Usual Adult Dose for Attention Deficit Disorder

IMMEDIATE-RELEASE (IR):
ORAL TABLETS, ORAL SOLUTION, CHEWABLE TABLETS:

• Average dose: 20 to 30 mg orally in 2 or 3 divided doses, preferably 30 to 45 minutes before meals
• Maximum dose: 60 mg/day

EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR):

• May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day

Once daily ER tablet (with 12-hour duration of effect, e.g., Concerta):
Methylphenidate-naive:

• Initial dose: 18 or 36 mg orally once a day

Patients Currently Using IR Methylphenidate:

• Initial dose: 18 mg orally once a day if current IR dose is 5 mg 2 or 3 times a day
• Initial dose: 36 mg orally once a day if current IR dose is 10 mg 2 or 3 times a day
• Initial dose: 54 mg orally once a day if current IR dose is 15 mg 2 or 3 times a day
• Initial dose: 72 mg orally once a day if current IR dose is 20 mg 2 or 3 times a day

TITRATE in 18 mg increments weekly to achieve optimal response
Maximum dose: 72 mg/day

Once daily (40% IR/60% ER) oral capsule (e.g., Aptensio XR):
Initial Dose: 10 mg orally once a day

• Titrate in increments of 10 mg weekly; individualize dose according to needs and response of patient

Maximum dose: 60 mg/day

Once daily (30% IR/70% ER) oral capsule (e.g., Metadate CD)
Initial Dose: 20 mg orally once a day

• Titrate in increments of 10 to 20 mg weekly depending upon tolerability and degree of efficacy observed

Maximum dose: 60 mg/day

Once daily (30% IR/70% ER) chewable tablet (e.g., QuilliChew ER)
Initial Dose: 20 mg orally once a day in the morning

• Titrate up or down in increments of 10, 15, or 20 mg to achieve a well-tolerated therapeutic dose

Maximum dose: 60 mg/day

Once daily (20% IR/80% ER) oral capsule (e.g., Adhansia XR)
Initial dose: 25 mg orally once a day

• Titrate in increments of 10 to 15 mg at intervals of no less than 5 days based on assessment of clinical benefit and tolerability

Maximum dose: 100 mg/day (doses above 85 mg/day have been associated with increased adverse reactions)

Once daily (20% IR/80% ER) oral suspension (e.g., Quillivant XR)
Initial Dose: 20 mg orally once a day in the morning

• Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved

Maximum Dose: 60 mg/day

Once daily evening capsule (e.g., Jornay PM)
Initial dose: 20 mg orally once a day at 8 PM; adjust timing between 6:30 PM and 9:30 PM to optimize tolerability and efficacy the next morning and throughout the following day

• Titrate in increments of 20 mg weekly until a well-tolerated, therapeutic dose is achieved

Maximum dose: 100 mg/day

Comments:

• Individualize treatment; clinical judgment should be used when selecting starting doses.
• Many of the once-daily products are formulated to deliver a fixed percent of IR and ER methylphenidate.
• Do not substitute products on a milligram-per-milligram basis because of the differing pharmacokinetic profiles with each product.
• If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage; if after appropriate dosage adjustment over a 1-month, improvement is not observed, consider drug discontinuation.
• See Other Comments/Administration Advice for instructions on administration, including with or without food (consistency with or without food is encouraged), opening of capsules, etc.

Use: For the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Usual Adult Dose for Narcolepsy

IMMEDIATE-RELEASE (IR):
ORAL TABLETS, ORAL SOLUTION, CHEWABLE TABLETS:
Average dose: 20 to 30 mg orally in 2 or 3 divided doses, preferably 30 to 45 minutes before meals
Maximum dose: 60 mg/day

EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR):

• May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day

Comments:

• If medication causes insomnia, take last dose before 6 PM.

Use: Treatment of Narcolepsy

Usual Pediatric Dose for Attention Deficit Disorder

6 years or older:
IMMEDIATE-RELEASE (IR):
ORAL TABLETS, ORAL SOLUTION, CHEWABLE TABLETS:
Initial dose: 5 mg orally twice a day (before breakfast and lunch)

• Increase dose gradually in increments of 5 to 10 mg per week; individualize dose according to needs and response of patient

Maximum dose: 60 mg/day

EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR):

• May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day

Once daily ER tablet (with 12-hour duration of effect, e.g., Concerta):
Methylphenidate-naive:

• Initial dose: 18 mg orally once a day

Patients Currently Using IR Methylphenidate:

• Initial dose: 18 mg orally once a day if current IR dose is 5 mg 2 or 3 times a day
• Initial dose: 36 mg orally once a day if current IR dose is 10 mg 2 or 3 times a day
• Initial dose: 54 mg orally once a day if current IR dose is 15 mg 2 or 3 times a day
• Initial dose: 72 mg orally once a day if current IR dose is 20 mg 2 or 3 times a day

TITRATE in 18 mg increments weekly to achieve optimal response
Maintenance doses:

• Children 6 to 12 years: 18 to 54 mg orally once a day
• Adolescents 13 years or older: 18 to 72 mg orally once a day; not to exceed 2 mg/kg/day

Maximum doses: 54 mg/day (6 to 12 years old); 72 mg/day (13 years or older)

Once daily (50% IR/50% ER) oral capsule (e.g., Ritalin LA):
Age: 6 to 12 years of age (methylphenidate-naive):

• Initial Dose: 20 mg orally once a day in the morning; may initiate at 10 mg orally once a day when a lower dose is appropriate

Patients Currently Using Immediate-release (IR) or Sustained-release (SR) Methylphenidate:

• Initial dose: 10 mg orally once a day if current IR dose is 5 mg twice a day
• Initial dose: 20 mg orally once a day if current IR dose is 10 mg 2 times a day or SR dose is 20 mg once a day
• Initial dose: 30 mg orally once a day if current IR dose is 15 mg 2 times a day
• Initial dose: 40 mg orally once a day if current IR dose is 20 mg 2 times a day or SR dose 40 mg once a day
• Initial dose: 60 mg orally once a day if current IR dose is 30 mg 2 times a day or SR dose 60 mg once a day

TITRATE gradually in 10 mg increments weekly to optimal response
Maximum dose: 60 mg/day

Once daily (40% IR/60% ER) oral capsule (e.g., Aptensio XR):
Initial Dose: 10 mg orally once a day

• Titrate in increments of 10 mg weekly; individualize dose according to needs and response of patient

Maximum dose: 60 mg/day

Once daily (30% IR/70% ER) oral capsule (e.g., Metadate CD)
Initial Dose: 20 mg orally once a day

• Titrate in increments of 10 to 20 mg weekly depending upon tolerability and degree of efficacy observed

Maximum dose: 60 mg/day

Once daily (30% IR/70% ER) chewable tablet (e.g., QuilliChew ER)
Initial Dose: 20 mg orally once a day in the morning

• Titrate up or down in increments of 10, 15, or 20 mg to achieve a well-tolerated therapeutic dose

Maximum dose: 60 mg/day

Once daily (25% IR/75% ER) oral disintegrating tablet (e.g., Cotempla XR)
Initial dose: 17.3 mg orally once a day in the morning

• Titrate in increments of 8.6 mg to 17.3 mg weekly according to needs and responses of the patient

Maximum dose: 51.8 mg/day

Once daily (20% IR/80% ER) oral capsule (e.g., Adhansia XR)
Initial dose: 25 mg orally once a day

• Titrate in increments of 10 to 15 mg at intervals of no less than 5 days based on assessment of clinical benefit and tolerability

Maximum dose: 85 mg/day (doses above 70 mg/day have been associated with increased adverse reactions)

Once daily (20% IR/80% ER) oral suspension (e.g., Quillivant XR)
Initial Dose: 20 mg orally once a day in the morning

• Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved

Maximum Dose: 60 mg/day

Once daily evening capsule (e.g., Jornay PM)
Initial dose: 20 mg orally once a day at 8 PM; adjust timing between 6:30 PM and 9:30 PM to optimize tolerability and efficacy the next morning and throughout the following day

• Titrate in increments of 20 mg weekly until a well-tolerated, therapeutic dose is achieved

Maximum dose: 100 mg/day

Transdermal patch, 9-hour extended release (e.g., Daytrana)

• Apply patch 2 hours before effect is needed and remove 9 hours after application; recommended dose titration schedule:

Week 1: Apply 10 mg patch to hip area once a day; remove 9 hours later
Week 2: Apply 15 mg patch to hip area once a day; remove 9 hours later
Week 3: Apply 20 mg patch to hip area once a day; remove 9 hours later
Week 4: Apply 30 mg patch to hip area once a day; remove 9 hours later

• Individualize final dose and wear time to needs and response of the patient; patients converting from other formulation of methylphenidate should follow the above titration schedule

Comments:

• Individualize treatment; clinical judgment should be used when selecting starting doses.
• Many of the once daily products are formulated to deliver a fixed percent of IR and ER methylphenidate.
• Do not substitute products on a milligram-per-milligram basis because of the differing pharmacokinetic profiles with each product.
• All methylphenidate products are FDA approved for pediatric patients 6 years or older with 1 exception; The once daily 50% IR/50% ER oral capsules (Ritalin LA) are approved for patients 6 to 12 years of age only.
• If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage; if after appropriate dosage adjustment over a 1-month, improvement is not observed, consider drug discontinuation.
• See Other Comments/Administration Advice for instructions on administration, including with or without food (consistency with or without food is encouraged), opening of capsules, etc.

Use: For the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Usual Pediatric Dose for Narcolepsy

6 years or older:
IMMEDIATE-RELEASE (IR):
ORAL TABLETS, ORAL SOLUTION, CHEWABLE TABLETS:
Initial dose: 5 mg orally twice a day (before breakfast and lunch)

• Increase dose gradually in increments of 5 to 10 mg per week; individualize dose according to needs and response of patient

Maximum dose: 60 mg/day

EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR):

• May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day

Use: Treatment of Narcolepsy

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Elderly:

• This drug has not been systematically studied patients 65 years or older
• ER 20%IR/80% ER oral capsules (e.g., Adhansia XR) have not been studied in patients over 72 years
• ER 12-hour oral tablets (Concerta) are not labeled for use in patients 65 years or older

Dose adjustment: Extended-release products should generally not be substituted on a mg-per-mg basis because products have differing pharmacokinetic profiles

Switching from Other Methylphenidate Products:

• Once daily 20% IR/80% ER oral capsule (e.g., Adhansia XR); once daily 30%IR/70% ER chewable tablet (e.g., QuilliChew ER); once daily evening dose oral capsule (e.g., Jornay PM): Discontinue prior methylphenidate product and titrate as described in Usual Dosage

• Transdermal patch, 9-hour extended release (Daytrana): Follow the titration schedule outlined in Usual Dosage

Precautions

US BOXED WARNING: ABUSE AND DEPENDENCE:

• CNS stimulants, including methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
• Should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. (Concerta, Daytrana, Methylin PIs)

CONTRAINDICATIONS:

• Hypersensitivity to active substance or any product excipients
• Concomitant, or within 14 days of treatment with an MAOI (monoamine oxidase inhibitor)

ADDITIONAL CONTRAINDICATIONS FOR DAYTRANA PATCH, METHYLIN:

• Marked anxiety, tension, and agitation, since this drug may aggravate these symptoms
• Glaucoma
• Tics; motor tics or with a family history or diagnosis of Tourette's syndrome

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:

• Pediatrics: Take orally twice a day before breakfast and lunch
• Adults: Take orally 2 or 3 times a day preferably 30 to 45 minutes before meals

Once daily formulations: Administration times relative to meals and meal composition may need to be individually titrated; generally, take consistently with or without food

• Once daily 8-hour oral tablet (Ritalin SR): Swallow whole; do not crush or chew
• Once daily 12-hour oral tablet (Concerta): Take orally once a day in the morning with or without food; Swallow whole, do not chew, divide, or crush
• Once daily (20% IR/80% ER) oral suspension (Quillivant XR): Take orally once a day in the morning with or without food; vigorously shake bottle for at least 10 seconds before measuring dose; measure dose with enclosed oral dosing dispenser
• Once daily (20% IR/80% ER) oral capsule (Adhansia XR): Take orally once a day in the morning with or without food; swallow whole or may open capsule and sprinkle on small amount of applesauce or yogurt; once contents sprinkled on applesauce or yogurt, consume within 10 minutes; do not crush, chew, or divide capsule or contents of capsule
• Once daily (25% IR/75% ER) oral disintegrating tablet (Cotempla XR): Take orally once a day in the morning consistently with or without food; remove from blister pack with dry hands just prior to dosing by peeling back foil, do not push tablet through foil; place tablet on tongue and allow to disintegrate without chewing or crushing; no liquid is needed to take tablet
• Once daily (30% IR/70% ER) oral capsule (Metadate CD): Take orally once a day in the morning with or without food; swallow whole with water or open capsule and sprinkle on small amount of applesauce, follow with water or other liquid; once contents sprinkled on applesauce, consume immediately; do not crush, chew, or divide capsule or contents of capsule
• Once daily (30% IR/70% ER) chewable tablet (QuilliChew ER): Take orally once a day in the morning with or without food; scored tablets may be broken in half if needed to titrate doses; patients with phenylketonuria should know this drug contains phenylalanine
• Once daily (40% IR/60% ER) oral capsule (Aptensio XR): Take orally once a day in the morning consistently with or without food (patients should establish a routine pattern with food and stick to it); swallow whole or may open capsule and sprinkle on small amount of applesauce; once contents sprinkled on applesauce, consume immediately; do not crush, chew, or divide capsule or contents of capsule
• Once daily (50% IR/50% ER) oral capsule (Ritalin LA): Take orally once a day in the morning; swallow whole or open capsule and sprinkle on small amount of cold or room-temperature applesauce; once contents sprinkled on applesauce, consume immediately; do not crush, chew, or divide capsule or contents of capsule
• Once daily evening dose oral capsule (Jornay PM): Take orally once a day in the evening consistently with or without food (maintain a consistent dosing time once the optimal administration time is arrived at); swallow whole or open and sprinkle on applesauce; once contents sprinkled on applesauce, consume immediately; do not crush, chew, or divide capsule or contents of capsule
• Transdermal patch, 9-hour extended release (Daytrana): Apply adhesive side of patch to clean, dry area of the hip 2 hours before effect is needed and remove 9 hours later; patients should be encouraged to use administration chart included with each carton to monitor application and removal times; avoid application to oily, damaged, or irritated skin; avoid applying to same spot, alternate hips and avoid waistline as clothing may cause patch to rub off

Reconstitution/preparation techniques:

• Once daily (20% IR/80% ER) ORAL SUSPENSION (Quillivant XR):
• Reconstitute with water prior to dispensing; tap bottle until powder flows freely; add specified amount of water; fully insert bottle adapter into neck of bottle, replace bottle cap; shake with vigorous back and forth motion for at least 10 seconds to prepare suspension; stable at room temperature for 4 months after reconstitution

TRANSDERMAL PATCH 9-hour extended release (Daytrana):

• Apply patch immediately after opening pouch and removing protective liner; do not cut patches
• Press patch firmly in place with palm of hand for approximately 30 seconds; Exposure to water during bathing, swimming, or showering can affect patch adherence; if patch becomes partially or fully detached during wear time, the patch should be discarded and a new patch may be applied at a different site; patches should not be applied or re-applied with dressings, tape, or other common adhesives; total recommended wear time for day should not exceed 9 hours regardless of the number of patches used.
• Application sites should not be exposed to direct external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, etc.
• Patch removal: Peel off slowly, if necessary may apply an oil-based product to facilitate removal; patient should be counseled not to use any other products to remove patch or adhesive
• Patch disposal: Fold adhesive side of the patch to itself flush down toilet or dispose of in an appropriate lidded container. Unused patches should be removed from pouch, separated from the protective liner, folded onto itself, and disposed of in the same manner as used patches.
• Consult product labeling for more detailed instructions with illustrations.

Storage Requirements:

• Protect from light and moisture
• Once daily (20% IR/80% ER) oral suspension (Quillivant XR): Stable at room temperature for 4 months after reconstitution
• Transdermal patch, 9-hour extended release (Daytrana): Patches should be used or disposed of within 2 months after opening sealed tray or outer pouch

General:

• This drug should be used along with other measures (psychological, educational, social) as part of a total treatment for ADHD.
• Periodically reevaluate need for continued use; long-term efficacy of use in pediatric patients has not been established.
• Monitor growth (height and weight) at appropriate intervals in pediatric patients; patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
• This drug has a high potential for abuse and dependence and therefore patients/caregivers should be advised to secure drug to prevent abuse; patients/caregivers should be instructed to comply with laws and regulations on drug disposal.

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
• For Patients on Transdermal Patch: Monitor for signs of skin depigmentation

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 who use the transdermal patch should be instructed to call their healthcare provider if they notice loss/change of skin color.
• Patients should be cautioned to avoid alcohol; consumption of alcohol with many formulations of this drug can lead to a more rapid release of the methylphenidate.
• 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.

Frequently asked questions

• What is metilfenidato used for?
• Concerta vs Adderall - What's the difference between them?
• Ritalin vs Vyvanse - What's the difference between them?
• What are the brands of methylphenidate?
• Jornay PM vs other methylphenidate formulations - how do they compare?
• How is Cotempla XR-ODT different to other brands of methylphenidate?