Serdexmethylphenidate and dexmethylphenidate (Oral)

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

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

It is very important for your doctor to check your or your child's progress during regular visits to ensure this medicine is working properly and to determine if you should continue taking 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 that has monoamine oxidase (MAO) inhibitor activity (for example, 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 believe you may have become mentally or physically dependent on it, contact 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 achieve the same effects.
• Withdrawal symptoms 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 checked before starting this medicine and while using it. If you notice any change in your blood pressure, call your doctor immediately. If you have questions about this, speak with your doctor.

This medicine may cause serious heart or blood vessel problems. This risk may be higher in patients with a family history of heart disease. Contact your doctor right away if you experience chest pain, trouble breathing, or fainting while using this medicine.

Inform your doctor right away if you or your family notice any unusual changes in behavior, such as increased aggression, hostility, agitation, irritability, or suicidal thoughts or actions. 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 worsening quickly.

If you or your child experience a prolonged or painful erection of the penis, contact your doctor immediately.

Symptoms of overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when standing 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 one arm or leg, sudden and severe. Call your doctor immediately 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 your 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 taking this medicine, the doctor will need to monitor your child's height and weight.

Inform any doctor or dentist treating you that you are using this medicine. You may need to stop taking this medicine on the day of 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, especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus issues.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, here are some important points to keep in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been conducted on how the serdexmethylphenidate and dexmethylphenidate combination affects children younger than 6 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Studies on how the serdexmethylphenidate and dexmethylphenidate combination affects older adults have not been done.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are significant and may not be a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines can also cause interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Other medical conditions may affect how this medicine works. Be sure to tell your doctor about any other medical issues you have, especially:

• History of alcohol abuse
• History of drug abuse or dependence—Use with caution. Dependence may be more likely to develop.
• History of bipolar disorder (manic-depressive illness)
• History of depression
• History of eye or vision problems (e.g., intraocular pressure, open-angle glaucoma)
• Heart disease (e.g., cardiomyopathy, coronary artery disease) or
• Heart rhythm problems (e.g., arrhythmia, ventricular arrhythmia), or a family history of these issues
• Hypertension (high blood pressure)
• Priapism (painful and prolonged erection of the penis)
• History of psychosis (mental illness)
• History of Raynaud's phenomenon (blood vessel disease)
• Tachycardia (rapid heart rate)
• Tourette syndrome, or family history of this condition—Use with caution. May worsen these conditions.

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.

In the U.S.

• Azstarys

Available Dosage Forms:

• Capsule

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

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.