Drug Class: CNS stimulants
Usual Adult Dose for Attention Deficit Disorder
Doses are expressed as serdexmethylphenidate/dexmethylphenidate
Initial dose: 39.2 mg/7.8 mg orally once a day
- After 1 week, increase to 52.3 mg/10.4 mg orally once a day
Maximum dose: 52.3 mg/10.4 mg per day
Comments:
- Pretreatment screening for the presence of cardiac disease should be performed prior to initiating therapy.
- Dosing is once a day in the morning.
- Treatment of Attention Deficit Hyperactivity Disorder (ADHD) may be needed for an extended period; periodically re-evaluate long-term use and adjust dose as needed.
Use: For the treatment of ADHD.
Usual Pediatric Dose for Attention Deficit Disorder
Doses are expressed as serdexmethylphenidate/dexmethylphenidate
6 to 12 years:
Initial dose: 39.2 mg/7.8 mg orally once a day
- After 1 week, may increase to 52.3 mg/10.4 mg orally once a day or decrease to 26.1 mg/5.2 mg orally once a day depending on response and tolerability
Maximum dose: 52.3 mg/10.4 mg per day
13 years or older:
Initial dose: 39.2 mg/7.8 mg orally once a day in the morning
- After 1 week, increase to 52.3 mg/10.4 mg orally once a day
Maximum dose: 52.3 mg/10.4 mg per day
Comments:
- Pretreatment screening for the presence of cardiac disease should be performed prior to initiating therapy.
- Dosing is once a day in the morning.
- Treatment of Attention Deficit Hyperactivity Disorder (ADHD) may be needed for an extended period; periodically re-evaluate long-term use and adjust dose as needed.
Use: For the treatment of ADHD in patients 6 years or older.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Use with caution; there is no experience with use in patients with hepatic impairment
Dose Adjustments
If Switching from Other Methylphenidate Products:
- Discontinue methylphenidate and titrate with this drug as described in Usual Dose
- Methylphenidate products should not be substituted on a mg-per-mg basis due to their differing pharmacokinetic profiles
Dose Reduction and Discontinuation:
- Therapy should be reduced or discontinued if paradoxical aggravation or other adverse reactions occur
- Pediatric patients should periodically discontinue/interrupt therapy to assess condition.
- If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued
Precautions
US BOXED WARNING: ABUSE AND DEPENDENCE
- CNS stimulants, including this drug, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence.
- Assess risk of abuse prior to prescribing and monitor for signs of abuse and dependence during therapy.
CONTRAINDICATIONS:
- Hypersensitivity to active substances, methylphenidate, or other product excipients
- Concomitant use with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation because of the risk of hypertensive crisis
Safety and efficacy have not been established in patients younger than 6 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule II
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day in the morning with or without food
- Capsules may be take whole, or opened and sprinkled into 50 mL of water or over 2 tablespoons of applesauce
Storage requirements: Protect from moisture
Reconstitution/preparation techniques:
- Capsules may be opened and sprinkled into 50 mL of water or over 2 tablespoons of applesauce; all drug/food mixtures should be consumed immediately or within 10 minutes; do not store for future use
General:
- This coformulated drugs contains the prodrug serdexmethylphenidate with immediate-release dexmethylphenidate; this coformulated product is intended to provide immediate and prolonged duration of action.
- Because CNS stimulants have been associated with weight loss and slowing of growth in pediatric patients, carefully monitor growth, therapy may need to be interrupted in patients who are not growing or gaining height or weight as expected.
- Periodically reevaluate long-term use and adjust doses as needed.
Monitoring:
- Pre-Treatment: Screen for the presence of cardiac disease, including a physical exam and careful family history; assess risk of abuse
- Monitor height and weight in pediatric patients
- Monitor blood pressure and heart rate
- Monitor for abuse and dependence
- Monitor for psychotic or manic symptoms
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
- Patients should understand that this is a controlled substance and it can be abused; this drug should be stored in a safe place and disposed of promptly when no longer needed.
- Patients should understand the serious cardiovascular risks associated with use and should know to contact their healthcare provider immediately if they develop symptoms such as chest pain with exertion, unexplained syncope, or any other symptoms suggestive of cardiac disease.
- Patients/caregivers should be aware that this drug may cause slowing of growth and weight loss; height and weight should be routinely monitored in pediatric patients.
- Patients should be instructed to contact their healthcare provider immediately with any signs of circulation problems in fingers and toes, priapism, or any new or worsening psychotic or manic symptoms.
