Lisdexamfetamine 20mg Capsules

Manufacturer SUN PHARMACEUTICALS Active Ingredient Lisdexamfetamine Capsules(lis dex am FET a meen) Pronunciation lis-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 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
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 moderate to severe Binge Eating Disorder (BED). It works by increasing the levels of certain natural substances in the brain that help with focus, attention, and impulse control.
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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 this medication late in the day.

When taking the capsule, swallow it whole without chewing, breaking, or crushing. However, if needed, you can open the capsule and mix the powder with water, orange juice, or yogurt. If the powder clumps together, you can use a spoon to gently break it apart. Mix well and swallow the mixture immediately. Do not store the mixed medication for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Store the medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use.

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.
  • Do not take later in the day to avoid sleep problems.
  • Swallow capsules whole or open and mix contents with water, yogurt, or orange juice; consume immediately.
  • Avoid alcohol, as it can increase side effects.
  • Maintain a healthy diet and regular exercise.
  • Ensure adequate sleep hygiene.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 30 mg once daily in the morning. Titrate in 10-20 mg increments weekly to a maximum of 70 mg/day. Binge Eating Disorder (BED): Initial 30 mg once daily in the morning. Titrate in 20 mg increments weekly to a target dose of 50-70 mg/day. Max 70 mg/day.
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

ADHD: Initial 30 mg, titrate to 30-70 mg/day
Binge Eating Disorder: Initial 30 mg, titrate to 50-70 mg/day
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Pediatric Dosing

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

Renal Impairment:

Mild: No adjustment needed (eGFR 60-89 mL/min/1.73 m²)
Moderate: Max 50 mg/day (eGFR 30-59 mL/min/1.73 m²)
Severe: Max 30 mg/day (eGFR <30 mL/min/1.73 m²)
Dialysis: Avoid use in end-stage renal disease (ESRD) requiring dialysis.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

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. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (prodrug conversion)
Tmax: Lisdexamfetamine: 1 hour; Dextroamphetamine: 3.5 hours (oral)
FoodEffect: Food does not affect the extent of absorption of dextroamphetamine, but may prolong Tmax by approximately 1 hour.

Distribution:

Vd: Not available (for lisdexamfetamine); Dextroamphetamine: 2.6-4.8 L/kg
ProteinBinding: Not available (for lisdexamfetamine); Dextroamphetamine: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: Approximately 10-13 hours (adults), 9-11 hours (children)
Clearance: Not available
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites)
Unchanged: Less than 1% of lisdexamfetamine is excreted unchanged in urine.
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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. Administration of CNS stimulants for prolonged periods of time may lead to drug dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
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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 immediate medical attention:

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
Fast or abnormal heartbeat
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (hands, feet, or other areas), which may turn pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the 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 died suddenly, notify your doctor. Seek immediate medical help if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

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. Call your doctor right away if you experience any of the following symptoms:

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

While many people may not experience side effects or only have mild ones, 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
Difficulty sleeping
Dizziness

If you're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • Manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Blurred vision or other vision changes
  • Severe headache
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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 of:
+ 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 lead to 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 conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify 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. If you have been taking this drug for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is not working as well as it should, contact your doctor. Do not exceed the prescribed dose.

Long-term or regular use of this medication can lead to dependence, and suddenly stopping it may cause withdrawal symptoms. Before reducing the dose or stopping this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor.

Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. This drug can cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.

Additionally, this medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. 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.

Be aware that a severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur, which may lead to severe 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 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, as you will need 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
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

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 levels and prolong half-life
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine levels and shorten half-life
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Moderate Interactions

  • Adrenergic blockers (e.g., guanethidine) - may inhibit adrenergic neuron blocking effects
  • Phenothiazines (e.g., chlorpromazine) - may inhibit stimulant effects
  • Haloperidol - may inhibit stimulant effects
  • Propoxyphene - may increase dextroamphetamine levels
  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects
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Minor Interactions

  • Proton Pump Inhibitors (PPIs) - minimal effect on absorption

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular events, including hypertension and tachycardia.

Timing: Prior to initiation of therapy.

Height and Weight (especially in pediatric patients)

Rationale: Risk of growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric history (personal and family)

Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation of therapy.

Pre-existing cardiac disease screening

Rationale: Risk of sudden death in patients with structural cardiac abnormalities or other serious heart problems.

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: Significant or sustained increases; consider dose reduction or discontinuation.

Weight and Height (pediatric patients)

Frequency: Regularly (e.g., every 3-6 months)

Target: Normal growth trajectory

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

Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania)

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

Target: Absence of new or worsening symptoms

Action Threshold: Emergence of new or worsening symptoms; consider dose reduction or discontinuation.

ADHD/BED symptom control

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

Target: Improved symptoms with acceptable side effects

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms
  • Severe headache
  • Unexplained weight loss
  • Changes in sleep patterns

Special Patient Groups

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Pregnancy

Based on animal studies and postmarketing experience, amphetamines may cause fetal harm. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There is a pregnancy exposure registry for women exposed to ADHD medications during pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of congenital malformations (e.g., cardiac defects) with amphetamine exposure.
Second Trimester: Potential for adverse fetal growth effects.
Third Trimester: Risk of premature delivery and withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia) in neonates exposed to amphetamines during the third trimester.
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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: Moderate to High (L3-L4). Potential for irritability, poor feeding, sleep disturbances, and reduced weight gain in the infant. Long-term neurodevelopmental effects are unknown.
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Psychiatric adverse events (e.g., new psychosis, mania, aggression) can occur. Cardiovascular monitoring is essential.

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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. Renal function should be monitored.

Clinical Information

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Clinical Pearls

  • Lisdexamfetamine is a prodrug, meaning it is inactive until converted in the body, which contributes to its smoother onset and longer duration of action compared to immediate-release stimulants.
  • It has a lower abuse potential than immediate-release amphetamines due to its prodrug nature, as rapid release of dextroamphetamine is prevented even if crushed or snorted.
  • Can be taken with or without food, but consistency in timing (morning) is key for optimal effect and to avoid sleep disturbances.
  • Patients should be advised to report any new or worsening psychiatric symptoms or cardiovascular symptoms immediately.
  • For patients who have difficulty swallowing capsules, the capsule can be opened and the entire contents mixed with water, yogurt, or orange juice and consumed immediately.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Amphetamine/dextroamphetamine (e.g., Adderall)
  • Dexmethylphenidate (e.g., Focalin)
  • Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Other treatments for Binge Eating Disorder (e.g., Topiramate, SSRIs, psychotherapy)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$400+ per 30 capsules (brand)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (brand), Tier 1 or 2 (generic)
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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 reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.