Focalin

— THERAPEUTIC CATEGORIES —
  • ADHD
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Focalin Generic Name & Formulations

    Legal Class

    CII

    General Description

    Dexmethylphenidate HCl (single-isomer methylphenidate) 2.5mg, 5mg, 10mg+; tabs; +dye-free.

    Pharmacological Class

    CNS stimulant.

    See Also

    How Supplied

    XR caps, tabs—100

    How Supplied

    Focalin Tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are supplied in bottles of 100 and are available in the following strengths:

    • 2.5 mg tablets: blue

    • 5 mg tablets: yellow

    • 10 mg tablets: white

    Storage

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

    Manufacturer

    Novartis Pharmaceuticals Corp

    Generic Availability

    YES

    Mechanism of Action

    Dexmethylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynatic neuron and increase the release of these monoamines into the extraneuronal space. The mode of therapeutic action in ADHD is not known.

    Focalin Indications

    Indications

    Attention deficit hyperactivity disorder.

    Focalin Dosage and Administration

    Prior to Treatment Evaluations

    Assess for the presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

    Assess the risk of abuse, misuse, and addicition. After prescribing, keep prescription records, educate patients about these risks, monitor for signs of abuse, misuse, and addiction, and re-evaluate the need for Focalin XR use.

    Adults and Children

    <6yrs: not established. Individualize. ≥6yrs: initially 2.5mg twice daily at least 4hrs apart; may increase by 2.5–5mg weekly; max 20mg/day. Switching from racemic methylphenidate (eg, Ritalin): ½ of racemic methylphenidate dose.

    Administration

    May be taken with or without food.

    Nursing Considerations

    May be taken with or without food.

    Focalin Contraindications

    Contraindications

    During or within 14 days of MAOIs.

    Focalin Boxed Warnings

    Boxed Warning

    Abuse, misuse, and addiction.

    Boxed Warning

    Abuse, Misuse, and Addiction

    • High potential for abuse and misuse, leading to a substance use disorder, including addiction.

    • Assess the risk of abuse, misuse, and addiction prior to prescribing and monitor during therapy.

    Focalin Warnings/Precautions

    Warnings/Precautions

    High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Risk for acute angle closure glaucoma. History of increased IOP or open angle glaucoma; monitor closely. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

    Warnings/Precautions

    Abuse, Misuse, and Addiction 

    • High potential for abuse, misuse, and addiction.

    • Assess the risk of abuse, misuse, and addiction prior to prescribing and monitor during therapy.

    Risks to Patients with Serious Cardiac Disease 

    • Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease receiving CNS stimulants.

    • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac disease.

    • Evaluate further if exertional chest pain, unexplained syncope, or arrhythmias develop during treatment.

    Increased Blood Pressure and Heart Rate

    • Monitor all patients for potential tachycardia and hypertension.

    Psychiatric Adverse Reactions

    • Exacerbation of pre-existing psychosis: May exacerbate symptoms of behavior disturbance and thought disorders in patients with pre-existing psychotic behavior.

    • Induction of a manic episode in patients with bipolar disorder: May induce a mixed/manic episode in patients with bipolar disorder. Screen for risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

    • New psychotic or manic symptoms: May cause psychotic or manic symptoms in patients without a history of psychotic illness or mania. Consider discontinuing if symptoms occur.

    Priapism

    • Prolonged and painful erections, sometimes requiring surgical intervention, have been reported.

    • Priapism has not been reported during drug initiation but developed after some time on the drug.

    • Seek immediate medical attention if priapism occurs.

    Peripheral Vasculopathy, including Raynaud’s Phenomenon

    • Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown.

    • These signs and symptoms generally improve after reduction in dose or discontinuation.

    • Observe carefully for digital changes during treatment. Evaluate further (eg, rheumatology referral) for certain patients.

    Long-Term Suppression of Growth 

    • In pediatric patients, closely monitor growth (weight and height).

    • May need to interrupt treatment in patients who are not growing or gaining height or weight as expected.

    Acute Angle Closure Glaucoma

    • Risk for acute angle closure glaucoma (eg, those with significant hyperopia); refer to ophthalmologist for evaluation.

    Increased Intraocular Pressure and Glaucoma

    • Elevation of intraocular pressure (IOP) has been  reported. Monitor closely in those with a history of abnormally increased IOP or open angle glaucoma.

    Motor and Verbal Tics, and Worsening of Tourette's Syndrome

    • Before initiating, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Monitor for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

     

     

     

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Focalin XR, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.

    Risk Summary

    • Use in pregnant women have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. 

    • The estimated background risk of major birth defects and miscarriage is unknown.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause vasoconstriction and may decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported, but premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. 

    Nursing Mother Considerations

    Risk Summary  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Focalin XR and any potential adverse effects on the breastfed infant from Focalin XR or from the underlying maternal condition. 

    Clinical Considerations

    • Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. 

    Pediatric Considerations

    The safety and efficacy of Focalin XR in pediatric patients less than 6 years have not been established.

    The long-term efficacy of Focalin XR in pediatric patients has not been established.

    Long-Term Suppression of Growth: Monitor growth during treatment with stimulants, including Focalin XR. May need to interrupt treatment in pediatric patients who are not growing or gaining weight as expected.

    Geriatric Considerations

    Focalin XR has not been studied in the geriatric population.

    Focalin Pharmacokinetics

    Absorption

    Capsules

    • Time to first peak concentration: 1.5 hours (typical range, 1 to 4 hours). Mean time to the interpeak minimum and time to the second peak concentration: ~6.5 hours (range, 4.5 to 7 hours).

    Distribution

    Plasma protein binding of dexmethylphenidate is not known. Racemic methylphenidate is bound to plasma proteins by 12% to 15% (concentration-independent). Volume of distribution: 2.65 ± 1.11 L/kg.

    Metabolism

    Hepatic. Primarily via de-esterification.

    Elimination

    Renal. Half-life: ~2.2 hours (tabs); 2–3 hours (XR caps).

    Focalin Interactions

    Interactions

    See Contraindications. Hypertensive crisis with MAOIs. Risk of serotonin syndrome with serotonergic drugs. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

    Focalin Adverse Reactions

    Adverse Reactions

    Dyspepsia, dry mouth, decreased appetite, headache, anxiety, pharyngolaryngeal pain, anorexia, nausea, abdominal pain, fever; weight loss, hypertension, tachycardia, priapism, glaucoma, motor/verbal tics.

    Focalin Clinical Trials

    Clinical Trials

    Pediatric Patients – Study 1

    The efficacy and safety of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 103 pediatric patients aged 6 to 17 who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive or combined inattentive/hyperactive-impulsive subtypes. 

    Patients were randomly assigned to receive either a flexible-dose of Focalin XR (5 to 30mg/day) or placebo once daily for 7 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the DSM-IV total subscale score of the Conners ADHD/DSM-IV Scales for teachers (CADS-T), which includes the ADHD Index and the DSM-IV total subscale.

    Results showed that treatment with Focalin XR achieved a statsticalliy significant treatment effect for the CADS-T total scores compared with placebo (placebo-subtracted difference, 10.64 [95% CI, 5.38-15.91]).

     

    Pediatric Patients – Studies 2 and 3

    In the 2 crossover studies (Studies 2 and 3), pediatric patients aged 6 to 12 years received Focalin XR 20mg or placebo. Findings showed treatment with Focalin XR achieved statistically significant treatment effect compared with placebo according to the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) rating scale total scores at all-time points after dosing in each study (0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 hours in Study 2 and 1, 2, 4, 6, 8, 9, 10, 11, and 12 hours in the study 3). 

    In an additional study, the treatment effect of Focalin XR 20mg was seen 0.5 hours after administration in patients aged 6 to 12 years with ADHD.

     

    Adult Patients - Study 4

    The efficacy and safety of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 221 adult patients aged 18 to 60 who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive or combined inattentive/hyperactive-impulsive subtypes. 

    Patients were randomly assigned to receive either a flexible-dose of Focalin XR (20, 30, or 40mg/day) or placebo once daily for 5 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the investigator-administered DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS).

    Results showed that all 3 Focalin XR doses achieved a statistically significant treatment effect compared with placebo.

    • Focalin XR 20mg/day: Placebo-subtracted difference, 5.71 (95% CI, 1.64-9.78).

    • Focalin XR 30mg/day: Placebo-subtracted difference, 5.31 (95% CI, 1.18-9.44).

    • Focalin XR 40mg/day: Placebo-subtracted difference, 8.96 (95% CI, 4.83-13.08).

    Focalin Note

    Not Applicable

    Focalin Patient Counseling

    Patient Counseling

    Controlled Substance Status/High Potential for Abuse and Dependence

    • Advise patients that Focalin XR can be abused and lead to dependence. Do not give Focalin XR to anyone else. Store Focalin XR in a safe place, preferably locked, to prevent abuse.

    Serious Cardiovascular Risks

    • Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with Focalin XR use. Contact healthcare provider if patients experience symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

    Blood Pressure and Heart Rate Increases 

    • May cause elevations to blood pressure and pulse rate.

    Psychiatric Risks

    • May cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania.

    Priapism

    • May cause painful or prolonged penile erections. Seek immediate medical attention in the event of priapism.

    Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] 

    • May cause peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. 

    • Contact physician immediately if any signs of unexplained wounds appear on fingers or toes during treatment.

    Suppression of Growth

    • May cause slowing of growth and weight loss.

    Increased Intraocular Pressure (IOP) and Glaucoma

    • Advise that IOP and glaucoma may occur during treatment with Focalin XR.

    Motor and Verbal Tics, and Worsening of Tourette's Syndrome

    • Advise that motor and verbal tics, and worsening of Tourette’s Syndrome may occur during treatment with Focalin XR.

    Pregnancy Registry

    • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Focalin XR, during pregnancy.

    Cost Savings Program

    Focalin XR Savings Card

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