CONCERTA

CONCERTA- methylphenidate hydrochloride tablet, extended release
Janssen Pharmaceuticals, Inc.

WARNING: ABUSE, MISUSE, AND ADDICTION

CONCERTA has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including CONCERTA, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing CONCERTA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout CONCERTA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1)and Drug Abuse and Dependence (9.2)].

1 INDICATIONS AND USAGE

CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)] .

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to treating patients with CONCERTA, assess:

  • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].
  • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating CONCERTA [see Warnings and Precautions (5.13)].

2.2 Recommended Dosage

CONCERTA should be administered orally once daily in the morning with or without food.

CONCERTA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17)] .

2.3 Patients New to Methylphenidate

The recommended starting dose of CONCERTA for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).

Table 1. CONCERTA Recommended Starting Doses and Dose Ranges
Patient Age Recommended Starting Dose Dose Range
Children 6–12 years of age 18 mg/day 18 mg – 54 mg/day
Adolescents 13–17 years of age 18 mg/day 18 mg – 72 mg/day not to exceed 2 mg/kg/day
Adults 18–65 years of age 18 or 36 mg/day 18 mg – 72 mg/day

2.4 Patients Currently Using Methylphenidate

The recommended dose of CONCERTA for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.

Table 2. Recommended Dose Conversion from Methylphenidate Regimens to CONCERTA
Previous Methylphenidate Daily Dose Recommended CONCERTA ® Starting Dose
5 mg Methylphenidate twice daily or three times daily 18 mg every morning
10 mg Methylphenidate twice daily or three times daily 36 mg every morning
15 mg Methylphenidate twice daily or three times daily 54 mg every morning
20 mg Methylphenidate twice daily or three times daily 72 mg every morning

Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.

2.5 Dose Titration

Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.

A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.

2.6 Dosage Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue CONCERTA.

If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue CONCERTA.

3 DOSAGE FORMS AND STRENGTHS

CONCERTA (methylphenidate HCl) Extended-Release Tablets are available in the following dosage strengths: 18 mg tablets are yellow and imprinted with “alza 18,” 27 mg tablets are gray and imprinted with “alza 27,” 36 mg tablets are white and imprinted with “alza 36,” and 54 mg tablets are brownish-red and imprinted with “alza 54.”

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Methylphenidate

Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with CONCERTA. Therefore, CONCERTA is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see Adverse Reactions (6.5)] .

4.2 Monoamine Oxidase Inhibitors

CONCERTA is contraindicated during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a MAO inhibitor (hypertensive crises may result) [see Drug Interactions (7.1)] .

5 WARNINGS AND PRECAUTIONS

5.1 Abuse, Misuse, and Addiction

CONCERTA has a high potential for abuse and misuse. The use of CONCERTA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. CONCERTA can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)] . Misuse and abuse of CNS stimulants, including CONCERTA, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing CONCERTA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA to anyone else. Throughout CONCERTA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

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