Vyvanse 20mg 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 Stimulant
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Pharmacologic Class
Prodrug of Dextroamphetamine
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Pregnancy Category
Not available
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 Binge Eating Disorder (BED). It 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 helps provide a smoother, longer-lasting effect.
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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.

When taking your medication, swallow the capsule whole - do not chew, break, or crush it. However, if you need to, 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 the powder well with your chosen liquid. If you mix the medication with a liquid, take it immediately - do not store it for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, keep your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to store your medication. Keep all medications out of reach of pets.

When disposing of your medication, do not flush it down the toilet or pour it down the drain unless you are instructed to do so. Instead, check with your pharmacist for guidance on the best way to dispose of unused or expired medication. You may also want to explore local drug take-back programs in your area.

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, with or without food.
  • Do not take in the afternoon or evening as it may cause sleep problems.
  • Swallow capsules whole, or open and mix the entire contents with yogurt, water, or orange juice and consume immediately.
  • Avoid alcohol, as it can increase side effects.
  • Maintain a healthy diet and regular exercise.
  • Report any new or worsening psychiatric symptoms or cardiovascular symptoms immediately.

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 dose 30 mg once daily in the morning. May be increased in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg/day.
Binge Eating Disorder (BED): Initial dose 30 mg once daily in the morning. May be increased in 20 mg increments at approximately weekly intervals to a target dose of 50 mg/day to 70 mg/day. Maximum 70 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose 30 mg once daily in the morning for ADHD (ages 6-12 years). May be increased in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg/day.
Adolescent: Initial dose 30 mg once daily in the morning for ADHD (ages 13-17 years). May be increased in 10 mg or 20 mg increments at approximately weekly intervals to a maximum of 70 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (eGFR 60-89 mL/min/1.73 m²)
Moderate: Consider reducing maximum dose to 50 mg/day (eGFR 30-59 mL/min/1.73 m²)
Severe: Maximum dose 30 mg/day (eGFR <30 mL/min/1.73 m²)
Dialysis: Supplemental dose after dialysis is not needed. Avoid use in end-stage renal disease (ESRD) due to lack of data.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: No dosage 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 exerts its therapeutic effect by releasing norepinephrine and dopamine from nerve terminals in the brain, primarily in the prefrontal cortex. It also inhibits the reuptake of these monoamines.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly measured for lisdexamfetamine, but dextroamphetamine bioavailability is high (approx. 75-90%)
Tmax: Lisdexamfetamine: 3.5 hours; Dextroamphetamine: 4.5 hours (after oral administration of lisdexamfetamine)
FoodEffect: Food does not affect the extent of absorption (AUC) or peak plasma concentration (Cmax) of lisdexamfetamine or dextroamphetamine, but it may delay Tmax by approximately 1 hour.

Distribution:

Vd: Dextroamphetamine: 2.4-4.5 L/kg
ProteinBinding: Dextroamphetamine: Approximately 15-20%
CnssPenetration: Yes

Elimination:

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

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 3-4 hours (for therapeutic effect, correlating with dextroamphetamine peak)
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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating

If you have a heart condition or defect, inform your doctor, as sudden deaths have occurred in people with certain heart problems. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek immediate medical help if you experience:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Call your doctor right away if you experience:

Agitation
Balance problems
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

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Anxiety
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Feeling jittery
Weight loss
Difficulty sleeping
* Dizziness

This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. 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, coolness, or pain in fingers or toes
  • Unexplained wounds on fingers or toes
  • New or worsening aggression or hostility
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics (uncontrolled movements or sounds)
  • Unusual changes in mood or behavior (e.g., extreme happiness, irritability, racing thoughts)
  • Severe headache, blurred vision, confusion, seizures (signs of hypertensive crisis)
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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 been diagnosed with:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, including:
+ Drug abuse
+ Stroke
Current medications, especially:
+ Acetazolamide
+ Sodium bicarbonate
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Use of other specific medications, including:
+ 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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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 drug is not intended for weight loss, so if you have any questions or concerns, be sure to discuss them with your doctor.

Safety Precautions

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

Risk of Dependence and Withdrawal

Long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may result in withdrawal symptoms. Before reducing the dose or stopping the medication, consult with your doctor and follow their instructions. If you experience any adverse effects, report them to your doctor.

Heart-Related Precautions

You may need to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. This medication may 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 and Lab Tests

This medication may affect certain lab tests, so inform all of your healthcare providers and lab personnel that you are taking it. Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult with your doctor.

Severe Skin Reactions

A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems that may be permanent and, in some cases, fatal. 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.

Behavior and Mood Changes

This medication may 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 hallucinations, changes in behavior, or signs of mood changes such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.

Effects on Growth in Children and Teens

This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss any concerns with your doctor.

Use in Children

This medication is not approved for use in children under the age of 6. The risk of long-term weight loss is increased in children under 6 years old.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of using this medication during pregnancy.
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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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic treatment, 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 (risk of hypertensive crisis)
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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 counteract hypotensive effect
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase dextroamphetamine blood levels and prolong half-life
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine blood levels and shorten half-life
  • Halogenated anesthetics - risk of arrhythmias
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Moderate Interactions

  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
  • Lithium - may inhibit stimulant effects
  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of stimulants
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - generally no significant interaction due to non-gastric conversion of lisdexamfetamine
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Minor Interactions

  • Not specifically listed as minor for lisdexamfetamine, but general caution with other CNS stimulants or depressants.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR; screen for pre-existing cardiovascular conditions.

Timing: Prior to initiation

Height and Weight

Rationale: Monitor for growth suppression in pediatric patients.

Timing: Prior to initiation

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

Rationale: Stimulants can exacerbate or unmask psychiatric symptoms.

Timing: Prior to initiation

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: Screen for underlying cardiac risk factors.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and periodically thereafter (e.g., every 3-6 months)

Target: Within normal limits for age/patient

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant further evaluation or dose adjustment.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss may require dose reduction or drug holiday.

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

Frequency: At each visit

Target: Absence of new or worsening symptoms

Action Threshold: Emergence or worsening of symptoms may require dose adjustment or discontinuation.

Abuse/Diversion Potential

Frequency: At each visit

Target: No signs of abuse or diversion

Action Threshold: Signs of abuse or diversion require intervention and re-evaluation of treatment plan.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms
  • Motor or vocal tics
  • Numbness, coolness, or pain in extremities (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes

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 fetal harm, including premature birth 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 (limited data, conflicting studies).
Second Trimester: Risk of premature birth and low birth weight.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
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Lactation

Lisdexamfetamine and its active metabolite, dextroamphetamine, are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), advise mothers not to breastfeed during treatment with Vyvanse.

Infant Risk: High (L3 - Moderate risk)
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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 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 its conversion to dextroamphetamine occurs in the blood, not the GI tract, which may reduce abuse potential by injection or snorting and provides a smoother, longer-lasting effect compared to immediate-release amphetamines.
  • The 20mg capsule contains 20mg of lisdexamfetamine dimesylate, which is equivalent to 5.8mg of dextroamphetamine base.
  • Patients should be advised to take Vyvanse in the morning to avoid insomnia.
  • Capsules can be opened and mixed with water, orange juice, or yogurt for patients who have difficulty swallowing pills.
  • Careful cardiovascular assessment is crucial before initiating therapy due to the risk of increased blood pressure and heart rate.
  • Monitor for emergence or exacerbation of psychiatric symptoms, especially in patients with a history of bipolar disorder or psychosis.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Amphetamine/dextroamphetamine (e.g., Adderall, Mydayis)
  • Atomoxetine (Strattera)
  • Guanfacine extended-release (Intuniv)
  • Clonidine extended-release (Kapvay)
  • Bupropion (Wellbutrin - off-label for ADHD)
  • Cognitive Behavioral Therapy (CBT) for ADHD and BED
  • Other psychotherapies for BED
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Cost & Coverage

Average Cost: $350 - $450 per 30 capsules (20mg)
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'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 consult 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.