What are the common side effects of Vyvanse 20mg. How does Vyvanse work for ADHD in adults and children. What are the potential risks and warnings associated with Vyvanse use. How should Vyvanse be safely used and monitored.

Understanding Vyvanse: Mechanism of Action and Therapeutic Uses

Vyvanse, also known by its generic name lisdexamfetamine dimesylate, is a central nervous system stimulant medication primarily used to treat attention deficit hyperactivity disorder (ADHD) in both children and adults. It belongs to a class of drugs called amphetamines.

The active ingredient in Vyvanse, lisdexamfetamine, is a prodrug that is converted to dextroamphetamine in the body. This conversion process results in a gradual onset of effects and a longer duration of action compared to immediate-release stimulants.

How does Vyvanse work?

Vyvanse works by increasing the levels of neurotransmitters, particularly dopamine and norepinephrine, in the brain. These neurotransmitters play crucial roles in attention, focus, and impulse control. By enhancing their activity, Vyvanse helps improve concentration, reduce hyperactivity, and manage impulsive behaviors associated with ADHD.

Approved uses of Vyvanse

• Treatment of ADHD in children aged 6 and older
• Treatment of ADHD in adults
• Management of moderate to severe binge eating disorder in adults

Can Vyvanse be used for conditions other than ADHD? While Vyvanse is primarily prescribed for ADHD, it has shown efficacy in treating binge eating disorder in adults. However, it’s important to note that any off-label use should be discussed thoroughly with a healthcare provider.

Common Side Effects of Vyvanse 20mg in Adults with ADHD

While Vyvanse can be highly effective in managing ADHD symptoms, it may also cause various side effects. It’s crucial for patients to be aware of these potential adverse reactions and report them to their healthcare provider.

Frequently reported side effects

• Decreased appetite
• Weight loss
• Dry mouth
• Insomnia or difficulty sleeping
• Irritability
• Anxiety
• Nausea
• Headache
• Dizziness

Are these side effects persistent? Many side effects of Vyvanse tend to be mild and may subside as the body adjusts to the medication. However, if side effects persist or worsen, it’s important to consult with a healthcare provider.

Managing common side effects

1. Take Vyvanse early in the day to minimize sleep disturbances
2. Maintain a balanced diet and stay hydrated to combat decreased appetite
3. Practice good sleep hygiene to improve sleep quality
4. Use stress-reduction techniques to manage anxiety and irritability
5. Consider dose adjustments under medical supervision if side effects are problematic

Vyvanse in Children: Safety Profile and Side Effect Considerations

When prescribing Vyvanse for children with ADHD, healthcare providers must carefully weigh the potential benefits against the risks. While the medication can significantly improve ADHD symptoms, it may also cause side effects that require close monitoring.

Common side effects in children

• Decreased appetite
• Weight loss or slowed weight gain
• Sleep problems
• Irritability
• Mood swings
• Stomachache
• Dizziness

How can parents monitor their child’s response to Vyvanse? Parents should keep a close eye on their child’s behavior, appetite, sleep patterns, and overall mood. Regular check-ins with the prescribing physician are crucial to assess the medication’s effectiveness and manage any side effects.

Growth considerations in children

One concern with stimulant medications like Vyvanse is their potential impact on growth in children. Some children may experience slowed growth rate while taking Vyvanse. Healthcare providers typically monitor height and weight regularly and may recommend “drug holidays” during school breaks to mitigate this effect.

Serious Warnings and Precautions for Vyvanse Use

While Vyvanse can be an effective treatment for ADHD, it comes with several important warnings and precautions that both patients and healthcare providers must be aware of.

Cardiovascular risks

Vyvanse, like other stimulant medications, can increase heart rate and blood pressure. This poses potential risks for individuals with pre-existing heart conditions.

• Sudden death in patients with heart problems or heart defects
• Stroke and heart attack in adults
• Increased blood pressure and heart rate

Who should exercise caution when considering Vyvanse? Individuals with a history of heart problems, heart defects, high blood pressure, or a family history of these conditions should be carefully evaluated before starting Vyvanse. Regular monitoring of blood pressure and heart rate is essential during treatment.

Psychiatric side effects

Vyvanse may exacerbate existing mental health conditions or trigger new psychiatric symptoms in some individuals.

• New or worsening behavior and thought problems
• New or worsening bipolar illness
• New psychotic symptoms (such as hallucinations or delusions)
• New manic symptoms

Patients with a personal or family history of mental health disorders should be closely monitored when taking Vyvanse. Any new or worsening psychiatric symptoms should be reported to a healthcare provider immediately.

Potential for Abuse and Dependence: Important Considerations

Vyvanse is classified as a Schedule II controlled substance due to its potential for abuse and dependence. This classification reflects the need for careful prescribing and monitoring practices.

Risk factors for abuse

• History of substance abuse
• Family history of substance abuse
• Mental health disorders
• Environmental factors (e.g., peer pressure, stress)

How can the risk of Vyvanse abuse be minimized? Healthcare providers should conduct thorough assessments before prescribing Vyvanse, including screening for substance abuse history. Patients should be educated about the risks of misuse and the importance of taking the medication exactly as prescribed.

Signs of dependence

Physical dependence on Vyvanse can develop with long-term use, leading to withdrawal symptoms when the medication is stopped abruptly.

• Fatigue
• Depression
• Sleep disturbances
• Increased appetite
• Irritability

To minimize the risk of dependence, Vyvanse should be prescribed at the lowest effective dose and for the shortest duration necessary to achieve therapeutic goals. Any changes in dosage or discontinuation should be done under medical supervision.

Vyvanse Interactions: Medications and Substances to Avoid

Vyvanse can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial for patients to inform their healthcare providers about all medications, supplements, and substances they are using.

Common drug interactions

• Monoamine oxidase inhibitors (MAOIs)
• Serotonergic drugs (e.g., SSRIs, SNRIs)
• CYP2D6 inhibitors
• Antacids and other gastrointestinal acidifying agents
• Other stimulant medications

Why is it important to avoid certain substances while taking Vyvanse? Some substances can interact with Vyvanse, potentially leading to dangerous side effects or reducing the medication’s effectiveness. For example, combining Vyvanse with MAOIs can cause a severe, potentially life-threatening reaction.

Substances to avoid

Patients taking Vyvanse should exercise caution with or avoid the following substances:

• Alcohol
• Caffeine
• Illegal drugs
• Over-the-counter cold and allergy medications containing decongestants

These substances can potentially interact with Vyvanse, exacerbating side effects or altering the medication’s effectiveness. Patients should consult their healthcare provider before using any new medications or supplements while taking Vyvanse.

Proper Usage and Dosing Guidelines for Vyvanse 20mg

Adhering to proper usage and dosing guidelines is essential for maximizing the benefits of Vyvanse while minimizing potential risks and side effects.

General dosing information

• Vyvanse is typically taken once daily in the morning
• It can be taken with or without food
• The capsule can be swallowed whole or opened and mixed with water, yogurt, or orange juice
• Dosage is individualized based on the patient’s response and tolerability

How should the Vyvanse dose be adjusted? Dosage adjustments should always be made under the guidance of a healthcare provider. The goal is to find the lowest effective dose that provides symptom control with minimal side effects.

Dosing considerations for different age groups

The initial and maximum doses of Vyvanse may vary depending on the patient’s age and the condition being treated:

• Children (6-12 years): Initial dose of 20-30 mg/day, maximum 70 mg/day
• Adolescents (13-17 years): Initial dose of 30 mg/day, maximum 70 mg/day
• Adults: Initial dose of 30 mg/day, maximum 70 mg/day

It’s important to note that these are general guidelines, and individual dosing may vary based on the patient’s specific needs and response to the medication.

Long-term Effects and Monitoring Guidelines for Vyvanse Use

While Vyvanse can be an effective long-term treatment for ADHD, ongoing monitoring is essential to ensure its continued safety and efficacy.

Long-term considerations

• Potential for growth suppression in children
• Cardiovascular health
• Mental health status
• Development of tolerance or dependence

How often should patients taking Vyvanse be monitored? Regular check-ups are typically recommended, with the frequency determined by the individual’s age, overall health, and response to the medication. These may occur every few months or as often as deemed necessary by the healthcare provider.

Monitoring guidelines

1. Regular assessment of ADHD symptoms and overall functioning
2. Monitoring of height and weight, especially in children
3. Periodic cardiovascular evaluations, including blood pressure and heart rate checks
4. Screening for new or worsening psychiatric symptoms
5. Evaluation of sleep patterns and appetite
6. Assessment of potential substance misuse or diversion

Long-term use of Vyvanse requires a collaborative approach between the patient (or parent/caregiver) and healthcare provider to ensure optimal outcomes and minimize potential risks.

In conclusion, Vyvanse 20mg can be an effective treatment option for ADHD in both children and adults when used appropriately and under close medical supervision. Understanding the potential side effects, warnings, and proper usage guidelines is crucial for patients and caregivers. Regular monitoring and open communication with healthcare providers are essential for maximizing the benefits of Vyvanse while minimizing potential risks.

What are Common Vyvanse® Side Effects? For Adult ADHD

What is the most important information I should know about VYVANSE?

VYVANSE is a federally controlled substance (Cll) because it can be abused or lead to dependence. Keep VYVANSE in a safe place to prevent misuse and abuse. Selling or giving away VYVANSE may harm others, and is against the law.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

VYVANSE is a stimulant medicine. Some people have had the following problems when taking stimulant medicines such as VYVANSE:

1. Heart-related problems including:

• sudden death in people who have heart problems or heart defects
• sudden death, stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you carefully for heart problems before starting VYVANSE.

Your doctor should check your blood pressure and heart rate regularly during treatment with VYVANSE.

Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking VYVANSE.

2. Mental (psychiatric) problems including:

    In Children, Teenagers, and Adults:

• new or worse behavior and thought problems
• new or worse bipolar illness

    In Children and Teenagers

• new psychotic symptoms such as:
  • hearing voices
  • believing things that are not true
  • being suspicious
• new manic symptoms

Tell your doctor about any mental problems you have, or if you have a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you have any new or worsening mental symptoms or problems while taking VYVANSE, especially:

• seeing or hearing things that are not real
• believing things that are not real
• being suspicious

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:

• Fingers or toes may feel numb, cool, painful
• Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have any signs of unexplained wounds appearing on fingers or toes while taking VYVANSE.

Vyvanse® for Children with ADHD: Side Effects and Safety

What is the most important information I should know about VYVANSE?

VYVANSE is a federally controlled substance (Cll) because it can be abused or lead to dependence. Keep VYVANSE in a safe place to prevent misuse and abuse. Selling or giving away VYVANSE may harm others, and is against the law.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

VYVANSE is a stimulant medicine. Some people have had the following problems when taking stimulant medicines such as VYVANSE:

1. Heart-related problems including:

• sudden death in people who have heart problems or heart defects
• sudden death, stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you carefully for heart problems before starting VYVANSE.

Your doctor should check your blood pressure and heart rate regularly during treatment with VYVANSE.

Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking VYVANSE.

2. Mental (psychiatric) problems including:

    In Children, Teenagers, and Adults:

• new or worse behavior and thought problems
• new or worse bipolar illness

    In Children and Teenagers

• new psychotic symptoms such as:
  • hearing voices
  • believing things that are not true
  • being suspicious
• new manic symptoms

Tell your doctor about any mental problems you have, or if you have a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you have any new or worsening mental symptoms or problems while taking VYVANSE, especially:

• seeing or hearing things that are not real
• believing things that are not real
• being suspicious

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:

• Fingers or toes may feel numb, cool, painful
• Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have any signs of unexplained wounds appearing on fingers or toes while taking VYVANSE.

Vyvanse – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Lisdexamfetamine belongs to the class of medications known as central nervous system stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD). It works by affecting the balance of natural chemicals in the brain. It helps to increase attention and decrease hyperactivity and impulsiveness in children with ADHD. Lisdexamfetamine should be part of a treatment plan that includes other treatments (e.g., counselling, education).

Lisdexamfetamine is also used to treat moderate-to-severe binge eating disorder (BED) in adults.

Your child’s doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your child’s doctor, or are not sure why your child is taking this medication, speak to their doctor. Your child should not stop taking this medication without consulting their doctor.

Do not give this medication to anyone else, even if they have the same symptoms as your child. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Capsules

10 mg
Each capsule with pink body and pink cap imprinted with “S489 10 mg” contains 10 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide.

20 mg
Each capsule with ivory body and ivory cap imprinted with “S489 20 mg” contains 20 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide.

30 mg
Each capsule with white body and orange cap imprinted with “S489 30 mg” contains 30 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No.  6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide No. 40.

40 mg
Each capsule with white body and blue-green cap imprinted with “S489 40 mg” contains 40 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide.

50 mg
Each capsule with white body and blue cap imprinted with “S489 50 mg” contains 50 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide.

60 mg
Each capsule with aqua blue body and aqua blue cap imprinted with “S489 60  mg” contains 60 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide.

70 mg
Each capsule with aqua blue body and aqua blue cap imprinted with “S489 70 mg” contains 70 mg of lisdexamfetamine dimesylate. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; capsule shell: gelatin, titanium dioxide, and one or more of the following: FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide.

Chewable Tablets

10 mg
Each white-to-off-white, round tablet, debossed with “10” on one side and “S489” on the other contains 10 mg of lisdexamfetamine. Nonmedicinal ingredients: artificial strawberry flavouring, colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, and sucralose.

20 mg
Each white-to-off-white, hexagonal tablet, debossed with “20” on one side and “S489” on the other, contains 20 mg of lisdexamfetamine. Nonmedicinal ingredients: artificial strawberry flavouring, colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, and sucralose.

30 mg
Each white-to-off-white, arc-triangular-shaped tablet, debossed with “30” on one side and “S489” on the other, contains 30 mg of lisdexamfetamine. Nonmedicinal ingredients: artificial strawberry flavouring, colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, and sucralose.

40 mg
Each white-to-off-white, capsule-shaped tablet, debossed with “40” on one side and “S489” on the other, contains 40 mg of lisdexamfetamine. Nonmedicinal ingredients: artificial strawberry flavouring, colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, and sucralose.

50 mg
Each white-to-off-white, arc-square-shaped tablet, debossed with “50” on one side and “S489” on the other, contains 50 mg of lisdexamfetamine. Nonmedicinal ingredients: artificial strawberry flavouring, colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, and sucralose.

60 mg
Each white-to-off-white, arc-diamond-shaped tablet, debossed with “60” on one side and “S489” on the other, contains 60 mg of lisdexamfetamine. Nonmedicinal ingredients: artificial strawberry flavouring, colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, and sucralose.

How should I use this medication?

The usual starting dose of lisdexamfetamine to treat ADHD is 30 mg once a day in the morning. Afternoon doses should be avoided as this medication may cause difficulty sleeping.

Although doses larger than 30 mg have not been shown to be more effective, and often cause more side effects, your child’s doctor may choose to increase the dose gradually, if the lower dose is not fully effective. The maximum daily dose is 60 mg per day.

The usual starting dose of lisdexamfetamine to treat BED is 30 mg once a day in the morning. The dose is then gradually increased to between 50 mg and 70 mg taken once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your child’s doctor has recommended a dose different from the ones listed here, do not change the way that your child is taking the medication without consulting your doctor.

Lisdexamfetamine may be taken with or without food. The capsules may be taken whole, or the contents of the capsule can be dissolved in yogurt or a glass of water or orange juice. Any compacted powder from inside the capsule can be broken apart with a spoon. The mixture should be taken immediately. Lisdexamfetamine chewable tablets should be chewed thoroughly before swallowing. The entire tablet should be taken.

It is important for your child to take this medication exactly as prescribed by their doctor. If your child misses a dose in the morning, skip the missed dose and wait until the next day to continue with their regular dosing schedule. Do not give your child a double dose to make up for a missed one. If you are not sure what to do after your child misses a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to lisdexamfetamine or any ingredients of the medication
• are allergic to amphetamines or related medications (e. g., epinephrine)
• are in an agitated state
• have a history of drug misuse
• have an overactive thyroid
• have glaucoma
• have hardened arteries (arteriosclerosis)
• have heart disease with symptoms (e.g., chest pain, shortness of breath)
• have moderate-to-severe high blood pressure
• have taken a monoamine oxidase inhibitor (MAOI; e.g., phenelzine, tranylcypromine, moclobemide) within the last 14 days










What side effects are possible with this medication?




Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• anxiety
• decreased or loss of appetite
• diarrhea
• difficulty sleeping
• dizziness
• dry mouth
• headache
• increased sweating
• irritability
• nausea
• upper belly pain
• vomiting
• weight loss

The following side effects have also been reported by adults taking lisdexamfetamine for BED:

• cold symptoms (e.g., sore throat, cough, nasal congestion)
• constipation
• fatigue
• feeling jittery
• racing thoughts

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• behaviour changes (agitation, aggression, paranoia)
• blurred vision
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased blood pressure
• mania (racing thoughts, rapid talking, impulsiveness, extremely elevated mood, extremely high energy)
• mood swings
• pounding or fast heartbeat
• Raynaud’s phenomenon (e.g., bluish, white, or purple discolouration of fingers and toes; sensation of cold and/or numbness, pain)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of heart problems (e.g., fast or irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• slowed growth (in children)
• new tics (involuntary movements or vocalizations)
• vision changes

You should stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• suicidal thoughts or behaviour
• symptoms of a severe allergic reaction (hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.









Are there any other precautions or warnings for this medication?




Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, and any other significant facts about your health. These factors may affect how you should take this medication.

Behaviour changes: This medication can cause behaviour changes such as increased aggression and agitation. If you seem more aggressive or have other behaviour changes while taking this medication, contact your doctor.

Blood pressure: Lisdexamfetamine and other stimulant medications can cause an increase in blood pressure and heart rate. Your doctor will monitor your blood pressure and heart rate while you are taking this medication.

If you have high blood pressure, heart failure, or an abnormal heart rhythm, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with moderate-to-high blood pressure should not use this medication.

Dependence: This medication has the potential to be misused. People with a history of past or current substance-use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse of medications such as lisdexamfetamine can result in serious heart problems and death.

People who have taken too much of this medication may experience difficulty sleeping, irritability, hyperactivity, and personality changes. If you notice any of these symptoms, contact your doctor immediately.

Dizziness and vision changes: This medication may cause side effects including blurred vision, trouble focusing, and dizziness. These side effects may affect your ability to perform dangerous activities or drive. Ensure you are not experiencing these side effects before performing such activities.

Growth and weight gain: This medication can cause children to lose weight and can slow their growth rate. The doctor will monitor them for slowed growth while they are taking this medication. Children who are not growing or gaining weight as expected may need to stop their treatment with this medication, as recommended by their doctor.

Heart effects: When given at usual doses, lisdexamfetamine and other stimulant medications can cause sudden death in children with heart defects and other serious heart problems. This medication should generally not be given to people with heart defects and other heart problems (e.g., enlarged heart, serious abnormal heart rhythms).

If you have a heart problem, exercise strenuously, or have a family history of sudden death, talk with your doctor about how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Children with heart disease or hardening of the arteries should not use this medication.

If you experience chest pain, shortness of breath, or fainting while taking this medication, contact your doctor immediately.

Lisdexamfetamine can cause increased blood pressure and heart rate in adults. There have been reports of sudden death, stroke, and heart attack among adults taking other stimulant medications. Generally, adults with heart defects and other heart problems should not take this medication.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental health issues: This medication can worsen mental health issues such as psychosis or bipolar disorder. Before starting this medication, people with depression (feelings of sadness, hopelessness, or worthlessness) should be properly screened to ensure they do not have or are not at risk for bipolar disorder.

If you experience hallucinations (seeing, hearing, or feeling things that are not there), distorted thoughts, or mania (racing thoughts, rapid talking, impulsiveness, extremely elevated mood, extremely high energy), contact your doctor immediately.

Seizures: This medication may increase the risk of seizures, especially for people with seizure disorders. If you have a history of epilepsy or medical conditions that increase your risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have a seizure while taking this medication, get immediate medical attention. This medication should be stopped if seizures occur.

Self-harm: There have been rare reports of people who are taking this medication feeling that they want to hurt themselves or commit suicide. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behavioural changes while taking this medication.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. Suicidal thoughts or behaviours may occur at any time during treatment. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Tics: This medication may worsen motion and verbal tics, or Tourette’s syndrome. If you have tics or Tourette’s syndrome, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking lisdexamfetamine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication to treat ADHD have not been established for children less than 6 years of age. Lisdexamfetamine should not be used to treat BED in children and adolescents under the age of 18.

Seniors: Older adults are more likely to have conditions such as high blood pressure that can make taking lisdexamfetamine dangerous. This medication is not recommended for people over 55 years old.







What other drugs could interact with this medication?




There may be an interaction between lisdexamfetamine and any of the following:

• abiraterone
• acetazolamide
• aliskiren
• alpha-agonists (e. g., clonidine, methyldopa)
• amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• ascorbic acid (vitamin C)
• atomoxetine
• beta-blockers (e.g., atenolol, propranolol)
• beta-2 agonists (e.g., salbutamol, salmeterol, terbutaline)
• bromocriptine
• bupropion
• buspirone
• caffeine
• calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
• cannabis
• cyclobenzaprine
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e. g., naphazoline, oxymetazoline, xylometazoline)
• dextroamphetamine
• dextromethorphan
• diuretics (water pills; e.g., furosemide, metolazone, hydrochlorothiazide)
• dorzolamide
• dronedarone
• epinephrine
• ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• ethosuximide
• imatinib
• isoniazid
• ketoconazole
• linezolid
• lithium
• lopinavir
• methadone
• methylene blue
• methylphenidate
• mirabegron
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• multivitamins (with ADE)
• nabilone
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
• nilotinib
• phenobarbital
• phenytoin
• quinidine
• quinine
• ritonavir
• St. John’s wort
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e. g., desvenlafaxine, duloxetine, venlafaxine)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• sodium bicarbonate
• tapentadol
• terbinafine
• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
• ticlopidine
• tipranavir
• topiramate
• tramadol
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, imipramine)
• “triptan” migraine medications (e.g., rizatriptan, sumatriptan)
• tryptophan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Vyvanse

Vyvanse side effects and how to avoid them

Vyvanse side effects | Vyvanse crash | Weight loss | Anxiety | Withdrawal | How long do side effects last? | Warnings | Interactions | How to avoid side effects

Vyvanse (active ingredient: lisdexamfetamine dimesylate) is a brand-name prescription drug that treats attention deficit hyperactivity disorder (ADHD) in adults and children older than 6 years. It’s also approved for binge-eating disorder (BED) in adults but is typically used as a second-line therapy. 

Vyvanse belongs to a class of central nervous system stimulants called amphetamines. Its primary effect is to speed up the brain. Unlike most other stimulant medications, Vyvanse is a prodrug, which means it has no effect until it’s metabolized by the body into its active form, dextroamphetamine. Like all stimulant medications, Vyvanse may not be right for everyone. Side effects, warnings, and drug interactions need to be discussed with a doctor before starting this medication. 

RELATED: Learn more about Vyvanse | Get Vyvanse discounts

Common side effects of Vyvanse

Vyvanse side effects will vary between patients. Stimulants reduce hyperactivity, inattentiveness, and impulsiveness in patients with ADHD, but may have the opposite effect in patients incorrectly diagnosed with ADHD. Someone who takes Vyvanse but doesn’t need it can experience anxiety, restlessness, agitation, nervousness, racing heartbeat, or excessive sweating.

When taken for ADHD, the most common side effects of Vyvanse are:

• Decreased appetite
• Loss of appetite
• Weight loss
• Diarrhea
• Nausea
• Vomiting
• Upper stomach pain
• Dry mouth
• Dizziness
• Insomnia
• Irritability
• Anxiety

When taken for binge-eating disorder, the most common side effects of Vyvanse are:

• Decreased appetite
• Constipation
• Dry mouth
• Increased heart rate
• Insomnia
• Anxiety
• Feeling jittery

Serious side effects of Vyvanse

All medications that alter the central nervous system can produce serious and even life-threatening side effects. Many severe side effects of Vyvanse are related to its effects on speeding up the brain and the nervous system.

The most serious side effects of Vyvanse include:

• Psychiatric problems such as anxiety, aggression, or mania
• Neurological disorders such as tics, seizures, or serotonin syndrome
• Heart problems such as rapid heartbeat, heart attack, and sudden death in people with heart problems
• Circulation problems such as high blood pressure, stroke, peripheral blood vessel damage, skin color changes, and Raynaud’s phenomenon
• Severe allergic reactions
• Dependence, drug abuse, and withdrawal symptoms if discontinued abruptly

Vyvanse crash

The effects of a morning dose of Vyvanse typically wear off by the afternoon or evening. When they do, some patients experience a “Vyvanse crash” characterized by fatigue, tiredness, depression, irritability, anxiety, nervousness, and mood swings. Symptoms of a Vyvanse crash are very similar to Vyvanse withdrawal. 

The Vyvanse crash can’t always be avoided, but it can be successfully managed:

• Plan your schedule: Plan the day’s most important activities during the hours that Vyvanse is most active in the body. Schedule a long break around the time of day the Vyvanse crash typically occurs.
• Avoid depressants: Vyvanse crash symptoms may worsen if you’re taking other substances that depress the central nervous system such as alcohol, sedatives, muscle relaxants, anticonvulsants, and sleep aids.
• Practice good sleep hygiene: Lack of sleep also contributes to the Vyvanse crash. There are several good habits you can use to ensure sufficient sleep at night such as engaging in relaxing activities before bedtime, going to bed at the same time every night, and eliminating distractions when you go to bed.
• Talk to your doctor: Vyvanse isn’t necessarily for everyone. Your healthcare provider may suggest alternatives such as modifying the dose, changing the dosing schedule, or switching to another medication.

Weight loss

Two pronounced side effects of Vyvanse are decreased appetite and weight loss. While decreased appetite is equally common among adults and children, weight loss is a more common side effect of Vyvanse in children. In the initial clinical trials of Vyvanse, almost 1 in 10 children taking Vyvanse for four weeks lost weight in proportion to the dose: the larger the dose, the greater the average amount of weight was lost. Children on Vyvanse also exhibit slower growth than other children.

Only 3% of adults taking Vyvanse for ADHD lost weight in a similar four-week period. However, when Vyvanse is taken for binge eating disorder, weight loss was experienced in 4% of patients. Later studies show that a clinically significant number of people with binge eating disorder lose weight when taking Vyvanse by reducing appetite and the number of binge eating episodes each week.

Because lowered appetite and weight loss are side effects of Vyvanse, some physicians prescribe Vyvanse off-label for severe obesity in children and adolescents.

Anxiety

In previous studies, 5% to 6% of adults report anxiety as a side effect of Vyvanse. Children experience anxiety as a Vyvanse side effect less often. In one study, anxiety and agitation was reported in less than 1% of children.

Normally, stimulants such as Vyvanse speed up and excite the brain, so alertness, energy, nervousness, restlessness, agitation, racing thoughts, and anxiety are common side effects. However, in people with ADHD, certain stimulants increase alertness, attention, and impulse control while reducing hyperactivity, anxiety, and restlessness. These stimulants increase certain chemicals in the brain—dopamine and norepinephrine. Because patients with ADHD do not produce enough of these chemicals, stimulants improve their ability to manage hyperactivity and attention.

Too much dopamine and norepinephrine, a chemical similar to adrenaline, overexcites the brain and causes high energy, inattention, nervousness, agitation, excitability, or euphoria. If a person with normal levels of dopamine and norepinephrine is experiencing anxiety, Vyvanse will probably worsen the anxiety. Side effects such as anxiety, jitteriness, and tension may be indications that either Vyvanse or the dose prescribed is inappropriate.

Withdrawal

Vyvanse is a Schedule II controlled substance, meaning it has a high potential for abuse and dependence. When used over a long period, Vyvanse can cause withdrawal symptoms if the dose is reduced or the drug is suddenly discontinued. These symptoms include:

• Fatigue
• Excessive sleeping
• Depression
• Mood swings
• Increased appetite
• Cravings

Most Vyvanse withdrawal symptoms resolve in five to seven days. The prescribing physician may use a tapering dose to prevent or reduce withdrawal symptoms. There are certain side effects such as serotonin syndrome or heart problems that will require that Vyvanse be immediately discontinued. 

How long do side effects last?

Vyvanse remains active in the body for eight to 14 hours, so side effects should fade in that time. Vyvanse withdrawal symptoms, however, can last as long as seven days. If side effects do not go away after discontinuing Vyvanse, talk to a doctor.

Vyvanse contraindications & warnings

Vyvanse is not the right medication for everyone. People with the following health conditions should not take Vyvanse:

• Hypersensitivity to amphetamines or any of the other ingredients in Vyvanse
• Pregnant or breastfeeding women
• Heart disease, heart defects, arrhythmias, or coronary artery disease

Other cautions exist.

People taking monoamine oxidase inhibitors (MAOIs), a class of drugs that includes some types of antidepressants, antibiotics, or drugs that treat Parkinson’s disease, will not be prescribed Vyvanse until they have stopped taking MAO inhibitors for at least 14 days.

Slowed growth in children

Vyvanse has been FDA approved as a safe treatment for ADHD in children between the ages of 6 and 17. However, Vyvanse suppresses growth in children, so height and weight need to be carefully monitored. Vyvanse therapy may need to be modified if growth suppression is too pronounced.

Pregnancy and breastfeeding

There’s not enough data available to determine the safety of Vyvanse use in pregnant or nursing mothers. Dextroamphetamine does cross the placenta and is present in small amounts in breast milk. However, if you have been taking Vyvanse, do not suddenly discontinue it without speaking to your healthcare provider.

Seniors

The safety of Vyvanse use in people older than 65 has not been well-studied. When deemed safe by a healthcare professional, seniors often start with a low dose of Vyvanse.

Vyvanse interactions

Vyvanse has clinically significant interactions with more than 200 drugs and other substances. Most of these interactions are not hazardous, but people may notice that either Vyvanse or other drugs are less effective when taken together.

MAO inhibitors

Vyvanse should never be taken within at least 14 days of taking monoamine oxidase inhibitors (MAOIs), including certain types of antidepressants, antibiotics, and Parkinson’s medications such as:

• Tranylcypromine
• Marplan (isocarboxazid)
• Nardil (phenelzine)
• Linezolid
• Selegiline
• Xadago (safinamide)
• Methylene blue injection

In combination with Vyvanse, the effects of these drugs can cause dangerously high blood pressure.

Stimulants

Vyvanse can enhance the effects of other CNS stimulants, including increased blood pressure and heart rate. CNS stimulants include:

• Caffeine, cocaine, or ginseng
• Other ADHD medications
• Certain nasal decongestants
• Appetite suppressants such as phendimetrazine
• Wakefulness agents that treat narcolepsy
• Steroids
• Sympathomimetic medications such as epinephrine or norepinephrine

Depressants

In general, combining stimulants with depressants is rarely advisable. Amphetamines such as Vyvanse usually blunt the effects of depressants, but some combinations of amphetamines and depressants can be hazardous. Vyvanse should not be used with depressants such as:

• Alcohol, marijuana, or cannabinoids
• Cough medications
• Narcotics
• Sedatives
• Barbiturates
• Anxiety medications
• Nerve pain drugs
• Anti-nausea drugs
• Anticonvulsants
• Some Parkinson’s disease medications

Antidepressants and serotonergic medications

Unless deemed safe by a healthcare provider, do not use Vyvanse in combination with any other drug that alters levels of serotonin. Antidepressants, some migraine medications, and certain appetite suppressants taken in combination with Vyvanse increase the risk of serotonin syndrome.

Blood pressure medications

Amphetamines such as Vyvanse raise blood pressure, so they block the effects of medications intended to lower blood pressure. Combining amphetamines with blood pressure medications will require close monitoring and possibly therapy modification. Amphetamines are also avoided in combination with medications that raise blood pressure.

Acidifying or alkylating agents

Drugs that increase (acidify) or decrease (alkylate) the acid content in the stomach or urine will reduce the body’s ability to absorb Vyvanse and interfere with the ability to eliminate Vyvanse. In particular, when taking Vyvanse, avoid antacids, acidic foods, citrates, and diuretics. Certain multivitamins should also be avoided. 

Ask a healthcare professional for a complete list of drug and food interactions.

How to avoid Vyvanse side effects

Stimulants such as Vyvanse commonly cause side effects. Because Vyvanse speeds up the brain, it’s not uncommon to experience side effects such as decreased appetite, insomnia, elevated blood pressure, fast heart rate, agitation, or restlessness. Some patients experience a “Vyvanse crash” similar to withdrawal when the drug wears off later in the day.

A few tips can help manage Vyvanse side effects:

• Take Vyvanse as directed. Don’t increase or decrease the dose. If the medicine does not seem to be working or side effects occur, talk to the prescribing physician about changing the dose or switching to a new medication. Always follow instructions on the medication guide.
• Take Vyvanse at the same time each morning. Vyvanse should be taken early in the morning. Pick a time that is at least one hour before alertness and focus is required and stick to that schedule. If you miss a dose, take it later in the morning. However, avoid taking a dose in the afternoon to avoid sleeplessness at bedtime. 
• Disclose all of your medical conditions and medications. This will prevent side effects and dangerous interactions from occurring.
• Find a coffee alternative. Other stimulants may increase the risk and severity of Vyvanse side effects, so it’s a good idea to avoid them. In addition to certain medications, stimulants also include caffeine. You may need to find an alternative pick-me-up to your daily cup of coffee.
• Practice good sleep hygiene. Difficulty sleeping is one of the most common side effects of Vyvanse. The first step in overcoming medication-induced sleeplessness is to practice good, daily sleep hygiene practices. Avoid TV or video games before bedtime, develop a nighttime relaxation routine, and go to bed at the same time every night.
• Take a medication holiday (if approved by your doctor). If side effects are a problem when taking ADHD stimulants, the prescribing doctor may suggest taking a “medication holiday” where the medication is discontinued or the dose reduced for a few days, weeks, or even months. 

Taking a medication holiday, however, is not for everyone. Patients with moderate to severe ADHD symptoms may need to keep to a rigorous dosing schedule. Taking a medication holiday for binge eating disorder will raise the risk of severe binge eating. Seek professional medical advice first; there may be alternative therapies with fewer side effects.

Resources:

• Binge eating disorder, StatPearls
• Vyvanse, Epocrates
• Vyvanse prescribing information, FDA 
• Review of lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder, Journal of Central Nervous System Disease
• Vyvanse for binge eating disorder, Takeda
• Vyvanse for ADHD, Takeda
• Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults, Neuropsychiatric Disease and Treatment
• Use of lisdexamfetamine to treat obesity in an adolescent with severe obesity and binge eating, Children
• Reduced risk of anxiety with psychostimulant treatment in children with attention deficit hyperactivity disorder, Journal of Child and Adolescent Psychopharmacology
• Are there risks of long-term damage from abusing Vyvanse?, American Addiction Centers
• Transfer of dexamphetamine into breast milk during treatment for attention deficit hyperactivity disorder, British Journal of Clinical Pharmacology

Vyvanse Capsules – NPS MedicineWise

What is in this leaflet

Please read this leaflet before you/your child start taking VYVANSE.

This leaflet answers some common questions about VYVANSE.

It does not contain all available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you or your child taking VYVANSE against the benefit it is expected to have.

If you have any concerns about taking VYVANSE, talk to your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What VYVANSE is used for

VYVANSE is a central nervous system stimulant used to treat:

• Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE increases attention and decreases impulsiveness and hyperactivity in patients with ADHD.
• Binge Eating Disorder (BED). VYVANSE may help to reduce the number of binge eating days in patients with moderate to severe BED.

VYVANSE is not for weight loss.

It is not to be taken by children with ADHD under 6 years of age or in patients with BED under 18 years of age. VYVANSE should be used as part of a comprehensive treatment program which usually includes psychological, educational and social therapy. For BED, VYVANSE should only be prescribed by a psychiatrist as part of a comprehensive treatment program.

The main ingredient in VYVANSE is lisdexamfetamine dimesilate which itself is not active (such medicines are sometimes called a pro-drug). After VYVANSE is taken, it is converted in the blood to dexamphetamine which is the active medicine.

Your doctor may have prescribed VYVANSE for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you/your child.

VYVANSE can be abused or lead to dependence. VYVANSE is a controlled substance and should be handled responsibly. It is illegal for anyone prescribed VYVANSE to sell or give it to other people.

Keep VYVANSE in a safe place to prevent misuse and abuse. Also, return any unused capsules to your pharmacy to safeguard against them being taken by anyone else (see Disposal section).

Before you take VYVANSE

VYVANSE capsules are not suitable for everyone.

When you must not take it

Do not take VYVANSE if you/your child:

• have a disease of the arteries due to cholesterol deposits e.g. atherosclerosis
• are allergic (hypersensitive) to amphetamines or any of the other ingredients of VYVANSE listed in “Other ingredients” section of this leaflet
• have heart disease such as angina or myocardial infarction (heart attack)
• have moderate to severe high blood pressure
• have hyperthyroidism (hyperactive thyroid)
• have an eye condition called glaucoma
• have a tumour of the adrenal gland tissue (phaeochromocytoma)
• have tics (muscle twitching usually in the face and shoulders)
• have Tourette’s syndrome
• have severe depression, suicidal ideation or behaviour, thoughts or acts of self-harm or mental illness
• have periods of severe anxiety, tension or agitation
• suffer with drug dependence or abuse alcohol
• are taking or have taken an antidepressant called a monoamine oxidase inhibitor or MAOI within the past 14 days.

Do not use VYVANSE if the bottle shows signs of tampering.

Do not use VYVANSE beyond the expiry date (month and year) printed on the bottle.

If you/your child takes VYVANSE after the expiry date has passed, it may have no effect, or worse, there may be an entirely unexpected effect.

Do not give it to children unless your doctor has prescribed it. VYVANSE is not recommended for use in children with ADHD under 6 years of age or in patients with BED under 18 years of age.

If you are not sure whether you/your child should start using VYVANSE, contact your doctor.

Before you take it

Tell your doctor or pharmacist if you or your child:

• are allergic to any other medicines, or any foods, dyes or preservatives
• are pregnant or planning to become pregnant
• are breastfeeding or wish to breastfeed
• have any other medical conditions or heart problems, including ischemic heart disease (such as angina or myocardial infarction), suspicion or presence of any cardiac or heart -related abnormalities, irregular heartbeats or rate, family history of sudden/cardiac death
• suffer from blood pressure and/or taking medications to treat blood pressure
• disorders of the blood vessels of the brain e.g. stroke
• suffer from depression, bipolar illness, or schizophrenia or other mental illness
• have liver or kidney disease. Your doctor may lower the dose if you have kidney disease.
• have epilepsy or other seizures or have had an abnormal brain wave test (EEG)
• have circulation problems in fingers and toes

If you have not told your doctor or pharmacist about any of the above, tell them before you/your child take any VYVANSE.

Taking other medicines

Tell your doctor or pharmacist about all the medicine you/your child are taking or have recently taken, including prescription and non-prescription medicines, vitamins and herbal supplements. VYVANSE can affect the way other medicines work, and other medicines may affect how VYVANSE works. Using VYVANSE with other medicines can cause serious side effects.

It is especially important to tell your doctor or pharmacist if you or your child is taking medicines to treat any of the following conditions:

• depression including MAOIs
• anxiety, mania or bipolar disorder
• high blood pressure
• schizophrenia or schizophrenia-like illness
• strong pain

In addition, the following medicines may also interact with VYVANSE:

• Urinary acidifying agents eg. ascorbic acid (Vitamin C), ammonium chloride, sodium acid phosphate
• Urinary alkalinising agents eg. sodium bicarbonate, acetazolamide, some thiazides

Tell your doctor or pharmacist if you/your child are taking or have recently taken other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Do not start any new medicine while taking VYVANSE without talking to your doctor first.

How to take VYVANSE

Follow all directions given to you by your pharmacist or doctor carefully as this may differ from the information contained in this leaflet.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking VYVANSE. Children should have their height and weight checked often while taking VYVANSE. VYVANSE treatment may be stopped if a problem is found during these check-ups.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to take

The usual starting dose for children, adolescents and adults is 30 mg once a day. Your doctor may increase the dose until it is right for you or your child. For treatment of BED your psychiatrist will assess the response to VYVANSE after 12 weeks.

How to take it

• Take VYVANSE exactly as prescribed. VYVANSE comes in 6 different strength of capsules.
• Take VYVANSE once a day in the morning.
• VYVANSE can be taken with or without food.
• If you have trouble swallowing capsules, you may open your VYVANSE capsule and pour all of the powder into a soft food such as yogurt, water or orange juice.
• Use all of the VYVANSE powder from the capsule so you get all of the medicine.
• Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE powder and yogurt, water or orange juice until they are completely mixed together.
• Consume all of the yogurt, water or orange juice right away after it has been mixed. Do not store the yogurt, water or orange juice after it has been mixed with VYVANSE.
• Do not worry if there is a film or residue left in the glass or container afterwards – this is not the active ingredient.
• From time to time, your doctor may stop VYVANSE treatment for a while to check your/your child’s ADHD or your BED symptoms.

If you forget to take it

If you/your child forget to take capsules then take them as usual the next morning. Do not take a double dose to make up for a forgotten capsule.

Avoid taking VYVANSE in the afternoon or evening as it can cause an inability to sleep.

A Dosage Chart is provided on the VYVANSE carton to help track the capsules are taken properly. Cross off a symbol each time a capsule is taken.

If you take too much

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you/your child or anyone else may have used too much VYVANSE. Do this even if there are no signs of discomfort or poisoning.

If too much VYVANSE is taken, following symptoms may be experienced: confusion, restlessness, tremor, irregular heart beat, nausea, vomiting, diarrhoea, stomach aches, seizures and coma.

While you are taking VYVANSE

Things you must do

• VYVANSE should be taken in the morning
• Make sure that all of your doctors, dentists, ophthalmologists, psychologists and pharmacists know you/your child are taking VYVANSE. Remind them if any new medicines are about to be started.
• Like all stimulants, VYVANSE may become habit-forming and can be abused by some people. If it is taken correctly as instructed by your doctor, this should not happen, either now or later in life.
• Be sure to keep all doctors’ appointments so that you/your child’s progress can be checked.
• Your doctor will want to check your/your child’s blood pressure and pulse
• Tell your doctor immediately if you/your child become pregnant while on VYVANSE.

Things you must not do

• Do not stop treatment or change the dosage without checking with your doctor
• Do not give VYVANSE to anyone else, even if they have the same condition as you/your child. It may not be safe for another person to take VYVANSE
• Do not take VYVANSE to treat any other complaints unless your doctor tells you to. It may not be safe to use VYVANSE for another complaint.
• Do not take VYVANSE for a longer time than your doctor has prescribed

Things to be careful of

Do not drive or operate machinery until you know how VYVANSE affects you

VYVANSE may cause dizziness, drowsiness and blurry or double vision. This is uncommon; but if affected, you/your child should avoid driving or using heavy machinery. Check with your doctor if driving is advisable for you/your child while you/your child are taking VYVANSE.

Be careful when drinking alcohol while taking VYVANSE

If you/your child drink alcohol, it could make some of the unwanted side effects of VYVANSE worse. Your doctor may suggest that you/ your child avoid alcohol completely or reduce the amount you drink while you are taking VYVANSE.

Side effects

Tell your doctor or pharmacist as soon as possible if you/your child feel unwell while you/your child are taking VYVANSE.

Like all medicines, VYVANSE can cause some side effects. Sometimes they are serious, most of the time they are mild and temporary.

Do not be alarmed by this list of possible side effects. You/your child may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you/your child notice any of the following and they worry you:

• decreased or loss of appetite
• trouble sleeping
• headache
• dry mouth
• weight loss
• upper belly pain
• agitation, anxiety, aggression, affect lability, irritability, feeling jittery, feeling tired, feeling sleepy
• dizziness, restlessness, excessive motor activity with or without feelings of restlessness, tic, tremor
• rapid heart beat (tachycardia), palpitations, increased blood pressure
• nausea, vomiting, diarrhoea
• involuntary clenching or grinding of the teeth
• rash, fever, shortness of breath
• excessive sweating
• excessive widening of the pupil
• decreased sex drive, erectile dysfunction
• circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon): Fingers or toes may feel numb, cool, painful; change colour or have sensitivity to temperature

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you/your child develop:

• allergic reaction which may result in a rash or more rarely to a sharp drop in blood pressure, difficulty breathing, and hives/itching (anaphylactic reaction)
• chest pain or tightness in the chest
• shortness of breath
• irregular heart beat
• seizures (fits)
• vision problems
• mood changes such as depression or irritability
• new or worsening aggressive behaviour
• excitement, overactivity and uninhibited behaviour
• confusion, delusion or hallucinations (seeing or feeling things that are not really there)
• abnormal thinking (psychosis)

These may be serious side effects. You/your child may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you/your child notice anything that is making you/your child feel unwell.

Other side effects not listed above may also occur in some people.

After taking VYVANSE

Storage

• Keep the capsules in the bottle until it is time to take them.
• Keep medicines where children cannot see or reach them.
  A locked cupboard at least one-and-a-half metres (1.5m) above the floor is a good place to store medicines.
• Store VYVANSE in a cool dry place where the temperature is below 25°C. Keep the container tightly closed.
  Do not store VYVANSE or any other medicines in the bathroom or near a sink. Do not leave medicines in the car or on windowsills. Heat and dampness can destroy medicines.

Disposal

Return any unused or out of date medicine to your pharmacist. Do not keep unused or expired VYVANSE as it can be abused or taken by someone else. Do not throw out with your household waste.

For more information about proper disposal of medicines, please contact the RUM Project (Return Unwanted Medicines):
Telephone 1300 650 835
Website: www.returnmed.com.au

It is illegal for anyone prescribed VYVANSE to sell or give it to other people.

Product description

What VYVANSE looks like

VYVANSE 20 mg capsule: ivory opaque body and ivory opaque cap, printed ‘S489′ and ’20 mg’ in black ink.

VYVANSE 30 mg capsule: white opaque body and pink opaque cap, printed ‘S489′ and ’30 mg’ in black ink.

VYVANSE 40 mg capsule: white opaque body and blue/green opaque cap, printed ‘S489′ and ’40 mg’ in black ink.

VYVANSE 50 mg capsule: white opaque body and blue opaque cap, printed ‘S489′ and ’50 mg’ in black ink.

VYVANSE 60 mg capsule: aqua blue opaque body and aqua blue opaque cap, printed ‘S489′ and ’60 mg’ in black ink.

VYVANSE 70 mg capsule: blue opaque body and pink opaque cap, printed ‘S489′ and ’70 mg’ in black ink.

VYVANSE is supplied in bottles of 30 capsules, inside a cardboard box.

Ingredients

Active ingredient
The active ingredient is lisdexamfetamine dimesilate

Other ingredients
The inactive ingredients are: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells contain gelatin, titanium dioxide (E171) (all strengths) erythrosine (E127) (30 mg and 70 mg), brilliant blue (E133) (40 mg, 50 mg, 60 mg and 70 mg), iron oxide yellow (20 mg and 40 mg), iron oxide black (40 mg) and TekPrint SW-9008 (all strengths).

Sponsor

Shire Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Australia
Phone: 1800 012 612

This leaflet was prepared in January 2018.

Australian Registration Number:

VYVANSE 20 mg AUST R 284019

VYVANSE 30 mg AUST R 199227

VYVANSE 40 mg AUST R 284020

VYVANSE 50 mg AUST R 199226

VYVANSE 60 mg AUST R 284021

VYVANSE 70 mg AUST R 199228

VYVANSE® is a registered trademark of Shire LLC.

Vyvanse Drug / Medicine Information

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

Why am I using VYVANSE?

VYVANSE contains the active ingredient lisdexamfetamine dimesilate. VYVANSE is used
to treat 1) Attention Deficit Hyperactivity Disorder (ADHD) AND 2) Binge Eating Disorder
(BED).

What should I know before I use VYVANSE?

Do not use if you: have ever had an allergic reaction to VYVANSE or any of the ingredients
listed at the end of the CMI; taking a medicine called a ‘monoamine oxidase inhibitor’
(MAOI) or have taken an MAOI in the last 14 days; have a thyroid problem; feel unusually
excited, over-active, or un-inhibited; have ever had heart problems.

Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.

What if I am taking other medicines?

How do I use VYVANSE?

Take VYVANSE capsule once a day in the morning with or without food. The usual starting
dose is 30 mg once a day, your doctor may change the dose until it is right for you.
If you have trouble swallowing capsules, you may open your VYVANSE capsule and pour
all of the powder into a soft food such as yogurt, water or orange juice; mix completely
and consume mixed contents right away.

Follow all directions given to you by your doctor or pharmacist carefully.

What should I know while using VYVANSE?

Are there any side effects?

Common side effects include decreased appetite, insomnia, dry mouth, headache, upper
abdominal pain, weight decreased, feeling tired. Serious side effects include allergic
reaction, chest pain, shortness of breath, mood changes, confusion, seizures.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.

Active ingredient: lisdexamfetamine dimesilate

Consumer Medicine Information (CMI)

This leaflet provides important information about using VYVANSE. It does not take
the place of talking to your doctor or pharmacist. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VYVANSE. The information in this leaflet was last updated on the date listed on the final
page. More recent information on the medicine may be available. You should ensure
that you speak to your pharmacist or doctor to obtain the most up to date information
on this medicine. You can also download the most up to date leaflet from www.takeda.com/en-au . Those updates may contain important information about the medicine and its use of
which you should be aware.

Where to find information in this leaflet:

Why am I using VYVANSE?

The main ingredient in VYVANSE is lisdexamfetamine dimesilate which itself is not
active (such medicines are sometimes called a pro-drug). After VYVANSE is taken, it
is converted in the blood to dexamphetamine which is the active ingredient. VYVANSE is a central nervous system stimulant.

VYVANSE is used to treat:

Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE increases attention and decreases
impulsiveness and hyperactivity in patients with ADHD.

Binge Eating Disorder (BED). VYVANSE may help to reduce the number of binge eating
days in patients with moderate to severe BED.

VYVANSE is not for weight loss.

It is not to be taken by children with ADHD under 6 years of age or in patients with
BED under 18 years of age. VYVANSE should be used as part of a comprehensive treatment
program which usually includes psychological, educational and social therapy. For
BED, VYVANSE should only be prescribed by a psychiatrist as part of a comprehensive
treatment program.

What should I know before I use VYVANSE?

Warnings

Do not use VYVANSE if you:

have a disease of the arteries due to cholesterol deposits e.g. atherosclerosis

are allergic to amphetamines, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.

have heart disease such as angina or myocardial infarction (heart attack)

have moderate to severe high blood pressure

have hyperthyroidism (hyperactive thyroid)

have an eye condition called glaucoma

have a tumour of the adrenal gland tissue (phaeochromocytoma)

have tics (muscle twitching usually in the face and shoulders)

have Tourette’s syndrome

have severe depression, suicidal ideation or behaviour, thoughts or acts of self-harm
or mental illness

have periods of severe anxiety, tension or agitation

suffer with drug dependence or abuse alcohol

are taking or have taken an antidepressant called a monoamine oxidase inhibitor (MAOI)
within the past 14 days.

Check with your doctor if you:

are allergic to any other medicines, or any foods, dyes or preservatives

take any medicines for any other condition

have any other medical conditions or heart problems, including ischemic heart disease
(such as angina or myocardial infarction), suspicion or presence of any cardiac or
heart-related abnormalities, irregular heartbeats or rate, family history of sudden/cardiac
death

suffer from blood pressure and/or taking medications to treat blood pressure

disorders of the blood vessels of the brain e.g. stroke

suffer from depression, bipolar illness, or schizophrenia or other mental illness

have liver or kidney disease. Your doctor may lower the dose if you have kidney disease.

have epilepsy or other seizures or have had an abnormal brain wave test (EEG)

have circulation problems in fingers and toes

During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines may interfere with VYVANSE and affect how it works.

It is especially important to tell your doctor or pharmacist if you or your child
is taking medicines to treat any of the following conditions:

depression including class of medicines called monoamine oxidase inhibitor (MAOI)

anxiety, mania or bipolar disorder

high blood pressure

schizophrenia or schizophrenia-like illness

strong pain

In addition, the following medicines may also interact with VYVANSE:

Urinary acidifying agents e.g. ascorbic acid (Vitamin C), ammonium chloride, sodium
acid phosphate

Urinary alkalinising agents e.g. sodium bicarbonate, acetazolamide, some thiazides

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VYVANSE.

How do I use VYVANSE?

How much to take

The usual starting dose for children, adolescents and adults is 30 mg once a day.
Your doctor may increase the dose until it is right for you or your child. For treatment
of BED your psychiatrist will assess the response to VYVANSE after 12 weeks.

Follow the instructions provided and use VYVANSE until your doctor tells you to stop.

When to take VYVANSE

Take VYVANSE once a day in the morning.

How to take VYVANSE

VYVANSE can be taken with or without food.

If you have trouble swallowing capsules, you may open your VYVANSE capsule and pour
all of the powder into a soft food such as yogurt, water or orange juice.

Use all of the VYVANSE powder from the capsule so you get all of the medicine.

Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE powder
and yogurt, water or orange juice until they are completely mixed together.

Consume all of the yogurt, water or orange juice right away after it has been mixed.
Do not store the yogurt, water or orange juice after it has been mixed with VYVANSE.

Do not worry if there is a film or residue left in the glass or container afterwards
– this is not the active ingredient.

From time to time, your doctor may stop VYVANSE treatment for a while to check your/your
child’s ADHD or your BED symptoms.

If you forget to use VYVANSE

VYVANSE should be used regularly in the morning each day. If you miss your dose, then
take VYVANSE as usual the next morning. Avoid taking VYVANSE in the afternoon or evening
as it can cause an inability to sleep.

Do not take a double dose to make up for the dose you missed.

A Dosage Chart is provided on the VYVANSE carton to help track the capsules are taken
properly. Cross off a symbol each time a capsule is taken.

If you use too much VYVANSE

If you think that you have used too much VYVANSE, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling
13 11 26 in Australia; 0800 POISON or 0800 764766 in New Zealand), or

contact your doctor, or

go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

What should I know while using VYVANSE?

Things you should do

VYVANSE should be taken in the morning

Make sure that all of your doctors, dentists, ophthalmologists, psychologists and
pharmacists know you/your child are taking VYVANSE. Remind them if any new medicines
are about to be started.

Like all stimulants, VYVANSE may become habit-forming and can be abused by some people.
If it is taken correctly as instructed by your doctor, this should not happen, either
now or later in life.

Be sure to keep all doctors’ appointments so that you/your child’s progress can be
checked.

Your doctor will want to check your/your child’s blood pressure and pulse.

Tell your doctor immediately if you/your child become pregnant while on VYVANSE.

Things you should not do

Do not stop treatment or change the dosage without checking with your doctor.

Do not give VYVANSE to anyone else, even if they have the same condition as you/your
child. It may not be safe for another person to take VYVANSE.

Do not take VYVANSE to treat any other complaints unless your doctor tells you to.
It may not be safe to use VYVANSE for another complaint.

Do not take VYVANSE for a longer time than your doctor has prescribed.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how VYVANSE
affects you.

VYVANSE may cause dizziness, drowsiness and blurry or double vision. This is uncommon;
but if affected, you/your child should avoid driving or using heavy machinery. Check
with your doctor if driving is advisable for you/your child while you/your child are
taking VYVANSE.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may make some of the unwanted side effects of VYVANSE worse. Your doctor may
suggest that you avoid alcohol completely or reduce the amount you drink while you
are taking VYVANSE.

Looking after your medicine

Keep the capsules in the bottle until it is time to take them. Store VYVANSE in a
cool dry place where the temperature is below 25°C. Keep the container tightly closed.

Do not store it in the bathroom or near a sink, or in the car or on windowsill.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal. Do not keep unused or expired VYVANSE as it can be abused or taken
by someone else. Do not throw out with your household waste.

It is illegal for anyone prescribed VYVANSE to sell or give it to other people.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.

Product details

This medicine is only available with a doctor’s prescription.

What VYVANSE contains

Do not take this medicine if you are allergic to any of these ingredients.

What VYVANSE looks like

VYVANSE 20 mg capsule (AUST R 284019): ivory opaque body and ivory opaque cap, printed
‘S489′ and ’20 mg’ in black ink.

VYVANSE 30 mg capsule (AUST R 199227): white opaque body and pink opaque cap, printed
‘S489′ and ’30 mg’ in black ink.

VYVANSE 40 mg capsule (AUST R 284020): white opaque body and blue/green opaque cap,
printed ‘S489′ and ’40 mg’ in black ink.

VYVANSE 50 mg capsule (AUST R 199226): white opaque body and blue opaque cap, printed
‘S489′ and ’50 mg’ in black ink.

VYVANSE 60 mg capsule (AUST R 284021): aqua blue opaque body and aqua blue opaque
cap, printed ‘S489′ and ’60 mg’ in black ink.

VYVANSE 70 mg capsule (AUST R 199228): blue opaque body and pink opaque cap, printed
‘S489′ and ’70 mg’ in black ink.

VYVANSE is supplied in bottles of 30 capsules, inside a cardboard box.

Who distributes VYVANSE

Takeda Pharmaceuticals Australia Pty Ltd

Level 39

225 George Street

Sydney NSW 2000

Australia

Phone: 1800 012 612

www.takeda.com/en-au

This leaflet was prepared in October 2020.

VYVANSE^® and the VYVANSE Logo^® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc.

Lisdexamfetamine: MedlinePlus Drug Information

Lisdexamfetamine can be habit-forming. Do not take a larger dose, take it more often, take it for a longer time, or take it in a different way than prescribed by your doctor. If you take too much lisdexamfetamine, you may feel a need to continue to take large amounts of the medication, and you may experience symptoms such as unusual changes in your behavior. You or your caregiver should tell your doctor immediately, if you experience any of the following symptoms: fast, pounding, or irregular heartbeat; sweating; dilated pupils; abnormally excited mood; irritability; restlessness; difficulty falling sleeping or staying asleep; hostility; aggression; anxiety; loss of appetite; loss of coordination; uncontrollable movement of a part of the body; flushed skin; vomiting; stomach pain; or thinking about harming or killing oneself or others or planning or trying to do so. Overusing lisdexamfetamine may also cause sudden death or serious heart problems, such as heart attack or stroke.

Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications. Your doctor will probably not prescribe lisdexamfetamine for you.

Do not suddenly stop taking lisdexamfetamine without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression and extreme tiredness if you suddenly stop taking lisdexamfetamine after overusing it.

Do not sell, give away, or let anyone else take your medication. Selling or giving away lisdexamfetamine may harm others and is against the law. Store lisdexamfetamine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many capsules are left so you will know if any are missing.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with lisdexamfetamine and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

instructions for use, dosage, composition, analogs, side effects / Pillintrip

Agents that change the pH of urine can affect urine excretion and alter the level of amphetamine in the blood. Acidifying agents (eg, ascorbic acid) lower blood levels, and alkalizing agents (eg, sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly.

AS SUPPLIED

Dosage of Forms and Strengths

Information for VYVANSE capsules:

• 10 mg capsules: pink body cap / pink cap (printed S489 and 10 mg)
• 20 mg capsules: ivory body / ivory lid (printed S489 and 20 mg)
• Capsules 30 mg: white body cap / orange cap (printed S489 and 30 mg)
• Capsules 40 mg: white body / blue-green cap (printed S489 and 40 mg)
• Capsules 50 mg: white body / blue cap (printed S489 and 50 mg)
• 60 mg capsules: aqua blue body / aqua blue cap (printed S489 and 60 mg)
• 70 mg capsules: blue / orange body cap (printed S489 and 70 mg)

Information for VYVANSE Chewable Tablets:

• 10 mg Chewable Tablets: White to off-white round tablet with “10” on one side and “S489” on the other
• 20 mg Chewable Tablets: White to off-white hexagonal tablet with “20” on one side and “S489” on the other
• 30 mg Chewable Tablets: White to off-white arc triangular tablets with “30” on one side and “S489” on the other
• 40 mg Chewable Tablets: White to off-white capsule tablets with “40” on one side and “S489” on the other
• 50 mg Chewable Tablets: White to off-white arc square tablet with “50” on one side and “S489” on the other
• 60 mg Chewable Tablets: White to off-white arc-shaped tablet with “60” on one side and “S489” on the other

Storage and handling

Information for VYVANSE capsules:

• VYVANSE 10 mg capsules : pink cap / pink cap (printed with S489 and 10 mg), vials of 100, NDC 59417-101-10
• VYVANSE 20 mg capsules : ivory / ivory cap (printed S489 and 20 mg), vials of 100, NDC 59417-102-10
• VYVANSE 30 mg capsules : white body cap / orange cap (printed S489 and 30 mg), vials of 100, NDC 59417-103-10
• VYVANSE 40 mg capsules : white body / blue-green cap (S489 and 40 mg printed), vials of 100, NDC 59417-104-10
• VYVANSE 50 mg capsules : white body / blue cap (S489 and 50 mg printed), vials of 100, NDC 59417-105-10
• VYVANSE 60 mg capsules : aqua blue body / aqua blue cap (printed S489 and 60 mg), vials of 100, NDC 59417-106-10
• VYVANSE 70 mg capsules : blue body cap / orange cap (S489 and 70 mg printed), vials of 100, NDC 59417-107-10

Information for VYVANSE Chewable Tablets:

• VYVANSE 10 mg chewable tablets : White to off-white round tablet with “10” on one side and “S489” on the other, bottles of 100 NDC 59417-115-01
• VYVANSE 20 mg chewable tablets : White to off-white hexagonal tablet with “20” on one side and “S489” on the other, bottles of 100 NDC 59417-11601
• VYVANSE 30 mg chewable tablets : White to off-white arc triangular tablet with “30” on one side and “S489” on the other, bottles of 100 NDC 59417-11701
• VYVANSE 40 mg chewable tablets : White to off-white capsule tablet with “40” on one side and “S489” on the other, bottles of 100 NDC 59417-118-01
• VYVANSE 50 mg chewable tablets : White to off-white arc square tablet with “50” on one side and “S489” on the other, bottles of 100 NDC 59417-11901
• VYVANSE 60 mg Chewable Tablets : White to off-white arc-shaped tablet with “60” on one side and “S489” on the other, bottles of 100 NDC 59417-12001

Storage and handling

Dispense in a tight, lightweight container as defined in USP

Store at room temperature 20 ° C to 25 ° C (68 ° F to 77 ° F).Guided tours are permitted in temperatures between 15 ° C and 30 ° C (59 ° F to 86 ° F).

Disposal

Observe local laws and regulations for disposal of CNS stimulant drugs. Dispose of leftover, unused, or expired VYVANSE through the Drug Return Program.

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. Revised: July 2017

Side effects and drug interactions

SIDE EFFECTS

The following adverse reactions are discussed in more detail elsewhere on the labeling:

• Known hypersensitivity to amphetamine products or other VYVANSE ingredients
• Hypertensive crisis when used simultaneously with monoamine oxidase inhibitors
• Drug addiction
• Serious cardiovascular reactions
• Blood pressure and heart rate increase
• Psychiatric Adverse Reactions
• Growth suppression
• Peripheral vasculopathy, including Raynaud’s phenomenon
• Serotonin syndrome

Clinical trials experience

Because clinical trials are conducted in widely varying settings, the incidence of adverse reactions observed in clinical trials of a drug cannot be directly correlated with the frequency of clinical trials of another drug and may not reflect rates observed in practice.

Attention deficit hyperactivity disorder

The safety data in this section are based on 4-week, parallel-group, controlled clinical trials of VYVANSE in pediatric and adult ADHD patients

Adverse Reactions Associated with Treatment Discontinuation in ADHD Clinical Trials

In a controlled trial in patients aged 6 to 12 years (Study 1), 8% (18/218) of patients receiving VYVANSE discontinued due to adverse reactions compared with 0% (0/72) of patients receiving placebo …The most common adverse reactions (1% or more and double placebo) were ECG stress criteria for ventricular hypertrophy, tics, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 cases for each adverse reaction, ie 2/218 (1%)]. Less frequent adverse reactions (less than 1% or less than twice the placebo) included abdominal pain, dry mouth, weight loss, dizziness, drowsiness, burnout, chest pain, anger, and hypertension.

In a controlled trial in patients aged 13 to 17 years (Study 4), 3% (7/233) of patients receiving VYVANSE discontinued due to adverse reactions compared with 1% (1/77) of patients receiving placebo …The most common adverse reactions (1% or more and double placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1% or less than twice the placebo) included irritability, dermatillomania, mood swings, and shortness of breath.

In a controlled adult study (Study 7), 6% (21/358) of patients receiving VYVANSE discontinued due to adverse reactions compared with 2% (1/62) of patients receiving placebo.The most common adverse reactions (1% or more and twice as likely as placebo) were insomnia (8/358; 2%)
tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%) and shortness of breath (3/358; 1%). Less frequent adverse reactions (less than 1% or less than twice the placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia, and anxiety.

Adverse reactions occurring at a frequency of ≥5% or more among VYVANSE treated
ADHD patients in clinical trials

Most common adverse reactions (incidence ≥5% and incidence at least twice placebo)
children, adolescents, and / or adults have had anorexia, anxiety, decreased appetite, weight loss, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.

Adverse reactions occurring at an incidence of 2% or more among VYVANSE patients with ADHD in clinical trials

Adverse reactions reported in controlled trials in pediatric patients aged 6 to 12 years (Study 1), in adolescents aged 13 to 17 years (Study 4) and in adults (Study 7) who received VYVANSE or placebo are presented in Tables 1, 2 and 3 below.

Table 1: Adverse Reactions Reported by 2% or More of Children (Ages 6-12)
with ADHD taking VYVANSE and at least twice as much as patients
Placebo in a 4-week clinical study (Study 1)

Table 2: Adverse Reactions Reported by 2% or more of adolescents (ages 13 to 17).ADHD patients take VIVANS and are at least twice as likely to be patients taking placebo in a 4-week clinical study (Study 4)

Table 3: Adverse Reactions Reported by 2% or more of adult ADHD patients taking VYVANSE and at least double those reported by placebo patients in a 4-week clinical trial (Study 7 )

In addition, in the adult population, erectile dysfunction was observed in 2.6% of men on VYVANSE and 0% on placebo; decreased libido was observed in 1.4% of subjects on VYVANSE and 0% on placebo.

Weight loss and growth retardation in children with ADHD

In a controlled trial of VYVANSE in children aged 6 to 12 years (Study 1), the mean weight loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for patients receiving 30 mg, 50 mg, and 70 mg VYVANSE compared to a 1 pound weight gain for patients receiving placebo. Higher doses were associated with greater weight loss with 4 weeks of treatment. Close monitoring of weight in children 6 to 12 years of age who have received VYVANSE for 12 months suggests that children are constantly receiving medication (i.e.i.e., treatment for 7 days a week for a year) has a growth retardation measured by body weight, as evidenced by the mean change in age and gender from baseline in percentile, -13.4 per year (mean percentile at baseline level and 12 months were 60.9 and 47.2, respectively). In the 4-week controlled VYVANSE study in adolescents ages 13 to 17, the mean baseline to endpoint weight loss was -2.7, -4.3, and -4.8 lb, respectively, for patients who received 30 mg. 50 mg and 70 mg VYVANSE, compared to a 2.0 lb weight gain for patients receiving placebo.

Careful observation of weight and height in children aged 7 to 10 years who were randomized to methylphenidate or non-pharmacological treatment for 14 months, as well as in naturalistic subgroups of newcomers to methylphenidates and children who did not receive medical treatment for 36 months (ages 10 to 13) assumes that children are continuously treated (i.e. treatment for 7 days a week for a year) has a temporary slowdown in growth (on average, about 2 cm less in total, and 2.7 kg less weight gain over 3 years), with no signs of regrowth during this period.development. In a controlled trial of amphetamine (3: 1 d-l-enantiomer ratio) in adolescents, the mean weight change from baseline during the first 4 weeks of therapy was -1.1 lb and -2.8 lb, respectively, for patients who received 10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss during the first 4 weeks of treatment.

Weight loss in adults with ADHD

In a controlled adult study (Study 7), the mean weight loss after 4 weeks of therapy was 2.8 lbs.
3.1 lb and 4.3 lb for patients receiving final doses of 30 mg, 50 mg and 70 mg of VYVANSE, respectively, compared to a mean weight gain of 0.5 lb for patients receiving placebo.

Overeating disorder

The safety data in this section are based on data from two 12-week, parallel group, flexible dose, placebo-controlled studies in adults with BED. Patients with cardiovascular risk factors other than obesity and smoking were excluded.

Adverse reactions associated with discontinuation of treatment in clinical trials BED

In controlled studies of patients aged 18 to 55 years, 5.1% (19/373) of patients receiving VYVANSE discontinued due to adverse reactions compared with 2.4% (9/372) of patients receiving placebo.No adverse reactions resulted in discontinuation in 1% or more of patients receiving VYVANSE. Less frequent adverse reactions (less than 1% or less than twice the placebo) included heart palpitations, headache, upper abdominal pain, shortness of breath, rash, insomnia, irritability, feeling nervous, and anxiety.

Most common adverse reactions (incidence ≥5% and incidence at least twice placebo)
in adults, dry mouth, insomnia, decreased appetite, increased heart rate, constipation, nervousness, and anxiety have been reported.

Adverse reactions reported in pooled controlled trials in adult patients (Study 11 and 12) receiving VYVANSE or placebo are shown in Table 4 below.

Table 4: Adverse Reactions Reported by 2% or More of Adult BED patients taking VYVANSE and at least double those reported by placebo patients in 12-week clinical trials (Study 11 & 12)

Post-marketing experience

The following adverse reactions have been identified with the use of VYVANSE after approval. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship with drug exposure. These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulty with visual placement, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson syndrome , angioedema, convulsions, changes in libido, frequent or prolonged erections.

DRUG INTERACTIONS

Drugs with clinically significant interactions with amphetamines

Table 5: Drugs with clinically important interactions with amphetamines.

Drugs that have no clinically significant interactions with VYVANSE

From a pharmacokinetic point of view, dose adjustment of VYVANSE is not required when VYVANSE is coadministered with guanfacine, venlafaxine, or omeprazole.In addition, no dose adjustment of guanfacine or venlafaxine is required when VYVANSE is administered concurrently.

From a pharmacokinetic point of view, there is no dose adjustment for drugs that are substrates for CYP1A2 (eg theophylline, duloxetine, melatonin), CYP2D6 (eg atomoxetine, desipramine, venlafaxine), CYP2C19 (eg omeprazole, lansoprazole) and clobazoprazole, CYP3A4 (eg, midazolam, pimozide, simvastatin) is required with concomitant administration of VYVANSE.

Drug abuse and dependence

Controlled substance

VYVANSE contains lisdexamphetamine, a prodrug of amphetamine, a Schedule II controlled substance.

Abuse

CNS stimulants, including VYVANSE, other amphetamines and products containing methylphenidate, have a high potential for abuse. Abuse is characterized by weakened drug control, compulsive use, persistent use despite harm, and thirst.

Signs and symptoms of CNS stimulant abuse may include increased heart rate, breathing rate, blood pressure and / or sweating, dilated pupils, hyperactivity, anxiety, insomnia, decreased appetite, loss of coordination, tremors, skin redness, vomiting, and / or pain in stomach.Anxiety, psychosis, hostility, aggression, suicidal or murderous thoughts have also been observed. CNS stimulant abusers may chew, snort, inject drugs, or use other unapproved routes of administration that can lead to overdose and death.

To reduce abuse of CNS stimulants, including VYVANSE, assess the risk of abuse prior to prescribing. Once prescribed, keep accurate prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse during therapy, and re-evaluate the need for VYVANSE.

VYVANSE research in drug addicts

A randomized, double-blind, placebo-controlled, cross-responsibility study of abuse in 38 patients with a history of drug abuse was performed with single doses of 50, 100, or 150 mg VYVANSE, 40 mg immediate release d-amphetamine sulfate (controlled substance II) and 200 mg diethylpropion hydrochloride (controlled substance IV). VYVANSE 100 mg produced significantly fewer “drug-related effects” as measured on the Drug Evaluation Questionnaire Scale compared to d-amphetamine 40 mg; and 150 mg of VYVANSE showed similar “drug use effects” compared to 40 mg of d-amphetamine and 200 mg of diethylpropion.

Intravenous administration of lisdexamphetamine dimesylate 50 mg to persons with a history of drug abuse produced positive subjective responses on scales measuring drug, euphoria, amphetamine effects, and benzedrine effects, which were greater than placebo but less than those , which are obtained with an equivalent dose (20 mg) of intravenous d-amphetamine.

Dependency

Tolerance

Tolerance (a state of adaptation in which exposure to a drug leads to a decrease in the desired and / or unwanted drug exposure over time) can occur during chronic therapy with CNS stimulants, including VIVANS

Dependency

Physical dependence (a state of adaptation, manifested by a withdrawal syndrome caused by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants, including VIVANS.Withdrawal symptoms following abrupt cessation following prolonged administration of high-dose CNS stimulants include severe fatigue and depression.

Vyvanse Tablet in English – Item

Lisdexamfetamine: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Vyvanse

Trade names: Canada

Vyvanse

Warning

• This drug carries a risk of abuse and misuse.This drug can also be habit-forming with prolonged use. Do not use for longer than the time prescribed by your doctor. Use only as directed. Tell your doctor if your child has ever abused or depended on any drug or alcohol. Misuse of this drug can cause heart side effects or even sudden death.

What is this drug used for?

• Used to treat attention deficit hyperactivity disorder.
• Used to treat binge eating disorder.
• This drug can be given to children for other indications. Check with your doctor.

What should I tell my doctor BEFORE my child takes this drug?

• If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
• If your child or family member has any of the following health problems: Blood vessel disease, high blood pressure, structural heart disease or other heart problems, or Tourette’s or tics.
• If your child has any of the following health conditions: glaucoma, agitation, anxiety, or overactive thyroid gland.
• If your child has ever had any of the following health problems: Drug / drug dependence or stroke.
• If your child is taking any of the following drugs: acetazolamide or sodium bicarbonate.
• If your child has been taking drugs for depression or some other medical condition in the past 14 days.These include isocarboxazid, phenelzine, and tranylcypromine. An episode of very high blood pressure may occur.
• If your child is receiving any of the following: linezolid or methylene blue.

If your daughter is breastfeeding:

• Make sure your daughter is not breastfeeding while using this drug.

This list of drugs and diseases that can be adversely combined with the use of this drug is not exhaustive.

Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns. You need to make sure it is safe to take this drug if your child is ill and in combination with any other drugs he or she is already taking. You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

What do I need to know or do while my child is taking this drug?

• Tell all healthcare providers with your child’s care that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• This drug is not approved for weight loss or obesity. Check with your doctor.
• Have your child avoid tasks or activities that require attention until you see how this drug is working for your child.This includes cycling, playing sports, or using items such as scissors, a lawn mower, electric scooter, toy cars, or motorized vehicles.
• If your child has been using this drug for a long time or at high doses, its effectiveness may be reduced and a higher dose may be needed to get the desired effect. The patient develops what is known as drug tolerance. Call your doctor if this drug stops working.Do not give your child any higher doses of this drug than the doctor has prescribed.
• If your child has been taking this drug for several weeks, talk to the doctor before stopping the drug. It may be best to gradually stop taking this medication.
• Your child may need to have a heart test before using this drug. If you have any questions, talk to your child’s healthcare provider.
• This drug may cause high blood pressure.
• The child’s blood pressure and heart rate should be checked regularly.
• This drug may interfere with some laboratory tests. Tell all healthcare professionals and laboratory staff providing your child’s care that your child is taking this drug.
• Talk to your doctor before using over-the-counter drugs that may increase blood pressure.These include cough and cold remedies, diet pills, stimulants, ibuprofen or similar foods, and certain natural foods or supplements.
• In some cases, the drug may affect the growth rate in children and adolescents. They may need to have their growth rate checked regularly. Check with your doctor.

If your daughter is pregnant:

• Talk to your doctor if your girl is pregnant or becomes pregnant.The benefits and risks of taking this drug during pregnancy will need to be discussed.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people. Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blisters or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure, such as very severe headache, or dizziness, or loss of consciousness, or blurred vision.
• Increased or abnormal heart rhythm.
• Changing the color of the brushes or feet. The skin may become pale, bluish, or red.
• Numbness, pain, tingling, or coldness in the hands or feet.
• Any ulceration or wounds on the fingers or toes.
• Pain or weakness in muscles, darkening of urine, difficulty urinating.
• Sudden death has been reported with this drug in children with certain heart problems or heart defects. Stroke, myocardial infarction, and sudden death have also happened in adults who take this drug. Call your doctor right away if your child has a fast, slow heartbeat, or an irregular heartbeat; weakness on 1 side of the body; difficulty speaking or thinking; imbalance; omission of 1 side of the face; changes in vision; chest pain or angina; dyspnea; severe dizziness or fainting.
• New or worsening mood and behavior changes such as thinking changes, anger and hallucinations have happened with this drug. If your child or a blood relative has been diagnosed with a mental or emotional disorder, such as depression or bipolar disorder, or if a family member has committed suicide, tell the doctor. Call your doctor right away if your child has hallucinations, movement disorders, or signs of emotional distress such as depression, suicidal thoughts, nervousness, ups and downs, distorted thinking, anxiety, or low interest in life.
• Possible severe skin reaction (Stevens-Johnson syndrome / toxic epidermal necrolysis). This can lead to serious and permanent health problems and sometimes death. Get medical help right away if your child has symptoms such as redness, skin swelling with blistering or scaling (with or without a high fever), redness or irritation of the eyes, painful sores on the lining of the mouth, throat, nose, or eyes …
• When your child takes this drug with other drugs, a serious and sometimes deadly condition called serotonin syndrome can develop. Call your child’s healthcare provider right away if the child develops agitation, balance disorders, confusion, hallucinations, fever, tachycardia or abnormal heart rhythms, flushing, muscle twitching or stiffness, seizures, tremors or tremors, excessive sweating, severe diarrhea, nausea or vomiting, severe headache.

What are some other side effects of this drug?

Any drug can have side effects. However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

• Constipation, diarrhea, abdominal pain, nausea, vomiting, or decreased appetite.
• Weight loss.
• Sleep disorders.
• Anxiety.
• Dry mouth.
• Dizziness.
• Feeling anxious.

This list of potential side effects is not comprehensive. If you have any questions about side effects, talk to your child’s doctor. Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor. Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

• Give this drug at the same time of the day.
• Give the drug in the morning to prevent sleep disorders.
• Give this drug with or without food.

Capsules:

• Have your child swallow whole. Tell your child not to chew, crush, or crush the tablet.
• You can open the capsule and pour the powder into a glass of water, orange juice or yogurt. If necessary, caked powder can be crushed with a spoon. Mix well.
• If taken mixed, swallow immediately. Do not store for future use.

Chewable Tablets:

• Make sure that the child chews the drug thoroughly before swallowing.

What if my child misses a dose of a drug?

• Give the missed dose as soon as possible.
• If it is time for your child to take the next dose, do not take the missed dose and then return to your normal child’s schedule.
• Do not give a double dose at the same time or additional doses.

How do I store and / or discard this drug?

• Store in a dry place.Do not store in the bathroom.
• Store this medication in a protected place, out of the reach of children, and out of the reach of other people. A box or room, which is locked with a key, can act as a protected storage location for the drug. Keep all medicines out of the reach of pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so.If you have any questions about the disposal of your medicinal products, consult your pharmacist. There may be drug recycling programs in your area.

General information on medicinal products

• If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
• Do not share your child’s medicine with others or give anyone’s medicine to your child.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

90,000 What you need to know about Vyvanse (lisdexamphetamine dimesylate)

Vyvanse (lisdexamphetamine dimesylate) is a stimulant medicine that helps reduce or improve symptoms of attention deficit hyperactivity disorder (ADHD), such as distraction and inability to focus.

LumiNola / Getty Images

Vyvanse belongs to a class of drugs called central nervous system (CNS) stimulants. These medications work by increasing the amount of certain chemicals in the brain. The therapeutic effect is unclear, but these chemicals (particularly dopamine and norepinephrine) are thought to play an important role in thinking and attention.

Vyvanse

is also used to treat adults with moderate to severe eating disorder (BED), the most common eating disorder in the United States.Vyvanse has been shown to significantly reduce the frequency of binge eating and is effective in preventing relapse.

Vyvanse is available in capsule or chewable tablet form. It is not available as a generic product.

Uses

Vyvanse is approved for the treatment of ADHD in adults and children over 6 years of age. It is only approved for the treatment of moderate to severe BED in adults.

This is a long-acting amphetamine stimulant that is believed to improve adherence and has a lower risk of abuse compared to short-acting stimulants.

Immediate-release stimulants last four to six hours and must be repeated throughout the day. Vyvanse works by releasing the stimulant gradually over a longer period. It is reported to last up to 13 hours in children and 14 hours in adults.

Outside label use

It is not known if this drug is safe and effective for the treatment of obesity. While it can lead to weight loss with BED treatments, the FDA has clearly stated that Vyvanse should not be used for weight loss.

Before reception

Vyvanse, available as a prescription, is the first line treatment for ADHD for both adults and children. A diagnosis of ADHD requires careful evaluation by a pediatrician, psychologist, or psychiatrist with experience in treating ADHD.

Vyvanse is the first drug approved for the treatment of moderate to severe BED. Psychotherapy is still the first line treatment for BED, but Vyvanse can be helpful for those who do not respond to psychotherapy or for those in settings where psychotherapy is not available.

Before you are prescribed this treatment, you must be screened for several medical conditions, including mental disorders. In particular, be sure to tell your doctor if you: 6

• Have a family history of sudden death

• Have or have a family history of heart disease, including sudden or ventricular arrhythmias.

• You have a history of high blood pressure or high blood pressure

• Have or have a family history of bipolar disorder.

• Have or have a family history of depression

• Substance abuse or a history of substance abuse.

Vyvanse should be avoided or used with caution under certain circumstances. This includes:

• Serious heart problems: Central nervous system stimulants such as Vyvanse should not be used by people with severe heart problems.Sudden death, strokes, and heart attacks have been reported in those taking stimulant medications.

• High risk of substance abuse: CNS stimulants, including Vyvanse, have a high potential for abuse and dependence. Its use may not be appropriate if you are at high risk for substance abuse.

• Bipolar Disorder: CNS stimulants can cause manic episodes in people with bipolar disorder, as well as new or worsening psychotic symptoms.Before treatment, patients should be screened for risk factors for a manic episode.

• Alkalizing Agents: Both Vyvanse and urine alkalizing agents such as Diamox (acetazolamide) and some thiazides should be avoided.

• Breastfeeding: It is not recommended to take Vivans while breastfeeding. Amphetamines can be passed to an infant through breast milk. There is a risk of serious adverse reactions such as serious cardiovascular reactions, increased blood pressure and heart rate, growth suppression, and peripheral vasculopathy.

Limited data are available on the use of Vyvanse in pregnant women. There is a risk of premature birth and low birth weight in babies born to amphetamine-dependent mothers during pregnancy. There is also a risk of long-term behavioral or neurochemical changes.

Precautions and contradictions

Absolute contraindications to the use of Vivance et al. None.

• Allergy to the compound itself

• Concomitant use of a monoamine oxidase inhibitor (MAOI) or if you took an MAOI within 14 days prior to starting Vyvanse treatment.

MAOIs are used to treat conditions such as depression and Parkinson’s disease. They work by slowing down the metabolism of amphetamines and increasing their effects. The interaction between MAOI and Vyvanse can cause toxic neurologic effects and malignant hyperpyrexia, which can be fatal.

Other medicines may interact with Vyvanse. Be sure to talk to your doctors about all medications, supplements, and vitamins you are currently taking.While some drugs pose a minor risk of interaction, others may directly contraindicate use or prompt careful consideration of whether the benefits of treatment outweigh the disadvantages in your case.

Especially be sure to mention if you accept any of the following: 7

• Diamox (acetazolamide)

• Other ADHD medicines

• Sodium bicarbonate (baking soda)

• OsmoPrep or Visicol (sodium phosphate)

Other central nervous stimulants

Other central nervous system stimulants used to treat ADHD are Adderal (dextroamphetamine-amphetamine) and Concerta (methylphenidate HCl).

Dosage

Vyvanse is available as a capsule or chewable tablet. Take the capsule or tablet as a whole, do not divide the dose.

The recommended starting dose for BED and ADHD and for adults and children is 30 milligrams (mg) per day. The maximum dose is 70 mg per day. For BEDs, your dose will increase weekly from the recommended dose of 50 to 70 mg per day.

If you or your child are being treated for ADHD, your dose may be adjusted weekly so the doctor can find the right dose for you.

For people with severe renal failure, the maximum dose is 50 mg per day, and for patients with end-stage renal failure, the maximum dose is 30 mg per day.

Both capsules and chewable tablets are available in dosages of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg. The capsules also have a dosage of 70 mg.

Do not increase the dose without consulting your doctor. You should take Vyvanse exactly as your doctor tells you.

All indicated dosages are indicated by the manufacturer of the drug.Check your prescription and talk to your doctor to make sure you are taking the correct dose.

How to take and store

According to the manufacturer, Vyvanse should be taken once a day in the morning and can be taken with or without food. The capsule can be swallowed whole or mixed with orange juice, yogurt, or water.

You must store Vyvanse in a safe place, such as a locked cabinet. Do not throw unused medications in your household waste, as they may harm other people or animals.

Side effects

Side effects may occur when taking Vivance. Most side effects reported in clinical trials are mild to moderately severe.8 However, you should talk to your doctor if you have any side effects that bother you or do not go away.

General

The most common side effects of Vyvanse vary depending on which condition is being treated.When treating people with ADHD, these include: 6

• Decreased appetite

• Dry mouth

• Pain in the upper abdomen

• Irritability

• Dizziness

• Dry mouth

• Decreased appetite

• Increased heart rate

• Feeling nervous

According to a systematic review of clinical trials in 2014, the side effects reported in long-term trials are very similar to those reported in long-term trials. reported in short term trials8.

Serious

Some side effects can be serious. You should call your doctor right away or get emergency medical attention if you experience any of the following: 7

• Shortness of breath

• Slow or difficult speech

• Weakness or numbness in an arm or leg

• Symptoms of psychosis, such as hallucinations, seeing things or hearing voices that do not exist, or delusions, including paranoia.

• Mood swings

• Motor or verbal tics

• Swelling of the eyes, face, tongue, lips, or mouth

• Blurred vision or other vision problems

• Unexplained wounds on fingers or toes

Alerts and interactions

Given the potential risks associated with Vyvanse, especially if you have certain health problems, your doctor may need to monitor you regularly while you are taking this medication.

Signs of abuse or addiction

Vyvanse carries the black box warning, the FDA’s most serious warning regarding its high potential for abuse and dependence. While taking this medication, it is important to watch for signs of abuse and dependence and be screened for substance abuse before using it.

Influence on the growth of children

Weight loss and expected growth have been reported in numerous clinical trials evaluating the use of stimulants for the treatment of ADHD in children.

A controlled cohort study of children aged 6 to 12 years, conducted in 2016, found growth retardation associated with stimulant dose, but did not find significant delay in bone age after three years of treatment. It was concluded that a lack of correlation between height and bone age could negatively impact a child’s growth potential.

In a 2017 follow-up of children with ADHD, the group was assessed in early adulthood.The effect of long-term treatment with stimulant drugs has been studied.

He showed that long-term drug use from childhood to adulthood was associated with greater suppression of adult growth, but no relative reduction in symptom severity in adulthood10.

Children should be under close medical supervision while they are taking Vyvanse. Their doctor can stop treatment if a problem is found.

Psychiatric symptoms

New or worsening psychiatric symptoms may or may not occur in those with a history of mental illness.Depending on who is taking Vyvans, you will experience different symptoms.

In adults, it can cause: 6

• New or worsening behavior and thinking problems

• New or worsening bipolar disorder

In children and adolescents, it can cause the symptoms listed above and:

• New symptoms of psychosis such as audible voices, belief in lies, suspicion

• New manic symptoms

You should talk to your doctor if you or your child develop any new or worsening mental symptoms or problems especially those associated with psychosis.

Blood pressure

CNS stimulants can cause an increase in blood pressure and heart rate. You should watch for potential tachycardia, heartbeats over 99 beats per minute, and high blood pressure.

Circulatory problems

Vyvanse can cause circulatory problems in fingers and toes. Signs of this include:

• Numbness, coldness, or pain in fingers or toes

• Pale to blue to red discoloration of fingers or toes

Serotonin syndrome

When amphetamines are used in combination with certain medications, it can cause a potentially life-threatening but rare reaction called serotonin syndrome.These medicines include:

• Monoamine oxidase inhibitors (MAOIs)

• Selective serotonin reuptake inhibitors (SSRIs)

• Serotonin-norepinephrine reuptake inhibitors (SNRIs)

11 Tricyclic antidepressant syndrome

… Symptoms can vary greatly from person to person. Among them: 11

• Anxiety and / or anxiety

• Confusion and / or disorientation

• Pressure speech

• Diarrhea and vomiting

• Muscle stiffness, especially in the legs

• Difficulty with balance

See your doctor right away if you feel unwell or worried about serotonin syndrome.

If you suddenly stop taking Vivance after taking high doses for a long time, you may experience withdrawal symptoms. These include extreme tiredness and depression.6 Your doctor will tell you how to safely stop taking this medication.

.