Serdexmethylphenidate; Dexmethylphenidate Capsules

What is this medication?

SERDEXMETHYLPHENIDATE; DEXMETHYLPHENIDATE (SER dex METH il FEN i date; dex meth il FEN i date) treats attention-deficit hyperactivity disorder (ADHD). It works by improving focus and reducing impulsive behavior. It belongs to a group of medications called stimulants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AZSTARYS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Circulation problems in fingers or toes (Raynaud's)
• Heart attack
• Heart disease or a heart defect
• High blood pressure
• History of substance use disorder
• Irregular heartbeat or rhythm
• Lack or loss of appetite
• Stroke
• Mental health condition
• Suicidal thoughts, plans, or attempt by you or a family member
• Taken an MAOI, such as Marplan, Nardil, or Parnate, in the last 14 days
• An unusual or allergic reaction to dexmethylphenidate, serdexmethylphenidate, methylphenidate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the capsules whole. You may open the capsule and put the contents in 1 teaspoon of applesauce. Swallow the medication and applesauce right away. Do not chew the medication or applesauce.

You can take it with or without food. If it upsets your stomach, take it with food.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Other stimulant medications for attention disorders, weight loss, or to stay awake

This medication may also interact with the following:

• Certain medications for blood pressure, heart disease, irregular heartbeat
• General anesthetics, such as halothane, isoflurane
• Risperidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This prescription requires that you follow special procedures with your care team and pharmacy. You will need to have a new written prescription from your care team or care team every time you need a refill.

This medication has a risk of abuse and dependence. Your care team will check you for this while you take this medication.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

Do not take this medication close to bedtime. It may prevent you from sleeping

Tell your care team right away if you notice unexplained wounds on your fingers or toes while taking this medication. You should also tell your care team if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Prolonged or painful erection
• Raynaud's—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Blurry vision
• Dizziness
• Dry mouth
• Loss of appetite with weight loss
• Trouble sleeping
• Upset stomach
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.