Dexmethylphenidate and serdexmethylphenidate is a combination stimulant called Azstarys, which is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children at least 6 years old.

Dexmethylphenidate and serdexmethylphenidate may also be used for purposes not listed in this medication guide.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

dexmethylphenidate and serdexmethylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; or signs of psychosis--paranoia, aggression, new thought or behavior problems, seeing or hearing things that are not real.

This medicine may be habit-forming. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Azstarys may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away dexmethylphenidate and serdexmethylphenidate is against the law.

This medicine is usually taken once daily in the morning, with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with 2 ounces of water or 2 tablespoons of applesauce. Swallow the mixture within 10 minutes, without chewing. Do not save the mixture to take later.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Tell your doctor if you have a planned surgery.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Azstarys could be harmful to someone using it improperly. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

Usual Adult Dose for Attention Deficit Disorder:

Doses are expressed as serdexmethylphenidate/dexmethylphenidate

Initial dose: 39.2 mg/7.8 mg orally once a day
-After 1 week, increase to 52.3 mg/10.4 mg orally once a day
Maintenance dose: 52.3 mg/10.4 mg orally once a day
Maximum dose: 52.3 mg/10.4 mg per day

Comments:
-Pretreatment screening for the presence of cardiac disease should be performed prior to initiating therapy.
-Dosing is once a day in the morning.
-Treatment of Attention Deficit Hyperactivity Disorder (ADHD) may be needed for an extended period; periodically re-evaluate long-term use and adjust dose as needed.

Use: For the treatment of ADHD.

Usual Pediatric Dose for Attention Deficit Disorder:

Doses are expressed as serdexmethylphenidate/dexmethylphenidate

6 to 12 years:
Initial dose: 39.2 mg/7.8 mg orally once a day
-After 1 week, may increase to 52.3 mg/10.4 mg orally once a day or decrease to 26.1 mg/5.2 mg orally once a day depending on response and tolerability
Maintenance dose: 26.1 mg/5.2 mg to 52.3 mg/10.4 mg orally once a day
Maximum dose: 52.3 mg/10.4 mg per day

13 years or older:
Initial dose: 39.2 mg/7.8 mg orally once a day in the morning
-After 1 week, increase to 52.3 mg/10.4 mg orally once a day
Maintenance dose: 52.3 mg/10.4 mg orally once a day
Maximum dose: 52.3 mg/10.4 mg per day

Comments:
-Pretreatment screening for the presence of cardiac disease should be performed prior to initiating therapy.
-Dosing is once a day in the morning.
-Treatment of Attention Deficit Hyperactivity Disorder (ADHD) may be needed for an extended period; periodically re-evaluate long-term use and adjust dose as needed.

Use: For the treatment of ADHD in patients 6 years or older.

You should not take this medicine if you are allergic to dexmethylphenidate, serdexmethylphenidate, or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Azstarys could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• blood circulation problems in the hands or feet; or

• alcoholism or drug addiction.

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Azstarys on the baby.

If you are breastfeeding, tell your doctor if you notice agitation, feeding problems, or reduced weight gain in the nursing baby.

Not approved for use by anyone younger than 6 years old.

Take the medicine as soon as you can, but avoid taking it late in the day. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose could be fatal.

Overdose symptoms may include dry mouth, vomiting, diarrhea, tremors, muscle twitches, overactive reflexes, agitation, anxiety, feeling restless, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, rapid breathing, seizure (convulsions), fainting, or coma.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: fever; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Dexmethylphenidate and serdexmethylphenidate may cause serious side effects. Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis--hallucinations (seeing or hearing things that are not real), new thought or behavior problems, aggression, hostility, paranoia;

• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or

• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Azstarys can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common side effects of dexmethylphenidate and serdexmethylphenidate may include:

• loss of appetite, weight loss;

• indigestion, stomach pain, nausea, vomiting;

• dizziness, fast heart rate, increased blood pressure;

• mood changes, feeling anxious or irritable;

• sleep problems (insomnia); or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• an antidepressant; or

• blood pressure medication.

This list is not complete. Other drugs may affect Azstarys, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.