Vyvanse 50mg Chewable Tablets

Manufacturer SHIRE US INC. Active Ingredient Lisdexamfetamine Chewable Tablets(lis dex am FET a meen) Pronunciation lis dex AM fet a meen
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat binge eating disorder.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System Stimulant
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Pharmacologic Class
Prodrug of Dextroamphetamine; Sympathomimetic Amine
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Pregnancy Category
Not available
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FDA Approved
Feb 2007
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Vyvanse is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and moderate to severe Binge Eating Disorder (BED). It is a stimulant medication that works by increasing certain natural substances in the brain that help with focus and impulse control. It's a 'prodrug,' meaning your body converts it into the active form (dextroamphetamine) after you take it, which provides a smooth and long-lasting effect.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. To minimize sleep disturbances, avoid taking it late in the day. Be sure to chew the medication thoroughly before swallowing.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To ensure safety, store your medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Taking it in the afternoon or evening may cause sleep problems.
  • Can be taken with or without food.
  • Chewable tablets should be chewed thoroughly before swallowing.
  • Do not crush, chew, or divide the capsule form (if applicable, though this is for chewable).
  • Avoid alcohol, as it may increase side effects.
  • Maintain a healthy diet and regular exercise.
  • Report any new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, aggression) or cardiovascular symptoms (e.g., chest pain, shortness of breath) immediately.
  • Store securely to prevent misuse.

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg once daily in the morning, titrated to effect. Max 70 mg/day.
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

ADHD: Initial 30 mg once daily, titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Binge Eating Disorder (BED): Initial 30 mg once daily, titrate in 20 mg increments weekly to a target dose of 50-70 mg/day. Max 70 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 30 mg once daily, titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
Adolescent: ADHD (13-17 years): Initial 30 mg once daily, titrate in 10-20 mg increments weekly to a maximum of 70 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 50-80 mL/min)
Moderate: Consider dose reduction (CrCl 30-50 mL/min). Max 50 mg/day.
Severe: Max 30 mg/day (CrCl <30 mL/min).
Dialysis: Not recommended in end-stage renal disease (ESRD) due to lack of data and potential for prolonged exposure.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

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, particularly in the prefrontal cortex. This increases the levels of these neurotransmitters in the synaptic cleft, leading to enhanced attention, focus, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high (75-100%).
Tmax: Lisdexamfetamine: 3.5 hours (prodrug); Dextroamphetamine: 3.5-4.5 hours (active metabolite)
FoodEffect: Food does not affect the extent of absorption (AUC) or the rate of absorption (Tmax) of dextroamphetamine after lisdexamfetamine administration.

Distribution:

Vd: Dextroamphetamine: 2.6-4.8 L/kg
ProteinBinding: Dextroamphetamine: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance: Dextroamphetamine: Approximately 0.33-0.62 L/hr/kg
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites)
Unchanged: Approximately 50% of dextroamphetamine is excreted unchanged in urine, depending on urinary pH.
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 3.5-4.5 hours (for dextroamphetamine)
DurationOfAction: Up to 14 hours

Safety & Warnings

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BLACK BOX WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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Side Effects

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
+ Fainting
+ 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 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 fainting

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
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 may only have minor 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, fainting
  • Numbness, tingling, or coldness in fingers or toes
  • Unexplained wounds on fingers or toes
  • New or worsening aggression, hostility
  • New or worsening tics (uncontrolled movements or sounds)
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Mania (unusually elevated mood, increased energy, decreased need for sleep)
  • Severe anxiety or panic attacks
  • Blurred vision
  • Unexplained weight loss
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Before Using This Medicine

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
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Use of other medications, such as:
+ Linezolid
+ 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & 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, 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. Additionally, be aware that long-term or high-dose use of this drug can lead to tolerance, where the medication may not work as effectively, and you may need higher doses to achieve the same effect. If you experience a decrease in the drug's effectiveness, contact your doctor. Do not exceed the prescribed dose.

Prolonged or regular use of this medication may result in dependence, and suddenly stopping it can lead to withdrawal symptoms. Before reducing the dose or discontinuing the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.

Prior to starting this medication, you may need to undergo certain heart tests. If you have 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.

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, can interact with this medication and increase blood pressure. Inform your doctor before using these products, and tell all your healthcare providers and laboratory personnel that you are taking this medication.

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.

This medication can also cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood disorders, 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 mood changes such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

In some cases, this medication can affect growth in children and adolescents, and they may require regular growth checks. This medication is not approved for use in children under 6 years of age, as it can increase the risk of long-term weight loss in this age group.

If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Restlessness, tremor, hyperreflexia, rapid breathing
  • Confusion, assaultiveness, hallucinations, panic states
  • High fever, rhabdomyolysis
  • Arrhythmias, hypertension or hypotension, circulatory collapse
  • Nausea, vomiting, diarrhea, abdominal cramps
  • Convulsions, coma, death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management includes symptomatic treatment, gastric lavage, activated charcoal, and supportive care. Acidification of urine may increase excretion but is controversial due to risk of renal failure.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
  • Linezolid
  • Methylene blue
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensive agents (may reduce efficacy of antihypertensives)
  • Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life
  • Urinary acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine blood levels and shorten half-life
  • Adrenergic blockers (e.g., guanethidine) - may inhibit adrenergic neuron blocking effects
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Moderate Interactions

  • Antacids (may increase absorption of dextroamphetamine)
  • Proton pump inhibitors (PPIs) (may increase absorption of dextroamphetamine)
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
  • Tricyclic antidepressants (TCAs) - may potentiate cardiovascular effects of stimulants
  • Alcohol (may alter release characteristics of extended-release formulations, though Vyvanse is not an ER formulation in the typical sense, it's a prodrug)
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Minor Interactions

  • Caffeine (additive stimulant effects)

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause dose-related increases in BP and HR.

Timing: Prior to initiation

Height and Weight

Rationale: Stimulants can cause growth suppression in pediatric patients and weight loss in all patients.

Timing: Prior to initiation

Psychiatric history (e.g., bipolar disorder, psychosis, tics)

Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new psychotic/manic symptoms.

Timing: Prior to initiation

Cardiac history (e.g., structural cardiac abnormalities, cardiomyopathy, arrhythmias)

Rationale: Risk of sudden death in patients with pre-existing cardiac conditions.

Timing: Prior to initiation (ECG may be considered if clinically indicated)

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 3-6 months thereafter

Target: Within normal limits for age/individual

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric); Annually (adults)

Target: Normal growth trajectory (pediatric); Stable weight (adults)

Action Threshold: Significant growth deceleration (pediatric) or clinically significant weight loss; consider drug holiday or alternative treatment.

Mental Status/Behavioral Changes

Frequency: At each visit

Target: Stable mood, absence of new or worsening psychiatric symptoms

Action Threshold: Emergence of psychotic symptoms, mania, aggression, or severe anxiety; discontinue treatment.

ADHD/BED symptom control

Frequency: Regularly, at each visit

Target: Improved symptoms with tolerable side effects

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Tics
  • Blurred vision
  • Numbness/tingling in extremities (Raynaud's phenomenon)
  • Unexplained weight loss

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are conflicting.
Second Trimester: Risk of premature delivery, low birth weight.
Third Trimester: Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypertonia).
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Lactation

Dextroamphetamine is excreted into 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 with lisdexamfetamine.

Infant Risk: High (L4 - Possibly hazardous)
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Long-term effects on growth have been observed with stimulant use.

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Geriatric Use

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.

Clinical Information

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Clinical Pearls

  • Vyvanse is a prodrug, meaning its effects are smoother and longer-lasting compared to immediate-release stimulants, with less potential for 'crash' or rebound effects.
  • The chewable tablet can be chewed thoroughly or dissolved in water, orange juice, or yogurt and consumed immediately.
  • Due to its prodrug nature, crushing or dissolving the tablet does not bypass the controlled release mechanism, making it less prone to abuse by injection or snorting compared to other stimulants.
  • Always take in the morning to avoid sleep disturbances.
  • Monitor for cardiovascular effects (BP, HR) and psychiatric symptoms (anxiety, psychosis, mania) regularly.
  • Growth suppression is a concern in pediatric patients; monitor height and weight closely.
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Alternative Therapies

  • Other CNS stimulants (e.g., methylphenidate, mixed amphetamine salts, dextroamphetamine)
  • Non-stimulants (e.g., atomoxetine, guanfacine, clonidine)
  • Behavioral therapy (for ADHD and BED)
  • Psychotherapy (for BED)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$400+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand name), Tier 1 (Generic)
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General Drug Facts

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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.