Lisdexamfetamine dimesylate is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. This medicine is also used to treat moderate to severe binge eating disorder (BED). It belongs to the group of medicines called central nervous system (CNS) stimulants. Lisdexamfetamine dimesylate increases attention and decreases restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.
This medicine is available only with your doctor's prescription.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lisdexamfetamine dimesylate to treat ADHD in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age. Appropriate studies have not been performed on the relationship of age to the effects of lisdexamfetamine dimesylate to treat binge eating disorder in the pediatric population.
Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lisdexamfetamine dimesylate in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving lisdexamfetamine dimesylate.
Other Medical Problems:
Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of
- Drug abuse and dependence, history of - Use with caution. Dependence may be more likely to develop
- Allergy to amphetamine-containing products (eg, Adderall, Desoxyn, Dexedrine, Dextrostat)
- Coronary artery disease
- Heart attack, recent
- Heart disease (eg, cardiomyopathy), severe
- Heart failure
- Heart rhythm problems (eg, ventricular arrhythmia), severe
- Stroke, history of - Should not be used in patients with these conditions unless your doctor tells you otherwise
- Bipolar disorder (manic-depressive illness), or a family history of
- Blood vessel problems (eg, Raynaud disease)
- Depression, or a family history of
- Heart rhythm problems (eg, fast heartbeat), mild
- Hypertension (high blood pressure)
- Mania, history of
- Motor tics (repeated muscle movements)
- Psychosis (mental illness), history of
- Seizures, history of
- Tourette's syndrome, or family history of - Use with caution. May make these conditions worse
- Kidney disease, severe - Use with caution. The effects may be increased because of slower removal of the medicine from the body
This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain. This medication is not recommended for use for weight loss due to the risk of serious side effects.
This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
For the 4.4 million American children who have attention deficit hyperactivity disorder (ADHD), there will soon be another option for treatment. The Food & Drug Administration recently approved the first prodrug to treat the condition: lisdexamfetamine dimesylate (Vyvanse). The drug is designed to have a reduced abuse potential. Lisdexamfetamine shares substantial pharmacologic effects with amphetamines, including its efficacy. While it appears that this drug will be very similar to products already on the market, at this time there are no published studies comparing lisdexamfetamine to either dextroamphetamine or methylphenidate, there may be situations in which it would be advantageous for a patient to have a medication supply that is not easily tampered with or has very little street value.
Because Shire's leading ADHD product, Adderall XR, will lose its patent protection in two years, the company is hoping to transition patients currently taking Adderall XR over to lisdexamfetamine, which will maintain its patent until 2024.
91st most prescribed medicine in the United States for 2017
Lisdexamfetamine is a prescription stimulant drug, better known as the brand name drug Vyvanse. Lisdexamfetamine stimulates the central nervous system and impacts certain brain neurotransmitters, including dopamine and norepinephrine. It's a prodrug and has a slower onset of action, making it slightly less addictive than other prescription stimulants like Adderall. When someone takes Vyvanse, the drug is released at the same levels over time -rather than all at once, so it's unique from Adderall and Ritalin. When someone takes lisdexamfetamine as prescribed for ADHD, it can help them focus and concentrate. It can also reduce hyperactivity and impulsiveness. When someone uses lisdexamfetamine recreationally, there is an increased availability of certain neurotransmitters in the brain like dopamine and norepinephrine. These levels are what create a euphoric high. People who use lisdexamfetamine often don't sleep for long periods of time. Other effects of lisdexamfetamine can include irritability, increased motivation, and distortion of time. When the effects of lisdexamfetamine wear off, people may experience a crash.
The half-life of Vyvanse, the brand-name version of lisdexamfetamine, is estimated to be around 45 minutes to an hour, on average. That means that the primary parent drug of Vyvanse would be eliminated within anywhere from 4 to 5 and a half hours. Lisdexamfetamine is a short-lasting drug that is quickly eliminated from the system; however, lisdexamfetamine can leave behind longer-lasting metabolites that remain even when the parent drug is eliminated. For most people, an entire dose of Vyvanse, including metabolites, would be eliminated from the system in less than three days.
Vyvanse speeds up brain activity, improves attention, suppresses appetite, and increases energy, which makes it a suitable medication for treatment of various psychiatric disorders. Lisdexamfetamine belongs to a class of compounds called substituted amphetamines. Once absorbed, it triggers a reaction that results in the production of dextroamphetamine, a powerful central nervous system stimulant. Vyvanse is a stimulant, used to treat various conditions like ADHD and binge eating disorder. Still, while it is beneficial for some, lisdexamfetamine dimesylate, which is the main component of Vyvanse, has a high potential for abuse. Reportedly, around 31% of U.S. college students obtain and use Vyvanse and other stimulants illicitly. Even more disturbingly, almost 90% of students taking ADHD meds get them by faking symptoms of the disorder. While the range of Vyvanse positive effects is indisputably broad, abusing lisdexamfetamine can cause severe mental and physical problems.
Lisdexamfetamine (LDX) is a d-amphetamine (d-AMPH) pro-drug used to treat Attention Deficit and Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). After oral administration, lisdexamfetamine dimesylate is rapidly absorbed from the gastrointestinal tract and converted to dextroamphetamine, which is responsible for the drug's activity. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Most common adverse reactions in children, adolescents and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Needs to adjust Lisdexamfetamine dosage accordingly.
What is the difference between Vyvanse and Ritalin?
Both drugs are stimulants used to treat ADHD. The major difference is that Vyvanse is a once-a-day drug which is typically taken in the morning and has long-lasting effects, whereas Ritalin comes in both short-acting and long-acting form. Both drugs are classified as controlled substances, meaning they have the potential to be abused. Because of the way the Vyvanse breaks down in the body, it may have a slightly less risk of being abused than Ritalin.
How long does it usually take for Vyvanse to work?
Vyvanse was shown to start working within 1.5 hours after taking the medication in a clinical trial of children ages 6 to 12 with ADHD. In a study of adults diagnosed with ADHD, the drug was shown to start working within 2 hours.
Are there any disadvantages to Vyvanse?
Some patients do not respond to Vyvanse as strongly as they do to other ADHD medications, such as Adderall. Also, there is currently no generic version of Vyvanse available, which makes it more expensive.
Are Vyvanse and Adderall the Same?
Vyvanse and Adderall are two different medications. However, because they are both stimulant medications from the same drug family (amphetamine) they may be confused as being the same medication.
- Faster absorption rate, starts working in 30 minutes. Effects last 4 hours for Adderall IR, 10 to 12 hours for Adderall XR. More potential for abuse. Generic available. Intermediate (IR) and extended (XR) versions for flexibility.
- Slower absorption rate, starts working in 1 to 2 hours. Effects last 14 hours. Lower risk of abuse since cannot be inhaled or injected. No generic available until after 2023.
Perhaps the biggest distinction between Adderall and Vyvanse is that Vyvanse is a prodrug. This means that it needs to be taken orally in order to be metabolized by the body's enzymes to become effective. Vyvanse is often described as smoother than Adderall. One of the reasons for this is that - because it has a slower absorption rate - there is not a 'kick' or jolt to the system when the medication starts to work. In addition, there is less medication rebound when Vyvanse starts to wear off.
Amphetamines have a high potential for abuse:
Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
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, thinking about harming or killing oneself or others or planning or trying to do so. 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. 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.
What is the most important information I should know about Lisdexamfetamine?
- Lisdexamfetamine may be habit-forming, and this medicine is a drug of abuse.
- Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.
- Do not use lisdexamfetamine if you have used an MAO inhibitor in the past 14 days.
- Lisdexamfetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.
- You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.
World Health Organization 2014:
As a central nervous system stimulant, lisdexamfetamine is used as an adjunct in the treatment of attention deficit hyperactivity disorder (ADHD). As a prodrug, lisdexamfetamine was specifically designed as an abuse-resistant product. After oral administration and absorption, enzyme hydrolysis following contact with red blood cells will break lisdexamfetamine into L-lysine, a naturally occurring essential amino acid and active d-amphetamine which is responsible for the drug's pharmacological activity. The safety and efficacy of lisdexamfetamine in the treatment of ADHD has been established in children 6 - 12 years of age, adolescents, and adults and the toxicology and adverse effect profile appears similar to other stimulant drugs for this indication.
The observation that lisdexamfetamine produces substantial and sustained increases in catecholaminergic neurotransmission in the prefrontal cortex and striatum without inducing locomotor activation in preclinical studies is consistent with the clinical observations that lisdexamfetamine has a long duration of action and a reasonable separation between its beneficial effects in treating ADHD and the induction of psychostimulant adverse events.To date, there appears to be little evidence of non-medical use of lisdexamfetamine. Nevertheless, the fact that lisdexamfetamine is a prodrug of d-amphetamine implies similar clinical oversight and cautions for the monitoring and scheduling of this CNS stimulant.
Summary of Use During Lactation:
Lisdexamfetamine is a prodrug of dextroamphetamine.
In dosages prescribed for medical indications, some evidence indicates that dextroamphetamine might not affect nursing infants adversely.The effect of dextroamphetamine in milk on the neurological development of the infant has not been well studied.
It is possible that large dosages of dexroamphetamine might interfere with milk production, especially in women whose lactation is not well established.Relevant published information was not found as of the revision date on the safety of breastfeeding during amphetamine abuse. One expert recommends that amphetamines not be used therapeutically in nursing mothers.
Alternate Drugs to Consider:
|Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.|
Call your doctor at once if you have:
|Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.|
|Lisdexamfetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.|
Common side effects may include:
|This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
Also known as lisdexamphetamine, this drug is a CNS stimulant often prescribed for ADHD, narcolepsy and obesity. It is also a pro-drug for dextroamphetamine, and functions as a method for providing extended-release stimulation. It is sometimes prescribed alongside an SSRI for depression.
|Oral:||60-90 minutes||6-14 hours||1-16 hours|
Increased alertness, Euphoria, Increased motivation, Reduced appetite, Flushing of the face, Increased body temperature, Tachycardia (Increased heart rate), Paranoia, Insomnia.
Lisdexamfetamine may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.
Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.Do not use lisdexamfetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Lisdexamfetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.
Call your doctor right away if you have:
- signs of heart problems - chest pain, feeling light-headed or short of breath;
- signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real;
- signs of circulation problems - unexplained wounds on your fingers or toes.
Lisdexamfetamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drug Interactions (147) Alcohol/Food Interactions (2) Disease Interactions (10)
What other drugs will affect Lisdexamfetamine?
Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs lisdexamfetamine, and may increase side effects. Other drugs may interact with lisdexamfetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
A total of 147 drugs are known to interact with Lisdexamfetamine.
- 37 major drug interactions
- 102 moderate drug interactions
- 8 minor drug interactions
|Prescribers Digital Reference|
|Adults:||70 mg/day PO.|
|Geriatric:||70 mg/day PO.|
|Adolescents:||70 mg/day PO.|
|Children:||>= 6 years: 70 mg/day PO.|
|Children:||< 6 years: Safety and efficacy have not been established.|
|Infants:||Safety and efficacy have not been established.|
|Neonates:||Safety and efficacy have not been established.|
- Best medication i've been on! Comes on very smooth and do not get anxious or jittery like i did with Methylphenidate. Lasts long and helps me function the best i have my whole life.
- I switched from Adderall to Vyvanse 2 months ago. I took 20mg 2xday Adderall for 11 years. I was unable to get much more than 6 hours of efficacy from the 40mg total. I now take 60 mg Vyvanse 1 per day in the AM. I love the 1x dosing. Vyvanse gives me a good 12 hours of ADHD symptom relief. Vyvanse does not work as well as Adderall but well enough to keep me happy. The trade off of a little less effectiveness for 2 times longer relief is well worth it ... for me. Some people love Adderall, others hate it. Same for Vyvanse. I tried Strattera for a month. It raised my BP, nothing more. I hated Strattera. Yet I know a few people who swear by it. Moral to my story: The only way you can determine with certainty how you'll react to a particular medication is to try it under your doctor's direction.
- I have been on over one dozen medications throughout the last 20 years for ADD/MDD and it has only been Vyvanse that, at last, secured a permanent difference. Second, I would say that only Dexedrine was anywhere near as helpful.
- this medicine worked fantastics for me in the first 2 weeks. the last 3 weeks, i needed to raise the dosage and my body never had the same response.
Despite the marketed anti-abuse design, many users report that lisdexamfetamine is capable of producing dependence and addiction like other euphoric stimulants, particularly when it is taken above the recommended dosage. For this reason, it is highly advised to use harm reduction practices if using this substance.
Vyvanse (lisdexamfetamine) is an expensive drug used to treat attention-deficit hyperactivity disorder (ADHD). This drug is more popular than comparable drugs. There are currently no generic alternatives for Vyvanse. It is not covered by most Medicare and insurance plans, but manufacture and pharmacy coupons can help offset the cost.
Lisdexamfetamine is a central nervous system (CNS) stimulant that works after being converted by the body into dextroamphetamine. It was developed with the intention of creating a longer-lasting and less-easily abused version of dextroamphetamine. Lisdexamfetamine was approved for medical use in the United States in 2007. Common side effects of lisdexamfetamine include loss of appetite, anxiety, diarrhea, trouble sleeping, irritability, and nausea. Rare but serious side effects include mania, sudden cardiac death in those with underlying heart problems, and psychosis. In 2016, it was the 99th most prescribed medication in the United States, with more than 7 million prescriptions.
The ADHD medication shortage is getting worse. What went wrong? - Neither drugmakers nor the DEA anticipated a sharp rise in ADHD diagnoses during the pandemic. Now an entire class of medications may be in short supply.
Sunday February 05, 2023 - nbcnews.com
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