Pronunciation:

ser-dex-meth-il-FEN-i-date, dex-meth-il-FEN-i-date

Brand Names:

• Azstarys

Dosage Forms:

• Capsule

Warnings:

Warning: Abuse, Misuse, and AddictionDexmethylphenidate/serdexmethylphenidate have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate/serdexmethylphenidate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dexmethylphenidate/serdexmethylphenidate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine Related

Uses of This Medicine:

Serdexmethylphenidate and dexmethylphenidate combination is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of serdexmethylphenidate and dexmethylphenidate combination in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of serdexmethylphenidate and dexmethylphenidate combination have not been performed in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Isocarboxazid
• Linezolid
• Methylene Blue
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amphetamine
• Desflurane
• Dextroamphetamine
• Enflurane
• Halothane
• Iobenguane I 131
• Isoflurane
• Levoketoconazole
• Lisdexamfetamine
• Methotrexate
• Methoxyflurane
• Risperidone
• Sevoflurane

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Use with caution. Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or
• Depression, history of or
• Eye or vision problems (eg, intraocular pressure, open angle glaucoma), history of or
• Heart disease (eg, cardiomyopathy, coronary artery disease) or
• Heart rhythm problems (eg, arrhythmia, ventricular arrhythmia), or a family history of or
• Hypertension (high blood pressure) or
• Priapism (painful and prolonged erection of the penis) or
• Psychosis (mental illness), history of or
• Raynaud's phenomenon (blood vessel disease) or
• Tachycardia (rapid heart rate) or
• Tourette syndrome, or family history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

This medicine may be taken with or without food.

You may swallow the capsule whole, or open it and sprinkle the contents into 50 mL of water or over 2 tablespoons of applesauce. Swallow the mixture right away or within 10 minutes of mixing. Do not store the mixture for future use.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules):
  • For attention deficit hyperactivity disorder (ADHD):
    • Adults and children 13 years of age and older—At first, 39.2 milligrams (mg) serdexmethylphenidate and 7.8 mg dexmethylphenidate once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 52.3 mg serdexmethylphenidate and 10.4 mg dexmethylphenidate.
    • Children 6 to 12 years of age—At first, 39.2 mg serdexmethylphenidate and 7.8 mg dexmethylphenidate once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 52.3 mg serdexmethylphenidate and 10.4 mg dexmethylphenidate.
    • Children younger than 6 years of age—Use and dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Mixed unused medicine with used coffee grounds or kitty litter, then place it in a sealable bag, empty can, or other container before throwing into the trash.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take serdexmethylphenidate and dexmethylphenidate combination with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop extremely high blood pressure.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine, such as irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

If you or your child experience a prolonged or painful erection of the penis, check with your doctor right away.

Symptoms of overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, seeing, hearing, or feeling things that are not there, seizures, shivering, slow or fast heartbeat, slurred speech, sweating, talking or acting with excitement you cannot control, temporary blindness, thirst, trembling or shaking, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine on the day you have your surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Actions that are out of control

anxiety

blurred vision

chest pain or discomfort

confusion

difficulty in speaking

dizziness

double vision

enlarged pupils

false beliefs that cannot be changed by facts

fast, slow, pounding, or irregular heartbeat or pulse

headache

inability to move the arms, legs, or facial muscles

inability to speak

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold, clammy skin

irritability

lack or slowing of normal growth in children

loss in sexual ability, desire, drive, or performance

nausea

nervousness

pain or discomfort in the arms, jaw, back, or neck

pounding in the ears

seeing, hearing, or feeling things that are not there

stiff or sore neck

talking, feeling, and acting with excitement

trouble breathing

trouble sleeping

vomiting

weight loss

Incidence not known

Agitation

arm, jaw, or back pain

bleeding gums

blood in the urine or stools

bloody nose

bloody, black, or tarry stools

chest tightness or heaviness

chills

cough

dark-colored urine

decreased interest in sexual intercourse

diarrhea

difficulty in moving

difficulty swallowing

double vision

dry mouth

extra heartbeats

fainting

feeling of constant movement of self or surroundings

fever

hair loss, thinning of hair

heavier menstrual periods

hives, itching, skin rash

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

light-colored stools

lightheadedness

muscle aches, cramps, pain, stiffness, or twitching

overactive reflexes

pain in the joints

painful or prolonged erection of the penis

pale skin

paleness or cold feeling in the fingertips and toes

pinpoint red spots on the skin

poor coordination

redness of the skin

restlessness

seeing double

seizures

sensation of spinning

shakiness in the legs, arms, hands, feet

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

swollen joints

tingling or pain in the fingers or toes when exposed to cold

trembling or shaking of the hands or feet

twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

blurred vision

change in consciousness

chest pain or discomfort

confusion

dark urine

diarrhea

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

extremely high fever or body temperature

fast, slow, or irregular heartbeat

fever

headache

inability to speak

loss of consciousness

muscle cramps, spasms, pain, or stiffness

nausea

nervousness

overactive reflexes

pain or discomfort in the arms, jaw, back, or neck

pale, clammy skin

palpitations

pounding in the ears

seeing, hearing, or feeling things that are not there

seizures

shivering

slurred speech

sweating

talking or acting with excitement you cannot control

temporary blindness

thirst

trembling or shaking of the hands or feet

trouble breathing

unusual tiredness or weakness

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

decreased appetite

heartburn

indigestion

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.