Adzenys XR-ODT

Adzenys XR-ODT is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 years and older. Adzenys XR-ODT belongs to a group of drugs called amphetamine stimulants. These work to improve focus and decrease hyperactivity by altering the levels of certain natural chemicals in the brain.

This medication is available in an extended-release orally disintegrating tablet. It is typically taken once a day in the morning, with or without food. Allow tablet to fully disintegrate in saliva and then swallow. 

Common side effects of Adzenys XR-ODT include loss of appetite, difficulty falling asleep, and stomach pain. 

Adzenys XR-ODT is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 years and older.

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

Serious side effects have been reported with Adzenys XR-ODT. See the “Adzenys XR-ODT Precautions” section.

Common side effects of Adzenys XR-ODT include the following:

• headache
• abdominal pain
• loss of appetite
• fever
• insomnia
• dry mouth
• anxiety
• weight loss

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

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:

• Acidifying agents such guanethidine, reserpine, glutamic acid HCl, ascorbic acid, and fruit juices 
• Urinary acidifying agents such as ammonium chloride and sodium acid phosphate 
• Adrenergic blockers
• Gastrointestinal alkalizing agents such as sodium carbonate and urinary alkalizing agents such as acetazolamide
• Tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)

• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• Antihistamines
• Antihypertensives
• Chlorpromazine
• Haloperidol
• Ethosuximide
• Lithium
• Methenamine
• Norepinephrine
• Phenobarbital
• Phenytoin
• Propoxyphene
• Medications that reduce the acid level in your stomach such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (Aciphex), cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
• Veratrum alkaloids

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

Serious side effects have been reported with Adzenys XR-ODT including the following:

Potential for abuse and dependence. Medications similar to Adzenys XR-ODT have a high potential for abuse and dependence. Consult with your physician prior to beginning therapy with Adzenys XR-ODT if you have a history of medication abuse and/or dependence.

Serious heart problems. Sudden death, stroke, and heart attacks have been reported in adults using medications similar to Adzenys XR-ODT at normal doses. Sudden death has also been reported in pediatric patients taking medications similar to Adzenys XR-ODT. If you have heart problems or any heart diseases, consult with your physician prior to beginning therapy with Adzenys XR-ODT.

Increases in blood pressure and/or heart rate. Medications similar to Adzenys XR-ODT can cause an increase in both blood pressure and heart rate. If you have high blood pressure or heart rate abnormalities, consult with your physician prior to beginning therapy with Adzenys XR-ODT.

Psychiatric side effects. Medications similar to Adzenys XR-ODT may worsen pre-existing psychiatric disorders including bipolar disorder, depression, and/or psychotic disorders. If you have or have ever had any psychiatric disorders, consult with your physician prior to beginning therapy with Adzenys XR-ODT.

Slowed growth in children. Medications similar to Adzenys XR-ODT have been known to cause weight loss and slowed growth rate in children. Your child's pediatrician will monitor their growth rate during therapy with Adzenys XR-ODT.

Blood vessel problems. Medications similar to Adzenys XR-ODT have been known to cause blood vessel problems including peripheral vasculopathy and Raynaud's Phenomenon. Your physician will monitor you for the development of these types of problems during the course of your therapy as well as instruct you on how to be aware of the development of symptoms of these types of problems.

Do not take Adzenys XR-ODT if you:

• are allergic to Adzenys XR-ODT or to any of its ingredients
• currently take or have taken an monoamine oxidase inhibitor medication (MAOI) within 14 days

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 Adzenys XR-ODT, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Adzenys XR-ODT, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Adzenys XR-ODT or to any of its ingredients
• have a history of medication abuse and/or dependence
• have high blood pressure
• have or have ever had any psychiatric disorders
• have a history of blood vessel problems
• have been diagnosed with dwarfism or any other growth disorders
• have heart problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Adzenys XR-ODT falls into category C. There are no well-controlled studies that have been done in pregnant women. Adzenys XR-ODT 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.

The active ingredient in Adzenys XR-ODT has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Adzenys XR-ODT, women should not breastfeed during treatment with Adzenys XR-ODT. A choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Adzenys XR-ODT exactly as prescribed

• Adzenys XR-ODT is available in an extended-release orally disintegrating tablet and is typically taken once a day in the morning
• Adzenys XR-ODT can be taken with or without food.
• Allow Adzenys XR-ODT to fully disintegrate in saliva then swallow.
• The Adzenys XR-ODT tablet should remain in the blister pack until you are ready to take it

Taking Adzenys XR-ODT

• Use dry hands to open the blister; tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet; the tablet should not be pushed through the foil
• As soon as the blister is opened, the tablet should be removed and placed on your tongue
• The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. The tablet will disintegrate in saliva so that it can be swallowed.

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 age

The recommended dose range of Adzenys XR-ODT for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 years and older is 6.3 mg - 18.8 mg taken by mouth, once daily in the morning.

If you take too much Adzenys XR-ODT, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 20°C to 25º C (68°F to 77º F)
• Store this and all medications away from children

Warning: Abuse and Dependence

• Central nervous system stimulants, including Adzenys XR-ODT, 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