Lisdexamfetamine 40mg Chewable Tabs

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. The therapeutic effect in ADHD and BED is thought to be mediated through these actions.

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 feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine

If you have a history of heart problems or heart defects, inform your doctor, as sudden deaths have occurred in people with these conditions. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify 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

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
Upset stomach
Throwing up
Severe headache

Other Possible Side Effects

While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects. If you're concerned about any of these symptoms or if they persist, contact your doctor:

Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
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, 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.

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

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

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 family history of or personal experience with:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Existing health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline), as they may cause very high blood pressure
+ Linezolid or methylene blue
Breastfeeding status: Do 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 treatment. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and 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, and if you have any questions or concerns, you should discuss them with your doctor.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness and clear vision.

Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the drug may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication can cause dependence, and stopping it abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Heart-Related Precautions
You may need to undergo heart tests before starting this medication. Your doctor will monitor your blood pressure and heart rate, and you should follow their instructions for checking these vital signs. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure regularly.

Interactions with Other Medications and Lab Tests
Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests. Before using over-the-counter (OTC) 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.

Severe Skin Reaction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems, permanent damage, 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.

Behavior and Mood Changes
This medication may cause new or worsening behavior and mood changes, including changes in thinking, anger, and hallucinations. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.

Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, and you should 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.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of using this medication during pregnancy.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
• Linezolid (MAOI activity)

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
• Antihypertensives (may counteract effects)
• 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
• Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects

• Tricyclic Antidepressants (TCAs) - increased cardiovascular effects
• Proton Pump Inhibitors (PPIs) / H2 Blockers - minimal effect on absorption, but monitor for altered pH effects
• Opioids (e.g., meperidine) - increased risk of serotonin syndrome

• Not available

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hostility
• Psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, racing thoughts, decreased need for sleep)
• Tics or Tourette's syndrome exacerbation
• Peripheral vasculopathy (e.g., Raynaud's phenomenon)
• Unexplained wounds on fingers or toes
• Blurred vision
• Severe headache

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Amphetamines can cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.

Dextroamphetamine is excreted into human milk. Because of the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), advise women not to breastfeed during treatment with lisdexamfetamine.

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Long-term safety and efficacy in children under 6 years have not been established.

Clinical studies of lisdexamfetamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, 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.

• Lisdexamfetamine is a prodrug, meaning its effects are smoother and longer-lasting compared to immediate-release amphetamines, with less potential for 'drug liking' due to slower onset.
• The chewable tablet can be chewed thoroughly and swallowed, or dispersed in water, orange juice, or yogurt and consumed immediately.
• Patients should be advised to avoid taking the medication in the late afternoon or evening to prevent insomnia.
• Careful cardiovascular assessment is crucial before initiating therapy, especially in patients with pre-existing cardiac conditions.
• Monitor for signs of abuse and dependence, as lisdexamfetamine is a Schedule II controlled substance.
• Growth suppression can occur in pediatric patients; regular monitoring of height and weight is essential.

• Methylphenidate (e.g., Concerta, Ritalin, Focalin)
• Amphetamine/Dextroamphetamine (e.g., Adderall, Mydayis)
• Atomoxetine (Strattera)
• Guanfacine extended-release (Intuniv)
• Clonidine extended-release (Kapvay)
• Bupropion (Wellbutrin - off-label for ADHD)
• Cognitive Behavioral Therapy (CBT) for ADHD and BED
• Other psychotherapies for BED (e.g., Interpersonal Therapy, Dialectical Behavior Therapy)

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 discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.