Lisdexamfetamine 30mg 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; Sympathomimetic Amine
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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) in adults and children 6 years and older, and moderate to severe Binge Eating Disorder (BED) in adults. It is a 'prodrug' which means 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.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day.

When taking your medication, swallow the capsule whole - do not chew, break, or crush it. However, if you need to, 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 the powder well with the liquid 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, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. When you're finished with your medication or it expires, dispose of it 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 the best way to dispose of your medication, and consider participating in a local drug take-back program.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's 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 one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Can be taken with or without food.
  • Swallow capsules whole, or open and mix contents with yogurt, water, or orange juice and consume immediately.
  • Avoid taking late in the day to prevent sleep problems.
  • Store securely to prevent misuse or diversion.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol consumption.
  • Do not stop taking abruptly without consulting your doctor, as withdrawal symptoms may occur.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 30 mg orally once daily in the morning. Titrate in 10 mg or 20 mg increments weekly to a maximum of 70 mg/day.
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial: 30 mg orally once daily in the morning. Titrate in 10 mg or 20 mg increments weekly to a maximum of 70 mg/day.
Adolescent: ADHD (13-17 years): Initial: 30 mg orally once daily in the morning. Titrate in 10 mg or 20 mg increments weekly to a maximum of 70 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl 50-80 mL/min).
Moderate: Maximum dose 50 mg/day (CrCl 30-50 mL/min).
Severe: Maximum dose 30 mg/day (CrCl <30 mL/min).
Dialysis: Avoid use in end-stage renal disease (ESRD) requiring dialysis.

Hepatic Impairment:

Mild: No dosage adjustment needed.
Moderate: No dosage adjustment needed.
Severe: No dosage adjustment needed.

Pharmacology

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Mechanism of Action

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a central nervous system (CNS) stimulant that blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly measured for lisdexamfetamine; dextroamphetamine bioavailability is high.
Tmax: Lisdexamfetamine: ~1 hour; Dextroamphetamine (after conversion): ~3.5 hours.
FoodEffect: Food does not affect the extent of absorption of dextroamphetamine, but may prolong Tmax by approximately 1 hour.

Distribution:

Vd: Dextroamphetamine: 2.4-4.5 L/kg.
ProteinBinding: Dextroamphetamine: Approximately 15-20% (to albumin).
CnssPenetration: Yes

Elimination:

HalfLife: Lisdexamfetamine: Less than 1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children).
Clearance: Not available for lisdexamfetamine; Dextroamphetamine: 0.33-0.68 L/hr/kg.
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites).
Unchanged: Approximately 50% of dextroamphetamine is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for dextroamphetamine effect).
PeakEffect: Approximately 3.5 hours (for dextroamphetamine concentration).
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Fast or abnormal heartbeat
Trouble controlling body movements
Uncontrollable sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold 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 heart problem or defect, or a family history of abnormal heartbeat or sudden death, inform 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

Additionally, 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
Changes in balance
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 severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Anxiety
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
* Dizziness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention).
  • New or worsening aggression, hostility, or irritability.
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions).
  • New or worsening manic symptoms (e.g., extreme energy, racing thoughts).
  • Unexplained wounds on fingers or toes, or numbness/pain/color change in fingers or toes (Raynaud's phenomenon).
  • Blurred vision or other vision changes.
  • Uncontrolled movements or tics.
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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 health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may 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. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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 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 well, 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, consult 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 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 some natural products or aids, consult your doctor.

Be aware of the risk of a severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause severe health problems and 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 problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.

In some cases, this medication can 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 (very high fever)
  • Rhabdomyolysis
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis).
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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.
  • Antihypertensives (may decrease hypotensive effect).
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life.
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine blood levels and shorten half-life.
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of stimulants.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects.
  • Proton Pump Inhibitors (PPIs) / H2 blockers - may alter gastric pH, but less significant for lisdexamfetamine due to blood hydrolysis.
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Minor Interactions

  • Not available

Monitoring

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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: Monitor for growth suppression in pediatric patients.

Timing: Prior to initiation.

Psychiatric History (including family history of sudden death, ventricular arrhythmia)

Rationale: Assess for pre-existing psychiatric conditions or risk factors for cardiac events.

Timing: Prior to initiation.

ECG (Electrocardiogram)

Rationale: Consider if patient has pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.

Timing: Prior to initiation (if indicated).

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: 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 Status (e.g., emergence or worsening of psychotic or manic symptoms, aggression, anxiety)

Frequency: At each visit.

Target: Stable mood and behavior.

Action Threshold: New or worsening psychiatric symptoms requiring intervention.

Abuse/Misuse Potential

Frequency: At each visit.

Target: No signs of abuse or diversion.

Action Threshold: Evidence of abuse or diversion.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depression
  • Tics or dyskinesias
  • Blurred vision
  • Numbness, coolness, or pain in extremities (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 may 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: Potential for growth restriction and premature birth.
Third Trimester: Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
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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 (L3 - Moderate risk)
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms.

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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, lower initial doses and careful titration are recommended due to increased sensitivity to adverse effects and potential for comorbidities.

Clinical Information

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Clinical Pearls

  • Lisdexamfetamine is a prodrug, meaning its effects are smoother and longer-lasting compared to immediate-release amphetamines, reducing the potential for 'crashes' and abuse.
  • The conversion of lisdexamfetamine to dextroamphetamine is not dependent on GI pH, making its absorption more consistent than other amphetamines.
  • It can be opened and mixed with food or liquid, which is beneficial for patients who have difficulty swallowing capsules.
  • Careful monitoring for cardiovascular and psychiatric adverse effects is crucial, especially at baseline and during dose titration.
  • Due to its Schedule II classification, strict prescribing regulations apply, including no refills and specific prescription requirements.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Daytrana)
  • 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)
  • Cognitive Behavioral Therapy (CBT) for ADHD and BED
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Cost & Coverage

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

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a detailed patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide information about the medication taken, the amount consumed, and the time it occurred, as this will help healthcare professionals provide appropriate care and treatment.