Dosage & Administration
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Concerta Prescribing Information
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)].
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)] .
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)].
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)] .
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).
| 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 |
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.
| 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.
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.
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.
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."
Pregnancy
Pregnancy Category C
Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m 2basis, respectively.
A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of CONCERTA on a mg/kg and mg/m 2basis, respectively. The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of CONCERTA based on the AUC.
The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women. CONCERTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery
The effect of CONCERTA on labor and delivery in humans is unknown.
Nursing Mothers
It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if CONCERTA is administered to a nursing woman.
In lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma.
Pediatric Use
CONCERTA should not be used in children under six years, since safety and efficacy in this age group have not been established. Long-term effects of methylphenidate in children have not been well established.
Geriatric Use
CONCERTA has not been studied in patients greater than 65 years of age.
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)] .
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)] .