Focalin (Dexmethylphenidate Hydrochloride)
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Focalin (Dexmethylphenidate Hydrochloride)

Focalin®
(dexmethylphenidate hydrochloride) Tablets

DRUG DESCRIPTION

Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in three tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R')-(+)-. Its empirical formula is C14H19NO2•HCl. Its molecular weight is 269.77 and its structural formula is

Focalin® (dexmethylphenidate hydrochloride) Structural Formula Illustration

Note: * = asymmetric carbon centers

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.

Focalin also contains the following inert ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.

What are the possible side effects of dexmethylphenidate (Focalin, Focalin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:

  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior, confusion; or
  • twitching or tics.

Less...

Read All Potential Side Effects and See Pictures of Focalin »

What are the precautions when taking dexmethylphenidate hydrochloride (Focalin)?

Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis),...

Read All Potential Precautions of Focalin »

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Focalin in the treatment of ADHD was established in two controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD (see Clinical Studies).

A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause 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 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 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 patients with this syndrome. Stimulants are not intended for use in the patient 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 patient's symptoms.

Long-term Use

The effectiveness of Focalin for long-term use, i.e., for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Focalin for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Focalin is administered twice daily, at least 4 hours apart. Focalin may be administered with or without food.

Dosage should be individualized according to the needs and responses of the patient.

Patients New to Methylphenidate

The recommended starting dose of Focalin for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).

Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.

Patients Currently Using Methylphenidate

For patients currently using methylphenidate, the recommended starting dose of Focalin is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).

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. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Focalin for extended periods in patients with ADHD should periodically re-evaluate 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.

HOW SUPPLIED

Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face

2.5 mg Tablets - blue

Bottles of 100…………………………….NDC 0078-0380-05

5 mg Tablets - yellow

Bottles of 100…………………………….NDC 0078-0381-05

10 mg Tablets - white

Bottles of 100…………………………….NDC 0078-0382-05

Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F).

[see USP Controlled Room Temperature]

Protect from light and moisture.

REFERENCE

American Psychiatric Association. Diagnosis and Statistical Manual of Mental Disorders. 4th ed. Washington DC: American Psychiatric Association 1994.

Manufactured for: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. By: Mikart, Inc. Atlanta, GA 30318.

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The pre-marketing development program for Focalin included exposures in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects). These participants received Focalin 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in two controlled clinical studies, two clinical pharmacology studies, and two uncontrolled long-term safety studies. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, and results of physical examinations, vital sign and body weight measurements, and laboratory analyses.

Adverse events during exposure were primarily obtained by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings in Clinical Trials with Focalin

Adverse Events Associated with Discontinuation of Treatment

No Focalin-treated patients discontinued due to adverse events in two placebo-controlled trials. Overall, 50 of 684 children treated with Focalin (7.3%) experienced an adverse event that resulted in discontinuation. The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each).

Adverse Events Occurring at an Incidence of 5% or More Among Focalin-Treated Patients

Table 1 enumerates treatment-emergent adverse events for two, placebo-controlled, parallel group trials in children with ADHD at Focalin doses of 5, 10, and 20 mg/day. The table includes only those events that occurred in 5% or more of patients treated with Focalin where the incidence in patients treated with Focalin was at least twice the incidence in placebo-treated patients. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 1 : Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment in Clinical Trials of Focalin®

Body System Preferred Term Focalin
(n=79)
Placebo
(n=82)
Body as a Whole Abdominal Pain Fever 15% 6%
5% 1%
Digestive System Anorexia Nausea 6% 1%
9% 1%
1Events, regardless of causality, for which the incidence for patients treated with Focalin was at least 5% and twice the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number.

Adverse Events from Post-Marketing Experience

The following additional adverse reactions have been identified during postapproval use of Focalin XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

Adverse Events with Other Methylphenidate HCl Products

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other reactions include

Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia

Gastrointestinal: nausea

Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

Nervous System: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette's syndrome, toxic psychosis

Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood/lymphatic: leukopenia and/or anemia

Hepatobiliary: abnormal liver function, ranging from transaminase elevation to hepatic coma

Psychiatric: transient depressed mood, aggressive behavior

Skin/subcutaneous: scalp hair loss

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

Drug Abuse And Dependence

Controlled Substance Class

Focalin, like other methylphenidate products, is classified as a Schedule II controlled substance by Federal regulation.

Abuse, Dependence, and Tolerance

See WARNINGS for boxed warning containing drug abuse and dependence information.

Read the Focalin (dexmethylphenidate hydrochloride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Because of possible effects on blood pressure, Focalin should be used cautiously with pressor agents.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). 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 concomitant methylphenidate.

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Serious Cardiovascular Events

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.

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.

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.

Psychiatric Adverse Events

Pre-Existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

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.

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.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing 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.

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. 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.

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.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Use in Children Under 6 Years of Age

Focalin (dexmethylphenidate hydrochloride) should not be used in children under 6 years, since safety and efficacy in this age group have not been established.

Drug Dependence

Focalin (dexmethylphenidate hydrochloride) 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 drug 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.

PRECAUTIONS

Hematologic Monitoring

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

Information for Patients

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 (dexmethylphenidate hydrochloride) . 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.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Racemic methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.

In a 24-week study of racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60-74 mg/kg/day of racemic methylphenidate.

Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, the in vitro mouse lymphoma cell forward mutation assay, or the in vivo mouse bone marrow micronucleus test.

Racemic methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or the in vitro mouse lymphoma cell forward mutation assay, and was negative in vivo in the mouse bone marrow micronucleus assay. However, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay of racemic methylphenidate in cultured Chinese Hamster Ovary (CHO) cells.

Racemic methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses of up to 160 mg/kg/day.

Pregnancy

Pregnancy Category C

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 the maximum recommended human dose of 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.

Adequate and well-controlled studies in pregnant women have not been conducted. Focalin (dexmethylphenidate hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 (dexmethylphenidate hydrochloride) is administered to a nursing woman.

Pediatric Use

The safety and efficacy of Focalin (dexmethylphenidate hydrochloride) in children under 6 years old have not been established.Long-term effects of Focalin (dexmethylphenidate hydrochloride) in children have not been well established (see WARNINGS).

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/m² 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/m² basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the racemic MRHD on a mg/m² basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

Recommended Treatment

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.

Poison Control Center

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

CONTRAINDICATIONS

Agitation

Focalin is contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.

Hypersensitivity to Methylphenidate

Focalin is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. Hypersensitivity reactions, including angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate [see ADVERSE REACTIONS].

Glaucoma

Focalin is contraindicated in patients with glaucoma.

Tics

Focalin is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome (see ADVERSE REACTIONS).

Monoamine Oxidase Inhibitors

Focalin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Pharmacodynamics

Dexmethylphenidate hydrochloride is a central nervous system stimulant. Focalin, the more pharmacologically active enantiomer of the d-and l-enantiomers, 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.

Effects on QT Interval

The effect of Focalin® XR on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Focalin® XR 40mg in 75 healthy volunteers. ECGs were collected up to 12 h post-dose. Frederica's method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was < 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.

Pharmacokinetics

Absorption

Dexmethylphenidate hydrochloride is readily absorbed following oral administration of Focalin. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1½ hours post-dose. No differences in the pharmacokinetics of Focalin were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD.

When given to children as capsules in single doses of 2.5 mg, 5 mg, and 10 mg, Cmax and AUC0-inf of dexmethylphenidate were proportional to dose. In the same study, plasma dexmethylphenidate levels were comparable to those achieved following single dl-threo-methylphenidate HCl doses given as capsules in twice the total mg amount (equimolar with respect to Focalin).

Food Effects

In a single dose study conducted in adults, coadministration of 2 x 10 mg Focalin with a high fat breakfast resulted in a dexmethylphenidate tmax of 2.9 hours post-dose as compared to 1.5 hours post-dose when given in a fasting state. Cmax and AUC0-inf were comparable in both the fasted and non-fasted states.

Distribution

Plasma dexmethylphenidate concentrations in children decline exponentially following oral administration of Focalin.

Metabolism and Excretion

In humans, dexmethylphenidate is metabolized primarily to d-α-phenyl-piperidine acetic acid (also known as d-ritalinic acid) by de-esterification. This metabolite has little or no pharmacological activity. There is little or no in vivo interconversion to the l-threo-enantiomer, based on a finding of minute levels of l-threo-methylphenidate being detectable in a few samples in only 2 of 58 children and adults. After oral dosing of radiolabeled racemic methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was ritalinic acid, accountable for approximately 80% of the dose.

In vitro studies showed that dexmethylphenidate did not inhibit cytochrome P450 isoenzymes.

The mean plasma elimination half-life of dexmethylphenidate is approximately 2.2 hours.

Special Populations

Gender

Pharmacokinetic parameters were similar for boys and girls (mean age 10 years).

In a single dose study conducted in adults, the mean dexmethylphenidate AUC0-inf values (adjusted for body weight) following single 2 x 10 mg doses of Focalin were 25%-35% higher in adult female volunteers (n=6) compared to male volunteers (n=9). Both tmax and t½ were comparable for males and females.

Race

There is insufficient experience with the use of Focalin to detect ethnic variations in pharmacokinetics.

Age

The pharmacokinetics of dexmethylphenidate after Focalin administration have not been studied in children less than 6 years of age. When single doses of Focalin were given to children between the ages of 6 to 12 years and healthy adult volunteers, Cmax of dexmethylphenidate was similar, however, children showed somewhat lower AUCs compared to the adults.

Renal Insufficiency

There is no experience with the use of Focalin in patients with renal insufficiency. After oral administration of radiolabeled racemic methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid. Since very little unchanged drug is excreted in the urine, renal insufficiency is expected to have little effect on the pharmacokinetics of Focalin.

Hepatic Insufficiency

There is no experience with the use of Focalin in patients with hepatic insufficiency. (See DRUG INTERACTIONS.)

Clinical Studies

Focalin was evaluated in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients aged 6 to 17 years old with a DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). Both studies included all three subtypes of ADHD, i.e., Combined Type, Predominantly Inattentive Type, or Predominantly Hyperactive-Impulsive Type. While both children and adolescents were included, the sample was predominantly children, thus, the findings are most pertinent to this age group. In both studies, the primary comparison of interest was Focalin versus placebo.

Focalin (5, 10, or 20 mg/day total dose), dl-threo-methylphenidate HCl (10, 20, or 40 mg/day total dose), and placebo were compared in a multicenter, 4-week, parallel group study in n=132 patients. Patients took the study medication twice daily, 3.5 to 5.5 hours between doses. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose. The change from baseline to week 4 of the averaged score (an average of two ratings during the week) of the teacher's version of the SNAP-ADHD Rating Scale, a scale for assessing ADHD symptoms, was the primary outcome. Patients treated with Focalin showed a statistically significant improvement in symptom scores from baseline over patients who received placebo.

Figure 1 : Mean Change from Baseline in Teacher SNAP-ADHD Scores in a 4-week Double-Blind Placebo-Controlled Study of Focalin®*

Mean Change from Baseline in Teacher SNAP-ADHD Scores - Illustration

*Figure 1: Error bars represent the standard error of the mean.

The other study, involving n=75 patients, was a multicenter, placebo-controlled, double-blind, 2-week treatment withdrawal study in children who were responders during a 6-week, open label initial treatment period. Children took study medication twice a day separated by a 3.5 to 5.5 hour interval. The primary outcome was proportion of treatment failures at the end of the 2-week withdrawal phase, where treatment failure was defined as a rating of 6 (much worse) or 7 (very much worse) on the Investigator Clinical Global Impression - Improvement (CGI-I). Patients continued on Focalin showed a statistically significant lower rate of failure over patients who received placebo.

Figure 2 : Percent of Treatment Failures following a 2-week Double-Blind Placebo-Controlled Withdrawal of Focalin®

Percent of Treatment Failures following a 2-week Double-Blind Placebo-Controlled Withdrawal of Focalin - Illustration

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

MEDICATION GUIDE

FOCALIN®
(dexmethylphenidate hydrochloride tablets)

Read the Medication Guide that comes with FOCALIN® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with FOCALIN®.

What is the most important information I should know about FOCALIN®?

The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines.

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting FOCALIN®.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with FOCALIN®.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking FOCALIN®.

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking FOCALIN®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is FOCALIN®?

FOCALIN® is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). FOCALIN® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

FOCALIN® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

FOCALIN® is a federally controlled substance (CII) because it can be abused or lead to dependence. KeepFOCALIN® in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN® may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take FOCALIN®?

FOCALIN® should not be taken if you or your child:

  • are very anxious, tense, or agitated
  • have an eye problem called glaucoma
  • have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated
  • movements or sounds.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • are allergic to anything in FOCALIN®. See the end of this Medication Guide for a complete list of ingredients.

FOCALIN® should not be used in children less than 6 years old because it has not been studied in this age group.

FOCALIN® may not be right for you or your child. Before starting FOCALIN® tell your or your child's doctor about all health conditions (or a family history of) including:

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can FOCALIN® be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. FOCALIN® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking FOCALIN®.

Your doctor will decide whether FOCALIN® can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • anti-depression medicines including MAOIs
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking FOCALIN® without talking to your doctor first.

How should FOCALIN® be taken?

  • Take FOCALIN exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take FOCALIN® twice a day, at least 4 hours apart.
  • FOCALIN® can be taken with or without food.
  • From time to time, your doctor may stop FOCALIN® treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking FOCALIN®. Children should have their height and weight checked often while taking FOCALIN®. FOCALIN® treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much FOCALIN® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of FOCALIN®?

See “What is the most important information I should know about FOCALIN®?” for information on reported heart and mental problems.

Other serious side effects include:

Serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes

  • and hives, fever)
  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision

Common side effects include:

  • stomach ache
  • nausea
  • decreased appetite
  • fever

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store FOCALIN®?

  • Store FOCALIN® in a safe place at room temperature, 59 to 86° F (15 to 30° C).
  • Keep FOCALIN® and all medicines out of the reach of children.

General information about FOCALIN®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOCALIN® for a condition for which it was not prescribed. Do not give FOCALIN® to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about FOCALIN®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOCALIN® that was written for healthcare professionals. For more information about FOCALIN® call 1-888-669-6682.

What are the ingredients in FOCALIN®?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

MEDICATION GUIDE

FOCALIN®
(dexmethylphenidate hydrochloride tablets)

Read the Medication Guide that comes with FOCALIN® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with FOCALIN®.

What is the most important information I should know about FOCALIN®?

The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines.

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting FOCALIN®.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with FOCALIN®.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking FOCALIN®.

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking FOCALIN®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is FOCALIN®?

FOCALIN® is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). FOCALIN® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

FOCALIN® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

FOCALIN® is a federally controlled substance (CII) because it can be abused or lead to dependence. KeepFOCALIN® in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN® may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take FOCALIN®?

FOCALIN® should not be taken if you or your child:

  • are very anxious, tense, or agitated
  • have an eye problem called glaucoma
  • have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated
  • movements or sounds.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • are allergic to anything in FOCALIN®. See the end of this Medication Guide for a complete list of ingredients.

FOCALIN® should not be used in children less than 6 years old because it has not been studied in this age group.

FOCALIN® may not be right for you or your child. Before starting FOCALIN® tell your or your child's doctor about all health conditions (or a family history of) including:

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can FOCALIN® be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. FOCALIN® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking FOCALIN®.

Your doctor will decide whether FOCALIN® can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • anti-depression medicines including MAOIs
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking FOCALIN® without talking to your doctor first.

How should FOCALIN® be taken?

  • Take FOCALIN exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take FOCALIN® twice a day, at least 4 hours apart.
  • FOCALIN® can be taken with or without food.
  • From time to time, your doctor may stop FOCALIN® treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking FOCALIN®. Children should have their height and weight checked often while taking FOCALIN®. FOCALIN® treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much FOCALIN® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of FOCALIN®?

See “What is the most important information I should know about FOCALIN®?” for information on reported heart and mental problems.

Other serious side effects include:

Serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes

  • and hives, fever)
  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision

Common side effects include:

  • stomach ache
  • nausea
  • decreased appetite
  • fever

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store FOCALIN®?

  • Store FOCALIN® in a safe place at room temperature, 59 to 86° F (15 to 30° C).
  • Keep FOCALIN® and all medicines out of the reach of children.

General information about FOCALIN®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOCALIN® for a condition for which it was not prescribed. Do not give FOCALIN® to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about FOCALIN®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOCALIN® that was written for healthcare professionals. For more information about FOCALIN® call 1-888-669-6682.

What are the ingredients in FOCALIN®?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Focalin Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DEXMETHYLPHENIDATE - ORAL

(dex-METH-il-FEN-i-date)

COMMON BRAND NAME(S): Focalin

WARNING: Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

This medication can be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Before taking this medication, tell your doctor if you have abused or been dependent on drugs or alcohol. Do not increase your dose, take it more often, or take it for a longer time or in a different way than prescribed. Doing so may result in a decrease in the effect of this drug, drug dependence, or abnormal thoughts/behavior.

Your doctor may monitor you for a while after the medication is stopped, especially if you have taken this drug for a long time or in high doses. (See also How to Use section.)

USES: Dexmethylphenidate is used as part of a treatment program (including psychological, educational, and social measures) to treat attention deficit hyperactivity disorder - ADHD. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills. Dexmethylphenidate is a mild stimulant that is thought to work by changing the amounts of certain natural substances in the brain.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat a certain sleep disorder (narcolepsy).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking dexmethylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice a day with or without food. Take the first dose as soon as you wake up in the morning and the second dose at least 4 hours later, or take as directed by your doctor. Taking this medication late in the day may cause trouble sleeping (insomnia).

The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor. The total daily dose is usually 20 milligrams or less. Carefully follow your doctor's instructions.

Methylphenidate and dexmethylphenidate are different medications and do not provide the same amount of medicine. Do not switch between products unless your doctor tells you to.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Focalin Consumer (continued)

SIDE EFFECTS: Trouble sleeping, nervousness, nausea, stomach pain, headache, loss of appetite, weight loss, dizziness, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Focalin (dexmethylphenidate hydrochloride) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis), personal/family history of uncontrolled muscle movements (motor tics, Tourette's syndrome), overactive thyroid (hyperthyroidism), seizure disorder.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If used for a long time, this drug may affect a child's growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child's weight and height regularly, and consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Focalin Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before and during treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, agitation, confusion, sweating, flushing, muscle twitching, hallucinations, seizures, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (such as blood pressure, complete blood count, height/weight monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near bedtime or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised February 2012. Copyright(c) 2012 First Databank, Inc.

Focalin Patient Information Including Side Effects

Brand Names: Focalin, Focalin XR

Generic Name: dexmethylphenidate (Pronunciation: dex METH il FEN i date)

What is dexmethylphenidate (Focalin)?

Dexmethylphenidate is a mild stimulant to the central nervous system (brain and nerves).

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

Dexmethylphenidate may also be used for other purposes not listed in this medication guide.

Dexmethylphenidate 10 mg-TEV

round, white, imprinted with 93, 5277

Dexmethylphenidate 2.5 mg-TEV

round, blue, imprinted with 93, 5275

Dexmethylphenidate 5 mg-TEV

round, yellow, imprinted with 93, 5276

Focalin XR 40 mg

green/white, imprinted with NVR, D40

What are the possible side effects of dexmethylphenidate (Focalin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:

  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior, confusion; or
  • twitching or tics.

Less serious side effects may include:

  • sleep problems (insomnia);
  • loss of appetite;
  • upset stomach;
  • feeling restless, anxious, or jittery;
  • dry mouth, sore throat; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Focalin (dexmethylphenidate hydrochloride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about dexmethylphenidate (Focalin)?

Do not use dexmethylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dexmethylphenidate before the MAO inhibitor has cleared from your body.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have severe depression or a history of mental illness, seizures or epilepsy, high blood pressure, a history of drug or alcohol addiction, congestive heart failure, or if you have recently had a heart attack.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dexmethylphenidate may be habit-forming and should be used only by the person it was prescribed for. Dexmethylphenidate should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many pills have been used from each new bottle of this medicine. Dexmethylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Side Effects Centers

Focalin Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking dexmethylphenidate (Focalin)?

Do not use dexmethylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dexmethylphenidate before the MAO inhibitor has cleared from your body.

You should not take dexmethylphenidate if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta), or if you have:

  • glaucoma;
  • motor tics (twitches);
  • a personal or family history of Tourette's syndrome; or
  • if you have significant tension, agitation, or anxiety.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use dexmethylphenidate:

  • severe depression or a history of mental illness;
  • a history of drug or alcohol addiction;
  • seizures or epilepsy;
  • high blood pressure;
  • heart disease, heart rhythm problems, or congestive heart failure; or
  • if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether dexmethylphenidate is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether dexmethylphenidate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give this medication to a child younger than 6 years old.

Dexmethylphenidate may be habit-forming and should be used only by the person it was prescribed for. Dexmethylphenidate should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many pills have been used from each new bottle of this medicine. Dexmethylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

How should I take dexmethylphenidate (Focalin)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take this medicine with a full glass of water.

This medication is usually taken in the morning before breakfast. You may take it with or without food.

You may open the dexmethylphenidate capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store dexmethylphenidate at room temperature away from moisture and heat.

Side Effects Centers

Focalin Patient Information including If I Miss a Dose

What happens if I miss a dose (Focalin)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, or if it is already evening, skip the missed dose and take the medicine the next morning. Taking this medicine late in the day can cause sleep problems. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Focalin)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include dry mouth, sweating, headache, warmth or tingly feeling, vomiting, agitation, tremors, muscle twitches, confusion, hallucinations, fast or pounding heartbeats, large pupils, and seizure (convulsions).

What should I avoid while taking dexmethylphenidate (Focalin)?

Avoid taking dexmethylphenidate in the evening because it may cause sleep problems (insomnia).

Dexmethylphenidate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect dexmethylphenidate (Focalin)?

Before taking dexmethylphenidate, tell your doctor if you are using any of the following medicines:

  • antacids;
  • blood pressure medications;
  • a blood thinner such as warfarin (Coumadin);
  • clonidine (Catapres);
  • seizure medications such as phenytoin (Dilantin), phenobarbital (Luminal, Solfoton), primidone (Mysoline); or
  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and there may be other drugs that can interact with dexmethylphenidate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about dexmethylphenidate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Side Effects Centers

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