Dexmethylphenidate Hydrochloride

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

The efficacy of Focalin in the treatment of ADHD was established in 2 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 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go,” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined 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).

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 By: Mikart, Inc. Atlanta, GA 30318. Revised: Jan 2017

The premarketing 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 2 controlled clinical studies, 2 clinical pharmacology studies, and 2 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

No Focalin-treated patients discontinued due to adverse events in 2 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).

Table 1 enumerates treatment-emergent adverse events for 2, 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

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:

Musculoskeletal: rhabdomyolysis

Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

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, serotonin syndrome in combination with serotonergic drugs, 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 severe hepatic injury

Psychiatric: transient depressed mood, aggressive behavior, libido changes

Skin/subcutaneous: scalp hair loss

Urogenital System: priapism

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 10-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.

Read the entire FDA prescribing information for Focalin (Dexmethylphenidate Hydrochloride)

Do not use dexmethylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before using this medication, tell your doctor if you have severe depression, seizures or epilepsy, high blood pressure, heart disease, a heart rhythm disorder, congestive heart failure, if you have recently had a heart attack, or if you have a history of mental illness or drug/alcohol addiction.

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 for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Keep track of the amount of medicine used from each new bottle. Dexmethylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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.

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• ADHD Medication for Children
• ADHD Medications for Adults

Contraindications

• Marked anxiety, tension, and agitation.1 4

• Glaucoma.1 4

• Motor tics or a family history or a diagnosis of Tourette’s syndrome.1 3 4 However, the AAP states that the presence of tics before or during medical management of ADHD is not an absolute contraindication to stimulant drug use.3

• Concomitant or recent (within 14 days) administration of MAO inhibitors.1 4 (See MAO Inhibitors under Interactions.)

• Known hypersensitivity to dexmethylphenidate, methylphenidate, or any ingredient in the formulation.1 4

Warnings/Precautions

Warnings

Dexmethylphenidate shares the toxic potentials of racemic methylphenidate; observe the usual precautions of racemic methylphenidate therapy.1 4

Potential for abuse and dependence.1 4 (See Boxed Warning.)

Use with caution in patients with a history of drug or alcohol dependence.1 4 5 Caution may be indicated in patients with comorbid conduct disorder or a chaotic family.5 If the risk of drug abuse by the patient or the patient’s peers or family is considered high, a nonstimulant drug may be preferable.5

Severe depression may occur during withdrawal from abusive use; careful supervision required.1 4

Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder; follow-up may be required.1 4

Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.1 4

Although an initial epidemiologic study showed an association between use of stimulants and sudden unexplained death in healthy children and adolescents,8 9 10 several subsequent large epidemiologic studies in children and young adults or in adults 25–64 years of age found no association between ADHD drug use (stimulants, atomoxetine, pemoline [no longer commercially available in US]) and serious cardiovascular events (MI, stroke, sudden cardiac death), although small increases in cardiovascular risk could not be excluded.13 14 15 16

No clinically important changes in corrected QT (QTc) interval observed in healthy individuals following 40-mg dose of extended-release dexmethylphenidate hydrochloride.1 4

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).1 4

In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.1 4 13 14

Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.1 4

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.1 4 Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.1 4 13 14

Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).1 4 13 14

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.1 4

Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.1 4 If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 4

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.1 4 Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).1 4

Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.1 4 If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 4

Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.1 4 No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.1 4

Long-term (i.e., >14 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 4

Manufacturer recommends monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.1 4 However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.3

Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.1 4 If seizures occur, discontinue therapy.1 4

Prolonged and painful erections, in some cases requiring surgical intervention, reported in adult and pediatric patients receiving methylphenidate.1 4 12 Priapism often reported following increase in dosage; also has occurred during temporary interruptions in therapy (e.g., drug holidays) or following drug discontinuance.1 4 12 Risk of permanent penile damage if not treated immediately.12 (See Advice to Patients.)

FDA states clinicians should be cautious if they consider switching patients from methylphenidate because of this risk; certain alternative ADHD treatments (e.g., atomoxetine) also may cause priapism.12

Peripheral vascular disorders, including Raynaud's phenomenon, reported in patients in all age groups receiving stimulants at therapeutic dosages and at various times throughout treatment course.1 4 Manifestations usually intermittent and mild, but ulceration of digits and/or breakdown of soft tissue occur rarely.1 4 Carefully observe for digital changes.1 4

Improvement generally observed following dosage reduction or drug discontinuance; however, some patients may require further evaluation (e.g., referral to a rheumatologist).1 4

Visual disturbances (difficulty with accommodation, blurred vision) reported with stimulants.1 4

Sensitivity Reactions

Hypersensitivity reactions, including angioedema and anaphylaxis, reported.1 4

General Precautions

Manufacturer recommends periodic monitoring of CBC (with differential) and platelet counts during prolonged therapy;1 4 however, AAP and many clinicians consider routine hematologic monitoring unnecessary in patients receiving recommended stimulants (e.g., methylphenidate, amphetamines) in the absence of clinical signs (e.g., fever, sore throat, unusual bleeding or bruising) suggestive of hematologic toxicity.3

Specific Populations

Category C.1 4

Not known whether dexmethylphenidate is distributed into milk; caution advised if used in nursing women.1 4

Limited data (case reports) suggest that exclusively breast-fed infants receive about 0.2–0.7% of the maternal weight-adjusted dosage of racemic methylphenidate; milk concentrations of methylphenidate ranged from undetectable to 15.4 ng/mL in lactating women receiving the racemic drug at dosages of 35–80 mg daily.4

Safety and efficacy not established in children <6 years of age.1 4

Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.1 4 (See Warnings under Cautions.)

Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.1 4 (See Sudden Death and Serious Cardiovascular Events under Cautions.)

Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 4 (See Growth Suppression under Cautions.)

Safety and efficacy not established.1 4

Safety and efficacy not established.1 4

Common Adverse Effects

Conventional tablets: Abdominal pain, fever, anorexia, nausea.1

Extended-release capsules: Decreased appetite/anorexia, headache, dyspepsia, dry mouth, anxiety, insomnia, vomiting, pharyngolaryngeal pain.4

Storage

Oral

25°C (may be exposed to 15–30°C).1 Protect from light and moisture.1

Tight container at 25°C (may be exposed to 15–30°C).4

• Appears to block norepinephrine and dopamine reuptake into the presynaptic neuron and increases their release into the extraneuronal space.1 4 Mechanism of action for treatment of ADHD not determined.1 4

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.1 4

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name