Vyvanse 10mg 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; Sympathomimetic Amine
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Pregnancy Category
Not available
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FDA Approved
Jan 2017
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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 that works by affecting certain natural chemicals in the brain to help improve focus, attention, and control over impulsive behavior.
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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 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 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 a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not take in the late afternoon or evening to avoid sleep problems.
  • Can be taken with or without food.
  • Chewable tablets should be chewed thoroughly before swallowing.
  • Store at room temperature away from moisture and heat.
  • Keep out of reach of children and pets.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol consumption.

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg once daily in the morning
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

ADHD: Initial 30 mg once daily; titrate in increments of 10 mg or 20 mg per week to a maximum of 70 mg/day.
BED: Initial 30 mg once daily; titrate in increments of 20 mg per week to a target dose of 50 mg/day or 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 increments of 10 mg or 20 mg per week to a maximum of 70 mg/day.
Adolescent: ADHD (13-17 years): Initial 30 mg once daily; titrate in increments of 10 mg or 20 mg per week to a maximum of 70 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl 50-80 mL/min).
Moderate: Maximum dose 50 mg/day (CrCl 30-50 mL/min).
Severe: Maximum dose 30 mg/day (CrCl < 30 mL/min, non-dialysis).
Dialysis: Maximum dose 30 mg/day. Administer after dialysis session.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended. Use with caution as amphetamine is metabolized by the liver.

Pharmacology

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Mechanism of Action

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine and L-lysine. Dextroamphetamine is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: High (prodrug conversion)
Tmax: Lisdexamfetamine: ~1 hour; Dextroamphetamine: ~3.5 hours
FoodEffect: Food does not affect the extent of absorption, but may prolong Tmax by approximately 1 hour.

Distribution:

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

Elimination:

HalfLife: Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance: Not readily available for lisdexamfetamine; Dextroamphetamine clearance is primarily renal.
ExcretionRoute: Renal (urine)
Unchanged: Lisdexamfetamine: <0.1%; Dextroamphetamine: Approximately 50% (pH-dependent)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 3-4 hours (for dextroamphetamine effect)
DurationOfAction: Approximately 10-14 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Vyvanse, other amphetamine products, and methylphenidate products, 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 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
Uncontrollable 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 possible 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 or seek medical attention. 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, or fainting (seek immediate medical attention)
  • New or worsening aggression or hostility
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • Manic symptoms (e.g., extreme energy, racing thoughts, unusual behavior)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision
  • Uncontrolled tics or repetitive movements
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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 and its symptoms.
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 or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may 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 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 whether it is safe to take this medication with your existing treatments and health conditions. 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, be sure to discuss them with your doctor.

When starting this medication, avoid operating a vehicle or engaging in activities that require alertness and clear vision until you understand how it affects you. Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication'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 initiating treatment, you may need to undergo heart tests. If you have questions or concerns, discuss them with your doctor. This medication 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 interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. Before using over-the-counter 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 certain natural products or aids, consult your doctor.

A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can lead to 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. 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 can affect growth in children and adolescents, and regular growth checks may be necessary. 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
  • Rhabdomyolysis
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, gastric lavage, and activated charcoal.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort)
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide)
  • Antihypertensives
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Moderate Interactions

  • Acidifying agents (e.g., ascorbic acid, ammonium chloride)
  • Tricyclic Antidepressants (TCAs)
  • Phenothiazines
  • Halogenated Anesthetics

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR.

Timing: Prior to initiation.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation.

Cardiovascular Assessment

Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation.

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

Rationale: Stimulants can exacerbate or unmask psychiatric symptoms.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., at each visit or every 3-6 months)

Target: Within normal limits for age

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

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment.

Psychiatric Symptoms (e.g., anxiety, agitation, psychosis, mania, tics)

Frequency: Regularly (e.g., at each visit)

Target: Absence of new or worsening symptoms

Action Threshold: Emergence or worsening of symptoms; consider dose adjustment or discontinuation.

Abuse/Dependence Potential

Frequency: Regularly (e.g., at each visit)

Target: No signs of misuse or diversion

Action Threshold: Signs of abuse or dependence; consider referral for substance use disorder treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Motor or verbal tics
  • Blurred vision
  • Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)

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. There are risks to the mother and fetus associated with the use of amphetamines during pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations not consistently established.
Second Trimester: Potential for premature delivery and low birth weight.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., dysphoria, agitation, significant lethargy) if used during the third trimester.
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Lactation

Amphetamines are excreted into human milk. Because of the potential for serious adverse reactions in nursing infants, including serious cardiovascular reactions, growth suppression, and behavioral adverse effects, advise patients that breastfeeding is not recommended during treatment with Vyvanse.

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

Safety and effectiveness established in pediatric patients 6 to 17 years of age for ADHD. Long-term effects on growth (weight and height) should be monitored. Psychiatric adverse events (e.g., psychosis, mania) can occur.

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Geriatric Use

Clinical studies of Vyvanse did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, 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 is inactive until metabolized in the body, which contributes to its smooth, long-lasting effect and lower abuse potential compared to immediate-release amphetamines.
  • The chewable tablet is bioequivalent to the capsule formulation and can be taken with or without food.
  • Patients should be advised to chew the tablet thoroughly before swallowing.
  • Due to its long duration of action, it should be taken in the morning to avoid insomnia.
  • Careful cardiovascular and psychiatric screening is essential before initiating therapy and during treatment.
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Alternative Therapies

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

Average Cost: Varies widely, typically high per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand name)
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General Drug Facts

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, 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 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.