VYVANSE® (Lisdexamfetamine Dimesylate), CII

VYVANSE® is a brand-name medication that contains the active ingredient lisdexamfetamine dimesylate, classified as a Schedule II controlled substance. It is primarily used to treat attention deficit hyperactivity disorder (ADHD) in children and adults and binge eating disorder (BED) in adults. VYVANSE® is a central nervous system stimulant that affects certain chemicals in the brain and nerves that contribute to hyperactivity and impulse control. It is designed to help individuals with ADHD improve their focus and reduce impulsivity and hyperactivity. In the case of BED, it helps to reduce the number of binge eating episodes.

Indications and Uses

VYVANSE® is indicated for the following purposes:

• Treatment of ADHD in pediatric patients aged 6 to 17 years and in adults.

• Treatment of BED in adults.

Dosage and Administration

The dosage of VYVANSE® is determined by a healthcare provider based on the patient's specific condition and age. The medication is taken orally once daily in the morning. The dose may be adjusted over time to achieve the desired therapeutic effect.

Contraindications

VYVANSE® should not be used in individuals with a known hypersensitivity to amphetamine products or any of its components. It is also contraindicated in individuals with a history of drug abuse, glaucoma, or severe anxiety or agitation.

Adverse Effects and Side Effects

Common side effects of VYVANSE® may include:

• Insomnia.

• Dry mouth.

• Decreased appetite.

• Nausea.

• Weight loss.

Serious side effects are rare but may include:

• Cardiovascular problems (e.g., heart attack, stroke).

• Mental/mood changes (e.g., agitation, aggression).

• Circulation problems (e.g., fingers or toes turning white, blue, or purple).

It is crucial to report any severe or unusual side effects to your healthcare provider.

Safety and Precautions

• VYVANSE® has the potential for abuse and dependence and should be used with caution in individuals with a history of substance abuse.

• Long-term use may result in slowed growth in children. Regular monitoring of growth is essential.

• Do not stop the medication suddenly, as withdrawal symptoms may occur.

Storage and Shelf Life

Store VYVANSE® at room temperature (25°C or 77°F).Keep it out of reach of children. Do not use VYVANSE® after the expiration date.

Packaging and Presentation

VYVANSE® is available as capsules with various strengths of lisdexamfetamine dimesylate.

Regulatory Information

VYVANSE® is a controlled substance and subject to regulation by health authorities to ensure its safe and proper use. It is essential to use this medication as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the official prescribing information and product labeling for the most up-to-date and comprehensive information on VYVANSE®. Your healthcare provider will guide you in the proper use of this medication, monitor your progress, and tailor the treatment to your specific medical condition.