Vyvanse 60mg Capsules

Manufacturer SHIRE US INC. Active Ingredient Lisdexamfetamine Capsules(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 (Risk Summary)
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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's a 'prodrug' which means your body converts it into an active form (dextroamphetamine) after you take it. This active form helps increase certain natural chemicals in your brain, which can improve focus, attention, and control over impulsive behaviors.
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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 this medication late in the day.

When taking the capsule, swallow it whole without chewing, breaking, or crushing. However, if needed, you can open the capsule and mix the powder with water, orange juice, or yogurt. If the powder clumps together, you can use a spoon to gently break it apart. Mix well and swallow the mixture immediately. Do not store the mixed medication for later use.

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. Store the medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Keep all medications out of reach of pets.

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. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.

Missing 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 one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not take in the afternoon or evening as it can cause sleep problems.
  • Can be taken with or without food.
  • Capsules can be swallowed whole, or opened and mixed with yogurt, water, or orange juice and consumed immediately.
  • Maintain a healthy diet and ensure adequate sleep.
  • Avoid alcohol, as it can increase side effects.
  • Store safely to prevent misuse or abuse.

Dosing & Administration

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Adult Dosing

Standard Dose: 30-70 mg orally once daily in the morning
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.
BED: Initial 30 mg once daily; titrate in 20 mg increments weekly to a target dose of 50-70 mg/day. Maximum 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: Maximum 50 mg/day (CrCl 30-50 mL/min)
Severe: Maximum 30 mg/day (CrCl <30 mL/min)
Dialysis: Maximum 30 mg/day; administer after dialysis. Consider alternative treatment.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (Lisdexamfetamine is a prodrug activated in blood, not liver)

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 causes the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also inhibits the reuptake of these monoamines into the presynaptic neuron, thereby increasing their concentrations in the synaptic cleft.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly applicable for prodrug, but conversion to dextroamphetamine is high.
Tmax: Lisdexamfetamine: ~1 hour; Dextroamphetamine: ~3.5 hours (oral solution) to 4.7 hours (capsule)
FoodEffect: Minimal effect on absorption or Tmax of dextroamphetamine.

Distribution:

Vd: Dextroamphetamine: ~2.4 L/kg
ProteinBinding: Dextroamphetamine: Low (15-20%)
CnssPenetration: Yes

Elimination:

HalfLife: Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance: Not readily available for lisdexamfetamine due to rapid conversion; Dextroamphetamine renal clearance is pH-dependent.
ExcretionRoute: Renal (primarily unchanged dextroamphetamine and its metabolites)
Unchanged: Approximately 50% of dextroamphetamine excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: ~1-2 hours
PeakEffect: ~3.5-4.7 hours (for dextroamphetamine)
DurationOfAction: Up to 14 hours
Confidence: High

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Vyvanse, other amphetamine products, and methylphenidate, 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 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
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 sensation 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 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. 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 minor 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 visit 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)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • New or worsening mental problems (e.g., seeing or hearing things that are not real, believing things that are not true, suspiciousness, agitation, aggression)
  • New or worsening tics (uncontrolled movements or sounds)
  • Unexplained wounds on fingers or toes
  • Severe headache or blurred vision
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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 to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Approved Use

This medication is not approved for weight loss. If you have any questions or concerns, be sure to discuss them with your doctor.

Safety Precautions

Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.

Long-Term Use and Dependence

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it once did. In this case, you may need to take higher doses to achieve the same effect. However, do not take more than the prescribed dose. Long-term or regular use of this medication can also lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this can cause withdrawal symptoms. Instead, talk to your doctor, who will provide guidance on how to safely reduce or stop the medication.

Monitoring and Follow-Up

Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss the details with you. Additionally, this medication can cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor.

Interactions with Other Medications

This medication can affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab personnel that you are taking this medication. Also, before using any over-the-counter (OTC) products, 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, talk to your doctor, as these can interact with your medication and increase your blood pressure.

Rare but Serious Side Effects

In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This can lead to serious health problems, including death. If you experience any 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, seek medical attention immediately.

Mental Health and Mood Changes

This medication can 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. If you experience any symptoms such as hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor right away.

Use in Children and Teens

This medication can affect growth in children and teens. If you are a parent or guardian, be sure to discuss this with your child's doctor, who may recommend regular growth checks. Additionally, this medication is not approved for use in children under the age of 6, as it can 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, who will discuss the benefits and risks of taking this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Aggressiveness
  • Hallucinations
  • Panic states
  • High fever (hyperpyrexia)
  • Rhabdomyolysis
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Seizures
  • Coma

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Management typically involves supportive care, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation
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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
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine blood levels and prolong half-life
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine blood levels and shorten half-life
  • Antihypertensives - may reduce the hypotensive effect of these drugs
  • Tricyclic Antidepressants (TCAs) - increased cardiovascular effects
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Moderate Interactions

  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines
  • Lithium - may antagonize the stimulant effects of amphetamines
  • Propoxyphene - may increase amphetamine levels
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular events (hypertension, tachycardia)

Timing: Prior to initiation

Height and Weight (Pediatric)

Rationale: Risk of growth suppression

Timing: Prior to initiation

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

Rationale: Risk of exacerbating psychiatric conditions or inducing new psychotic/manic symptoms

Timing: Prior to initiation

Cardiovascular Assessment (e.g., ECG if indicated by history/exam)

Rationale: To identify pre-existing cardiac conditions that may contraindicate use

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or every 3-6 months

Target: Within normal limits for age

Action Threshold: Sustained elevation requiring intervention or discontinuation

Weight and Height (Pediatric)

Frequency: Every 3-6 months

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss

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

Frequency: At each visit

Target: Absence of new or worsening symptoms

Action Threshold: Emergence or worsening of severe psychiatric symptoms

Clinical response to therapy and adverse effects

Frequency: Regularly, especially during titration and dose changes

Target: Improved ADHD/BED symptoms with tolerable side effects

Action Threshold: Lack of efficacy or intolerable side effects

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Unexplained dizziness
  • Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)
  • Hallucinations
  • Delusional thinking
  • Mania
  • Aggression
  • Agitation
  • New or worsening tics

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 may cause adverse pregnancy outcomes (e.g., preterm birth, low birth weight). Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations not definitively established.
Second Trimester: Potential for growth restriction.
Third Trimester: Risk of preterm birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
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Lactation

Amphetamines are excreted into human milk. Breastfeeding is not recommended during treatment with lisdexamfetamine due to the potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss).

Infant Risk: Moderate to High (L3 - Moderately safe, but significant concerns for CNS effects and growth suppression in infant. L4 - Possibly hazardous, often recommended to avoid).
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Long-term safety and efficacy in children younger than 6 years have not been established.

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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, use with caution due to increased risk of cardiovascular events and other adverse effects in older adults. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Vyvanse is a prodrug, meaning it is inactive until converted to dextroamphetamine in the body, primarily in the blood. This mechanism contributes to its longer duration of action and potentially lower abuse potential compared to immediate-release amphetamines.
  • The dose of Vyvanse is not equivalent to other amphetamine products on a milligram-to-milligram basis due to its prodrug nature.
  • Capsules can be opened and mixed with water, orange juice, or yogurt for easier administration, which does not affect its absorption or efficacy.
  • Patients should be advised to avoid taking Vyvanse in the late afternoon or evening to prevent insomnia.
  • Regular monitoring of cardiovascular parameters (BP, HR) and growth (in children) is crucial due to potential side effects.
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Alternative Therapies

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

Average Cost: Varies widely, typically $300-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
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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, which provides crucial information for patients. 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. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.