CONCERTA 54mg. Tablets.
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Description
Methylphenidate hydrochloride 54mg.
BOXED WARNING
Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior. Symptoms of chronic abuse of methylphenidate may include insomnia, irritability, change in personality, and psychotic symptoms that may be clinically indistinguishable from psychotic disorders, particularly with parenteral or inhalational abuse. Misuse of amphetamines may also cause sudden death and serious cardiovascular adverse events. Therefore, a careful assessment of benefit versus risk is recommended in patients with a known history of substance abuse, including alcoholism. The least amount reasonable should be prescribed or dispensed at one time in order to limit the potential for overuse or drug diversion. Close supervision is required during drug withdrawal from misuse since severe depression may occur. Withdrawal or abrupt discontinuation after chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. Drug ‘holidays’, the temporary discontinuation of drug during weekends, holidays, summer vacations, etc., is usually not associated with drug withdrawal symptoms, but such holidays are typically reserved for those patients with well-controlled ADHD symptoms.
DEA CLASS
Rx, schedule II
DESCRIPTION
CNS stimulant chemically similar to but with milder peripheral sympathomimetic actions than amphetamines
Used for attention-deficit hyperactivity disorder (ADHD) and narcolepsy
Pediatric patients with structural heart defects, cardiomyopathy, or heart-rhythm disturbances may be at risk for adverse cardiac events
COMMON BRAND NAMES
Aptensio XR, Concerta, Cotempla XR, Daytrana, JORNAY, Metadate CD, Metadate ER, Methylin, QuilliChew ER, Quillivan XR, RELEXXII, Ritalin, Ritalin LA, Ritalin SR
HOW SUPPLIED
Aptensio XR/Metadate CD/Methylphenidate Hydrochloride/Ritalin LA Oral Cap ER: 10mg, 15mg, 20mg, 30mg, 40mg, 50mg, 60mg
Concerta/Metadate ER/Methylin/Methylphenidate Hydrochloride/RELEXXII/Ritalin SR Oral Tab ER: 10mg, 18mg, 20mg, 27mg, 36mg, 54mg, 72mg
Daytrana Topical Film ER: 1h, 1.1mg, 1.6mg, 2.2mg, 3.3mg
Methylin/Methylphenidate Hydrochloride Oral Sol: 5mL, 5mg, 10mg
Methylin/Methylphenidate Hydrochloride Oral Tab Chew: 2.5mg, 5mg, 10mg
Methylin/Methylphenidate Hydrochloride/Ritalin Oral Tab: 5mg, 10mg, 20mg
Methylphenidate Oral Tab Orally Dis DR: 8.6mg, 17.3mg, 25.9mg
QuilliChew ER Oral Tab Chew ER: 20mg, 30mg, 40mg
Quillivan XR Oral Susp ER: 5mL, 25mg
DOSAGE & INDICATIONS
Initially, 18 to 36 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 18 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 36 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 54 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
72 mg PO once daily in the morning. Max: 72 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 18 mg PO once daily in the morning. Dose may be increased by 18 mg increments at weekly intervals. A 27-mg tablet is available for prescribers who wish to utilize a dosage between 18 to 36 mg. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 18 mg PO once daily in the morning. Titrate dose by 18 mg increments at weekly intervals as needed. A 27-mg tablet is available for patients who may benefit from a dosage between 18 to 36 mg. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 36 mg PO once daily in the morning. Titrate dose by 18 mg increments at weekly intervals as needed. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 54 mg PO once daily in the morning. Titrate dose by 18 mg increments at weekly intervals as needed and as clinically appropriate. FDA-approved Max: 54 mg/day in children and 72 mg/day (not to exceed 2 mg/kg/day) in adolescents; however, some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 72 mg PO once daily in the morning. While the FDA-approved maximum dosage is 72 mg/day (not to exceed 2 mg/kg/day), some experts recommend doses up to 108 mg, which may be appropriate in patients weighing more than 50 kg. Titrate dosage by 18 mg increments no more frequently than weekly intervals as clinically appropriate. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. When in the judgment of the clinician a lower dosage is indicated for initial treatment, it is recommended that patients begin treatment with an immediate-release product first. Dose may be increased by 10 to 20 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. Alternatively, give an equivalent total daily dosage as the previous methylphenidate product PO once daily, rounded to the closest available capsule size. For example, patients already taking 10 mg of immediate-release methylphenidate twice daily (20 mg/day) should start with 20 mg Metadate CD once daily; those taking 20 mg twice daily (40 mg/day) should start with 40 mg Metadate CD once daily. Dose may be increased by 10 to 20 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. Dose may be increased by 10 to 20 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day for patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. Alternatively, give no more than the equivalent total daily dose of the previous methylphenidate product, rounded to the nearest available capsule size, PO once daily. For example, patients already taking 10 mg of immediate-release methylphenidate twice daily (20 mg/day) should start with 20 mg Metadate CD once daily; those taking 20 mg twice daily (40 mg/day) could start with 40 mg Metadate CD once daily. Dose may be increased by 10 to 20 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day for patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. If a lower initial dose is desired, patients may begin treatment with 10 mg PO once daily. Dose may be increased by 10 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, give no more than the total daily dosage of the previous methylphenidate product PO once daily in the morning. Dose may be increased by 10 mg increments at weekly intervals. Max: 60 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. If a lower initial dose is desired, 10 mg PO once daily may be used. Dose may be increased by 10 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, give no more than the total daily dosage of the previous methylphenidate product PO once daily in the morning. For example, patients already taking 10 mg of immediate-release methylphenidate twice daily (20 mg/day) should start with 20 mg Ritalin LA once daily; those taking 20 mg of extended-release methylphenidate once daily (20 mg/day) should also start with 20 mg of Ritalin LA once daily. Dose may be increased by 10 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts recommend doses up to 100 mg/day in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 10 mg PO once daily in the morning. Dose may be increased by 10 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts have recommended doses up to 100 mg/day of other methylphenidate formulations in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. Dose may be titrated up or down in increments of 10 mg, 15 mg, or 20 mg at weekly intervals. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. FDA-approved Maximum: 60 mg/day PO; however, some experts have recommended doses up to 100 mg/day of other methylphenidate formulations in patients weighing more than 50 kg. If switching from another methylphenidate product, discontinue that treatment and titrate with QuilliChew ER as previously described; do not substitute QuilliChew ER for other methylphenidate products on a mg-for-mg basis. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 20 mg PO once daily in the morning. Dose may be increased by 10 to 20 mg increments at weekly intervals. FDA-approved Max: 60 mg/day; however, some experts have recommended doses up to 100 mg/day of other methylphenidate formulations in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, 17.3 mg PO once daily in the morning; take consistently with or without food. Dose may be increased by 8.6 to 17.3 mg increments at weekly intervals. FDA-approved Max: 51.8 mg/day. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Initially, apply a 10 mg/9-hour patch topically once daily in the morning, 2 hours before an effect is needed, regardless of previous methylphenidate therapy. If response is not maximized after 1 week, titrate to the next available patch strength in weekly intervals. The suggested upward titration schedule is Week 1: apply 10 mg/9-hour patch once daily; Week 2: apply 15 mg/9-hour patch once daily; Week 3: apply 20 mg/9-hour patch once daily; Week 4: apply 30 mg/9-hour patch once daily. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. Maximum: 30 mg/9-hour patch once daily. In clinical trials, there was no additional benefit of increasing the patch dose from 20 mg/9-hours to 30 mg/9-hours. Remove the patch 9 hours after application or may remove earlier if late day side effects appear and shorter duration of effect is desired.
Initially, 20 mg PO once daily in the evening. Dose may be titrated in increments of 20 mg at weekly intervals. Max: 100 mg/day. If switching from another methylphenidate product, discontinue that treatment and titrate with Jornay PM as previously described; do not substitute Jornay PM for other methylphenidate products on a mg-for-mg basis. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or discontinue the drug.
Average effective dose is 20 to 30 mg/day PO divided and given in 2 to 3 divided doses 30 to 45 minutes before meals. Range: 10 to 60 mg/day PO. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 pm.
Initially, 5 mg PO twice daily before breakfast and lunch. Dose may be increased by 5 to 10 mg/day at weekly intervals; some patients may require dosing up to 3 times daily (administer last dose of day before 6 pm to limit sleep interference). Max: 60 mg/day per FDA-approved labeling; however, some experts state that doses up to 100 mg/day may be needed in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If no improvement within 1 month, discontinue methylphenidate and consider an alternative treatment/therapy. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
The National Institute of Mental Health’s Preschool ADHD Treatment Study (PATS) provides clinical guidance for children with ADHD 3 to 5 years of age. In the PATS, the initial dose of immediate-release methylphenidate was 1.25 mg PO 3 times daily. Doses were increased gradually up to a maximum of 10 mg PO 3 times daily to reach optimum therapeutic response. The mean optimal total daily dose was 14.2 +/- 8.1 mg (0.7 +/- 0.4 mg/kg/day). Max: 30 mg/day. In all cases, treatment should start with a low dose and be titrated upward slowly. Use lowest effective dose. Higher doses have lead to social withdrawal in some children. Behavior therapy, parental training, and a structured preschool environment are considered first line treatment for preschool-aged children with ADHD; lack of significant improvement with such modalities may warrant the addition of methylphenidate.
The extended-release (ER) tablets have a duration of action of approximately 8 hours. Use in place of immediate-release (IR) tablets when the 8-hour dosage of these ER tablets corresponds to the previously titrated 8-hour dosage of the IR tablets. Max: 20 mg PO 3 times daily. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
The extended-release (ER) tablets have a duration of action of approximately 8 hours. Use in place of immediate-release (IR) tablets when the 8-hour dosage of the ER tablets corresponds to the previously titrated 8-hour dosage of the IR tablets. Alternatively, some experts recommend an initial dose of 10 mg PO once daily. Ritalin SR may be administered once or twice daily. Max: 60 mg/day per FDA-approved labeling; however, some experts state that doses up to 100 mg/day may be needed in patients weighing more than 50 kg. Individualize dosage based on psychosocial and comorbid factors; use lowest effective dose. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug.
Average dose 20 to 30 mg/day; range 10 to 60 mg/day PO in 2 to 3 divided doses, 30 to 45 minutes before meals. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Initially, 5 mg PO twice daily before breakfast and lunch. May increase by 5 to 10 mg/day PO at weekly intervals. Max: 60 mg/day.
The extended-release (ER) tablets have a duration of action of approximately 8 hours. Therefore, use in place of immediate-release (IR) tablets when the 8-hour dosage of the ER tablets corresponds to the previously titrated 8-hour dosage of the IR tablets. Max: 60 mg/day.
NOTE: The use of stimulants for the treatment of depressive disorders is usually limited to treatment-refractory cases or when standard medical therapies are not tolerated. Stimulants may aggravate coexisting anxiety or agitation in depressed patients.
Initially, 2.5 mg PO twice daily administered in the morning and at noon; increase by 2.5—5 mg PO every 2 or 3 days as tolerated, until the desired response is achieved. Roughly 50% of patients appear to respond to treatment.
Initially, 2.5 mg PO twice daily administered in the morning and at noon; increase by 2.5—5 mg PO every 2 or 3 days as tolerated, until the desired response is achieved. Dosage in elderly patients with post-stroke depression has ranged from 15—40 mg/day PO after dosage titration for a mean of 15 days. Roughly 50% of patients appear to respond to treatment.
†Indicates off-label use
MAXIMUM DOSAGE
72 mg/day PO.
72 mg/day PO.
72 mg/day (Max: 2 mg/kg/day) PO for Concerta (FDA-approved labeling) and 60 mg/day PO for all other oral formulations excluding Cotempla XR-ODT and Jornay PM (FDA-approved labeling); 51.8 mg/day PO for Cotempla XR-ODT and 100 mg/day PO for Jornay PM; however, doses up to 100 to 108 mg/day PO have been used in patients weighing more than 50 kg for some formulations. For the transdermal patch, 30 mg/9-hour patch per day is the maximum.
6 to 12 years: 54 mg/day PO for Concerta (FDA-approved labeling) and 60 mg/day PO for all other oral formulations excluding Cotempla XR-ODT and Jornay PM (FDA-approved labeling); 51.8 mg/day PO for Cotempla XR-ODT and 100 mg/day PO for Jornay PM; however, doses up to 100 to 108 mg/day PO have been used in patients weighing more than 50 kg for some formulations. For the transdermal patch, 30 mg/9-hour patch per day is the maximum.
3 to 5 years: Safety and efficacy have not been established. Maximum doses have not been adequately studied; however The Preschool ADHD Treatment Study (PATS) has suggested immediate-release doses up to 30 mg/day PO.
1 to 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Specific guidelines for dosage adjustments in hepatic impairment are not available.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Renal clearance is not an important predictor of methylphenidate clearance.
ADMINISTRATION
Methylin chewable tablets: Administer 30 to 45 minutes before meals in divided doses 2 to 3 times daily. Chewable tablets should be taken with at least 8 ounces of fluid to avoid choking. Twice-daily dosages may be administered in the morning and around noon. Individualized timing of the midday dose is usually necessary, as determined by the loss of positive drug effect, which occurs 2 to 6 hours after the morning dose. Administer the last dose of the day prior to 6 PM.
Immediate-release dosage forms (Ritalin, Methylin, Metadate, generic equivalents): Administer 30 to 45 minutes before meals in divided doses 2 to 3 times daily. Twice-daily dosages may be administered in the morning and around noon. Individualized timing of the midday dose is usually necessary, as determined by the loss of positive drug effect, which occurs 2 to 6 hours after the morning dose. Administer the last dose of the day prior to 6 PM.
Extended-release tablets (Ritalin SR, Metadate ER, generic methylphenidate ER): May be administered without regard to meals. Administer whole; do not cut, crush, or chew. Extended-release tablets have a duration of action of approximately 8 hours. Administer the last dose of the day several hours before bedtime.
Once-daily extended-release tablets (Concerta): Administer once daily in the morning with an adequate amount of fluid. May be administered without regard to meals. Administer whole; do not cut, crush, or chew. The biologically inert portion of this tablet may appear intact in the stool; this is normal.
Once-daily extended-release capsules (Metadate CD, Ritalin LA, Aptensio XR): May be administered without regard to meals; however, the manufacturer of Aptensio XR recommends that patients establish a routine pattern with regard to meals. Administer with an adequate amount of fluid. Do not cut, crush, or chew. If swallowing is difficult, the capsule may be opened and the contents gently sprinkled on one tablespoon of applesauce and swallowed immediately. The capsule contents (beads) should not be crushed or chewed. Instruct the patient to drink fluids (e.g., water, milk, or juice) after the intake of the sprinkles with applesauce.
The Institute for Safe Medication Practices states the capsule contents of Metadate CD and Ritalin LA may be administered via a nasogastric tube as long as they are not crushed and an adequate amount of fluid is used to wash the full dose down the tube.
Once-daily extended-release chewable tablets (QuilliChew ER): Administer once daily in the morning with or without food. The 10 mg and 15 mg doses can be achieved by breaking in half the scored 20 mg and 30 mg tablets, respectively.
Once-daily extended-release orally disintegrating tablets (Cotempla XR-ODT): Administer once daily in the morning consistently either with or without food. Do not remove tablet from the blister pack until just prior to dosing; use dry hands when opening the blister pack. Remove the tablet by peeling back the foil; do not push the tablet through the foil. Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing. No liquid is needed to take the tablet.
Once-daily extended-release capsules (Jornay PM): Administer once daily in the evening consistently either with or without food. Initiate dosing at 8:00 PM and adjust the timing of administration between 6:30 PM and 9:30 PM to optimize tolerability and efficacy the next morning and throughout the day. If a dose is missed, advise the patient to take it as soon as it’s remembered that same evening. If a patient remembers the missed dose the next morning, skip the dose and do not give until the next scheduled evening administration. If swallowing is difficult, the capsule may be opened and the contents gently sprinkled on applesauce and swallowed immediately. Do not crush or chew the capsule contents (beads).
Immediate-release oral solution (Methylin)
Measure methylphenidate dosage with an oral syringe or calibrated measuring device.
Administer 30 to 45 minutes before meals in divided doses 2 to 3 times daily. Twice-daily dosages may be administered in the morning and around noon. Individualized timing of the midday dose is usually necessary, as determined by the loss of positive drug effect which occurs 2 to 6 hours after the morning dose. Administer the last dose of the day prior to 6 PM.
Once-daily extended-release oral suspension (Quillivant XR)
Vigorously shake the bottle of suspension for a minimum of 10 seconds.
Measure dosage with the calibrated oral dosing dispenser provided.
Administer in the morning without regard to meals.
Reconstitution of once-daily extended-release oral suspension (Quillivant XR)
Review the manufacturer’s reconstitution instructions for the particular product and package size.
Prior to reconstitution, tap the bottle several times to loosen the powder.
To prepare the suspension, add the specified amount of water to the bottle, fully insert the bottle adapter into the bottle neck, replace the cap, and vigorously shake the bottle for at least 10 seconds.
Storage: Store reconstituted suspension at 77 degrees F; dispense in original packaging (bottle in container). The reconstituted suspension is stable for 4 months from date of reconstitution.
Daytrana transdermal system:
Patch should be applied 2 hours before the effect is needed.
Do not cut or trim patch.
Apply patch immediately after opening the pouch and removing protective liner. Do not use if pouch seal is broken. Do not touch the adhesive side of the patch during application to avoid absorption of methylphenidate. Wash hands immediately if adhesive side of the patch is touched. Discard the patch if difficulty is encountered in separating the patch from the release liner, or if tearing or other damage occurs. Discard patch if adhesive containing medication has transferred to the liner during removal of the patch from the liner.
Place on a dry, clean area of the hip and hold in place for 30 seconds with the palm of the hand. Do not apply to oily, damaged, or irritated skin. Do not apply topical preparations to the application site immediately prior to patch application. Avoid the waistline area where the patch could be rubbed by clothing.
Applications sites should be alternated from one hip to the next each day, avoiding sites where a patch was recently placed, when possible.
Instruct patient on proper application and disposal of patch. Adherence of the patch may be affected by showering, bathing, or swimming. The carton contains an administration chart that can help the patient monitor application and removal time, which the patient and/or caregiver should be encouraged to use. If a patch was removed without the caregiver’s knowledge, or if a patch is missing from the tray, the caregiver should be encouraged to ask the child when and how the patch was removed.
Avoid exposing the application site to hair dryers, heating pads, electric blankets, heated water beds, or other direct external heat sources. The rate and extent of absorption of methylphenidate are significantly increased during application of heat to the patch during use. Temperature-dependent increases in absorption may be greater than 2-fold, potentially resulting in overdose.
Do not apply or re-apply the patch with dressings, tape, or adhesives. If the patch is not fully adhered to the skin during application or wear time, discard the patch according to disposal instructions and apply a new patch.
The total daily wear time should not exceed 9 hours, regardless of patch replacement.
Patches should be peeled off slowly. Patch removal may be aided by applying an oil-based product (i.e., petroleum jelly, mineral oil, olive oil) to the patch edges and gently working the oil underneath the edges of the patch.
Disposal: Instruct patient and/or caregiver to fold used patches, so that the adhesive side of the patch adheres to itself, and then flush it down the toilet or dispose of in an appropriate lidded container. If the patient stops using the prescription, each unused patch should be removed from its pouch, separated from the protective liner, folded onto itself, and flushed down the toilet or disposed of in an appropriate lidded container. Do not flush pouch and protective liner down the toilet. Instead, dispose of them in an appropriate container with a lid.
STORAGE
Generic:
– Protect from moisture
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Aptensio XR:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Concerta:
– Avoid excessive humidity
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Cotempla XR:
– Product should always be stored in the blister and only removed immediately before use
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Daytrana:
– Do not freeze
– Do not refrigerate
– Product should be used within 2 months after opening
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
– Store unused product in foil pouch
JORNAY:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Metadate CD:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Metadate ER:
– Protect from moisture
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Methylin:
– Protect from light
– Protect from moisture
– Store at controlled room temperature (between 68 and 77 degrees F)
QuilliChew ER:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Quillivan XR:
– Store and dispense in original container
– Store reconstituted product in accordance with package insert instructions
– Store unreconstituted product at 77 degrees F; excursions permitted to 59-86 degrees F
RELEXXII:
– Avoid excessive humidity
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Ritalin:
– Protect from light
– Protect from moisture
– Store at controlled room temperature (between 68 and 77 degrees F)
Ritalin LA:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Ritalin SR:
– Protect from moisture
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Methylphenidate is contraindicated in patients with known hypersensitivity to methylphenidate or any component of this product. Cross-sensitivity with dexmethylphenidate should be expected. Life-threatening hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during methylphenidate administration. The use of transdermal methylphenidate may lead to contact sensitization. If contact sensitization is suspected, the methylphenidate patch should be discontinued. Patients who have previously developed contact dermatitis with transdermal methylphenidate may also be sensitized to oral methylphenidate and should be initiated on oral therapy under close supervision. Following initial development of contact dermatitis from the methylphenidate patch, re-exposure to the drug by other routes of administration may result in systemic sensitization or other systemic reactions. Symptoms may include a flare-up of a previous dermatitis, generalized skin eruptions to previously unaffected skin, headache, fever, malaise, arthralgia, diarrhea, or vomiting. Some patients who develop sensitization to the patch may not be able to use the oral products. Patients should alternate hip application sites each day to help prevent sensitization.
All patients should be advised to avoid exposing the methylphenidate patch application site to direct external heat sources (i.e., heating pads, electric blankets, heated water beds) while wearing the patch. There is a potential for temperature-dependent increases in methylphenidate release of greater than 2-fold from the patch when there is extreme ambient temperature increase at the site of application.
The Metadate CD product contains sucrose. The manufacturer of Metadate CD considers its product contraindicated in patients with hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase insufficiency.
Methylphenidate tablets (immediate-release, extended-release, and immediate-release chewable), transdermal patch, immediate-release oral solution, and some extended-release capsules (e.g., Metadate CD, Ritalin LA) are contraindicated in patients with marked anxiety, tension, or agitation because the drug can aggravate these conditions. Other dosage forms, including some extended-release capsules (e.g., Aptensio XR), extended-release chewable tablets, extended-release orally disintegrating tablets, and extended-release oral suspension are not specifically contraindicated by the manufacturer in these patient populations; however, extreme caution should be exercised if the drug is used in these patients. Stimulants should be used cautiously in those with bipolar disorder and/or mania due to the potential for manic episodes to occur. An assessment should be performed prior to initiation of therapy to determine the risk for bipolar disorder in patients presenting with symptoms of depression. Due to its toxic effects in overdose, methylphenidate should only be used in those with major depression or suicidal ideation when absolutely necessary. Aggression, hostility, and suicidal ideation or behaviors have been reported in both clinical trials and postmarketing experience with ADHD medications. Although causality has not been established and these behaviors may be inherent to ADHD, close monitoring is recommended. Patients and their caregivers should be advised to promptly report any changes in mood or behavior. If suicide-related events emerge during treatment, consideration should be given to dose reduction or drug discontinuation, especially if symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. In psychotic individuals (e.g., schizophrenia), stimulants may exacerbate behavioral disturbances, psychosis, or thought disorders; therefore, the drug should be avoided if possible in those with psychosis.
Methylphenidate tablets (immediate-release, extended-release, and immediate-release chewable), transdermal patch, immediate-release oral solution, and some extended-release capsules (e.g., Metadate CD, Ritalin LA) are contraindicated in patients with motor tics, Tourette’s syndrome, or a family history of Tourette’s syndrome because the drug may precipitate motor or phonetic tics. Other dosage forms, including some extended-release capsules (e.g., Aptensio XR), extended-release chewable tablets, extended-release orally disintegrating tablets, and extended-release oral suspension are not specifically contraindicated by the manufacturer in these patient populations; however, caution should be exercised if the drug is used in these patients. Tics did occur during clinical trials of the drug.
Use of methylphenidate tablets (immediate-release, extended-release, and immediate-release chewable), transdermal patch, immediate-release oral solution, and some extended-release capsules (e.g., Metadate CD, Ritalin LA) is contraindicated in patients with glaucoma, due to the ability of the drug to increase sympathetic stimulation and to raise intraocular pressure. Other dosage forms, including some extended-release capsules (e.g., Aptensio XR), extended-release chewable tablets, extended-release orally disintegrating tablets, and extended-release oral suspension are not specifically contraindicated by the manufacturer in these patient populations; however, use is not recommended. Occasionally, a visual disturbance, such as change in visual accommodation or blurred vision, has been reported in other individuals without ocular disease. Patients should report any new visual disturbance as ophthalmic evaluation may be needed.
Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior. Symptoms of chronic abuse of methylphenidate may include insomnia, irritability, change in personality, and psychotic symptoms that may be clinically indistinguishable from psychotic disorders, particularly with parenteral or inhalational abuse. Misuse of amphetamines may also cause sudden death and serious cardiovascular adverse events. Therefore, a careful assessment of benefit versus risk is recommended in patients with a known history of substance abuse, including alcoholism. The least amount reasonable should be prescribed or dispensed at one time in order to limit the potential for overuse or drug diversion. Close supervision is required during drug withdrawal from misuse since severe depression may occur. Withdrawal or abrupt discontinuation after chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. Drug ‘holidays’, the temporary discontinuation of drug during weekends, holidays, summer vacations, etc., is usually not associated with drug withdrawal symptoms, but such holidays are typically reserved for those patients with well-controlled ADHD symptoms.
Use stimulant medications, such as methylphenidate, with caution in patients with hypertension or other conditions in which a modest increase in blood pressure or heart rate could be detrimental. Stimulant medications cause a modest increase in average blood pressure (approximately 2—4 mmHg) and average heart rate (approximately 3—6 bpm); however, some individuals may have larger increases. Elevated blood pressure may require a dose reduction, discontinuation, and/or initiation of appropriate antihypertensive medication. Periodic blood pressure and heart rate monitoring is recommended in all patients taking methylphenidate. In pediatric clinical trials, methylphenidate increased heart rate by roughly 2—6 bpm and blood pressure by 1—4 mmHg. In a clinical trial of the extended-release preparation in adolescents, patients experienced a mean increase in resting pulse of 5 and 3 bpm for methylphenidate and placebo, respectively. Mean increases in systolic blood pressure were equal (0.7 mm Hg) in both treatment groups, and diastolic pressure increased by 2.6 and 1.4 mm Hg for the active and placebo treatments, respectively.
The FDA recommends that, in general, stimulant medications such as methylphenidate not be used in patients with known serious cardiac structural abnormalities, a history of acute myocardial infarction, aortic stenosis, prosthetic heart valves, valvular heart disease, cardiomyopathy, ventricular dysfunction or heart failure, cardiac arrhythmias, coronary artery disease, advanced arteriosclerosis or other serious cardiac disease or conditions. Stimulant medications may increase blood pressure or heart rate in some individuals (see hypertension precaution); more serious cardiac effects have also been associated with stimulant use. Sudden unexplained death (SUD) and myocardial infarction have occurred in adults receiving stimulants at standard dosages for attention-deficit hyperactivity-disorder (ADHD). Sudden death has also been associated with stimulant medications at usual doses in pediatrics with structural cardiac abnormalities or other serious heart problems. A large retrospective cohort study including over 1.2 million children and young adults 2—24 years of age did not find an increased risk of serious cardiovascular events in current users of drugs for the treatment of ADHD compared to nonusers (adjusted hazard ratio 0.75; 95% CI 0.31—1.85). Similar results were seen when current users of ADHD drugs were compared to former users and when current users with severe underlying cardiovascular disease were included in the analysis. The authors concluded that although the absolute magnitude of risk appears to be low, a modest increase in risk could not be ruled out. The American Heart Association (AHA) states that it is reasonable to consider the use of these medications in pediatric patients with congenital heart disease without current hemodynamic or arrhythmic concerns or congenital heart disease that is considered stable by the patient’s pediatric cardiologist, unless the cardiologist has specific concerns. However, these patients should be closely monitored and treatment discontinuation should be considered if the patient develops any of the following conditions: heart condition associated with sudden cardiac death (SCD), arrhythmia requiring cardiopulmonary resuscitation, direct current cardioversion/defibrillation or overdrive pacing, arrhythmia associated with SCD, any clinically significant arrhythmia that is not treated or controlled, QTc on electrocardiogram (ECG) > 0.46 sec, or heart rate or blood pressure > 2 SD above the mean for age. All patients being considered for treatment with stimulant medications should have a careful history taken, including assessment for a family history of sudden death or ventricular arrhythmias, and a physical exam to assess for the presence of cardiac disease. If cardiac disease is suspected, further cardiac evaluation including an ECG and echocardiogram is warranted. For pediatric patients, the AHA states that it is reasonable to obtain a baseline ECG as a part of the initial evaluation. If a child or adolescent has any significant findings on physical examination, ECG, or family history, consult a pediatric cardiologist before initiating the stimulant medication. Once the medication is started, a repeat ECG may be helpful if the original ECG was obtained before the child was 12 years old, if cardiac symptoms develop, or there is a change in family history.
Stroke has occurred in adults receiving stimulants, such as methylphenidate, at usual doses for ADHD; therefore, patients with cerebrovascular disease should be closely monitored. Stimulant medications may increase blood pressure or heart rate in some individuals (see hypertension precaution).
Children and adolescents 6 years of age and older have been successfully treated for attention-deficit hyperactivity disorder (ADHD) with methylphenidate; there is clinical off-label use with immediate-release oral products in younger children under close medical supervision. Concerta, Daytrana, Metadate CD, and Ritalin LA are not recommended for children < 6 years of age. It should be noted that not all children with ADHD will require medication; non-drug measures are often instituted concurrently with drug therapy. Monitoring of the effectiveness of stimulant therapy by the health care prescriber, parents, and teachers is important; periodic reassessment of the need for medication is recommended. Appropriate stimulant therapy should not suppress normal emotions or intellectual ability; the occurrence of certain side effects may indicate a need for dosage reduction. In psychotic children, methylphenidate may exacerbate behavioral disturbances, psychosis, or thought disorders. New onset psychotic or manic symptoms may develop in children receiving therapeutic doses of stimulants. Discontinuation of therapy may be required. Although a direct causal relationship has not been established, aggressive behavior and hostility have been reported during use of some stimulants for ADHD in pediatric populations. It is recommended to monitor for signs of aggression or worsening of pre-existing aggressive behavior when treatment is initiated. The potential for growth inhibition in pediatric patients should be monitored during stimulant therapy. Monitor height and weight parameters relative to age at treatment initiation and periodically thereafter (at minimum yearly). Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. Data obtained on the effects of methylphenidate on growth suppression in children 7— 10 years of age suggested that regularly medicated children (7 days/week) had a temporary average slowing in growth of 2 cm in height and 2.7 kg in weight over 3 years. Data are inadequate to determine whether chronic use of stimulants causes long-term growth inhibition. Although data are limited, available studies do not indicate that stimulant use compromises the attainment of normal adult height and weight in most children. Sudden death has been reported in association with CNS stimulant treatment at usual doses in children or adolescents with structural cardiac abnormalities or other serious heart problems (i.e., aortic stenosis, cardiomyopathy, congenital heart disease, prosthetic heart valves, valvular heart disease, ventricular dysfunction). Some case reports have involved concomitant medications, such as tricyclic antidepressants. A large retrospective cohort study including over 1.2 million children and young adults 2—24 years of age did not find an increased risk of serious cardiovascular events, including sudden cardiac death, myocardial infarction, or stroke in current users of drugs for the treatment of ADHD compared to nonusers (adjusted hazard ratio 0.75; 95% CI 0.31—1.85). The authors concluded that although the absolute magnitude of risk appears to be low, a modest increase in risk could not be ruled out. Although some structural cardiac abnormalities alone may carry an increased risk of sudden death, stimulant products generally should not be used in patients with known structural cardiac abnormalities or other serious cardiac problems. Exceptions to this warning do exist, but careful screening and monitoring is recommended by the American Heart Association (see separate paragraph detailing cardiac contraindications and precautions).
Methylphenidate should be used cautiously in patients with hyperthyroidism, as sympathomimetic stimulation may induce cardiac arrhythmias or other side effects.
Methylphenidate should be used cautiously in patients with a history of a seizure disorder because the seizure threshold can be reduced. Seizure threshold may be reduced in those with EEG abnormalities and rarely in patients without a seizure history or EEG abnormalities. Concomitant use of methylphenidate and anticonvulsants has not been established. If seizures occur, methylphenidate therapy should be discontinued.
The safety of methylphenidate during human pregnancy has not been established; therefore, methylphenidate should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. There are limited published studies and small case series that report on the use of methylphenidate during pregnancy; however, the data are insufficient to determine any drug-associated risks. Because stimulants cause vasoconstriction, they may decrease placental perfusion. Neonates born to stimulant-dependent mothers are at increased risk for premature delivery and low birth weight. In addition, neonates with in utero exposure to stimulants may experience withdrawal after delivery; monitor the newborn for symptoms of withdrawal such as feeding difficulty, irritability, agitation, and excessive drowsiness. It is unclear what effect, if any, a CNS stimulant such as methylphenidate would have on the developing fetal brain. In animal studies, teratogenic effects (increased incidence of fetal spina bifida), fetal skeletal variations, maternal toxicity, and/or decreased offspring weight gain were observed at doses that were 4 to 40 times the maximum recommended human dose (MRHD). The no effect level for embryo-fetal development in rats was 2 times the MRHD. Prescribers should enroll women exposed to methylphenidate during a pregnancy in a registry by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. The effect of methylphenidate on labor and delivery in humans is unknown.
The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for methylphenidate and any potential adverse effects on the breastfed infant from methylphenidate or from the underlying maternal condition. Methylphenidate has a low molecular weight and is excreted in human breast milk. Limited data from published literature have indicated a resulting infant dose of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk to plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Based on data from 2 breast-feeding mothers, one receiving 15 mg/day and one receiving 80 mg/day, the estimated infant dose ranged from 0.38 mcg/kg/day to 2.3 mcg/kg/day or 0.16% to 0.2% of the maternal weight-adjusted dose. The mothers of the infants, one an approximately 6.5 month old who received most of his nutrition from breast milk and one an 11 month old who was only sporadically breast fed, reported no adverse events. Although methylphenidate may be considered as an alternative to other stimulants in breast-feeding women, the medical use of stimulant medications has not been formally evaluated in controlled studies. If breast-feeding cannot be avoided during the use of stimulant medications, the nursing infant should be monitored for signs of central nervous system hyperactivity, including decreased appetite, insomnia, and irritability. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. The effect of stimulant medication exposure via breast milk on the long-term neurological development of the infant is not known. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The use of methylphenidate may cause dizziness, mask signs of fatigue or the need for rest, or impair the ability of a patient to participate in activities that require mental alertness. Patients should not use methylphenidate for the prevention or treatment of normal fatigue states. Patients should not perform such tasks, including driving or operating machinery, until they are aware of how this medication affects them.
The use of inhalational anesthetics during surgery may sensitize the cardiovascular system to the effects of methylphenidate. The manufacturer of Metadate CD and Metadate ER states that these products are contraindicated on the day of surgery due to the risk of sudden blood pressure increases during administration of halogenated anesthetics.
Patients with a history of seizures or previous EEG abnormalities are at risk for a decreased seizure threshold following administration of a stimulant. In rare instances, those with no risk factors for seizure activity may develop a lowered seizure threshold with stimulant use. Methylphenidate should be promptly discontinued if seizures occur. Because of a potential increased risk of seizures, methylphenidate should not be used during intrathecal radiographic contrast administration. Methylphenidate therapy should be discontinued 48 hours before and not restarted until at least 24 hours after myelography.
There is a potential for Concerta tablets to cause GI obstruction in susceptible patients. The Concerta extended-release tablet is nondeformable. Use with caution in patients who would have history of severe GI narrowing which would place them at risk, such as those patients with inflammatory bowel disease, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, diverticular disease, or ileus. Patients with dysphagia, esophageal motility disorders, or esophageal stricture may not be able to swallow extended-release methylphenidate dosage forms whole and may be at risk for GI obstruction.
Methylphenidate has not been evaluated in patients with hepatic disease, and caution is recommended.
The safety and efficacy of certain dosage forms of methylphenidate have not been specifically assessed in geriatric patients. Stimulant medications are used as the treatments of choice in the adult patient over 50 years of age with ADHD when behavioral and lifestyle modifications alone have failed to improve concerns associated with inattention, such as task focus and completion, or organization and time management. Medication should be titrated with low doses initially and with a slow increase. Debilitated or geriatric patients may be more susceptible to the CNS and sympathomimetic side effects of methylphenidate; use with caution in the older adult. Side effects of amphetamines or other stimulants are usually mild but may include mood or behavior changes, tremor, insomnia, increased blood pressure, headache, or gastroesophageal reflux or other GI complaints. Adults should have their blood pressure and heart rate checked at baseline and periodically during treatment. If treatment is considered necessary, periodically re-evaluate the long-term usefulness of the drug for the individual patient. According to the Beers Criteria, methylphenidate is considered a potentially inappropriate medication (PIM) for use in geriatric patients with insomnia and should be avoided due to the potential for drug-induced CNS stimulant effects.
Methylphenidate is contraindicated in patients who have received MAOI therapy within the past 14 days because of the possibility of precipitating a hypertensive crisis.
Stimulant medications are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Worsening of peripheral vascular disease is possible. Effects on circulation have been observed with therapeutic doses at different times throughout therapy in all age groups. Signs and symptoms are usually intermittent and mild and generally improve after reduction in dose or discontinuation of drug. However, very rare sequelae include digital skin ulcer and/or soft tissue breakdown. Carefully monitor all patients for digital changes during treatment with stimulant medications, especially those with pre-existing circulation problems. Instruct patients to seek immediate medical attention if any new digital numbness, pain, skin discoloration, or temperature sensitivity occur, or if unexplained wounds appear on their fingers or toes. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Chemical leukoderma, a condition that causes the skin to lose color from repeated exposure to specific chemical compounds, may occur with use of the methylphenidate patch. The condition is not physically harmful, but it is disfiguring and is thought to be irreversible, which may cause emotional distress. The areas of skin color loss described with the methylphenidate patch have ranged up to 8 inches in diameter, with a time of onset ranging from 2 months to 4 years after starting the patch. Skin hypopigmentation has occurred under and around the patch, and less frequently on parts of the body where the patch was never applied. Chemical leukoderma can mimic the appearance of vitiligo, particularly at remote sites of skin hypopigmentation. Individuals with a history of vitiligo and/or a family history of vitiligo may be more at risk. Patients and caregivers should be advised to watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to their health care providers. Alternative treatment should be considered in patients who experience these skin changes.]
Methylphenidate chewable tablets (e.g., Methylin, QuilliChew ER) contain aspartame. Phenylalanine is a component of aspartame and can be harmful to patients with phenylketonuria (PKU). Before prescribing these formulations in patients with PKU, consider the combined daily amount of phenylalanine from all sources.
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