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Uses

Attention Deficit Hyperactivity Disorder (ADHD)

Treatment of ADHD, alone or combined with behavioral treatment, as an adjunct to psychological, educational, social, and other remedial measures in carefully selected children ≥6 years of age, adolescents, and adults.

A drug of choice for the management of ADHD.

Used effectively in the management of ADHD in adolescents and adults, but experience is far less extensive than in children, and potential age-related differences in response remain to be elucidated.

Narcolepsy

Symptomatic treatment of narcolepsy.

Dosage and Administration

General

• Carefully adjust dosage according to individual requirements and response.
• For patients whose symptoms are not severe outside school, may attempt drug holidays for all or part of the summer to assess continuing efficacy and need for therapy, as well as to minimize adverse effects.
• Discontinue therapy if a beneficial effect is not attained after appropriate dosage adjustment over 1 month.
• If paradoxical aggravation of symptoms occurs, reduce dosage or discontinue the drug.
• Periodically discontinue therapy to assess the patient’s condition.

Administration

Administer orally or percutaneously by topical application of a transdermal system.

Oral Administration

Conventional Tablets, Chewable Tablets, or Oral Solution

Administer orally 2 or 3 times daily.

The manufacturers recommend that conventional tablets, chewable tablets, or oral solution be taken 30–45 minutes before meals.

To avoid insomnia, administer the last daily dose before 6 p.m.

Administer chewable tablets with a full glass (i.e., ≥240 mL [8 ounces]) of water or other fluid to avoid choking. (See GI Effects under Cautions and also see Advice to Patients.)

Extended-release Tablets (Metadate^® ER, Methylin^® ER, Ritalin–SR^®)

Swallow tablets whole; do not crush or chew.

May be used once the daily dosage has been titrated using conventional tablets (when the 8-hour dosage of the extended-release preparation corresponds to the titrated 8-hour dosage of the conventional tablets).

Extended-release Capsules (Metadate^® CD, Ritalin^® LA)

Administer orally once daily in the morning.

Manufacturer states that Metadate^® CD extended-release capsules should be administered before breakfast. Manufacturer states that administration of Ritalin^® LA relative to timing and composition of meals may need to be individually adjusted.

Swallow capsules whole; do not crush, chew, or divide.

Alternatively, open capsule and sprinkle contents (pellets) on a small amount of applesauce; swallow immediately without chewing.

Manufacturers state that extended-release capsules may be used to initiate methylphenidate therapy or for continued therapy in patients being switched from other methylphenidate formulations (see Switching to Extended-release Capsules [Metadate^® CD, Ritalin^® LA] under Dosage and Administration).

Extended-release Trilayer Core Tablets (Concerta^®)

Administer orally once daily in the morning without regard to meals.

Swallow tablets whole; do not crush or chew.

May be used to initiate methylphenidate therapy or for continued therapy in patients being switched from other methylphenidate formulations (see Switching to Extended-release Trilayer Core Tablets [Concerta^®] under Dosage and Administration).

Transdermal Administration

Apply once daily in the morning, 2 hours before an effect is needed; remove 9 hours after application.

Apply system immediately after opening individually sealed package and removing protective liner; do not use if package seal is broken.

Apply the transdermal system to a clean, dry area of the hip that is not oily, damaged, or irritated; avoid applying to the waistline or to areas under tight clothing, since system may rub off. Press system firmly in place with palm of hand for approximately 30 seconds, ensuring good contact with the skin, particularly around the edges. Alternate application sites daily (e.g., opposite hip) if possible.

Bathing, swimming, or showering should not affect adherence of a properly applied system. If a system does fall off, apply a new system at a different site, but total recommended wear time remains 9 hours per day.

After removal, fold system so that the adhesive side adheres to itself, then flush down the toilet or dispose of in an appropriate lidded container. For unused systems, remove from packaging, separate from the protective liner, fold so that the adhesive side adheres to itself, and then flush down the toilet or dispose of in an appropriate lidded container.

Parents or caregiver should be encouraged to record and monitor the application and removal times and method of disposal for each system.

Dosage

Available as methylphenidate and methylphenidate hydrochloride; dosage of methylphenidate hydrochloride is expressed in terms of the salt.

Pediatric Patients

ADHD

Initial Therapy with Conventional Tablets, Chewable Tablets, or Oral Solution

Oral

Initially, 5 mg twice daily, before breakfast and lunch. Increase dosage by 5–10 mg daily at weekly intervals based on response and tolerance, up to 60 mg daily; administer daily dosage in 2 or 3 divided doses.

Some clinicians recommend an initial dosage of 0.25 mg/kg daily; if adverse effects are not observed, double daily dosage each week until 2 mg/kg daily is reached.

Alternatively, dosage has been titrated over 28 days via daily-switch titration involving 5 randomly ordered repeats each of placebo and 5-, 10-, 15-, or 20-mg daily dosages (higher for children weighing >25 kg); each dose is repeated at breakfast and lunch, with a half dose given in the afternoon. The best dosage is selected based on clinical assessment of response.

Switching to Extended-release Tablets (Metadate^® ER, Methylin^® ER, Ritalin-SR^®)

Oral

Extended-release tablets can be substituted for conventional tablets at the nearest equivalent total daily dosage (e.g., patients receiving 10 mg as conventional tablets twice daily can be switched to 20 mg as extended-release tablets once daily).

Usual dosage: 20–60 mg daily, given as 20–40 mg once daily or as 40 mg in the morning and 20 mg in the early afternoon.

Initial Therapy with Extended-release Capsules (Metadate^® CD, Ritalin^® LA)

Oral

Metadate^® CD: Initially, 20 mg once daily in the morning. Increase dosage by 10 or 20 mg daily at weekly intervals, up to 60 mg daily.

Ritalin^® LA: Initially, 20 mg once daily in the morning. Alternatively, initiate with 10 mg once daily when a lower initial dosage is appropriate. Increase dosage by 10 mg daily at weekly intervals, up to 60 mg daily.

Switching to Extended-release Capsules (Metadate^® CD, Ritalin^® LA)

Oral

Adjust dosage of Metadate^® CD by 10 or 20 mg daily at weekly intervals, up to 60 mg daily.

Adjust dosage of Ritalin^® LA by 10 mg daily at weekly intervals, up to 60 mg daily.

For other conventional tablet regimens, substitute Ritalin^® LA at the nearest daily dosage based on clinical judgment.

Initial Therapy with Extended-release Trilayer Core Tablets (Concerta^®)

Oral

Initially, 18 mg once daily in the morning. If adequate response does not occur, increase dosage at approximately weekly intervals up to 54 mg daily in children 6–12 years of age or 72 mg daily (maximum 2 mg/kg daily) in adolescents 13–17 years of age. Some clinicians state that dosage in children 6–12 years of age may be increased to 72 mg daily.

Switching to Extended-release Trilayer Core Tablets (Concerta^®)

Oral

For patients being switched from other drugs to methylphenidate (as extended-release trilayer core tablets), follow dosage recommendations for initial therapy with the extended-release trilayer core tablets.

Initial dosage as extended-release trilayer core tablets in patients being switched from conventional tablets should not exceed 54 mg daily. Adjust dosage at weekly intervals, up to 72 mg once daily. A 27-mg extended-release trilayer core tablet also is available for patients who require a more gradual titration or who cannot tolerate a dosage of 36 mg daily.

Initial Therapy with or Switching to Transdermal System

Transdermal

Individualize dosage titration, final dosage, and wear time according to patient’s needs and response.

Initially, apply one system delivering 10 mg/9 hours once daily (for initial therapy or for patients switching from other methylphenidate preparations). Increase dosage at weekly intervals, based on response and tolerance, by using the next larger dosage system (i.e., 1 system delivering 15 mg/9 hours, then 1 system delivering 20 mg/9 hours, and then 1 system delivering 30 mg/9 hours).

If shorter duration of effect is desired or if late-day adverse effects appear, may remove system earlier than 9 hours. If aggravation of symptoms or other adverse events occur, reduce dosage or wear time or, if necessary, discontinue therapy.

Adults

Narcolepsy

Oral

Usual dosage of 10 mg (as conventional tablets or oral solution) 2 or 3 times daily; dosage range of 10–60 mg daily.

Prescribing Limits

Pediatric Patients

Conventional Tablets, Chewable Tablets, Oral Solution, Extended-release Tablets, and Extended-release Capsules

Maximum 60 mg daily.

Extended-release Trilayer Core Tablets (Concerta^®)

Initial therapy: Manufacturer recommends maximum dosage of 54 mg daily for children 6–12 years of age or 72 mg daily (maximum 2 mg/kg daily) for adolescents 13–17 years of age; however, some clinicians state that dosage for children 6–12 years of age may be increased to 72 mg daily.

Switched from other formulations: Maximum 72 mg daily.

Adults

Narcolepsy

Oral

Maximum 60 mg daily.