Vyvanse 30mg Chewable Tablets

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, primarily in the prefrontal cortex. It also inhibits the reuptake of these monoamines.

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 immediate medical attention:

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
Uncontrolled vocalizations, 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 sensation in the hands or feet
Sores or wounds on the 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 immediate medical attention 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:

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

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

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 concerns 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. 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 conditions with your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health issues. Never start, stop, or change the dosage of any medication without consulting your doctor.

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, so if you have any questions or concerns, discuss them with your doctor.

To ensure your safety, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. If you have been taking this drug for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is not working as well as it should, contact your doctor. Do not exceed the prescribed dose.

Long-term or regular use of this medication can lead to dependence, and suddenly stopping it may cause withdrawal symptoms. Before reducing the dose or stopping this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor.

Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with 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.

Additionally, this medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. Before using any 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, or certain natural products or aids, consult your doctor.

Be aware that 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 that may be permanent or even life-threatening. 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 also 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 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, thoughts of suicide, 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, so 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, as 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 discontinuation (risk of hypertensive crisis, serotonin syndrome)

• Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
• Antihypertensives - may decrease hypotensive effect
• Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase dextroamphetamine blood levels and prolong half-life
• Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine blood levels and shorten half-life

• Adrenergic blockers (e.g., guanethidine) - amphetamines may antagonize effects
• Antidepressants (e.g., TCAs) - may potentiate cardiovascular effects of amphetamines
• Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
• Proton pump inhibitors (PPIs) - no significant interaction expected as lisdexamfetamine hydrolysis is not pH-dependent.

• Not specifically listed for minor severity, but general caution with other CNS stimulants or drugs affecting heart rate/blood pressure.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Severe anxiety
• Persistent insomnia
• Tics or dyskinesias
• Unexplained weight loss
• Blurred vision

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. 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. Breastfeeding is not recommended during treatment with lisdexamfetamine due to the potential for serious adverse reactions in the infant (e.g., irritability, poor feeding, sleep disturbances, weight loss).

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Long-term effects on growth are a concern. Safety and efficacy in children under 6 years have not been established.

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.

• Vyvanse is a prodrug, meaning it is inactive until converted in the body, which contributes to its smoother onset and longer duration of action compared to immediate-release amphetamines.
• The chewable tablet can be chewed thoroughly or dissolved in water, orange juice, or yogurt, offering flexibility for administration.
• Due to its prodrug nature, crushing or dissolving Vyvanse does not bypass the conversion process, reducing its abuse potential via injection or snorting compared to other stimulants.
• Always take in the morning to avoid insomnia, even if a dose is missed, do not take it later in the day.
• Monitor for signs of stimulant-induced psychosis or mania, especially in patients with a personal or family history of psychiatric disorders.
• Regular cardiovascular monitoring is crucial due to the risk of increased blood pressure and heart rate.

• Methylphenidate (e.g., Ritalin, Concerta, Focalin)
• Mixed amphetamine salts (e.g., Adderall, Mydayis)
• Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
• Behavioral therapy (for ADHD and BED)
• Cognitive Behavioral Therapy (CBT) (for BED)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.