"The US Food and Drug Administration (FDA) has approved the amphetamine Dyanavel XR (Tris Pharma Inc), a once-daily extended-release oral liquid, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years "...
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social recredits. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
Need For Comprehensive Treatment Program
CONCERTA® is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
DOSAGE AND ADMINISTRATION
General Dosing Information
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 INFORMATION].
Patients New To Methylphenidate
The recommended starting dose of CONCERTAR® 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
|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 CONCERTAR® 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.
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.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with CONCERTAR®. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.
The effectiveness of CONCERTAR® for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use CONCERTAR® for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose Reduction And Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
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.”
CONCERTAR® (methylphenidate HCl) Extended-release Tablets are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. The 18 mg tablets are yellow and imprinted with “alza 18”. The 27 mg tablets are gray and imprinted with “alza 27”. The 36 mg tablets are white and imprinted with “alza 36”. The 54 mg tablets are brownish-red and imprinted with “alza 54”. All four dosage strengths are supplied in bottles containing 100 tablets.
18 mg 100-count bottle NDC 50458-585-01
27 mg 100-count bottle NDC 50458-588-01
36 mg 100-count bottle NDC 50458-586-01
54 mg 100-count bottle NDC 50458-587-01
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from humidity.
Manufactured by: Janssen-Cilag Manufacturing, LLC, Gurabo, Puerto Rico 00778 or Alza Corp. Vacaville, CA 95688. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Revised: April 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/6/2016
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