Vyvanse 20mg 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 (CNS) Stimulant
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Pharmacologic Class
Prodrug of Dextroamphetamine
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Pregnancy Category
Not available
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FDA Approved
Jan 2015
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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's a prodrug, meaning it's inactive until your body converts it into an active form (dextroamphetamine). This active form helps improve focus, attention, and control over impulsive behavior by affecting certain brain chemicals.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication at the same time every day, with or without food. To minimize the risk of sleep disturbances, avoid taking your medication late in the day. Be sure to chew the medication well 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 the bathroom. 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 to store your medication. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.

What to Do If You Miss a Dose

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

  • Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
  • Do not stop taking this medication abruptly without consulting your doctor.
  • Maintain a healthy diet and exercise routine.
  • Avoid alcohol consumption while on this medication.
  • Store medication securely to prevent misuse or diversion.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD/BED: Initial 30 mg once daily in the morning. Titrate by 10-20 mg/day weekly to a maximum of 70 mg/day.
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

ADHD: Initial 30 mg once daily, titrate to max 70 mg/day.
Binge Eating Disorder (BED): Initial 30 mg once daily, titrate to 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 in the morning. Titrate by 10-20 mg/day weekly to a maximum of 70 mg/day.
Adolescent: ADHD (13-17 years): Initial 30 mg once daily in the morning. Titrate by 10-20 mg/day weekly to a maximum of 70 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 60-89 mL/min).
Moderate: Maximum dose 50 mg/day (CrCl 30-59 mL/min).
Severe: Maximum dose 30 mg/day (CrCl <30 mL/min).
Dialysis: Not recommended; lisdexamfetamine and dextroamphetamine are not dialyzable to a significant extent.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

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 blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly measured for lisdexamfetamine due to rapid conversion; dextroamphetamine bioavailability is high.
Tmax: Lisdexamfetamine: ~1 hour; Dextroamphetamine: ~3.5 hours.
FoodEffect: Food does not significantly affect absorption or Tmax of dextroamphetamine.

Distribution:

Vd: Dextroamphetamine: ~0.8-1.2 L/kg
ProteinBinding: Dextroamphetamine: Low (~15-20%)
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance: Dextroamphetamine: ~0.7 L/kg/hr
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites)
Unchanged: Dextroamphetamine: ~50% excreted unchanged in urine
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 3-4 hours (for dextroamphetamine)
DurationOfAction: Up to 14 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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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 immediately or seek emergency 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
Difficulty controlling body movements
Trouble controlling sounds, such as:
+ Humming
+ Throat clearing
+ Yelling
+ Making loud noises
Changes in skin color (hands, feet, or other areas), which may turn:
+ Pale
+ Blue
+ Gray
+ Purple
+ 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 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 only have mild ones, 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain
  • Shortness of breath
  • Fainting (syncope)
  • Unexplained wounds on fingers or toes
  • New or worsening mental health problems (e.g., hallucinations, paranoia, severe anxiety, aggression)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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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. Be sure to 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 medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Recent use (within the last 14 days) of certain depression or Parkinson's disease medications, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: combining these medications can lead to 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 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 may 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 first.
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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 performing tasks that require alertness or 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 may cause 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 heart tests. If you have questions or concerns, discuss them with your doctor. This drug may 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, may 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, may occur, which can lead to severe health problems 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 may 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. If you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.

In some cases, this medication may 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 may 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
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis
  • Convulsions
  • Coma
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps

What to Do:

Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US) immediately. Seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use
  • Advanced arteriosclerosis
  • Symptomatic cardiovascular disease
  • Hyperthyroidism
  • Glaucoma
  • Severe hypertension
  • Agitated states
  • History of drug abuse
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensives (may reduce antihypertensive effect)
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase amphetamine excretion, decrease efficacy
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - decrease amphetamine excretion, increase efficacy/toxicity
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Moderate Interactions

  • Alcohol (may alter release/absorption characteristics)
  • Proton Pump Inhibitors (PPIs) / H2 Blockers (may slightly alter absorption, generally not clinically significant)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood pressure and heart rate

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation.

Height and weight

Rationale: Risk of growth suppression in children; general health assessment.

Timing: Prior to initiation (especially in pediatric patients).

Psychiatric history and family history

Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) and family history of sudden cardiac death or arrhythmias.

Timing: Prior to initiation.

ECG

Rationale: Consider if patient has pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.

Timing: Prior to initiation (if indicated).

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Routine Monitoring

Blood pressure and heart rate

Frequency: At each visit

Target: Within normal limits for age/baseline

Action Threshold: Sustained elevation requiring intervention or dose adjustment.

Height and weight

Frequency: Every 3-6 months (children), periodically (adults)

Target: Normal growth trajectory (children), stable weight (adults)

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric symptoms

Frequency: At each visit

Target: Absence of new or worsening psychosis, mania, aggression, severe anxiety, depression, suicidal ideation.

Action Threshold: Emergence or worsening of symptoms requiring intervention or discontinuation.

Signs of abuse/diversion

Frequency: Periodically

Target: Not applicable

Action Threshold: Evidence of abuse or diversion.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Unexplained wounds on fingers or toes (Raynaud's phenomenon)
  • New or worsening tics
  • Hallucinations
  • Delusions
  • Paranoia
  • Agitation
  • Aggression
  • Severe anxiety
  • Depression
  • Suicidal ideation
  • Growth suppression (in children)

Special Patient Groups

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Pregnancy

No adequate and well-controlled studies in pregnant women. May cause fetal harm. Use only if the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes (e.g., premature delivery, low birth weight). Neonatal withdrawal symptoms have been reported.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are limited and inconsistent.
Second Trimester: Potential for growth restriction and premature delivery.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence) if used near term.
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Lactation

Dextroamphetamine is excreted into human milk. Advise mothers not to breastfeed during treatment with Vyvanse due to potential serious adverse reactions in the breastfed infant.

Infant Risk: Irritability, poor feeding, sleep disturbances, and potential for long-term neurodevelopmental effects.
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Pediatric Use

Growth suppression (weight and height) has been observed. Monitor growth regularly. Psychiatric adverse events (psychosis, mania) can occur. Safety and efficacy not established in children younger than 6 years of age for ADHD or in pediatric patients for BED.

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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. 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 it's inactive until metabolized in the body, which contributes to its smoother onset and longer duration compared to immediate-release stimulants.
  • The chewable tablet can be chewed thoroughly and swallowed, or dissolved in water or orange juice and consumed immediately. Do not crush, chew, or divide the capsule formulation.
  • Dosing is based on the lisdexamfetamine dimesylate salt, not the dextroamphetamine base.
  • Patients should be advised to avoid taking doses in the late afternoon or evening to prevent sleep disturbances.
  • Monitor for signs of peripheral vasculopathy, including Raynaud's phenomenon, which can manifest as unexplained wounds on fingers or toes.
  • Careful assessment for pre-existing cardiac conditions and psychiatric disorders is crucial before initiating therapy.
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Alternative Therapies

  • Other CNS Stimulants (e.g., methylphenidate, mixed amphetamine salts, dexmethylphenidate)
  • Non-stimulants (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
  • Antidepressants (e.g., bupropion for ADHD, SSRIs for BED)
  • Behavioral therapy (e.g., Cognitive Behavioral Therapy for ADHD and BED)
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Cost & Coverage

Average Cost: $350-$450 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 2/3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, 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. Please read it 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.