Lisdexamfetamine 40mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Lisdexamfetamine 50mg Chewable Tabs
- Lisdexamfetamine 30mg Chewable Tabs
- Lisdexamfetamine 40mg Chewable Tabs
- Lisdexamfetamine 10mg Chewable Tabs
- Lisdexamfetamine 60mg Chewable Tabs
- Lisdexamfetamine 10mg Capsules
- Lisdexamfetamine 20mg Chewable Tabs
- Lisdexamfetamine 70mg Capsules
- Lisdexamfetamine 60mg Capsules
- Lisdexamfetamine 30mg Capsules
- Lisdexamfetamine 50mg Capsules
- Lisdexamfetamine 40mg Capsules
- Lisdexamfetamine 20mg Capsules
- Lisdexamfetamine 20mg Capsules
- Lisdexamfetamine 60mg Capsules
- Lisdexamfetamine 50mg Capsules
- Lisdexamfetamine 70mg Capsules
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
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
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)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: CNS stimulants can cause increases in BP and HR.
Timing: Prior to initiation of therapy.
Rationale: Stimulants have been associated with growth suppression.
Timing: Prior to initiation of therapy.
Rationale: To assess risk for new or worsening psychiatric symptoms.
Timing: Prior to initiation of therapy.
Rationale: To assess risk for serious cardiovascular events.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.
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.
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.
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
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:
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.
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.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Lisdexamfetamine is a prodrug, meaning 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.
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
Cost & Coverage
General Drug Facts
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.