Dexmethylphenidate and serdexmethylphenidate

Generic name: Dexmethylphenidate And Serdexmethylphenidate
Brand names: Azstarys
Dosage form: oral capsule (10.4 mg-52.3 mg; 5.2 mg-26.1 mg; 7.8 mg-39.2 mg)
Drug class: CNS stimulants

Usage of Dexmethylphenidate and serdexmethylphenidate

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.

Dexmethylphenidate and serdexmethylphenidate side effects

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.

Before taking Dexmethylphenidate and serdexmethylphenidate

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.

Relate drugs

How to use Dexmethylphenidate and serdexmethylphenidate

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.

Warnings

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.

What other drugs will affect Dexmethylphenidate and serdexmethylphenidate

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.