep all medications out of reach of pets.

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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning, with or without food.
  • Do not take in the afternoon or evening as it may cause sleep problems.
  • Do not crush, chew, or open the capsule and sprinkle contents on food or in liquid (unless specifically instructed for administration).
  • Store safely to prevent misuse or diversion.
  • Avoid alcohol while taking this medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any new or worsening mental health symptoms or heart-related symptoms immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 30 mg once daily in the morning. Titrate in 10-20 mg increments at approximately weekly intervals. Max: 70 mg once daily.
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

ADHD: Initial: 30 mg once daily. Max: 70 mg once daily.
Binge Eating Disorder (BED): Initial: 30 mg once daily. Target: 50-70 mg once daily. Max: 70 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial: 30 mg once daily. Max: 70 mg once daily.
Adolescent: ADHD (13-17 years): Initial: 30 mg once daily. Max: 70 mg once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: Reduce dose to 50 mg/day. For patients on 30 mg/day, consider 30 mg every other day.
Dialysis: Not recommended. Lisdexamfetamine and dextroamphetamine are not dialyzable to a significant extent.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed (prodrug conversion is not liver-dependent).

Pharmacology

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Mechanism of Action

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effect by blocking the reuptake of norepinephrine and dopamine into the presynaptic neuron and increasing the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly measured for lisdexamfetamine due to prodrug nature; 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 (AUC) or Cmax of dextroamphetamine, but it may prolong Tmax by approximately 1 hour.

Distribution:

Vd: Dextroamphetamine: 2.6-4.8 L/kg
ProteinBinding: Dextroamphetamine: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Lisdexamfetamine: Less than 1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance: Dextroamphetamine: Highly dependent on urinary pH.
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites)
Unchanged: Approximately 50% of dextroamphetamine is excreted unchanged in urine at normal urinary pH.
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 3.5 hours (for dextroamphetamine)
DurationOfAction: Up to 14 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Lisdexamfetamine, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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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 sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has 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 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
Vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following potential side effects:

Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness

If any of these side effects or other symptoms bother you or do not go away, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain
  • Shortness of breath
  • Fainting spells
  • 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 (psychosis)
  • Mania (unusual excitement, overactivity, or irritability)
  • Severe anxiety or panic attacks
  • Muscle stiffness or spasms, fever, sweating, confusion, rapid heart rate, shivering, twitching (signs of serotonin syndrome)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past 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 start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is not intended for weight loss, so if you have any questions or concerns, discuss them with your doctor.

To ensure your safety, avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Additionally, be aware that long-term or high-dose use of this drug can lead to tolerance, where the medication may not work as effectively, and you may 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 result in dependence, and suddenly stopping it may cause withdrawal symptoms. Before reducing the dose or discontinuing the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.

Prior to starting this medication, you may need to undergo certain heart tests. If you have questions, consult your doctor. This drug may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.

Certain laboratory tests may be affected by this medication, so inform all your healthcare providers and laboratory personnel that you are taking this drug. Before using over-the-counter products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult your doctor.

A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, potentially causing severe and long-lasting health problems 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 may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. 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. If you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.

In some cases, this medication may affect growth in children and adolescents, and they may require regular growth checks. Discuss this with your doctor. 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.

If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia
  • Rhabdomyolysis
  • Hypertension or hypotension
  • Arrhythmias
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

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 sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensive agents (may decrease efficacy of antihypertensives)
  • Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life
  • Urinary acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine blood levels and shorten half-life
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Moderate Interactions

  • Proton pump inhibitors (PPIs) and H2 blockers (may slightly alter absorption, but generally not clinically significant)
  • Antipsychotics (may antagonize stimulant effects)
  • Alcohol (may increase risk of adverse cardiovascular events)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: CNS stimulants can cause increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight (especially in pediatric patients)

Rationale: Stimulants have been associated with growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric history (including family history of suicide, bipolar disorder, depression)

Rationale: To assess risk for new or worsening psychiatric symptoms.

Timing: Prior to initiation of therapy.

Cardiovascular history (including family history of sudden death or ventricular arrhythmia)

Rationale: To assess risk for serious cardiovascular events.

Timing: Prior to initiation of therapy.

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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/individual

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight (especially in pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.

Psychiatric symptoms (e.g., new or worsening aggression, hostility, mania, psychosis, suicidal ideation)

Frequency: Regularly (e.g., at each visit)

Target: Absence of new/worsening symptoms

Action Threshold: Emergence of symptoms; consider dose reduction, discontinuation, or psychiatric consultation.

Abuse potential and diversion risk

Frequency: Regularly (e.g., at each visit)

Target: No signs of abuse/diversion

Action Threshold: Signs of abuse/diversion; consider discontinuation and referral for substance abuse treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • Unexplained fainting
  • New or worsening aggression
  • Hostility
  • Mania
  • Psychosis
  • Suicidal ideation
  • Severe anxiety
  • Panic attacks
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)

Special Patient Groups

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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 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 limited and conflicting.
Second Trimester: Risk of premature delivery and low birth weight.
Third Trimester: Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
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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 (L4 - Possibly hazardous)
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Safety and efficacy for BED not established in pediatric patients. Not recommended for children under 6 years of age.

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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

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Clinical Pearls

  • Lisdexamfetamine is a prodrug, meaning its effects are smoother and longer-lasting than immediate-release amphetamines, with a lower potential for abuse via injection or snorting due to the need for enzymatic conversion.
  • Capsules can be opened and the contents mixed with water, yogurt, or orange juice for patients who have difficulty swallowing, but consume immediately.
  • Patients should be advised to avoid taking doses in the late afternoon or evening to prevent insomnia.
  • Regular monitoring of cardiovascular parameters (BP, HR) and growth (in children) is crucial.
  • Educate patients and caregivers about the signs of serotonin syndrome and the importance of reporting any new or worsening psychiatric symptoms.
  • Due to its Schedule II classification, strict prescribing and dispensing regulations apply.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Mixed amphetamine salts (e.g., Adderall, Mydayis)
  • Dexmethylphenidate (e.g., Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine extended-release (Intuniv)
  • Clonidine extended-release (Kapvay)
  • Bupropion (Wellbutrin) - off-label for ADHD
  • Cognitive Behavioral Therapy (CBT) for ADHD and BED
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Cost & Coverage

Average Cost: $300 - $450 per 30 capsules (40mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.