Vyvanse 30mg 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.
đŸˇī¸
Drug Class
Central Nervous System Stimulant
đŸ§Ŧ
Pharmacologic Class
Prodrug of Dextroamphetamine; Sympathomimetic Amine
🤰
Pregnancy Category
Category C
✅
FDA Approved
Feb 2007
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

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 behaviors.
📋

How to Use This Medicine

Taking Your Medication

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 avoid sleep problems, try to take your medication earlier in the day, rather than late in the evening.

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 and swallow the mixture right away. Do not store the mixed medication 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. Keep your medication out of the reach of children and pets, and consider storing it in a locked box or area to prevent accidental ingestion or misuse.

When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist. Check with your pharmacist for guidance on how to dispose of your medication, and consider participating in a drug take-back program in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not take in the afternoon or evening as it may cause sleep problems.
  • Can be taken with or without food.
  • Capsules can be swallowed whole, or opened and the entire contents mixed with yogurt, water, or orange juice and consumed immediately.
  • Avoid alcohol, as it may increase side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 30 mg once daily in the morning, titrated to effect
Dose Range: 30 - 70 mg

Condition-Specific Dosing:

ADHD: Initial 30 mg once daily; maximum 70 mg/day. Dose adjustments in 10-20 mg increments at approximately weekly intervals.
BED: Initial 30 mg once daily; maximum 70 mg/day. Dose adjustments in 10-20 mg increments at approximately weekly intervals.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 30 mg once daily; maximum 70 mg/day. Dose adjustments in 10-20 mg increments at approximately weekly intervals.
Adolescent: ADHD (13-17 years): Initial 30 mg once daily; maximum 70 mg/day. Dose adjustments in 10-20 mg increments at approximately weekly intervals.
âš•ī¸

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)
Dialysis: Not recommended for patients on end-stage renal disease (ESRD) requiring dialysis. Lisdexamfetamine and dextroamphetamine are not dialyzable.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: No dosage adjustment needed

Pharmacology

đŸ”Ŧ

Mechanism of Action

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine, which is a central nervous system (CNS) stimulant. 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not directly measured for lisdexamfetamine due to prodrug nature; dextroamphetamine bioavailability is high.
Tmax: Lisdexamfetamine: 1 hour; Dextroamphetamine: 3.5-4.5 hours (after oral administration of lisdexamfetamine)
FoodEffect: Food does not affect the extent of absorption (AUC) or Cmax of dextroamphetamine, but it may prolong Tmax by approximately 1 hour.

Distribution:

Vd: Not available for lisdexamfetamine; Dextroamphetamine: 2.5-4.5 L/kg
ProteinBinding: Not available for lisdexamfetamine; Dextroamphetamine: Approximately 15-20% to plasma proteins
CnssPenetration: Yes (dextroamphetamine readily crosses the blood-brain barrier)

Elimination:

HalfLife: Lisdexamfetamine: <1 hour; Dextroamphetamine: 10-13 hours (adults), 9-11 hours (children)
Clearance: Not available for lisdexamfetamine; Dextroamphetamine: Primarily renal excretion
ExcretionRoute: Renal (primarily as dextroamphetamine and its metabolites)
Unchanged: Approximately 50% of dextroamphetamine is excreted unchanged in urine; the remainder is metabolized.
âąī¸

Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for clinical effects of dextroamphetamine)
PeakEffect: Approximately 3.5-4.5 hours (for dextroamphetamine plasma concentrations)
DurationOfAction: Up to 14 hours

Safety & Warnings

âš ī¸

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.
âš ī¸

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
Trouble 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 feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine

If you have a history of heart problems or heart defects, inform your doctor, as sudden deaths have occurred in people with these conditions. Additionally, if a family member has an abnormal heartbeat or 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
Upset stomach
Throwing up
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
Throwing up
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Trouble sleeping
Dizziness

If any of these side effects or other concerns bother you or do not go away, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

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., palpitations, irregular heartbeat)
  • New or worsening mental problems (e.g., hallucinations, paranoia, mania, aggression)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
  • Severe headache
  • Uncontrolled movements or tics
📋

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. Describe the allergic reaction and its symptoms.
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 (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ 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 determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
âš ī¸

Precautions & Cautions

Important Warnings and 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, and if you have any questions or concerns, you should discuss them with your doctor.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision.

Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the drug may not work as well, and you may need higher doses to achieve the same effect. If you experience this, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication can cause dependence, and stopping it suddenly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Monitoring and Testing
Before starting this medication, you may need to undergo heart tests. Your doctor will also monitor your blood pressure and heart rate, so it is crucial to follow their instructions for checking these vital signs. This medication may affect certain laboratory tests, so inform all your healthcare providers and lab workers that you are taking this medication.

Interactions with Other Medications
Be cautious when using 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 certain natural products or aids, as they may increase blood pressure. Consult your doctor before using these products.

Severe Skin Reactions
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. 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 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. Contact your doctor immediately 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.

Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, so discuss this with your doctor. 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.

Pregnancy and Breastfeeding
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.
🆘

Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Seek emergency medical attention.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
🔴

Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensives (may decrease hypotensive effect)
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine levels and prolong half-life
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine levels and shorten half-life
  • Alcohol (may alter absorption and increase exposure to dextroamphetamine)
🟡

Moderate Interactions

  • Proton pump inhibitors (PPIs) and H2 blockers (may slightly alter absorption, but generally not clinically significant)
  • Antipsychotics (may antagonize stimulant effects)
  • Antidepressants (e.g., bupropion, TCAs - may increase risk of seizures or cardiovascular effects)
  • Adrenergic blockers (e.g., guanethidine) - may inhibit adrenergic neuron blocking effects
đŸŸĸ

Minor Interactions

  • Not specifically listed as minor; most interactions are significant due to stimulant nature.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause dose-related increases in BP and HR.

Timing: Prior to initiation

Height and Weight

Rationale: Stimulants can cause growth suppression in pediatric patients.

Timing: Prior to initiation (especially pediatric)

Cardiovascular history (personal and family)

Rationale: To identify pre-existing cardiac conditions that may contraindicate use or require caution.

Timing: Prior to initiation

Psychiatric history (personal and family)

Rationale: To assess risk for new or exacerbated psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation

📊

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: Significant or sustained increases warrant dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Growth deceleration or weight loss may require dose adjustment or drug holiday.

Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania)

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

Target: Absence of new or worsening symptoms

Action Threshold: Emergence of symptoms warrants evaluation and potential discontinuation.

Abuse/Diversion potential

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

Target: No signs of abuse or diversion

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

đŸ‘ī¸

Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New-onset psychosis
  • Mania
  • Aggression
  • Hostility
  • Anxiety
  • Depression
  • Severe headache
  • Blurred vision
  • Numbness/tingling in extremities (Raynaud's phenomenon)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause adverse pregnancy outcomes, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of congenital malformations not definitively established.
Second Trimester: Potential for growth restriction and premature birth.
Third Trimester: Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypertonia) if used near term.
🤱

Lactation

Dextroamphetamine is 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: L3 (Moderate risk - potential for adverse effects on infant; monitor closely or consider alternative)
đŸ‘ļ

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.

👴

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, 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

💎

Clinical Pearls

  • Vyvanse is a prodrug, meaning it is inactive until converted in the body. This contributes to its smoother, longer-lasting effect and lower abuse potential compared to immediate-release amphetamines.
  • The conversion of lisdexamfetamine to dextroamphetamine is not affected by gastrointestinal pH, unlike some other stimulants, which can be beneficial for patients with GI issues.
  • It is crucial to educate patients about the potential for abuse and dependence, and to store the medication securely.
  • For patients who have difficulty swallowing capsules, the contents can be mixed with liquid or soft food, ensuring the entire mixture is consumed immediately.
  • Regular cardiovascular monitoring is essential, especially in patients with pre-existing cardiac conditions or risk factors.
🔄

Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Amphetamine/dextroamphetamine (e.g., Adderall, Mydayis)
  • Dexmethylphenidate (e.g., Focalin)
  • Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Other treatments for BED (e.g., Topiramate, SSRIs, psychotherapy)
💰

Cost & Coverage

Average Cost: $350 - $450 per 30 capsules (30mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.