Dexmethylphenidate (dex-meth-il-FEN-i-date), Serdexmethylphenidate (ser-dex-meth-il-FEN-i-date)

Treats attention deficit hyperactivity disorder (ADHD).

Brand Name(s):

Azstarys

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the capsule in the morning.
• You may swallow the capsule whole or open it and sprinkle the contents into 50 mL of water or over 2 tablespoons of applesauce. Swallow the mixture right away or within 10 minutes of mixing. Do not store the mixture for future use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Mixed unused medicine with used coffee grounds or kitty litter, then place it in a sealable bag, empty can, or other container before throwing into the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 14 days.
• Some medicines can affect how serdexmethylphenidate and dexmethylphenidate work. Tell your doctor if you are using risperidone or blood pressure medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart disease, heart rhythm problems, high blood pressure, circulation problems, Tourette syndrome, or a history of a heart attack or stroke. Tell your doctor if you or anyone in your family has a history of depression, bipolar disorder, suicide, mental illness, or drug or alcohol abuse.
• This medicine may cause the following problems:
  • Serious heart or blood vessel problems, including heart attack and stroke (especially in people who already have heart problems)
  • High blood pressure
  • Changes in mood or behavior or unusual thoughts
  • Painful or prolonged erection of the penis
  • Peripheral vasculopathy (a blood circulation problem), including Raynaud's phenomenon
  • Slow growth and weight loss in children
  • Onset or worsening of motor or verbal tics (including Tourette syndrome)
  • Eye or vision problems, including angle closure glaucoma and intraocular pressure
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine on the day you have your surgery.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, lightheadedness or fainting, muscle cramps, seeing, hearing, or feeling things that are not there, sweating, trouble breathing
• Chest pain that may spread to your arms, jaw, back, or neck, nausea, dizziness, fast, slow, pounding, or uneven heartbeat
• Extreme energy, mood or mental changes, confusion, anxiety, agitation, restlessness, trouble sleeping, unusual thoughts or behavior
• Eye pain, changes in vision
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Painful, prolonged erection of the penis
• Slow growth or weight loss in children
• Sores, coldness, numbness, or color changes on your fingers or toes

If you notice these less serious side effects, talk with your doctor:

• Stomach pain or upset, vomiting, loss of appetite

If you notice other side effects that you think are caused by this medicine, tell your doctor

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