Vyvanse 60mg Chewable Tablets

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a central nervous system (CNS) stimulant. The exact therapeutic mechanism in ADHD and BED is not fully known, but it is thought to be mediated through the release of norepinephrine and dopamine from nerve terminals in the brain, leading to increased levels of these monoamines in the synaptic cleft.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 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 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. 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 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.

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

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 personal or 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
Existing health problems, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current medications, particularly:
+ 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. 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 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 may cause dependence, and suddenly stopping it may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Heart-Related Precautions

Before starting this medication, you may need to undergo heart tests. 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

This medication may interact with certain over-the-counter (OTC) products, 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, which can increase blood pressure. Inform your doctor before using any OTC products, and tell all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

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.

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, 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 use) - risk of hypertensive crisis.

• Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
• Antihypertensives - may reduce hypotensive effects.
• Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life.
• Proton Pump Inhibitors (PPIs) / H2 Blockers - may reduce absorption of lisdexamfetamine (though clinical significance is minor).

• Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine blood levels and shorten half-life.
• Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects.
• Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of stimulants.
• Alcohol - may alter absorption or increase adverse effects.

• Not specifically listed as minor, but general caution with other CNS stimulants.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hostility
• Psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
• Severe anxiety
• Agitation
• Unexplained weight loss
• Growth deceleration (in children)

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 (e.g., premature delivery, low birth weight, withdrawal symptoms in neonates).

Lisdexamfetamine and its active metabolite, dextroamphetamine, are present in 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.

Approved for ADHD in children 6 years and older. Safety and efficacy for BED not established in pediatric patients. Monitor growth (height and weight) and cardiovascular parameters. Risk of psychiatric adverse events.

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. Renal function should be monitored.

• Lisdexamfetamine is a prodrug; its conversion to dextroamphetamine is not affected by GI pH, unlike some other amphetamines, which may lead to more consistent absorption.
• The chewable tablet formulation offers an alternative for patients who have difficulty swallowing capsules.
• Patients should be advised to chew the tablet thoroughly before swallowing.
• Due to its long duration of action, once-daily morning dosing is crucial to avoid insomnia.
• Careful titration is necessary to find the optimal dose, starting low and increasing gradually.
• Monitor for signs of abuse, misuse, and diversion, as it is a Schedule II controlled substance.
• Educate patients and caregivers on potential cardiovascular and psychiatric side effects.

• Other CNS Stimulants (e.g., Methylphenidate, Dextroamphetamine, Mixed Amphetamine Salts)
• Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
• Other medications for BED (e.g., Topiramate, SSRIs)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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 its safe and effective use. 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, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.