Lisdexamfetamine 30mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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 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.
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.
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 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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis).
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.
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.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: Stimulants can cause increases in BP and HR.
Timing: Prior to initiation.
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation.
Rationale: Assess for pre-existing psychiatric conditions or risk factors for cardiac events.
Timing: Prior to initiation.
Rationale: Consider if patient has pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.
Timing: Prior to initiation (if indicated).
Routine Monitoring
Frequency: At each visit or every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Persistent elevation requiring intervention or discontinuation.
Frequency: Every 3-6 months (pediatric patients).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss.
Frequency: At each visit.
Target: Stable mood and behavior.
Action Threshold: New or worsening psychiatric symptoms requiring intervention.
Frequency: At each visit.
Target: No signs of abuse or diversion.
Action Threshold: Evidence of abuse or diversion.
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
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:
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) carefully, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms.
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
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.
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
Cost & Coverage
General Drug Facts
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.