Usual Adult Dose for Attention Deficit Disorder

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:

• Initial dose: 2.5 mg orally twice a day, at least 4 hours apart

For patients CURRENTLY on methylphenidate:

• Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart

Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day (10 mg twice a day)

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:

• Initial dose: 10 mg orally once a day

For patients CURRENTLY on methylphenidate:

• Initial dose: One-half of the total daily dose of methylphenidate orally once a day

For patients CURRENTLY on dexmethylphenidate immediate-release (IR):

• Initial dose: Same dexmethylphenidate IR daily dose orally once a day

Adjust dose weekly in 10 mg increments according to the needs and responses

• Maximum dose: 40 mg/day

Comments:

• The dose should be individualized according to the needs and response of the patient.
• The immediate-release tablets should be taken twice a day at least 4 hours apart (with or without food); the extended-release capsules should be taken once a day in the morning (with or without food); if necessary, the capsule may be opened and sprinkled onto applesauce (see Administration Advice).
• If paradoxical aggravation of symptoms or other adverse reactions occur, dose reduction or discontinuation may be necessary.
• If improvement is not observed after 1-month of optimal dosing, this drug should be discontinued.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD).

Usual Pediatric Dose for Attention Deficit Disorder

Age 6 years or older:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:

• Initial dose: 2.5 mg orally twice a day, at least 4 hours apart

For patients CURRENTLY on methylphenidate:

• Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart

Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:

• Initial dose: 5 mg orally once a day

For patients CURRENTLY on methylphenidate:

• Initial dose: One-half of the total daily dose of methylphenidate orally once a day

For patients CURRENTLY on dexmethylphenidate immediate-release (IR):

• Initial dose: Same dexmethylphenidate IR daily dose orally once a day

Adjust dose weekly in 5 mg increments according to the needs and responses

• Maximum dose: 30 mg/day

Comments:

• The dose should be individualized according to the needs and response of the patient.
• The immediate-release tablets should be taken twice a day at least 4 hours apart (with or without food); the extended-release capsules should be taken once a day in the morning (with or without food); if necessary, the capsule may be opened and sprinkled onto applesauce (see Administration Advice).
• If paradoxical aggravation of symptoms or other adverse reactions occur, dose reduction or discontinuation may be necessary.
• If improvement is not observed after 1-month of optimal dosing, this drug should be discontinued.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 years or older.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING: ABUSE AND DEPENDENCE:
CNS stimulants, including this drug, other methylphenidate-containing products, and amphetamine, have a high potential for abuse and dependence. Ass the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

CONTRAINDICATIONS:

• Marked anxiety, tension, and agitation
• Hypersensitivity to methylphenidate or other components of the product
• Glaucoma
• Motor tics or a family history or diagnosis of Tourette's syndrome
• Concurrent or recent (within 14 days) use of monoamine oxidase inhibitors

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:
Immediate-release

• Take orally twice a day with or without food; doses should be at least 4 hours apart

Extended-release:

• Take orally once a day in the morning with or without food
• Swallow whole OR open capsule and sprinkle contents on a spoonful of applesauce and consume immediately
• Capsule and contents of capsule should not be chewed, crushed, or divided; patients should not take anything less than 1 capsule/day

General:

• The extended release capsules utilizes a bi-modal release; a single, once-daily dose of an extended release capsule provides the same amount of active ingredient as two immediate release tablets given 4 hours apart.
• 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 Screening:

• Assess for the presence of cardiac disease; physical exam and a careful history including family history of sudden death or ventricular arrhythmias should be performed prior to initiating therapy
• Assess risk of abuse

During Therapy:

• Cardiovascular: Monitor heart rate, blood pressure, digital changes
• General: Monitor risk of misuse, abuse, and diversion
• Pediatric Patients: Monitor height and weight at appropriate intervals
• Psychiatric: Monitor for behavioral changes, psychiatric symptoms, including bipolar disorder, psychotic or manic symptoms, or emergent suicidal ideation/behavior

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 because it can be abused and lead to dependence; 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.