Centanafadine

Studies have shown that children and teenagers with attention-deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) who take centanafadine are more likely to think about killing themselves than children and teenagers with ADHD who do not take centanafadine.

Watch your child's behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Ask other people who spend a lot of time with your child, such as brothers, sisters, and teachers to tell you if they notice changes in your child's behavior. Call your child's doctor right away if your child experiences any of these symptoms: acting more subdued or withdrawn than usual; feeling helpless, hopeless, or worthless; new or worsening depression; thinking or talking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive or violent behavior; acting without thinking; extreme increase in activity or talking; frenzied, abnormal excitement; or any other sudden or unusual changes in behavior.

Centanafadine can be habit-forming. Take centanafadine exactly as directed. Do not take more or less of it, take it in another manner, or take it more often than prescribed by your doctor. If you take too much centanafadine, you may have an increased risk of overdosage or death. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.

Do not sell, give away, or let anyone else take your medication. Selling or giving away centanafadine may harm others and is against the law. Store centanafadine in a safe place so no one else can take it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Centanafadine is used for the treatment of attention deficit hyperactivity disorder (ADHD). Centanafadine is in a class of medications called norepinephrine-dopamine-serotonin reuptake inhibitors and central nervous system stimulants. It works by increasing levels of chemicals in the brain that are needed to help control behavior.

Centanafadine comes as a capsule to take by mouth. Take with or without food once a day in the morning. Take centanafadine at around the same time every day.

Take centanafadine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsules whole, you can open the capsule and sprinkle the contents on a tablespoon of applesauce or yogurt or in one tablespoon of orange juice. Swallow all of the contents right away and follow with water. Do not chew the contents. Do not save for later.

Your doctor may start you on a low dose of centanafadine and gradually increase your dose.

Centanafadine controls ADHD but does not cure it. Continue to take centanafadine even if you feel well. Do not stop taking centanafadine without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking centanafadine,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with centanafadine. Other medications may cause dosing changes or extra monitoring when taken with centanafadine. Make sure you have discussed any medications you are currently taking or plan to take before starting centanafadine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking centanafadine, please get the advice of your doctor or pharmacist.
• you should know the following nonprescription or herbal products may interact with centanafadine: caffeine. Talk to your doctor or pharmacist about the safe use of caffeine with centanafadine.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors, including isocarboxazid, linezolid, methylene blue, phenelzine, rasagiline, selegiline, and tranylcypromine. Your doctor will probably tell you not to start centanafadine until at least 14 days have passed since topping the MAO inhibitor.
• tell your doctor if you have pheochromocytoma (a benign tumor of the adrenal gland that causes overproduction of stress hormones). Your doctor will probably tell you not to take centanafadine.
• tell your doctor if you or anyone in your family has or has ever had an irregular heartbeat or has died suddenly, a heart defect, hypertension (high blood pressure), cardiomyopathy, or any other heart problem; Tourette's syndrome (a condition that causes sudden repeated motions, sounds or words), facial or motor tics (repeated uncontrollable movements), or verbal tics (repeated sounds or words that are hard to control); depression, bipolar disorder (mood that changes from depressed to abnormally excited). Tell your doctor if you have Raynaud's Phenomenon (condition in which blood flow to fingers and toes gets restricted in response to stress or cold) or peripheral vascular disease (PVD; narrowing of blood vessels outside of heart and lungs).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking centanafadine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking centanafadine.
• do not drink alcoholic beverages with and for 2 hours after taking centanafadine. Alcohol can make the side effects from centanafadine worse.
• you should know that your blood pressure and heart rate may increase during your treatment with centanafadine. Your doctor will probably monitor your blood pressure and heart rate during your treatment.
• you should know that centanafadine may worsen certain psychiatric conditions. Tell your doctor if you or anyone in your family has or has had history of depression, bipolar disorder (manic depressive disorder; a condition that causes episodes of depression, episodes of frenzied, abnormal excitement and other abnormal moods), or has ever thought about or attempted suicide. Your doctor will monitor you closely during your treatment to make sure these conditions do not develop or get worse during treatment with centanafadine. Tell your doctor how you are feeling during treatment and call your doctor immediately if you develop any changes in mood, anxiety or worsening, hallucinations, racing thoughts, increased energy, or changes in thought.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if more than 4 hours have passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Centanafadine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• rash
• decreased appetite
• nausea
• headache
• abdominal pain
• difficulty falling or staying asleep
• dry mouth
• diarrhea

Some side effects can be serious. If you experience any of these symptoms, stop taking centanafadine and call your doctor immediately or get emergency medical treatment:

• feeling of racing heart
• rash; hives; itching; shortness of breath; tightness of throat; swelling of throat, lips, or mouth
• pain, cramping or tiredness in legs during walking or exercise; coldness or numbness in fingers or toes; sores, ulcers or wounds on arms or legs; changes in skin color of fingers or toes
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, nausea, vomiting, diarrhea, coma (loss of consciousness)
• motor or verbal tics (involuntary noises or movement)

Centanafadine may slow children's growth (height and/or weight gain) or cause weight loss. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your doctor about the risks of taking this medication.

Centanafadine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store centanafadine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many capsules are left so you will know if any are missing.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• headache
• changes in mental status
• changes in vision or blindness
• seizures

Keep all appointments with your doctor.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Simtriyo^®