Important Safety Information
Medication Guide and Prescribing Information
DYANAVEL XR Liquid Tris ADHD medication
Tris Pharma DYANAVEL XR Male Smiling
For patients 6 years and older with ADHD

DYANAVEL® XR
liquid frequently asked questions

Find answers to common questions about DYANAVEL XR (amphetamine)

DYANAVEL XR 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.

The XR stands for “eXtended Release.”

DYANAVEL XR 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.

The effectiveness of DYANAVEL XR 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.

DYANAVEL XR is bubblegum-flavored.

Store DYANAVEL XR 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.

DYANAVEL XR 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.

  • Take DYANAVEL XR 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

DYANAVEL XR is taken once each day in the morning

DYANAVEL XR 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.

DYANAVEL XR 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.

DYANAVEL XR 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.

tris pharma dyanavel adhd children playing instruments

ADHD – A Caregiver’s Practical Resource, a booklet that provides helpful educational information about ADHD.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCI), and QuilliChew ER® (methylphenidate HCI) 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.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCI), and QuilliChew ER® (methylphenidate HCI) 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.

DYANAVEL XR, or Quillivant XR and QuilliChew ER, should not be taken if you or your child are allergic to amphetamine or methylphenidate hydrochloride, respectively, or any of the ingredients in these medicines, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

DYANAVEL XR, Quillivant XR, and QuilliChew ER can cause serious side effects. Tell the doctor:

  • if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting any of these medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking any of these medicines.
  • if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • if you or your child have circulation problems in fingers and toes (called peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking DYANAVEL XR, Quillivant XR, or QuilliChew ER.
  • if your child is having slowing of growth (height and weight); Your child should have his or her height and weight checked often while taking DYANAVEL XR, Quillivant XR, or QuilliChew ER.
  • if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Priapism has occurred with methylphenidate (Quillivant XR and QuilliChew ER). Because priapism can cause long-lasting damage, it should be checked by a doctor right away.
  • if you or your child have symptoms of serotonin syndrome - agitation, hallucinations, coma, or other changes in mental status; fast heartbeat; sweating or fever; nausea, vomiting, diarrhea; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness. Serotonin syndrome may occur when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop DYANAVEL XR and call your doctor or go to the nearest hospital emergency room.
  • if you or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.
  • if you or your child are pregnant or plan to become pregnant. It is not known if DYANAVEL XR, Quillivant XR, or QuilliChew ER will harm your unborn baby. Tell your doctor if you or your child become pregnant during treatment with any of these medicines.
  • if you or your child is breastfeeding or plan to breastfeed. DYANAVEL XR, Quillivant XR, and QuilliChew ER pass into breast milk. You or your child should not breastfeed while you are taking any of these medicines.

Common side effects of amphetamine products include:

  • dry mouth
  • nausea
  • extreme mood changes
  • decreased appetite
  • trouble sleeping
  • dizziness
  • weight loss
  • restlessness
  • increased heart rate
  • stomach pain

Common side effects of methylphenidate products inlude:

  • decreased appetite
  • stomach pain
  • irritability
  • trouble sleeping
  • weight loss
  • mood swings
  • nausea
  • anxiety
  • fast heart beat
  • vomiting
  • dizziness
  • increased blood pressure
  • indigestion

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking DYANAVEL XR, Quillivant XR, or QuilliChew ER.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

APPROVED USE

DYANAVEL XR, Quillivant XR, and QuilliChew ER are central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. These medicines may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if DYANAVEL XR, Quillivant XR, and QuilliChew ER are safe and effective in children under 6 years of age.

See Medication Guide for DYANAVEL XR, Quillivant XR, and QuilliChew ER.

See Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse and Dependence.

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