Lisdexamfetamine

Attention Deficit Hyperactivity Disorder (ADHD)

Lisdexamfetamine is used to treat ADHD in adults and children who are at least 6 years of age. It works by changing the amounts of certain natural substances in the brain that control impulses and hyperactivity. When used as part of a complete treatment program, it may help to:

• Improve the ability to pay attention and stay focused.
• Decrease impulsiveness and hyperactivity.
• Improve organizational skills and listening skills.

Binge Eating Disorder (BED)

This medication is also used to treat moderate to severe binge eating disorder in adults. It can help reduce the number of days per week that an individual experiences binge eating episodes.

Important Limitations

Lisdexamfetamine is not recommended for weight loss or for the treatment of obesity. Using this medication for weight control can lead to serious heart-related side effects and other health risks. It should only be used for the specific conditions for which it was prescribed.

Mechanism of Action

Lisdexamfetamine belongs to a class of medications known as central nervous system stimulants. It works by altering the levels of certain natural substances in the brain that affect hyperactivity and impulse control.

A Prodrug Delivery System

Lisdexamfetamine is unique because it is a prodrug. This means the medication is inactive when first taken. After it is swallowed and absorbed into the bloodstream, enzymes in the red blood cells convert it into dextroamphetamine, which is the active medicine. This conversion process happens gradually, which allows for a steady release of the active drug into the body over time.

Impact on Neurotransmitters

Once converted into its active form, the medication increases the activity of two specific chemical messengers in the brain:

• Dopamine: A chemical associated with motivation, pleasure, and attention.
• Norepinephrine: A chemical that helps the brain focus and respond to stimuli.

By boosting these chemicals, lisdexamfetamine helps improve focus, increase the ability to pay attention, and decrease impulsivity and hyperactivity in people with Attention Deficit Hyperactivity Disorder (ADHD). For those with Binge Eating Disorder (BED), the medication helps reduce the frequency of binge eating episodes, although the exact biological process for this specific effect is not fully known.

Common Side Effects

Lisdexamfetamine may cause several common side effects as the body adjusts to the medication. These often include:

• Decreased appetite and weight loss
• Dry mouth
• Trouble sleeping (insomnia)
• Dizziness or feeling jittery
• Stomach pain, nausea, or vomiting
• Diarrhea or constipation
• Increased heart rate
• Anxiety or irritability

Serious Side Effects

Some side effects can be serious and require immediate medical attention. Seek help right away for symptoms such as:

• Heart problems: Chest pain, shortness of breath, or fainting.
• Psychiatric symptoms: New or worsening hallucinations (seeing or hearing things that are not real), paranoia, aggression, or manic episodes.
• Circulation issues: Numbness, pain, or skin color changes (such as turning pale, blue, or red) in the fingers or toes.
• Serotonin syndrome: Agitation, muscle twitching, sweating, or shivering, especially if taking other medications that affect serotonin levels.
• Growth suppression: Slowed growth or weight gain in children.

This medication may also cause blurred vision or seizures in some individuals. Always report new or worsening symptoms to a healthcare provider.

Abuse and Dependence

Lisdexamfetamine is classified as a controlled substance because it has a high potential for abuse and may lead to physical or psychological dependence. Healthcare providers typically assess the risk of abuse before prescribing this medication and monitor patients for signs of misuse or addiction during treatment.

Cardiovascular Risks

Serious cardiovascular events, including sudden death, stroke, and heart attack, have been reported in patients taking stimulant medications. These risks are highest in individuals with structural heart abnormalities, cardiomyopathy, or serious heart rhythm problems. Lisdexamfetamine can also cause increases in blood pressure and heart rate, requiring regular monitoring during therapy.

Psychiatric Warnings

Stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic conditions. In children and adolescents without a prior history of psychiatric illness, the medication may cause new psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania. It may also trigger mixed or manic episodes in patients with bipolar disorder.

Contraindications and Interactions

This medication is contraindicated in patients with a known hypersensitivity to amphetamine products or other components of the formulation. It must not be used concurrently with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI, as this can result in a hypertensive crisis. There is also a risk of serotonin syndrome when lisdexamfetamine is used with other serotonergic drugs.

Additional Precautions

• Growth Suppression: Long-term use of stimulants in pediatric patients may lead to a slowing of growth in both height and weight.
• Peripheral Vasculopathy: Some patients may experience circulation problems in the fingers and toes, such as Raynaud's phenomenon, which can cause skin color changes or sensitivity to temperature.
• Seizures: There is some evidence that stimulants may lower the seizure threshold in patients with a history of seizures.
• Visual Disturbances: Difficulties with vision clarity or eye focus have been reported with stimulant use.

Pregnancy

Taking lisdexamfetamine during pregnancy may increase the risk of premature birth, low birth weight, or withdrawal symptoms in the newborn baby. If you are pregnant or planning to become pregnant, discuss the potential risks and benefits of this medication with your healthcare provider.

There is a pregnancy registry for individuals who take ADHD medications while pregnant. This registry helps health professionals track the health of the mother and the baby to better understand the effects of the drug during pregnancy.

Breastfeeding

Lisdexamfetamine passes into breast milk and may cause serious side effects in a nursing infant. Because of these potential risks, breastfeeding is generally not recommended while using this medication. Consult your doctor to discuss the safest options for feeding your baby while you are receiving treatment.

Available Forms

Lisdexamfetamine is provided in the following oral forms:

• Capsules: These are intended to be swallowed whole. For patients who have difficulty swallowing, the capsule may be opened and the contents mixed with specific foods or liquids, such as water, orange juice, or yogurt.
• Chewable Tablets: These tablets must be chewed completely before swallowing.

FDA Approved Indications

Lisdexamfetamine is approved by the U.S. Food and Drug Administration (FDA) for the following uses:

• Attention Deficit Hyperactivity Disorder (ADHD): For treatment in adults and pediatric patients 6 years of age and older.
• Binge Eating Disorder (BED): For the treatment of moderate to severe BED in adults.

The FDA has noted that lisdexamfetamine is not indicated or recommended for weight loss or the treatment of obesity.

Boxed Warning

The FDA requires a boxed warning for lisdexamfetamine because central nervous system stimulants have a high potential for abuse and dependence. Before prescribing, healthcare providers should assess the risk of abuse. Patients should be monitored for signs of misuse and addiction throughout their treatment.

Controlled Substance Schedule

Lisdexamfetamine is classified as a Schedule II (CII) controlled substance under the Controlled Substances Act. This classification is due to the medication's high potential for misuse, which may lead to severe physical or psychological dependence. Regulatory requirements for Schedule II drugs include strict limits on prescriptions and refills to prevent diversion and improper use.

Generic Availability

The FDA has approved generic versions of lisdexamfetamine in both capsule and chewable tablet forms. These generic alternatives are required to meet the same quality and safety standards as the brand-name medication.

Risk of Misuse and Addiction

Lisdexamfetamine is a stimulant medication that can be habit-forming. Misuse involves taking the drug in ways other than prescribed, such as taking larger doses or using it more frequently. People with a personal or family history of substance use disorder, including drug or alcohol addiction, are at a higher risk for developing an addiction to this medication.

Physical Dependence and Withdrawal

Using lisdexamfetamine for a long period can lead to physical dependence. If you stop taking the medication suddenly, you may experience withdrawal symptoms. Common signs of withdrawal include:

• Extreme fatigue or exhaustion
• Severe depression
• Changes in sleep patterns

To prevent these symptoms, healthcare providers typically supervise a gradual reduction in dosage when the medication is no longer needed.

Safety and Storage

Because of its potential for abuse, lisdexamfetamine is classified as a Schedule II controlled substance. It is important to keep the medication in a safe place where others cannot access it. Misusing stimulants can cause serious health issues, including heart attack, stroke, and sudden death. Sharing or selling this medication is illegal and can cause harm to others.