Vyvanse 10mg 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
Category C
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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 Binge Eating Disorder (BED). It works by increasing the levels of certain natural substances in the brain that help with focus, attention, and impulse control. It's a 'prodrug,' meaning it's inactive until your body converts it into the active form, dextroamphetamine, which helps provide a smooth and long-lasting effect.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. To minimize sleep disturbances, avoid taking 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 bathrooms. 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 explore local drug take-back programs.

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 to avoid 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.
  • Avoid alcohol, as it can increase side effects.
  • Maintain a healthy diet and ensure adequate sleep.
  • Store securely to prevent misuse or diversion.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: 30 mg once daily in the morning. BED: 50-70 mg 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. Max 70 mg/day.
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Pediatric Dosing

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

Renal Impairment:

Mild: No adjustment necessary (CrCl 50-80 mL/min).
Moderate: Maximum dose 50 mg/day (CrCl 30 to <50 mL/min).
Severe: Maximum dose 30 mg/day (CrCl <30 mL/min).
Dialysis: Supplemental dose not needed after dialysis; consider lower dose due to reduced clearance.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended; use with caution due to potential for increased exposure.

Pharmacology

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Mechanism of Action

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine, which is a non-catecholamine sympathomimetic amine. Dextroamphetamine 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: Not directly measured for lisdexamfetamine; dextroamphetamine bioavailability is high (75-100%).
Tmax: Lisdexamfetamine: 1 hour; Dextroamphetamine: 3.5 hours (after oral administration of lisdexamfetamine).
FoodEffect: Food does not affect the extent of absorption of dextroamphetamine, but may prolong Tmax by approximately 1 hour.

Distribution:

Vd: Dextroamphetamine: 2.4-4.5 L/kg.
ProteinBinding: Dextroamphetamine: Approximately 15-25% to plasma proteins.
CnssPenetration: Yes

Elimination:

HalfLife: Lisdexamfetamine: Less than 1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children).
Clearance: Dextroamphetamine: Approximately 0.7 L/kg/hr.
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites).
Unchanged: Approximately 50% of dextroamphetamine is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for therapeutic effects of dextroamphetamine).
PeakEffect: Approximately 3.5 hours (for dextroamphetamine plasma concentrations).
DurationOfAction: Up to 14 hours (for ADHD symptom control).
Confidence: High

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
Abnormal or rapid heartbeat
Difficulty controlling body movements
Uncontrollable sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (hands, feet, or other areas), which may appear pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold sensations in the hands or feet
Sores or wounds on the fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:

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
Abnormal or rapid 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 symptoms, 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
Difficulty sleeping
Dizziness

If you experience any of these side effects or have concerns about other symptoms, 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).
  • New or worsening heart problems (e.g., high blood pressure, fast heartbeat).
  • New or worsening mental problems (e.g., hearing voices, believing things that are not true, becoming suspicious, aggression, hostility).
  • New or worsening tics (uncontrolled movements or sounds).
  • Numbness, pain, or discoloration in fingers or toes.
  • Unexplained weight loss or slowed growth in children.
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you or a family member has a 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
If you have any of the following health conditions:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have a history of:
+ Drug abuse
+ Stroke
If you are currently taking or have recently taken certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of 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 (prescription, over-the-counter, natural products, and vitamins) and health problems to ensure safe use. Do not 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, be sure to discuss them with your doctor.

To ensure your safety, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. Additionally, if you have been taking this drug 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 this medication is not working as well as it should, contact your doctor. Do not take more than the prescribed dose.

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

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

Certain over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, can interact with this medication and increase blood pressure. Inform your doctor before using any of these products, and tell all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, permanent damage, and 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 problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.

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

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

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis, serotonin syndrome).
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
  • Antihypertensives - may decrease the hypotensive effect of these drugs.
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine blood levels and prolong half-life.
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease dextroamphetamine blood levels and shorten half-life.
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of stimulants.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - generally no significant interaction as hydrolysis is not pH-dependent in the GI tract.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR)

Rationale: To identify pre-existing cardiovascular conditions and establish baseline for potential stimulant-induced changes.

Timing: Prior to initiation of therapy.

Height and Weight (especially in children)

Rationale: To establish baseline for growth monitoring due to potential for growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric history (personal and family)

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated.

Timing: Prior to initiation of therapy.

Drug abuse history

Rationale: To assess risk of abuse and diversion.

Timing: Prior to initiation of therapy.

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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; monitor for sustained elevations.

Action Threshold: Sustained elevation above baseline or age-appropriate norms; consider dose reduction or discontinuation.

Height and Weight (especially in children)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

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

Psychiatric status (mood, anxiety, tics, aggression, psychosis)

Frequency: At each visit.

Target: Stable or improved psychiatric symptoms.

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

Effectiveness of therapy (ADHD/BED symptoms)

Frequency: At each visit.

Target: Improved symptom control.

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Aggression
  • Hostility
  • New psychotic or manic symptoms (e.g., hallucinations, delusions)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy due to potential risks to the fetus, including premature delivery and low birth weight. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester: Potential for premature delivery and low birth weight.
Third Trimester: Potential for premature delivery, low birth weight, and withdrawal symptoms in the neonate (e.g., agitation, tremor, feeding difficulties).
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Lactation

Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, growth suppression), breastfeeding is not recommended during treatment with lisdexamfetamine.

Infant Risk: Moderate to High (L3 - L4)
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Psychiatric adverse events (e.g., new or worsening psychosis, mania, aggression) should be monitored. Cardiovascular assessment is crucial.

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Geriatric Use

Use with caution in elderly patients, generally starting at the lower end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Monitor for cardiovascular and psychiatric adverse effects.

Clinical Information

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Clinical Pearls

  • Vyvanse is a prodrug, meaning its effects are smoother and longer-lasting compared to immediate-release stimulants, with less potential for 'crash' or 'wear-off' effects.
  • The prodrug nature also reduces the potential for intravenous abuse compared to immediate-release amphetamines.
  • Hydrolysis to dextroamphetamine occurs in the blood, not the GI tract, so gastric pH changes do not significantly affect absorption.
  • Ensure patients are screened for cardiac abnormalities and psychiatric comorbidities before initiation.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is essential.
  • Educate patients and caregivers on the signs of stimulant abuse and the importance of secure storage.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Methylphenidate, Dextroamphetamine, Mixed Amphetamine Salts)
  • Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Other medications for BED (e.g., Topiramate, SSRIs)
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Cost & Coverage

Average Cost: $350 - $450 per 30 capsules (various strengths)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand, or generic tier if available)
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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 incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.