DRUG INTERACTIONS
7 Focalin XR should not be used in patients being treated (currently or within the preceding two weeks) with MAO Inhibitors [ see Contraindications (4.
5 ) ].
Because of possible effects on blood pressure, Focalin XR should be used cautiously with pressor agents.
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Dexmethylphenidate is metabolized primarily to d -ritalinic acid by de-esterification and not through oxidative pathways.
The effects of gastrointestinal pH alterations on the absorption of dexmethylphenidate from Focalin XR have not been studied.
Since the modified release characteristics of Focalin XR are pH dependent, the coadministration of antacids or acid suppressants could alter the release of dexmethylphenidate.
Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine).
Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate.
It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.
Focalin XR should not be used in patients being treated (currently or within the preceding two weeks) with MAO Inhibitors (4.5) Focalin XR should be used cautiously with pressor agents (7) Antacids or acid suppressants could alter the release of Focalin XR (7) Racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants, and tricyclic drugs (7)
OVERDOSAGE
10 10.1 Signs and Symptoms Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
10.2 Poison Control Center The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.
10.3 Recommended Treatment As with the management of all overdosage, the possibility of multiple drug ingestion should be considered.
When treating overdose, practitioners should bear in mind that there is a prolonged release of dexmethylphenidate from Focalin XR.
Treatment consists of appropriate supportive measures.
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present.
Gastric contents may be evacuated by gastric lavage as indicated.
Before performing gastric lavage, control agitation and seizures if present and protect the airway.
Other measures to detoxify the gut include administration of activated charcoal and a cathartic.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis for Focalin overdosage has not been established.
DESCRIPTION
11 Focalin XR 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 is available as 5, 10, 15, 20, 30, and 40 mg extended-release capsules.
Focalin XR 5, 10, 15, 20, 30, and 40 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, 7.5, 10, 15 or 20 mg of Focalin given b.i.d.
as tablets.
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 C 14 H 19 NO 2 •HCl.
Its molecular weight is 269.77 and its structural formula is Note* = asymmetric carbon center Dexmethylphenidate hydrochloride is a white to off white powder.
Its solutions are acid to litmus.
It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Inactive ingredients: ammonio methacrylate copolymer, FD&C Blue #2 (5 mg, 15 mg and 40 mg strengths), FDA/E172 yellow iron oxide (10 mg, 15 mg, 30, and 40 mg strengths), gelatin, ink Tan SW-8010, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate.
Dexmethylphenidate hydrochloride structural formula.
CLINICAL STUDIES
14 The effectiveness of Focalin XR in the treatment of ADHD was established in randomized, double-blind, placebo-controlled studies in children and adolescents and in adults who met Diagnostic and Statistical Manual 4 th edition (DSM-IV) criteria for ADHD [ see Indications and Usage (1) ].
14.1 Children and Adolescents The effectiveness of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 103 pediatric patients (ages 6 to 12, n=86; ages 13 to 17, n=17) who met DSM-IV criteria for ADHD.
Patients were randomized to receive either a flexible dose of Focalin XR (5 to 30 mg/day) or placebo once daily for 7 weeks.
During the first 5 weeks of treatment patients were titrated to their optimal dose and in the last 2 weeks of the study patients remained on their optimal dose without dose changes or interruption.
Signs and symptoms of ADHD were evaluated by comparing the mean change from baseline to endpoint for Focalin XR– and placebo-treated patients using an intent-to-treat analysis of the primary efficacy outcome measure, the DSM-IV total subscale score of the Conners ADHD/DSM-IV Scales for teachers (CADS-T).
There was a statistically significant treatment effect in favor of Focalin XR.
There were insufficient adolescents enrolled in this study to assess the efficacy for Focalin XR in the adolescent population.
However, pharmacokinetic considerations and evidence of effectiveness of immediate-release Focalin in adolescents support the effectiveness of Focalin XR in this population.
In two additional studies in pediatric patients aged 6-12 years who received 20 mg Focalin XR or placebo in a cross-over design, Focalin XR was found to have a statistically significant treatment effect versus placebo on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) rating scale combined score at all time points after dosing in each study (0.5, 1, 3, 4, 5, 7, 9, 10, 11 and 12 hours in one study and 1, 2, 4, 6, 8, 9, 10, 11 and 12 hours in the other study).
A treatment effect was also observed 0.5 hours after administration of Focalin XR 20 mg in an additional study of ADHD patients aged 6-12 years.
The SKAMP is a reliable and validated scale that assesses specific classroom behaviors related to attention (e.g., getting started, sticking with activities, completing work, and stopping for transition) and deportment or behavior (e.g., remaining quiet, remaining seated, interacting with other students, and interacting with the teacher.) Each item is rated on a 7-point impairment scale, and an average rating per item is calculated for the subscales of Attention and Deportment.
14.2 Adults The effectiveness of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 221 adult patients (ages 18 to 60) who met DSM-IV criteria for ADHD.
Patients were randomized to receive either a fixed dose of Focalin XR (20, 30, or 40 mg/day) or placebo once daily for 5 weeks.
Patients randomized to Focalin XR were initiated on a 10 mg/day starting dose and titrated in increments of 10 mg/week to the randomly assigned fixed dose.
Patients were maintained on their fixed dose (20, 30 or 40 mg/day) for a minimum of 2 weeks.
Signs and symptoms of ADHD were evaluated by comparing the mean change from baseline to endpoint for Focalin XR– and placebo-treated patients using an intent-to-treat analysis of the primary efficacy outcome measure, the investigator-administered DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS).
All three Focalin XR doses were statistically significantly superior to placebo.
There was no obvious increase in effectiveness with increasing dose.
HOW SUPPLIED
16 /STORAGE AND HANDLING 5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in Bottles of 10 NDC 54868-5681-1 Bottles of 30 NDC 54868-5681-0 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in Bottles of 10 NDC 54868-5682-1 Bottles of 30 NDC 54868-5682-0 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in Bottles of 10 NDC 54868-5683-1 Bottles of 30 NDC 54868-5683-0 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Bottles of 10 NDC 54868-5684-1 Bottles of 30 NDC 54868-5684-0 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).
GERIATRIC USE
8.5 Geriatric Use Focalin XR has not been studied in the geriatric population.
DOSAGE FORMS AND STRENGTHS
3 5 mg extended-release capsules 10 mg extended-release capsules 15 mg extended-release capsules 20 mg extended-release capsules 30 mg extended-release capsules 40 mg extended-release capsules Extended-release capsules: 5, 10, 15, 20, 30, and 40 mg
MECHANISM OF ACTION
12.1 Mechanism of Action Dexmethylphenidate hydrochloride, the active ingredient in Focalin XR, is a central nervous system stimulant.
Dexmethylphenidate, the more pharmacologically active d -enantiomer of racemic methylphenidate, is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known.
INDICATIONS AND USAGE
1 Focalin XR 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 (14) ].
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 a nd Administration (2.3) ].
Focalin XR is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older (1)
PEDIATRIC USE
8.4 Pediatric Use The safety and efficacy of Focalin XR in children under 6 years old have not been established.
Long-term effects of Focalin in children have not been well established [ see Warnings and Precautions (5.11) ].
In a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10).
When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of racemic methylphenidate on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the racemic MRHD on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the racemic MRHD on a mg/m 2 basis).
The clinical significance of the long-term behavioral effects observed in rats is unknown.
PREGNANCY
8.1 Pregnancy Pregnancy Category C: There are no adequate and well controlled studies of Focalin in pregnant women.
Dexmethylphenidate did not cause major malformations in rats or rabbits; however, it did cause delayed skeletal ossification and decreased postweaning weight gain in rats.
Focalin XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis.
No evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats.
When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed.
At the highest doses tested, plasma levels (AUCs) of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with 20 mg/day.
Racemic methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.
NUSRING MOTHERS
8.3 Nursing Mothers It is not known whether dexmethylphenidate is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised if Focalin XR is administered to a nursing woman.
Information from 4 published case reports on the use of racemic methylphenidate during breastfeeding suggest that at maternal doses of 35-80 mg/day, milk concentrations of methylphenidate range from undetectable to 15.4 ng/mL.
Based on these limited data, the calculated infant daily dose for an exclusively breastfed infant would be about 0.4 – 2.9 µg/kg/day or about 0.2-0.7% of the maternal weight adjusted dose.
BOXED WARNING
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.
WARNING: D RUG DEPENDENCE See full prescribing i nformation for complete boxed warning 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 .
WARNING AND CAUTIONS
5 WARNINGS AND PRECAUTIONS Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD.
Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
(5.1) Increased Blood Pressure and Heart Rate: have been reported.
Monitor patients for changes in blood pressure and heart rate.
Caution should be exercised in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate (5.2) Assess Cardiovascular Status: prior to stimulant treatment, assess for cardiac disease with history and exam and, if suggested by findings, conduct further cardiac evaluation.
Patients with emerging symptoms suggestive of cardiac disease should undergo a prompt cardiac evaluation (5.3) Psychotic Symptoms: may be exacerbated in patients with psychotic disorders (5.4) Bipolar Disorder: Use with particular care in ADHD patients with comorbid Bipolar Disorder.
Before initiating stimulant therapy, obtain a detailed psychiatric history for patients with comorbid depressive symptoms, in order to determine risk for Bipolar Disorder.
(5.5) Emergence of New Psychotic or Manic Symptoms: Treatment-emergent psychotic or manic symptoms without a prior history can be caused by stimulants at usual doses.
Discontinuation of stimulant therapy may be indicated (5.6) Aggression: Monitor for appearance of or worsening of aggressive behavior or hostility (5.7) Long-Term Suppression of Growth: monitor height and weight in pediatric patients at appropriate intervals.
Patients who are not growing or gaining weight as expected may need to have their treatment interrupted (5.8) Seizures: The threshold for seizures may be lowered.
In the presence of seizure, discontinue treatment.
(5.9) Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment (5.10) Hematologic Monitoring: periodic monitoring of CBC with differential is advised during prolonged therapy (5.12) 5.1 Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD.
Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
Adults with such abnormalities should also generally not be treated with stimulant drugs.
5.2 Hypertension and other Cardiovascular Conditions Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases.
While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure.
Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.
5.3 Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram).
Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
5.4 Pre-Existing Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
5.5 Bipolar Illness Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients.
Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
5.6 Emergence of New Psychotic or Manic Symptoms Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses.
If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate.
In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
5.7 Aggression Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the post marketing experience of some medications indicated for the treatment of ADHD.
Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
5.8 Long-Term Suppression of Growth Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
In the 7-week double-blind placebo-controlled study of Focalin XR, the mean weight gain was greater for patients receiving placebo (+0.4 kg) than for patients receiving Focalin XR (-0.5 kg).
Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well.
Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
5.9 Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures.
In the presence of seizures, the drug should be discontinued.
5.10 Visual Disturbance Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
5.11 Use in Children Under Six Years of Age Focalin XR should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established.
5.12 Hematologic Monitoring Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
INFORMATION FOR PATIENTS
17 PATIENT COUNSELING INFORMATION Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with dexmethylphenidate and should counsel them in its appropriate use.
A patient Medication Guide is available for Focalin XR.
The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.
Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
The complete text of the Medication Guide is reprinted at the end of this document.
DOSAGE AND ADMINISTRATION
2 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 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.
Focalin XR is intended for oral administration once daily in the morning.
Focalin XR capsules may be swallowed whole, or capsule contents can be sprinkled on applesauce.
Focalin XR and/or their contents should not be crushed, chewed, or divided (2) For patients new to methylphenidate: Begin treatment with Focalin XR at 5 mg/day for pediatrics and 10 mg/day for adults, titrating the dose weekly in 5 mg increments for pediatrics and in 10 mg increments for adults.
Doses above 30 mg/day in children and 40 mg/day in adults have not been studied.
(2.1) For patients already using methylphenidate: Initiate Focalin XR therapy with half (1/2) the current total daily dose of methylphenidate.
(2.2) Patients already using Focalin (dexmethylphenidate) immediate release: switch to the same daily dose of Focalin XR.
(2.2) 2.1 Patients N ew 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.
2.2 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.
2.3 Maintenance/Extended Treatment 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.
2.4 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.