Dosing - Dosage and Administration of CONCERTA

Summary

• CONCERTA (methylphenidate hydrochloride extended-release [MPH ER]) tablets should be administered orally once daily in the morning with or without food. CONCERTA tablets must be swallowed whole with the aid of liquids and must not be chewed, divided, or crushed.¹
• For pediatric patients 6 to 17 years of age, the recommended CONCERTA starting dosage in patients new to methylphenidate (MPH) is 18 mg once daily. Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. The maximum recommended dosage for pediatric patients is 54 mg/day for those aged 6 to 12 years and 72 mg/day for pediatric patients aged 13 to 17 years.¹
• For adult patients (up to 65 years of age), the recommended CONCERTA starting dosage in patients new to MPH is 18 or 36 mg once daily. Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose and up to 72 mg/day.¹
• For patients currently using MPH, dosing is based on current dose regimen and clinical judgment.¹
• Alternate doses outside of available dosage strengths may be achieved by combining multiples of 18, 27, or 36 mg to reach desired total daily doses. The two dosage strengths should be taken together, once daily in the morning to achieve the desired total daily dose.²
• A literature search did not identify any citations pertaining to dose equivalency or conversion to CONCERTA from other non-methylphenidate stimulant medications.

PRODUCT LABELING

Please refer to the following sections of the enclosed Full Prescribing Information that are relevant to your inquiry¹: DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS.

GENERAL DOSING INFORMATION

CONCERTA tablets should be administered orally once daily in the morning with or without food. CONCERTA tablets must be swallowed whole with the aid of liquids and must not be chewed, divided, or crushed.¹

Recommended CONCERTA DOSAGE In PATIENTS NEW TO MPH

The recommended once-daily dosage of CONCERTA in patients who were not taking a MPH product is 18 mg once daily for pediatric patients (6-17 years) and 18 or 36 mg once daily for adults (18-65 years, see Table: Recommended CONCERTA Dosage in Patients New to MPH).¹ For patients who do not achieve an optimal response at a lower dosage, increase the CONCERTA dosage in 18 mg increments at weekly intervals. However, if a slower titration is recommended for patients who have not achieved an optimal response taking 18 mg of CONCERTA once daily, increase their daily dosage to 27 mg once per day.

Recommended CONCERTA Dosage in patients switching from ANOTHER mPH product

The recommended starting dosage of CONCERTA in patients switching from an immediate-release methylphenidate product administered twice daily or 3 times daily, at total daily dosage of 10 to 60 mg/day, are provided in Table: Recommended Starting Dosage in Patients Switching from Another MPH Regimen.¹

For patients who do not achieve an optimal response at a lower dosage, increase the CONCERTA dosage in 18 mg increments at weekly intervals. The maximum recommended dosage in pediatric patients 6 to 12 years of age is 54 mg/day, and the maximum recommended dosage in patients 13-65 years old is 72 mg/day.¹

DOSE REDUCTION AND DISCONTINUATION

If paradoxical aggravation of ADHD symptoms or CONCERTA-associated adverse events occurs, the dosage should be reduced or if necessary, discontinue CONCERTA. If ADHD improvement is not observed after appropriate dosage modification over a 1-month period, discontinue CONCERTA.¹

COMBINING DOSAGE STRENGTHS

CONCERTA is available in 18, 27, 36 and 54 mg dosage strengths only.¹ If a healthcare provider wishes to prescribe CONCERTA at a dose outside of the four available strengths, they should ultimately determine how they prefer their patient receive the desired total daily dose. For example, CONCERTA may be prescribed as a once-a-day morning dose of one 18 mg and one 27 mg for a 45 mg daily dose or two CONCERTA 36 mg tablets for a 72 mg daily dose.

Modi et al (2000)² conducted a randomized, open-label, three-way cross-over study to evaluate the dose-ranging pharmacokinetics of multiple CONCERTA 18 mg systems used to establish 18 mg, 36 mg, and 54 mg doses in 35 healthy subjects, 18 to 45 years old. The comparison of the dose-normalized area under the concentration-time curve from extrapolation to infinity (AUC_inf), maximum methylphenidate and α-phenyl-2-piperidine acetic acid plasma concentrations (C_max), and time to peak concentration (t_max) values of the regimens (1×18 mg, 2×18 mg, and 3×18 mg) demonstrated the dose-proportional pharmacokinetics of CONCERTA.

literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 22 January 2025.

No citations were identified pertaining to dose equivalency or conversion to CONCERTA from another non-methylphenidate stimulant medication.