"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...
The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [see Clinical Studies].
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 2 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 6 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 6 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 Types 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 not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits 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 child's symptoms.
The effectiveness of Focalin XR for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Focalin XR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATION
Focalin XR is for oral administration once daily in the morning.
Focalin XR may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Focalin XR capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosage should be individualized according to the needs and responses of the patient.
Patients New To Methylphenidate
The recommended starting dose of Focalin XR for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.
Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose-related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.
Patients Currently Using Methylphenidate
For patients currently using methylphenidate, the recommended starting dose of Focalin XR is half the total daily dose of racemic methylphenidate. Patients currently using Focalin (dexmethylphenidate) may be switched to the same daily dose of Focalin XR.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Focalin XR. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Focalin XR for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods 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 1-month period, the drug should be discontinued.
Dosage Forms And Strengths
5 mg extended-release capsules
10 mg extended-release capsules
15 mg extended-release capsules
20 mg extended-release capsules
25 mg extended-release capsules
30 mg extended-release capsules
35 mg extended-release capsules
40 mg extended-release capsules
Storage And Handling
5 mg Extended-Release Capsules (NDC 0078-0430-05) light-blue, (imprinted NVR D5) supplied in bottles of 100
10 mg Extended-Release Capsules (NDC 0078-0431-05) light caramel (imprinted NVR D10) supplied in bottles of 100
15 mg Extended-Release Capsules (NDC 0078-0493-05) green (imprinted NVR D15) supplied in bottles of 100
20 mg Extended-Release Capsules (NDC 0078-0432-05) white (imprinted NVR D20) supplied in bottles of 100
25 mg Extended-Release Capsules (NDC 0078-0608-05) light-blue and white (imprinted NVR D25) supplied in bottles of 100
30 mg Extended-Release Capsules (NDC 0078-0433-05) light caramel and white (imprinted NVR D30) supplied in bottles of 100
35 mg Extended-Release Capsules (NDC 0078-0609-05) light-blue and light caramel (imprinted NVR D35) supplied in bottles of 100
40 mg Extended-Release Capsules (NDC 0078-0434-05) green and white (imprinted NVR D40) supplied in bottles of 100
Store FOCALIN XR at 25°C (77°F), excursions permitted 15°–30°C (59°–86°F). [See USP Controlled Room Temperature.]
Dispense in tight container (USP).
Manufactured for Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. By Alkermes Gainesville LLC Gainesville, GA 30504. Revised: December 2013
Last reviewed on RxList: 5/21/2015
This monograph has been modified to include the generic and brand name in many instances.
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