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Concerta360 Dosing Introduction

Welcome. I’m here to walk you through this interactive tool, which will help you understand how to optimize the effect of CONCERTA by optimizing the dose.

CONCERTA offers effective ADHD symptom management with minimal side effects in a once-daily dosing regimen. This tool allows you to create CONCERTA dosing scenarios for your pediatric and adult ADHD patients to find the optimal dose for each patient.

Your assessment of efficacy and tolerability through the use of this tool will help you determine the optimal dose of CONCERTA to provide a smooth effect. To reach this optimal dose, you may need to titrate CONCERTA, which may be done weekly to achieve the optimal effect.

Now, if you’ve been here before, you may want to click the Hide Video button and proceed with using the tool on your own. Let's get started.

Choosing a Dose

First decide whether you’ll make selections within the tool based on your observations of CONCERTA in an actual patient, or whether you’ll make your selections based on a theoretical patient scenario.

Feel free to use the tool to walk through as many patient scenarios as you wish. Simply click the Reset button to clear the selections and reset the tool.

At any time, you may click the Titration button to understand the immediate release amount of methylphenidate associated with each dose of CONCERTA. Or, you may click the Dosing button to understand the most common doses of CONCERTA used in clinical trials.

Let’s begin by selecting a dose of CONCERTA. The CONCERTA dosing options are 18mg, 27mg, 36mg, 45mg, 54mg, 63mg, and 72mg.

18 mg is the recommended starting dose for children and adolescents; and 18 mg or 36 mg are the recommended starting doses for adults not currently receiving methylphenidate.

For patients converting from other methylphenidate regimens, consult the dosage and administration section in the full Prescribing Information. If you have additional questions about dosages when converting a patient, click the Dose Conversion button for help in understanding how to convert methylphenidate doses to CONCERTA.

Begin by clicking on a dosage.

Titrate Up to Next Dose

Based on the selections you’ve made, the recommendation is to titrate up to the next dose.

The best dose of medication should produce an optimal effect with minimal side effects. Titrating up to the next dose may help you reach the optimal effect and lead to more successful ADHD treatment.

You may wish to use the tool to re-assess the efficacy and tolerability of the next highest dose.

Step Down to a Lower Dose

Based on the selections you’ve made, the recommendation is to step down to a lower dose.

The best dose of medication should produce an optimal effect with minimal side effects; and in this scenario, the side effects are not tolerable for the patient.

You may wish to use the tool to re-assess the efficacy and tolerability of the next lowest dose.

Titration Complete

Based on the selections you’ve made, you have completed titration.

When titrated to the proper dose, CONCERTA offers effective ADHD symptom management. The best dose of medication should produce an optimal effect with minimal side effects.

You may re-visit this interactive tool at any time. It is designed to help you understand different CONCERTA dosing scenarios for your pediatric and adult ADHD patients.

Re-evaulate Treatment

Based on the selections you’ve made, the recommendation is to re-evaluate treatment.

CONCERTA is approved for the treatment of ADHD in children, adolescents and adults as part of a total treatment program that may include counseling or other therapies.

If a patient responds poorly to treatment, then a further evaluation may be necessary to assess additional treatment options or to look for co-existing conditions.

Discontinue Treatment

Based on the selections you’ve made, the recommendation is to discontinue the use of CONCERTA.

Although approved for the treatment of ADHD in children, adolescents and adults, CONCERTA is not right for everyone.

If a patient responds poorly to treatment, then a further evaluation may be necessary to assess other additional treatment options or to look for co-existing conditions.

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Optimizing CONCERTA®: Prescribe the dose that makes the difference

  • Start with 18 mg qd in children/adolescent patients, and start with 18–36 mg in adult patients not currently receiving methylphenidate
  • CONCERTA® may be titrated weekly based on the immediate-release dose desired, assessing clinical response and tolerability

* Current starting dose for children and adolescents, and option for adults.

†Newly approved starting dose option for adults.

‡In patients aged 13 to 65 years; not to exceed 2 mg/kg/d in patients aged 13-17 years.

Dose conversion: Converting your patients to CONCERTA®

For children aged 6-12 currently on methylphenidate products, the initial conversion doses should not exceed 54 mg qd; after conversion, in patients aged 13-65, dosages may be adjusted to a maximum of 72 mg/d, not to exceed 2 mg/kg/d in patients aged 13-17 years.


Based on current dose regimen and clinical judgement

CONCERTA® tablets must be swallowed whole and must not be chewed, divided, or crushed.

CONCERTA® may be taken with or without food. Tablets shown not actual size.


References: 1. American Academy of Pediatrics, Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:1033-1044 2. Pliszka S, AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46:894-921. 3. Swanson J, Gupta S, Lam A, et al. Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies. Arch Gen Psychiatry. 2003;60:204-211. 4. Data on file (CON005), ALZA Corporation. 5. Pelham WE, Gnagy EM, Burrows-Maclean L, et al. Once-a-day Concerta methylphenidate versus three-times daily methylphenidate in laboratory natural settings. Pediatrics. 2001;107(6). Available at: http://www.pediatrics.org/cgi/content/full/107/6/e105. 6. Wilens TE, McBurnett K, Bukstein O, et al. Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2006;160:82-90

CONCERTA® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

IMPORTANT SAFETY INFORMATION

CONCERTA® should not be taken by patients with: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; Tourette's syndrome, tics, or family history of Tourette's syndrome; current or recent use of monoamine oxidase inhibitors (MAOIs). Children under 6 years of age should not take CONCERTA.®

Abuse of methylphenidate may lead to dependence. CONCERTA® should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, other serious cardiac problems, or patients with pre-existing severe gastrointestinal narrowing. Use with caution in patients with hypertension and other cardiovascular conditions, psychosis, bipolar disorder, and history of seizures/EEG abnormalities. Stimulants may cause new psychotic or manic symptoms; discontinuation of treatment may be appropriate. Aggressive behavior or hostility should be monitored in patients beginning ADHD treatment. Methylphenidate may produce difficulties with visual accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy. Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

The most common adverse reaction (>5%) reported in children and adolescents was abdominal pain upper. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Please see full U.S. Prescribing Information

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2010. All rights reserved. Your use of the information on this site is subject to the terms of our Legal Notice. Please see our Privacy Policy. This site is published by McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. which is solely responsible for its contents.

This information is intended for the use of our customers and healthcare professionals in the United States and Puerto Rico only. McNeil Pediatrics™ recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may be not be appropriate for use outside the United States and Puerto Rico.

CONCERTA® and OROS® are registered trademarks of ALZA Corporation © Ortho-McNeil-Janssen Pharmaceuticals, Inc. Titusville, NJ, USA. All rights reserved.

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Last Modified Date: Jun 15 2010 at 16:01:16 EDT