Dyanavel XR is the first, extended-release amphetamine-based oral liquid for the treatment of ADHD
The U.S. Food and Drug Administration (FDA) has approved Dyanavel XR (amphetamine) extended-release oral suspension for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older.
Important information
Dyanavel XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving it away may harm others and is against the law.
Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Dyanavel XR is a stimulant medicine. Some patients have had the following problems when taking stimulant medicines. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.
Heart-related problems:
sudden death in patients who have heart problems or heart defects
sudden death, stroke and heart attack in adults
increased blood pressure and heart rate
Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting treatment.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Dyanavel XR.
Mental (Psychiatric) problems:
new or worse behavior and thought problems
new or worse bipolar illness
new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you have or your child has any new or worsening mental symptoms or problems while taking Dyanavel XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
fingers or toes may feel numb, cool, painful
fingers or toes may change color from pale, to blue, to red
Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Dyanavel XR.
Dyanavel XR is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). It may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
It is not known if Dyanavel XR is safe and effective in children under 6 years of age.
Dyanavel XR should not be taken if you or your child:
are allergic to amphetamine, or any of the inactive ingredients listed at the end of this Medication Guide.
are taking or have taken within the past 14 days an antidepressant medicine called a monoamine oxidase inhibitor or MAOI.
Dyanavel XR may not be right for you or your child. Before starting treatment, tell your or your child’s doctor about all health conditions (or a family history of) including:
heart problems, heart defects, or high blood pressure
mental problems including psychosis, mania, bipolar illness, or depression
circulation problems in fingers and toes
Tell your doctor:
if you or your child have any kidney problems. Your doctor may lower the dose.
if you are or your child is pregnant, or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
If you are or your child is breastfeeding or plan to breastfeed. Dyanavel XR passes into breast milk. Talk to your doctor before you breastfeed if you or your child are taking Dyanavel XR.
Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Dyanavel XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dyanavel XR. Your doctor will decide whether Dyanavel XR can be taken with other medicines.
Dyanavel XR side effects
Dyanavel XR can cause serious side effects, including:
See Important information for information on reported heart and mental problems.
slowing of growth (height and weight) in children
Common side effects of amphetamine products include:
dry mouth
decreased appetite
weight loss
stomach pain
nausea
trouble sleeping
restlessness
extreme mood changes
dizziness
increased heart rate
Talk to your doctor if you or your child have any side effects that bother you or do not go away.
These are not all the possible side effects of Dyanavel XR. Ask your doctor or pharmacist for more information.
Source: drugs.com