Lisdexamfetamine 60mg Capsules

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effect by releasing norepinephrine and dopamine from nerve terminals in the brain, and by blocking their reuptake into the presynaptic neuron. This increases the concentrations of these neurotransmitters in the synaptic cleft.

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
Uncontrollable 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 sensations 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 a history of abnormal heartbeat or sudden death, notify your doctor. Seek medical help immediately if you experience any signs of heart problems, including:

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. 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, upset stomach, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or 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 persist, 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.

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

It is essential to inform your doctor about the following conditions 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 you experienced, including the symptoms that occurred.
A family 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
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause 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 treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.

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 understand how this medication affects you, avoid driving and engaging in activities that require alertness or 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 effectively, 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 sudden cessation may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Cardiovascular Monitoring
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 laboratory 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 Reactions
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, permanent damage, 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.

Behavioral and Mood Changes
This medication may cause new or worsening behavioral 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, as they will need to discuss the benefits and risks of using this medication during pregnancy.

• Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis and serotonin syndrome.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
• Antihypertensives - amphetamines may decrease the hypotensive effect of guanethidine and other antihypertensive drugs.
• Halogenated Anesthetics - increased risk of sudden death due to ventricular arrhythmias.

• Urinary Acidifiers (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine blood levels and efficacy by increasing urinary excretion.
• Urinary Alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life by decreasing urinary excretion.
• Proton Pump Inhibitors (PPIs) / H2 Blockers - may slightly increase amphetamine absorption due to increased gastric pH, but generally not clinically significant for lisdexamfetamine.
• Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.

• Tricyclic Antidepressants (TCAs) - may potentiate the cardiovascular effects of amphetamines.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• New tics
• Numbness/tingling/coldness in fingers or toes (Raynaud's phenomenon)
• Unexplained wounds on fingers or toes

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause adverse pregnancy outcomes, including premature birth and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.

Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss), advise mothers not to breastfeed during treatment with lisdexamfetamine.

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

Clinical studies 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, which means it is inactive until converted in the body. This mechanism is thought to reduce its potential for abuse via injection or snorting compared to immediate-release amphetamines.
• Its long duration of action (up to 14 hours) allows for once-daily morning dosing, providing symptom control throughout the school/work day.
• The conversion to dextroamphetamine is not dependent on CYP450 enzymes, which may reduce the risk of drug-drug interactions related to CYP inhibition or induction for the prodrug conversion step.
• Capsules can be opened and the entire contents mixed with yogurt, water, or orange juice and consumed immediately for patients who have difficulty swallowing capsules.
• Patients should be advised to avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., extreme fatigue, depression).

• Other CNS Stimulants (e.g., Methylphenidate, Dextroamphetamine, Mixed Amphetamine Salts)
• Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
• Behavioral therapy for ADHD
• Cognitive Behavioral Therapy (CBT) for Binge Eating Disorder
• Other medications for BED (e.g., Topiramate, SSRIs)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 details about the medication taken, the amount, and the time it occurred.