Serdexmethylphenidate-Dexmethylphenidate

Serdexmethylphenidate-Dexmethylphenidate is a combination medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). 

• Serdexmethylphenidate-Dexmethylphenidate is available under various brand names: Azstarys

Common side effects of Serdexmethylphenidate-Dexmethylphenidate include:

• decreased appetite
• nausea
• indigestion
• trouble sleeping
• vomiting
• stomach pain
• weight loss
• dizziness
• mood swings
• increased blood pressure
• anxiety
• irritability
• increased heart rate

Serious side effects of Serdexmethylphenidate-Dexmethylphenidate include:

• painful and prolonged erections,
• fingers or toes may feel numb, cool, or painful
• fingers or toes may change color from pale to blue, to red
• numbness, 
• pain, 
• skin color change, 
• sensitivity to temperature in the fingers or toes,
• unexplained wounds appearing on fingers or toes,
• slowing of growth (height and weight) in children

Rare side effects of Serdexmethylphenidate-Dexmethylphenidate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule: Schedule II

• 26.1 mg/5.2 mg
• 39.2 mg/7.8 mg
• 52.3 mg/10.4 mg
• Dexmethylphenidate is a Schedule II controlled substance; the controlled substance schedule pending for serdexmethylphenidate

Attention Deficit Hyperactivity Disorder

Adult dosage

• Initial: 39.2 mg/7.8 mg orally once in the morning
• After 1 week: Increase to 52.3 mg/10.4 mg orally once in the morning
• Not to exceed 52.3 mg/10.4 mg orally once in the morning

Pediatric dosage

• Aged below 6 years: Safety and efficacy not established
• 6-12 years
  • Initial: 39.2 mg/7.8 mg orally once in the morning
  • After 1 week: May increase to 52.3 mg/10.4 mg orally once in the morning OR decrease to 26.1 mg/5.2 orally once in the morning, depending on response and tolerability
  • Not to exceed 52.3 mg/10.4 mg orally once in the morning
• 13-17 years
  • Initial: 39.2 mg/7.8 mg orally once in the morning
  • After 1 week: Increase to 52.3 mg/10.4 mg orally once in the morning
  • Not to exceed 52.3 mg/10.4 mg orally once in the morning
• Dosage Considerations – Should be Given as Follows: 
  • See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Serdexmethylphenidate-Dexmethylphenidate has severe interactions with the following drugs:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Serdexmethylphenidate-Dexmethylphenidate has serious interactions with at least 32 other drugs.
• Serdexmethylphenidate-Dexmethylphenidate has moderate interactions with at least 65 other drugs.
• Serdexmethylphenidate-Dexmethylphenidate has no noted minor interactions with at least 65 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components; bronchospasm, rash, and pruritus reported with serdexmethylphenidate/methylphenidate; hypersensitivity reactions (eg, angioedema) and anaphylactic reactions reported in patients treated with other methylphenidate products
• Concomitant use with MAOIs or within 14 days following discontinuation with an MAOI

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Serdexmethylphenidate-Dexmethylphenidate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Serdexmethylphenidate-Dexmethylphenidate?”

Cautions

• CNS stimulants have a high potential for abuse and dependence; assess risks before prescribing and carefully monitor while on therapy
• Priapism, sometimes requiring surgical intervention, reported with methylphenidate in both pediatric and adults patients; not reported upon initiating, but may develop after some time on the drug (often subsequent to increased dose or during drug withdrawal); seek immediate medical attention for abnormally sustained or frequent and painful erections
• Peripheral vasculopathy, including Raynaud phenomenon, reported with CNS stimulants; signs and symptoms generally improve after dose reduction or discontinuation; observation for digital changes during treatment; further, clinical evaluation (eg, rheumatology referral) may be necessary
• Monitor growth in pediatric patients during treatment with stimulants; patients who are not growing or gaining weight as expected may need to have their treatment interrupted
• Periodically reevaluate long-term use and adjust dose; periodically discontinue to assess patient's condition
• Serious cardiovascular reactions
  • CNS stimulants cause increased blood pressure (mean increase ~2-4 mmHg) and heart rate (mean increase ~3-6 bpm); individuals may have larger increases; monitor all patients for hypertension and tachycardia; consider benefits and risks in patients for whom an increase in blood pressure would be problematic
  • Adults: Sudden death, stroke, and myocardial infarction reported with CNS stimulant treatment at recommended doses
  • Pediatric patients: Sudden death reported with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD
  • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems
  • Promptly evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment
• Psychiatric adverse reactions
  • May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorders
  • May induce manic or mixed mood episode; before prescribing, screen patients for risk factors for developing a manic episode (eg, comorbid or history of depressive symptoms, family history of suicide, bipolar disorder, or depression)
  • At recommended doses, CNS stimulants may cause psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) in patients without a prior history; if such symptoms occur, consider discontinuing the drug
• Drug interaction overview
  • MAOIs
• Contraindicated
  • Do not coadminister serdexmethylphenidate/methylphenidate with MAOIs or within 14 days after discontinuing MAOI treatment, owing to the potential for hypertensive crisis
• Antihypertensives
  • Monitor blood pressure and adjust the antihypertensive dose as needed
  • Serdexmethylphenidate/methylphenidate may decrease the effectiveness of antihypertensives
• Halogenated anesthetics
  • Avoid serdexmethylphenidate/methylphenidate on the day of surgery
  • Concomitant use of serdexmethylphenidate/methylphenidate with halogenated anesthetics (e.g., halothane, isoflurane, enflurane, desflurane, sevoflurane) may increase the risk of sudden blood pressure and heart rate increase during surgery
• Risperidone
  • Monitor for extrapyramidal symptoms (EPSs)
  • Coadministration of methylphenidate with risperidone may increase the risk of EPSs when there is dosage change (increased or decreased) of either or both medications

Pregnancy & Lactation

• Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388
• No data are available on use in pregnant females; dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate; published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• However, there may be risks to the fetus associated with the use of CNS stimulants use during pregnancy
• Clinical considerations
  • CNS stimulants can cause vasoconstriction and thereby decrease placental perfusion
  • No fetal and/or neonatal adverse reactions were reported with therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low-birth-weight infants were reported in amphetamine-dependent mothers
• Lactation
  • Serdexmethylphenidate: Data are unavailable on the presence in human milk, effects on breastfed infants, or effects on milk production
  • Dexmethylphenidate
    • Limited published literature, based on milk sampling from 7 mothers, reports methylphenidate is present in human milk, which resulted in infant doses of 0.16-0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.
    • There are no reports of adverse effects on breastfed infants and no effects on milk production
    • Clinical considerations: Monitor breastfeeding infants for adverse reactions (eg, agitation, anorexia, reduced weight gain)