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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Lisdexamfetamine Dimesylate
Generic Name
Lisdexamfetamine Dimesylate
Active Ingredient
Lisdexamfetamine DimesylateCategory
Other
Variants
134
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Lisdexamfetamine Dimesylate, you must consult a qualified healthcare professional.
| 10 mg/1 | CAPSULE | ORAL | 42858-161 |
| 40 mg/1 | CAPSULE | ORAL | 47781-565 |
| 60 mg/1 | CAPSULE | ORAL | 47781-567 |
| 30 mg/1 | CAPSULE | ORAL | 60505-4741 |
| 40 mg/1 | CAPSULE | ORAL | 60505-4742 |
| 50 mg/1 | CAPSULE | ORAL | 60505-4743 |
| 50 mg/1 | CAPSULE | ORAL | 60687-929 |
| 10 mg/1 | CAPSULE | ORAL | 0054-0660 |
| 50 mg/1 | CAPSULE | ORAL | 0406-5115 |
+ 38 more variants
Detailed information about Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate is a central nervous system (CNS) stimulant prodrug indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and moderate-to-severe Binge Eating Disorder (BED).
For the treatment of ADHD in adults, the recommended starting dose of Lisdexamfetamine Dimesylate is 30 mg once daily in the morning. Healthcare providers may titrate the dose in increments of 10 mg or 20 mg at approximately weekly intervals to achieve the desired clinical response. The maximum recommended dose is 70 mg per day.
For Binge Eating Disorder (BED) in adults, the starting dose is also 30 mg per day. The dose is typically increased by 20 mg weekly until a target dose of 50 mg to 70 mg per day is reached. If the patient does not tolerate the higher doses, the provider may adjust back to a lower effective dose. Clinical trials have shown that doses below 50 mg are generally less effective for BED.
Lisdexamfetamine Dimesylate is approved for pediatric patients aged 6 to 17 years for the treatment of ADHD. The starting dose is 30 mg once daily in the morning. Just as with adults, the dose may be adjusted by 10 mg or 20 mg weekly, with a maximum daily limit of 70 mg. It is not approved for use in children under the age of 6, as safety and efficacy have not been established in this age group. For pediatric patients with Binge Eating Disorder, the drug is not currently FDA-approved.
In patients with severe renal impairment (estimated GFR 15 to <30 mL/min/1.73 m²), the maximum dose should not exceed 30 mg per day. In patients with end-stage renal disease (ESRD, GFR <15 mL/min/1.73 m²), the use of Lisdexamfetamine is generally not recommended.
Specific dosage adjustments for hepatic impairment are not provided in the standard labeling, as the drug is primarily metabolized in the blood and excreted by the kidneys. However, clinicians should exercise caution in patients with severe liver dysfunction.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.
Lisdexamfetamine Dimesylate should be taken exactly as prescribed by your healthcare provider. It is usually taken once daily in the morning to avoid insomnia (difficulty sleeping). It can be taken with or without food.
If a dose is missed, it should be taken as soon as remembered in the morning. If it is already afternoon or evening, the missed dose should be skipped to prevent late-night insomnia. Do not take a double dose to make up for a missed one. Regularity is key to the effectiveness of the medication.
Signs of an overdose of Lisdexamfetamine Dimesylate can be severe and include restlessness, tremor, rapid breathing, confusion, aggression, hallucinations, panic states, hyperpyrexia (extremely high fever), and muscle pains (rhabdomyolysis). Cardiovascular effects may include arrhythmias, hypertension, or circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, and abdominal cramps.
In the event of a suspected overdose, contact the Poison Control Center immediately or seek emergency medical attention. Treatment typically involves supportive care and managing the symptoms, as there is no specific antidote for amphetamine toxicity.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or stop taking the medication without medical guidance.
Side effects are common when initiating CNS stimulants like Lisdexamfetamine Dimesylate, though many patients find they diminish over time as the body adjusts. In clinical trials, the most frequently reported adverse reactions included:
Lisdexamfetamine Dimesylate is a powerful medication that requires careful medical supervision. It is classified as a Schedule II controlled substance because it can be a target for people who abuse prescription medicines or street drugs. Keep your medication in a safe place to prevent theft. Never give your Lisdexamfetamine Dimesylate to anyone else, because it may cause death or harm them, and it is against the law.
Certain medications should never be taken with Lisdexamfetamine Dimesylate due to the risk of life-threatening interactions:
There are several conditions and situations where Lisdexamfetamine Dimesylate must NEVER be used because the risks far outweigh any potential benefits:
Lisdexamfetamine Dimesylate is classified under the former FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Data from animal studies suggest that amphetamines may have adverse effects on fetal development.
Amphetamines, including the active metabolite dextroamphetamine, are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants (such as tachycardia, irritability, and poor weight gain), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Lisdexamfetamine Dimesylate is a prodrug. After oral ingestion, it is converted into L-lysine (a natural amino acid) and dextroamphetamine (the active stimulant). The dextroamphetamine acts by increasing the levels of dopamine and norepinephrine in the synaptic cleft. It achieves this through two primary mechanisms:
The pharmacodynamic response is characterized by improved attention, increased alertness, and decreased impulsivity. Because the conversion of the prodrug is rate-limited by the enzymatic capacity of red blood cells, the rise in d-amphetamine levels is gradual, leading to a "smooth" onset of action and a long duration of effect (up to 14 hours). This profile helps avoid the "crash" often associated with immediate-release stimulants.
Common questions about Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate is primarily used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children aged 6 and older. It is also the first FDA-approved medication for the treatment of moderate-to-severe Binge Eating Disorder (BED) in adults. The medication works by increasing the levels of certain chemicals in the brain that help with focus and impulse control. It is not intended for use as a weight-loss drug or for treating obesity. Your healthcare provider will determine if it is appropriate for your specific symptoms as part of a comprehensive treatment plan.
The most common side effects reported by patients include a significant decrease in appetite, difficulty falling asleep (insomnia), and dry mouth. Many people also experience an increased heart rate, feeling anxious or jittery, and upper abdominal pain. In children, weight loss and a slight slowing of growth are common concerns that require monitoring by a pediatrician. Most of these side effects occur when first starting the medication or after a dose increase and may improve over time. If side effects become severe or persistent, you should contact your healthcare provider immediately.
It is strongly recommended that you avoid drinking alcohol while taking Lisdexamfetamine Dimesylate. Alcohol can interact with the medication in unpredictable ways, potentially worsening side effects like dizziness, anxiety, and heart palpitations. Furthermore, because Lisdexamfetamine is a stimulant, it can mask the depressant effects of alcohol, making you feel less intoxicated than you actually are. This increases the risk of alcohol poisoning or engaging in dangerous activities like impaired driving. Always consult your doctor about your lifestyle habits when starting a new stimulant medication.
The safety of Lisdexamfetamine Dimesylate during pregnancy has not been fully established in humans. Animal studies have shown that high doses of amphetamines can cause birth defects and other developmental issues. In humans, there is a risk that stimulant use during pregnancy may lead to premature birth, low birth weight, or withdrawal symptoms in the newborn. Because of these risks, the medication should only be used during pregnancy if the benefits clearly outweigh the potential risks to the baby. If you are pregnant or planning to become pregnant, you must discuss your treatment options with your healthcare provider.
Lisdexamfetamine Dimesylate is a prodrug, meaning it must be converted by the body into its active form, dextroamphetamine. Most patients begin to feel the effects within 1.5 to 2 hours after taking the dose. The peak effect usually occurs between 3 and 5 hours after ingestion. Because of its long-acting nature, the effects can last for up to 14 hours, providing coverage throughout the school or work day. It is important to take the medication early in the morning to ensure it is active when needed and to prevent it from interfering with your sleep at night.
You should not stop taking Lisdexamfetamine Dimesylate suddenly without first talking to your doctor, especially if you have been taking it for a long time. Abruptly stopping the medication can lead to a 'crash,' characterized by extreme fatigue, depression, and sleep disturbances. This is known as a withdrawal syndrome. Your healthcare provider will likely recommend a gradual dose reduction (tapering) to help your brain adjust slowly. If you experience severe mood changes or suicidal thoughts after stopping the medication, seek medical help immediately.
If you miss a dose of Lisdexamfetamine Dimesylate, take it as soon as you remember in the morning. However, if it is already late in the morning or early afternoon, it is usually best to skip the missed dose entirely. Taking the medication too late in the day can cause significant insomnia and disrupt your sleep cycle. Do not take two doses at once to make up for a missed one, as this increases the risk of dangerous side effects like high blood pressure or heart palpitations. Resume your normal schedule the following morning.
No, Lisdexamfetamine Dimesylate is much more likely to cause weight loss rather than weight gain. As a CNS stimulant, one of its primary side effects is appetite suppression. In clinical trials for both ADHD and Binge Eating Disorder, weight loss was a frequently reported adverse effect. For patients with Binge Eating Disorder, this may be a desired secondary effect, but for children with ADHD, it can be a concern for their development. If you notice significant or rapid weight loss, discuss nutritional strategies or dose adjustments with your healthcare provider.
Lisdexamfetamine Dimesylate can interact with many other drugs, some of which can be dangerous. It should never be taken with MAO inhibitors, and caution is needed when combining it with antidepressants (SSRIs or SNRIs) due to the risk of serotonin syndrome. It can also interfere with blood pressure medications and certain antacids. Always provide your doctor and pharmacist with a complete list of all medications, vitamins, and herbal supplements you are currently taking. They can check for potential interactions and adjust your treatment plan to ensure your safety.
Yes, as of late 2023, the FDA has approved several generic versions of Lisdexamfetamine Dimesylate capsules and chewable tablets. Generic versions contain the same active ingredient and are required to meet the same strict standards for quality and effectiveness as the brand-name version, Vyvanse. The availability of generics typically makes the medication more affordable for patients. However, availability can vary by pharmacy and insurance plan. Talk to your pharmacist to see if a generic version is available for your specific prescription and if it is a suitable option for you.
Other drugs with the same active ingredient (Lisdexamfetamine Dimesylate)
> Warning: Stop taking Lisdexamfetamine Dimesylate and call your doctor immediately if you experience any of these serious symptoms.
Prolonged use of stimulants may be associated with several long-term considerations:
Lisdexamfetamine Dimesylate carries a FDA Boxed Warning regarding its high potential for abuse and dependence.
Report any unusual symptoms to your healthcare provider. Early detection of side effects is essential for safe long-term management.
Patients taking Lisdexamfetamine Dimesylate require regular follow-up appointments. Monitoring typically includes:
Lisdexamfetamine Dimesylate may impair the ability of the patient to operate heavy machinery or drive, especially during the initial period of treatment or when the dose is being adjusted. While it can improve focus in many, it can also cause dizziness or tremors in others. Patients should observe their reaction to the medication before engaging in potentially hazardous activities.
Alcohol should be avoided while taking Lisdexamfetamine Dimesylate. Alcohol can unpredictably alter the release and effects of the medication, potentially increasing the risk of side effects like rapid heart rate, high blood pressure, or extreme anxiety. Furthermore, the stimulant effect of the drug can mask the intoxicating effects of alcohol, leading to a higher risk of alcohol poisoning.
Do not stop taking this medication abruptly without consulting your doctor. Sudden discontinuation after prolonged high-dose use can result in extreme fatigue and mental depression. A gradual tapering of the dose is often recommended to minimize withdrawal symptoms and allow the brain's neurochemistry to stabilize.
> Important: Discuss all your medical conditions, especially any history of heart problems or mental health issues, with your healthcare provider before starting Lisdexamfetamine Dimesylate.
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may also interfere with urinary steroid determinations. If you are undergoing lab tests, inform the laboratory that you are taking Lisdexamfetamine Dimesylate.
For each major interaction, the management strategy usually involves either avoiding the combination, adjusting the dose, or increasing the frequency of clinical monitoring.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to ensure your treatment plan is safe and effective.
These conditions require a careful risk-benefit analysis by a specialist:
Patients who are sensitive to other CNS stimulants, such as methylphenidate (Ritalin), may not necessarily be allergic to Lisdexamfetamine, but they may experience similar side effects. However, cross-sensitivity among different amphetamine salts is very high. If a patient has had a serious adverse reaction to any amphetamine-based product, Lisdexamfetamine should be avoided.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of heart disease or mental illness, before prescribing Lisdexamfetamine Dimesylate.
Lisdexamfetamine is FDA-approved for ADHD in children aged 6 to 17. It is not approved for children under 6 due to the lack of safety data and the high sensitivity of young children to stimulant effects.
Clinical studies did not include enough subjects over 65 to determine if they respond differently than younger subjects. In general, elderly patients have a higher prevalence of cardiovascular disease and reduced renal function. Therefore, if Lisdexamfetamine is prescribed, it should be started at the lowest possible dose (10-20 mg) with frequent monitoring of heart rate and blood pressure.
The kidneys play a major role in the elimination of the active metabolite.
Since the conversion of Lisdexamfetamine to dextroamphetamine occurs in the blood and not the liver, mild to moderate hepatic impairment does not typically require a dose adjustment. However, patients with severe hepatic failure should be monitored closely for overall metabolic health.
> Important: Special populations require individualized medical assessment and frequent follow-up to ensure safety and efficacy.
| Parameter | Value |
|---|---|
| Bioavailability | >99% (as prodrug) |
| Protein Binding | 2% to 5% |
| Half-life | <1 hour (Lisdex); 12 hours (Dex) |
| Tmax | ~1 hour (Lisdex); 3.5-4.5 hours (Dex) |
| Metabolism | Hydrolysis in Red Blood Cells |
| Excretion | Renal 96%, Fecal <1% |
Lisdexamfetamine Dimesylate is classified as a CNS Stimulant and a Phenethylamine derivative. It is a Schedule II controlled substance under the Controlled Substances Act. It is related to other medications like Dextroamphetamine Sulfate and Mixed Amphetamine Salts, but its prodrug delivery system is unique within the class.