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

DYANAVEL® XR liquid dosing and administration

Dosing as low as 2.5 mg to help balance side effects and efficacy.

DYANAVEL XR (amphetamine)
lets you or your child start medication slowly

DYANAVEL XR should be taken by mouth once every day in the morning.

  • Your healthcare provider may start DYANAVEL XR at a low dose and individualize the dose by adjusting it up or down in small amounts based on your or your child’s treatment response
  • DYANAVEL XR comes with an oral dosing dispenser that will help you measure the amount of medication
  • DYANAVEL XR can be taken with or without food
  • Take DYANAVEL XR exactly as prescribed and remember to shake the bottle well (up and down) prior to each use

Did you know...?

DYANAVEL XR starts working as quickly as 1 hour after taking.
From 1 hour bubble

How to take DYANAVEL XR

Read the Instructions for Use for DYANAVEL XR you received from your pharmacist before taking DYANAVEL XR and every time you get a refill so that you have the most up-to-date instructions.

If you have any questions, talk to your healthcare provider about your or your child’s medical condition or treatment.

Tris Pharma DYANAVEL XR ADHD Step 1

Step 1

  • Check the DYANAVEL XR bottle to make sure that the bottle adapter has been inserted into the bottle by the pharmacist. Do not remove the bottle adapter.
  • Check to make sure your pharmacist has given you an oral dosing dispenser.
  • Tell your pharmacist if an oral dosing dispenser is not provided or the bottle adapter is missing from the neck of the bottle.

Tris Pharma DYANAVEL XR ADHD Step 2

Step 2

  • Shake the bottle well (up and down).

Tris Pharma DYANAVEL XR ADHD Step 3

Step 3

  • Check the DYANAVEL XR oral dosing dispenser to find the right dose in milliliters (mL) that you or your child’s healthcare provider has prescribed.

Tris Pharma DYANAVEL XR ADHD Step 4-5

Step 4

  • Place the DYANAVEL XR bottle upright and insert tip of the oral dosing dispenser into the bottle.

Step 5

  • Push the plunger all the way down.

Tris Pharma DYANAVEL XR ADHD Step 6

Step 6

  • With the oral dosing dispenser in place, hold the DYANAVEL XR bottle with 1 hand and turn the bottle upside down. Pull the plunger down until the white end of the plunger reaches the number of mLs you need for the prescribed dose.

Tris Pharma DYANAVEL XR ADHD Step 7

Step 7

  • Turn the bottle over and place upright on a counter top, then remove the oral dosing dispenser from the bottle adapter.

Tris Pharma DYANAVEL XR ADHD Step 8

Step 8

  • Place the tip of the oral dosing dispenser into your or your child’s mouth. Point the tip toward the cheek and slowly push the plunger all the way down to give the DYANAVEL XR dose.

Tris Pharma DYANAVEL XR ADHD Step 9

Step 9

  • Put the DYANAVEL XR cap back on the bottle and close tightly.

Tris Pharma DYANAVEL XR ADHD Step 10

Step 10

  • Clean the oral dosing dispenser after each use by placing in the dishwasher, or by rinsing with tap water.

Keep DYANAVEL XR and all medicines out of the reach of children.

Learn about the steady medication release of DYANAVEL XR

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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