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Lisdexamfetamine dimesylate (L-lysine-dextroamphetamine dimesylate) is a psychostimulant prodrug of the phenethylamine and amphetamine chemical classes. Its molecular structure consists of dextroamphetamine coupled with the essential amino acid L-lysine. Lisdexamfetamine itself is inactive and acts as a prodrug to dextroamphetamine upon cleavage of the lysine portion of the molecule.
Lisdexamfetamine can be prescribed for the treatment of attention deficit hyperactivity disorder (ADHD) in children six to twelve years and in adults as a part of a treatment program that may include other measures (i.e., psychological, educational, social). The safety and the efficacy of lisdexamfetamine dimesylate in people three to five years old have not been established. Lisdexamfetamine is also being investigated for possible treatment of major depressive disorder, cognitive impairment associated with schizophrenia, excessive daytime sleepiness, and binge eating disorder.
Medical
Lisdexamfetamine is used primarily as a treatment for attention deficit hyperactivity disorder (ADHD) and has similar off-label uses as those of other pharmaceutical amphetamines.Long-term amphetamine exposure in some species is known to produce abnormal dopamine system development or nerve damage,but humans experience normal development and nerve growth.Magnetic resonance imaging studies suggest that long-term treatment with amphetamine decreases abnormalities in brain structure and function found in subjects with ADHD, and improves function of the right caudate nucleus.
Reviews of clinical stimulant research have established the safety and effectiveness of long-term amphetamine use for ADHD.Controlled trials spanning two years have demonstrated continuous treatment effectiveness and safety. One review highlighted a 9 month randomized controlled trial in children that found an average increase of 4.5 IQ points and continued improvements in attention, disruptive behaviors, and hyperactivity.
Psychosis
The main section for this topic is on the page Stimulant psychosis, in the section Substituted amphetamines.
Abuse of amphetamine can result in a stimulant psychosis that may present with a variety of symptoms (e.g., paranoia, hallucinations, delusions).A Cochrane Collaboration review on treatment for amphetamine, dextroamphetamine, and methamphetamine abuse-induced psychosis states that about 5–15% of users fail to recover completely.
Overdose
An amphetamine overdose can lead to many different symptoms, but is rarely fatal with appropriate care.A moderate overdose may induce symptoms including brisk reflexes, confusion, high or low blood pressure, hyperthermia, inability to urinate, involuntary muscle twitching, irregular heartbeat, muscle pain, painful urination, rapid breathing, and severe agitation.An extremely large overdose may produce symptoms such as amphetamine psychosis, bleeding in the brain, cardiogenic shock, circulatory collapse, compulsive and repetitive behavior, elevated blood potassium or low blood potassium, extreme fever, fluid accumulation in the lungs, high lung arterial blood pressure, kidney failure, metabolic acidosis, no urine production, rapid muscle breakdown, respiratory alkalosis, serotonin toxidrome, and sympathomimetic toxidrome. Fatal amphetamine poisoning usually involves convulsions and coma.
Dependence, addiction, and withdrawal
Addiction is a serious risk with heavy recreational amphetamine use; it is unlikely to arise from typical medical use.Tolerance develops rapidly in amphetamine abuse, so periods of extended use require increasing doses of the drug in order to achieve the same effect.
A Cochrane Collaboration review on amphetamine and methamphetamine dependence and abuse indicates that the current evidence on effective treatments is extremely limited.The review indicated that fluoxetine and imipramine have some limited benefits in treating abuse and addiction, but concluded, "no treatment has been demonstrated to be effective for the treatment of amphetamine dependence and abuse."
WARNINGS:
Misuse or abuse of amphetamines may cause serious (possibly fatal) heart and blood pressure problems. Amphetamine-type medications can be habit-forming. Use only as directed. If you use this drug for a long time, you may become dependent on it and may have withdrawal symptoms after stopping the drug. Consult your doctor or pharmacist for more details.
Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, stay focused, and stop fidgeting.
This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain.
How to use Vyvanse
Read the Medication Guide provided by your pharmacist before you start taking lisdexamfetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication with or without food as directed by your doctor, usually once daily in the morning. Do not take this medication in the afternoon or evening because it may cause you to have trouble sleeping. The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.
This medication may be swallowed whole. However, if you have trouble swallowing the medication, you may open the capsule and pour all of its contents (powder) in a glass of water. Use a spoon to break apart any powder that is stuck together. Stir well until the contents dissolve completely. Drink the mixture right away. Do not prepare a supply in advance. It is normal to see a filmy coating on the inside of your glass after you drink all of the medicine.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
During treatment, your doctor may occasionally recommend stopping the medication for a short time to see whether there are any changes in your behavior and whether the medication is still needed.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop this medication when so directed.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Tell your doctor if your condition does not improve or if it worsens.
Nausea, vomiting, stomach/abdominal pain, loss of appetite, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability, and restlessness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medicine because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor of any high results.
Tell your doctor right away if you have any serious side effects, including: blurred vision, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), uncontrolled movements, muscle twitching/shaking, numbness/pain/skin color change/sensitivity to temperature in the fingers or toes, outbursts of words/sounds, change in sexual ability/interest, swelling ankles/feet, extreme tiredness, rapid/unexplained weight loss, frequent/prolonged erections (in males).
Get medical help right away if you have any very serious side effects, including: shortness of breath, fainting, chest/jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, sudden vision changes.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic amines (such as dextroamphetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as severe agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat, coronary artery disease, previous heart attack, heart failure, cardiomyopathy, problems with heart structure such as valve problems), family history of heart problems (such as sudden death, irregular heartbeat), history of stroke, high blood pressure, overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), seizures, personal/family history of regular use/abuse of drugs/alcohol, personal/family history of uncontrolled muscle movements (such as Tourette's syndrome).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child's growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height. Consult your doctor or pharmacist for more details.
During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor immediately if you notice possible mood changes, agitation, or unusual tiredness in your newborn.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Check the labels on all your medicines (such as cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using these products safely.
Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking over-the-counter products that contain caffeine. Caffeine can increase the side effects of this medication.
Lisdexamfetamine is very similar to dextroamphetamine. Do not use medications containing dextroamphetamine while using lisdexamfetamine.
This medication may interfere with certain laboratory tests (including blood and urine steroid levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately.Symptoms of overdose may include: severe mental/mood changes (such as confusion, hallucinations), seizures, irregular heartbeat, severe restlessness, fast breathing.
Notes
Do not share this medication with others. It is against the law.
Laboratory and/or medical tests (such as blood pressure, heart rate, growth monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Missed Dose
If you miss a dose, take it as soon as you remember in the morning hours. If it is afternoon or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised January 2014. Copyright(c) 2014 First Databank, Inc.
