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dexmethylphenidate (Rx)Brand and Other Names:Focalin, Focalin XR

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg

capsule, extended-release

  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 25mg
  • 30mg
  • 35mg
  • 40mg
more...

Attention Deficit Hyperactivity Disorder

Focalin

  • Initial: 2.5 PO twice daily; may increase in 2.5- to 5-mg increments qWeek if warranted
  • Not to exceed 20 mg/day

Focalin XR

  • Not taking Focalin or methylphenidate: 10 mg PO qDay initially; may increase in 10-mg increments qWeek if warranted; not to exceed 20 mg/day
  • Switch from Focalin: Administer the same total daily dose as Focalin but administer qDay
  • Switch from methylphenidate: Initiate with half total daily dose of methylphenidate and administer qDay; not to exceed 40 mg/day

Dosing Modifications

Hepatic impairment: Safety and efficacy not established

Renal impairment: Not studied; expected to have minimal effects on kinetics of dexmethylphenidate considering its extensive metabolism to inactive compounds

Administration

Administer capsules once daily and tablets at least 4 hours apart

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg

capsule, extended-release

  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 25mg
  • 30mg
  • 35mg
  • 40mg
more...

Attention Deficit Hyperactivity Disorder

<6 years

  • Safety and efficacy not established

≥6 years (Focalin)

  • Initial: 2.5 PO twice daily; may increase in 2.5- to 5-mg increments qWeek if warranted
  • Not to exceed 20 mg/day

≥6 years (Focalin XR)

  • Not taking Focalin or methylphenidate: 5 mg PO qDay initially; may increase in 5-mg increments qWeek if warranted; not to exceed 30 mg/day
  • Switch from Focalin: Administer the same total daily dose as Focalin but administer qDay
  • Switch from methylphenidate: Initiate with half total daily dose of methylphenidate and administer qDay; not to exceed 30 mg/day
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Interactions

Interaction Checker

dexmethylphenidate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Abdominal pain (15%)

            Headache (25-39%)

            Insomnia (5-17%)

            Restlessness (12%)

            Anxiety (5-11%)

            1-10%

            Anorexia (5-7%)

            Fever (5%)

            Dizziness (6%)

            Mood swings (<3%)

            Nausea (9%)

            Pruritus (<3%)

            Pharyngolaryngeal pain (4-7%)

            Irritability (5%)

            Depression (<3%)

            Dyspepsia (5-9%)

            Postmarketing Reports

            Anaphylaxis

            Hypersensitivity reactions

            Rhabdomyolysis

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            Warnings

            Black Box Warnings

            Chronic abuse can lead to a marked tolerance and psychological dependence with varying degrees of abnormal behavior; frank psychotic episodes can occur, especially with parenteral abuse; withdrawal from abusive use may result in depression.

            Give cautiously to patients with a history of drug dependence or alcoholism

            Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up

            Contraindications

            Hypersensitivity to methylphenidate; reactions may include angioedema and anaphylaxis

            Notable tension and agitation, glaucoma, Tourette syndrome, motor tics, anxiety

            MAOIs: Risk of severe hypertensive reaction; do not use within 14 days of taking MAOI

            Cautions

            Should be used as part of a comprehensive treatment program of attention deficit disorder

            Caution in patients with history of drug dependence or alcoholism, HTN, preexisting structural cardiac abnormalities

            Discontinue if no improvement after 1 month

            Reevaluate need for treatment q6Week

            Associated with peripheral vasculopathy, including Raynaud phenomenon

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

            Do not use for depression, fatigue

            Sudden deaths, stroke, and myocardial infarction reported in adults taking stimulants at usual doses

            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

            Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients

            Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported

            Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected

            Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures

            Use with caution in patients who use other sympathomimetic drugs

            Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications

            Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections

            Use with caution in patients with hypertension and other vascular conditions, including heart failure, ventricular arrhythmia; recent myocardial infarction; CNS stimulants may increase heart rate and blood pressure

            Hypersensitivity reactions, including anaphylactic reactions and angioedema reported in patients treated with methylphenidate

            Use caution in patients with preexisting psychosis; stimulants may exacerbate symptoms of behavior and though disorder; use with caution in patients with bipolar disorder; stimulants may induce mixed/manic episodes; new onset of psychosis or mania may occur in children or adolescents with stimulant use; patients presenting with depressive symptoms should be screened for bipolar disorder, including family history of suicide, bipolar disorder, and depression; consider discontinuation of therapy if symptoms of psychosis develop

            Appetite suppression may occur in children; stimulant use is associated with weight loss and slowing growth rate; monitor growth rate and weight during treatment; consider interrupting therapy in patients who are not increasing in height or gaining weight as expected

            Abrupt discontinuation following high doses or prolonged periods may result in symptoms of wighdrawal including severe depression

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Excretion in milk unknown; use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            The more pharmacologically active CNS stimulant of the d-threo-enantiomers; blocks reuptake of norepinephrine and dopamine, causing an increase of their release into the extraneuronal space

            Absorption

            Bioavailability: 22-25%

            Onset of action: 12hr (extended release)

            Peak plasma time: 1-1.5 hr (Focalin XR: 2nd peak at 6.5 hr)

            Distribution

            Protein bound: 12-25%

            Vd: 1.54-3.76 L/kg

            Metabolism

            Metabolized by deesterification

            Metabolites: Inactive

            Elimination

            Half-life: 2-4.5 hr (adults); 2-3 hr (children)

            Excretion: Urine (90%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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