Dyanavel XR

Dyanavel XR is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD).

Dyanavel XR belongs to a group of drugs called nervous system stimulants. These work by changing the amounts of certain natural substances in the brain.  

This medication comes in solution form and is taken once a day, with or without food.

Common side effects of Dyanavel XR include dry mouth, decreased appetite, and weight loss. Dyanavel XR may also cause dizziness. Do not drive or operate machinery until you know how Dyanavel XR affects you.

Dyanavel XR is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD).

Dyanavel XR 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Tris Pharma, Inc.

Serious side effects have been reported with Dyanavel XR. See the “Dyanavel XR Precautions” section.

Common side effects of Dyanavel XR include the following:

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

This is not a complete list of Dyanavel XR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• Acidifying agents such guanethidine, reserpine, glutamic acid HCl, ascorbic acid, and fruit juices 
• Urinary acidifying agents such as ammonium chloride and sodium acid phosphate 
• Gastrointestinal alkalizing agents such as sodium carbonate and urinary alkalizing agents such as acetazolamide
• medications that reduce the acid level in your stomach such as omeprazole (Prilosec)

This is not a complete list of Dyanavel XR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Dyanavel XR including the following:

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 Dyanavel XR. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Dyanavel XR.

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:

All Patients

• 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.

​Do not take Dyanavel XR if you:

• are allergic to Dyanavel XR or to any of its ingredients
• are taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Dyanavel XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking over-the-counter products that contain caffeine can increase the side effects of this medication. Discuss consumption of caffeine-containing products with your doctor.

Before taking Dyanavel XR, tell your doctor about all of your medical conditions. Especially tell your or your child's doctor if you or your child: 

• are allergic to Dyanavel XR or to any of its ingredients
• have or have a family history of heart problems, heart defects, or high blood pressure
• have or have a family history of mental problems including psychosis, mania, bipolar illness, or depression
• have or have a family history of circulation problems in fingers and toes
• have any kidney problems. Your doctor may lower the dose.
• are pregnant or plan to become pregnant. It is not known if Dyanavel XR will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Dyanavel XR passes into breast milk. Discuss with your doctor before you breastfeed while you are taking Dyanavel XR.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements

Tell your doctor if you are pregnant or plan to become pregnant.

There is limited data on the use of amphetamine, such as Dyanavel XR, in pregnant women. It is not known if Dyanavel XR will harm your unborn baby.

Some babies have been born with problems, such as premature delivery and low birth weight, after exposure to amphetamines during pregnancy. Dyanavel XR should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Dyanavel XR has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Dyanavel XR, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered. Breastfeeding is not recommended during treatment with Dyanavel XR. 

Take Dyanavel XR exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.

This medication comes in solution form and is taken once a day, with or without food.

Take Dyanavel XR oral suspension 1 time each day in the morning.

Shake the Dyanavel XR bottle well before you use it.

Use an oral dosing syringe or another measuring device to help you measure the right amount of Dyanavel XR.

Your doctor may sometimes stop Dyanavel XR treatment for a while to check your ADHD symptoms.

Your doctor may do regular checks of your or your child’s 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.

Avoid drinking alcohol while taking Dyanavel XR.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

In children 6 years of age and older, the recommended starting dose is 2.5 mg or 5 mg once daily in the morning.

The dose may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days until you get the response you want. Doses of 20 mg/day are not recommended. 

If you or your child takes too much Dyanavel XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Dyanavel XR at room temperature between 68°F to 77°F (20°C to 25°C). 
• Keep this and all medicines out of the reach of children.
• Store Dyanavel XR in a safe place, like a locked cabinet.
• Dispose of remaining, unused, or expired Dyanavel XR by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. 

CNS stimulants, including Dyanavel XR, other amphetamine containing products, and methylphenidate, have a high potential for abuse and dependence.

Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.