WARNING: DRUG DEPENDENCE
Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
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FOCALIN XR SUMMARY
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Focalin™ XR (dexmethylphenidate hydrochloride) extended-release capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin™ XR uses the proprietary SODAS® (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a second delayed release of dexmethylphenidate. Focalin XR 5, 10, and 20 mg capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, or 10 mg of Focalin™ tablets given b. i. d. Dexmethylphenidate hydrochloride, the d-threo enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant. Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its empirical formula is C14H19NO2•HCl.
Focalin™ XR (dexmethylphenidate hydrochloride) extended-release capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in two 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 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 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.
Long-Term Use
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).
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NEWS HIGHLIGHTS
Published Studies Related to Focalin XR (Dexmethylphenidate)
Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD. [2009.03]
CONCLUSION: Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD.
Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. [2008.05]
BACKGROUND: Fatigue is a common complaint in patients with sarcoidosis. We studied the effectiveness of dexmethylphenidate hydrochloride (d-MPH) in treating sarcoidosis-associated fatigue... CONCLUSIONS: Treatment with d-MPH was associated with a significant improvement in sarcoidosis-associated fatigue. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00361387.
Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of Sarcoidosis Associated Fatigue. [2008.02.08]
Background Fatigue is a common complaint in sarcoidosis... Conclusions Treatment with d-MPH was associated with a significant improvement in sarcoidosis associated fatigue.
Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethyl-phenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man. [2007.12]
OBJECTIVE: The d-isomer of methylphenidate (d-MPH) is the pharmacologically active part of the racemic mixture of methylphenidate (d,l-MPH), which has been used for decades in the treatment of attention-deficit/hyperactivity disorder (ADHD). A modified release formulation with bimodal release for the pure d-enantiomer (Focalin XR) has been developed to enable a fast onset of action and a sustained activity for once-daily administration. It was intended to achieve a bimodal concentration-time profile as observed after administration of two immediate release Focalin tablets. The pharmacokinetics of this d-MPH bimodal release formulation were compared with a d-MPH immediate release formulation and a similar bimodal release formulation of d,l-MPH in healthy adult volunteers... CONCLUSIONS: In summary, the 20 mg extended (bimodal) release formulation of d-MPH (Focalin XR) demonstrated a bimodal concentration-time profile and was bioequivalent to two 10 mg doses of immediate release d-MPH (Focalin) and was bioequivalent to 40 mg extended (bimodal) release d,l-MPH (Ritalin LA).
Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. [2006.07]
CONCLUSIONS: Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents.
Clinical Trials Related to Focalin XR (Dexmethylphenidate)
Study of Dopamine Transporter Receptor Occupancy With Long-Acting Dex-Methylphenidate [Active, not recruiting]
The objectives of this study are to document the pharmacokinetics of the adequacy of DAT
receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET
scanning with C-11 Altropane as the ligand across a range of times. It has been estimated
that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has
been shown to be clinically effective in an analog classroom as early as 1 hour and as late
as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate
(50% or greater) at time periods corresponding to the times of clinical efficacy.
The first objective is to examine the onset of action by testing whether average DAT
occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20
mg, 30 mg, 40 mg).
The second objective is to test the adequacy of average DAT occupancy in a range of later
times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has
been shown to be clinically effective in an analogue classroom study. A range of times have
been chosen since, while effective at 12 hours, the degree of clinical effectiveness
decreased with later time periods. The adequacy of DAT occupancy across this range of time
periods will provide important details on the in vivo molecular action of the medicine at
periods of critical clinical activity.
The third exploratory objective is to examine a time period later then those previously
tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been
tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were
to be effective at 14 hours it would be more likely at the highest dose.
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients [Completed]
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder [Completed]
The purpose of this study is to determine which dosages of dexmethylphenidate HCl
extended-release capsules may represent effective treatment for ADHD in children 6-12 years
of age.
Efficacy and Safety of Dex-Methylphenidate Extended Release 20 mg Versus Placebo in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting [Completed]
This study will confirm the efficacy of dex-methylphenidate extended release 20 mg versus
placebo during an 8-hour laboratory classroom day.
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD [Completed]
The purpose of this study is to compare the safety and efficacy of two doses of
dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD
(MPH) and placebo in children ages 6-12 diagnosed with ADHD.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Focalin XR has an overall score of 7. The effectiveness score is 8 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Focalin XR review by 25 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | ADHD |
| Dosage & duration: | | 5mg taken 1/day for the period of 2 yrs |
| Other conditions: | | OCD |
| Other drugs taken: | | Allegra | | |
Reported Results |
| Benefits: | | Focalin XR reduced the severity of ADHD symptoms. It increased attention and reduced fidgeting. Also noticed an increased productivity at work and better interpersonal interactions. Additionally, the XR formulation is easier to take properly because it only has to be taken once a day, versus 3 - 4 times a day for the non extended release formula. |
| Side effects: | | The main side effects experienced included loss of appetite and increased anxiety, especially towards the end of the drug's effectiveness period (about 8 hours). This is an improvement over short-acting Focalin where these side effect was experienced up to 3xs a day. I did not experience any other side effects. |
| Comments: | | Diagnosed with ADHD at 17. On some form of Ritalin since 17. Ritalin had too many side effects so used Focalin. Unfortunately Focalin short-acting required me to remember to take it 3xs a day, and I have ADHD, so the extended release was a much better fit. |
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Page last updated: 2009-10-20
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