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DYANAVEL® XR FREQUENTLY ASKED QUESTIONS

Find answers to common questions about DYANAVEL® XR (amphetamine)

What is DYANAVEL XR?

DYANAVEL® XR (amphetamine) is the first once-daily, extended-release liquid amphetamine for the treatment of ADHD. It is a central nervous system stimulant prescription liquid medicine that is taken by mouth once every day in the morning, with or without food. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.

DYANAVEL XR should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

What does the XR stand for in DYANAVEL XR?

The XR stands for “eXtended Release.”

Why is DYANAVEL XR considered an extended-release medicine?

DYANAVEL® XR (amphetamine) is a long-lasting liquid amphetamine that uses technology to allow for a continuous release of medication throughout the day. This means that DYANAVEL XR only needs to be taken once each day in the morning, and the medicine is released into the body throughout the day.

In a clinical study performed in a laboratory classroom, DYANAVEL XR was found to reduce the symptoms of ADHD in children ages 6-12 years at all measured times (1, 2, 4, 6, 8, 10, and 12 hours after taking) compared to a sugar syrup.

How were the effects of DYANAVEL XR measured?

The effectiveness of DYANAVEL® XR (amphetamine) was assessed in a laboratory classroom study. At the end of each week, teachers and raters used a rating scale (SKAMP) to evaluate the efficacy of DYANAVEL XR on attention and behavior in children with ADHD ages 6-12 years. In a clinical study performed in a laboratory classroom, DYANAVEL XR was demonstrated to start working within as little as 1 hour, keep working for 13 hours after taking, and reduce the symptoms of ADHD in children ages 6-12 years at all measured times (1, 2, 4, 6, 8, 10, 12, and 13 hours after taking) compared to a sugar syrup.

What does DYANAVEL XR taste like?

DYANAVEL® XR (amphetamine) is bubblegum-flavored.

How do I store DYANAVEL XR?

Store DYANAVEL® XR (amphetamine) in a safe place at 68°F to 77°F (20°C to 25°C). Keep DYANAVEL XR and all medicines out of the reach of children.

How is DYANAVEL XR supplied?

DYANAVEL® XR (amphetamine) comes as a light-beige-to-tan viscous liquid. You will be given 1 bottle (containing the liquid form of DYANAVEL XR), 1 oral dosing dispenser, and 1 bottle adapter that will have already been inserted into the bottle by the pharmacist. Please refer to the Instructions for Use for a full description of each item.

How should DYANAVEL XR be taken?

  • Take DYANAVEL® XR (amphetamine) exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child
  • Take DYANAVEL XR once each day in the morning
  • DYANAVEL XR should be used with the oral dosing dispenser provided with the product. If the oral dosing dispenser is missing or not provided, please contact your pharmacist
  • DYANAVEL XR can be taken with or without food
  • From time to time, your healthcare provider may stop DYANAVEL XR treatment for a while to check ADHD symptoms
  • Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking DYANAVEL XR
  • Children should have their height and weight checked often while taking DYANAVEL XR. DYANAVEL XR treatment may be stopped if a problem is found during these check-ups
  • In case of poisoning, call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room

How often should DYANAVEL XR be taken?

DYANAVEL® XR (amphetamine) is taken once each day in the morning.

When does DYANAVEL XR start working?

DYANAVEL® XR (amphetamine) was demonstrated to start working within as little as 1 hour after taking. In a clinical study performed in a laboratory classroom, DYANAVEL XR was found effective at reducing the symptoms of ADHD in children ages 6-12 years at all measured times (1, 2, 4, 6, 8, 10, 12, and 13 hours after taking) compared to a sugar syrup.

How long do the effects of DYANAVEL XR last?

DYANAVEL® XR (amphetamine) works within as little as 1 hour and keeps working for 13 hours after taking. That means that if taken at 7 am, DYANAVEL XR can be effective through evening time. In a clinical study performed in a laboratory classroom, DYANAVEL XR was found effective at reducing the symptoms of ADHD in children ages 6-12 years at all measured times (1, 2, 4, 6, 8, 10, 12, and 13 hours after taking) compared to a sugar syrup.

Can DYANAVEL XR be habit-forming?

DYANAVEL® XR (amphetamine) is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others, and is against the law. Tell your healthcare provider if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.

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Important Safety Information & Approved Use

DYANAVEL XR, Quillivant XR, and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

See Additional Important Safety Information.