Adzenys ER

Adzenys ER is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 years and older. Adzenys ER 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 comes in a liquid suspension form. It is typically taken once a day in the morning, with or without food. 

Common side effects of Adzenys ER include loss of appetite and difficulty sleeping. 

Adzenys ER can also cause dizziness. Do not drive or operate heavy machinery until you know how Adzenys ER affects you.

Adzenys ER 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.

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:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Adzenys ER for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) is the following:

Adults: 12.5 mg (10 mL) once daily in the morning

Children:

• 6 to 12 years: Starting dose of 6.3 mg (5 mL) once daily in the morning
• 13 to 17 years: Starting dose of 12.5 mg (10 mL) once daily in the morning

The dose can be titrated up as needed. 

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including ADZENYS ER, 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.

Serious side effects have been reported with Adzenys ER including the following:

• Potential for abuse and dependence. Medications similar to Adzenys ER have a high potential for abuse and dependence. Consult with your physician before starting on Adzenys ER 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 ER at normal doses. Sudden death has also been reported in children who take medications similar to Adzenys ER. If you have heart problems or any heart diseases, consult with your physician before taking Adzenys ER.
• 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 an irregular heart rate, be sure to speak with your physician before starting Adzenys ER.
• Psychiatric side effects. Medications similar to Adzenys ER may worsen mental conditions including bipolar disorder, depression, and/or psychotic disorders. If you have or have ever had mental problems, speak with your physician before starting Adzenys ER.
• Slowed growth in children. Medications similar to Adzenys ER 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 ER.
• Problems with the circulation in the fingers and toes. Medications similar to Adzenys ER have been known to cause blood vessel problems including peripheral vasculopathy including Raynaud's Phenomenon. Your physician will monitor you and your child 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.

Adzenys ER can cause dizziness. Do not drive or operate heavy machinery until you know how Adzenys ER affects you.

This medication is a federally controlled substance (CII) because it contains amphetamine. Keep this medication in a safe place to protect it from theft.

Never give your medication to anyone else, because it may cause death or harm them. Selling or giving away this medication may harm others and is against the law. 

Do not take Adzenys ER if you:

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

Serious side effects have been reported with Adzenys ER. See the “Adzenys ER Precautions” section.

Common side effects of Adzenys ER include the following:

• loss of appetite/weight loss
• difficulty sleeping
• stomach pain
• nervousness, anxiety, or mood changes
• dry mouth
• headache 
• nausea
• dizziness
• fast heartbeat
• diarrhea
• lack of energy
• infections in the urinary tract

This is not a complete list of Adzenys ER 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:

• medications that change urinary pH such as guanethidine, reserpine, glutamic acid HCl, ascorbic acid, and fruit juices, sodium bicarbonate, acetazolamide, and some thiazide medications
• medications used to treat depression such as monoamine oxidase inhibitors which include tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar) and isocarboxazid (Marplan)
• medications used to treat depression such as those that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), desipramine,  protriptyline (Vivactil), and clomipramine (Anafranil)
• other medications that can lead to serotonin syndrome such as linezolid (Zyvox), fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), ritonavir fluoxetine (Prozac, Sarafem), and paroxetine (Paxil)
• medications that reduce the acid level in your stomach such as esomeprazole (Nexium), omeprazole (Prilosec), pantoprazole (Protonix), and cimetidine (Tagamet)

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

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

Based on the way they work, Adzenys ER and other amphetamines, cause vasoconstriction and therefore may lower the amount of blood available to the placenta. This medication may also lead to premature delivery.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Your doctor will determine what is the best course of action for you. 

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this medication during pregnancy. You can register by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. 

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

Adzenys ER has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Adzenys ER, a choice will be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother will be considered.