Serdexmethylphenidate

What it is used for

AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage (5.7, 8.4).

The most important thing to know

AZSTARYS can cause serious side effects, including: Abuse misuse, and addiction. AZSTARYS has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of AZSTARYS, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death.

The risk of overdose and death is increased with higher doses of AZSTARYS or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with AZSTARYS and will monitor you or your child during treatment.

AZSTARYS may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give AZSTARYS to anyone else. See “What is AZSTARYS?” for more information. Keep AZSTARYS in a safe place and properly dispose of any unused medicine. See “

Who should not take it

Do not take AZSTARYS if you or your child are: allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS. See the end of this Medication Guide for a complete list of ingredients in AZSTARYS. taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Before taking AZSTARYS, tell your healthcare provider about all medical conditions, including if you or your child: have heart problems, heart disease, heart defects, or high blood pressure have mental problems including psychosis, mania, bipolar illness, or depression, or has a family history of suicide, bipolar illness, or depression have circulation problems in fingers and toes have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness) have or had repeated movements or sounds (tics) or Tourrette's syndrome, or have a family history of tics or Tourette's syndrome are pregnant or plans to become pregnant.

It is not known if AZSTARYS will harm the unborn baby. There is a pregnancy registry for females who are exposed to ADHD medications, including AZSTARYS, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to AZSTARYS and their baby. If you or your child becomes pregnant during treatment with AZSTARYS, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

are breastfeeding or plans to breastfeed. AZSTARYS passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with AZSTARYS. Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

AZSTARYS and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with AZSTARYS. Your healthcare provider will decide whether AZSTARYS can be taken with other medicines. Especially tell your healthcare provider if you or your child takes: blood pressure medicines (anti-hypertensive) Know the medicines that you or your child take.

Keep a list of the medicines with you to show your healthcare provider and pharmacist. Do not start any new medicine during treatment with AZSTARYS without talking to your healthcare provider first. How should AZSTARYS be taken? Take AZSTARYS exactly as prescribed. Your healthcare provider may change the dose if needed.

Take AZSTARYS 1 time each day in the morning with or without food. AZSTARYS capsules may be swallowed whole with water or other liquids. If AZSTARYS capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto 2 tablespoonfuls of applesauce or into 2oz (50mL) of water. Swallow all the applesauce or water mixture right away or within 10 minutes of mixing.

Do not store applesauce or water and medicine mixture. If you or your child take too much AZSTARYS, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. What are possible side effects of AZSTARYS? AZSTARYS can cause serious side effects, including: Painful and prolonged erections (priapism).

Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away. Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Signs and symptoms may include: fingers or toes may feel numb, cool, or painful fingers or toes may change color from pale, to blue, to red Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or

Storing it

” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with AZSTARYS.

Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with AZSTARYS.

Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with AZSTARYS. Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with AZSTARYS, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What is AZSTARYS? AZSTARYS is a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.

AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD. AZSTARYS is not recommended for use in children under 6 years of age with ADHD. AZSTARYS is a federally controlled substance (CII) because it contains dexmethylphenidate that can be a target for people who abuse prescription medicines or street drugs.

Keep AZSTARYS in a safe place to protect it from theft. Never give AZSTARYS to anyone else because it may cause death or harm them. Selling or giving away AZSTARYS may harm others and is against the law.