Dexmethylphenidate and serdexmethylphenidate

Dexmethylphenidate and serdexmethylphenidate is a combination stimulant known as Azstarys. It is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children who are at least 6 years old.

Dexmethylphenidate and serdexmethylphenidate may also be used for other purposes that are not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as instructed.

Azstarys may be habit-forming. Misuse can lead to addiction, overdose, or death. Keep the medication out of reach of others. Selling or giving away dexmethylphenidate and serdexmethylphenidate is illegal.

This medicine is usually taken once a day 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 for later use.

Your doctor will need to check your progress regularly. Your heart and blood pressure may also need to be monitored often.

Inform your doctor if you have a scheduled surgery.

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

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

Stimulants can lead to stroke, heart attack, and sudden death in individuals 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 immediately if you experience: signs of heart problems—chest pain, feeling light-headed, or short of breath; or signs of psychosis—paranoia, aggression, new thought or behavior issues, seeing or hearing things that are not real.

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

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.

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.

Usual Adult Dose for Attention Deficit Disorder:

Doses are expressed as serdexmethylphenidate/dexmethylphenidateInitial 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 dayMaximum dose: 52.3 mg/10.4 mg per dayComments:-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/dexmethylphenidate6 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 day13 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 dayComments:-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.

Take the medicine as soon as you can, but do not take it late in the day. Do not take two doses at the same 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.

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.