What is Dyanavel XR? Uses, warnings & side effects

Take this medicine as directed. The dose may change several times during treatment.

Please read the Medication Guide (tablets) and the Instructions for Use (liquid) that come with this medicine.

Take only one dose daily.

Take the daily dose in the morning.

Doses can be taken with or without food.

How to take Dyanavel XR tablets:

• Swallow or chew the tablets.

• Dyanavel XR 5 mg tablets are scored to allow them to be divided into two 2.5 mg doses. If you don’t know how to divide a tablet, ask the pharmacist for a demonstration.

• Store Dyanavel XR tablets at room temperature in a safe place like a locked cabinet. 

How to administer Dyanavel XR oral suspension:

• Shake the bottle well before measuring a dose.

• Use the oral dosing syringe provided by the pharmacist. If you don’t have an oral dosing syringe or bottle adapter, ask the pharmacist to provide them.

• When dosing a child, place the tip of the dosing syringe against the inside of the child’s cheek to give a dose.

• Store Dyanavel XR oral suspension at room temperature in a safe place like a locked cabinet. 

Ask the prescriber what to do if a dose is missed.

Doses should only be taken in the morning.

Do not take two doses on the same day.

This medicine is not right for everyone. 

Do not use it if you have had an allergic reaction to amphetamines.

Tell any doctor or other healthcare provider who treats you that you are using this medicine.

In most states, amphetamine treatment requires monthly doctor’s visits. The prescriber will occasionally need to check on side effects or growth velocity (in a child). Keep all appointments.

Make sure your prescriber knows if you are pregnant, breastfeeding, or if you have: 

• Heart problems

• Heart disease

• Heart defects

• High blood pressure

• Blood circulation problems in your fingers or toes

• Tourette syndrome

• Any tics or any family history of tics

• A mental health condition

• A family history of bipolar disorder, depression, or suicide

• A drug addiction or a history of drug abuse or addiction

Amphetamines can cause serious problems including: 

• Abuse, misuse, and addiction

• Heart problems

• Blood circulation problems, particularly in the fingers and toes

• Sudden death in people with heart problems

• Heart attack

• Stroke

• High blood pressure

• Behavior changes

• Mood changes including mania

• Seizures

• Serotonin syndrome, a potentially life-threatening complication of taking certain types of drugs

• Slowed growth (in children)

Women should avoid breastfeeding when taking this medicine.

This medicine can be habit-forming. Do not use more than your prescribed dose. Call the prescriber if the dose does not seem to be working.

Dyanavel XR is a federally controlled substance. Giving or selling this medicine to other people is dangerous and illegal.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 14 days.

To avoid drug interactions, tell the prescribing healthcare provider about all the medications you take or plan to take, particularly:

• Other ADHD medications

• Other stimulants including weight loss medications

• Antidepressants, particularly tricyclic antidepressants, SSRIs, or buspirone

• Antipsychotic medications

• Any other drug that treats mental disorders

• Migraine medications called triptans

• Narcotic pain medications

• Anticonvulsants

• Drugs that reduce stomach acid

• Drugs that make urine acidic or alkaline

• The supplements St. John’s wort or tryptophan

• Acetazolamide, ammonium chloride, ascorbic acid (vitamin C), buspirone, guanethidine, meperidine, methenamine, Paxlovid, reserpine, ritonavir, sodium bicarbonate

Avoid alcohol while you are using this medicine.

Avoid products with caffeine or similar stimulants.

Tell other healthcare providers you are using this medicine before they prescribe new medications.