Lisdexamfetamine 50mg Chewable Tabs

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a non-catecholamine sympathomimetic amine that causes the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also inhibits the reuptake of these monoamines, thereby increasing their concentrations 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
Difficulty 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 feeling in the hands or feet
Sores or wounds on the fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine

Important Heart-Related Warnings

If you have a heart problem or defect, inform your doctor. 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

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
Change 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 possible side effects:

Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
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 visit 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. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Current or recent medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as 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 problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dosage 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 may lead to tolerance, where the drug becomes less effective, 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 may 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, and you should be aware of this potential risk.

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 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, 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.

Behavior and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. 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) - concurrent use or within 14 days of MAOI administration due to risk of hypertensive crisis.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
• Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase plasma levels and prolong half-life of dextroamphetamine.
• Antihypertensives - amphetamines may decrease the hypotensive effect of guanethidine and other antihypertensive drugs.

• Proton Pump Inhibitors (PPIs) / H2-receptor antagonists - may slightly decrease absorption but generally not clinically significant.
• Alcohol - may alter absorption and increase exposure to dextroamphetamine.
• Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
• Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.

• Not available

• Chest pain
• Shortness of breath
• Palpitations
• Syncope
• New or worsening aggression
• Hostility
• Psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, increased energy, decreased need for sleep)
• New or worsening tics
• Unexplained weight loss
• Blurred vision

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause adverse pregnancy outcomes, including preterm birth and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms (e.g., dysphoria, agitation, tremor, lethargy, feeding difficulty).

Dextroamphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, insomnia, weight loss, and potential for long-term neurodevelopmental effects), breastfeeding is generally not recommended during treatment with lisdexamfetamine.

Safety and efficacy established for ADHD in children 6 years and older. Not recommended for children under 6 years. Monitor growth (height and weight) carefully due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution, generally starting at the lower end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Monitor cardiovascular status closely.

• Lisdexamfetamine is a prodrug, meaning it is inactive until converted in the body, which may contribute to its smoother pharmacokinetic profile and potentially lower abuse liability compared to immediate-release amphetamines.
• The chewable tablet form offers an alternative for patients who have difficulty swallowing capsules.
• Take in the morning to avoid insomnia, as the effects can last up to 14 hours.
• Dose titration should be gradual (weekly intervals) to assess efficacy and tolerability.
• Patients should be advised to avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms.

• Other CNS Stimulants (e.g., methylphenidate, mixed amphetamine salts, dextroamphetamine)
• Non-stimulants for ADHD (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
• 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 is a patient fact sheet that provides crucial information. 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 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 details about the medication taken, the quantity, and the time it occurred.