Important Safety Information

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INDICATION
ATTENTION DEFICIT DISORDERS, NARCOLEPSY
Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.


DRUG ABUSE AND DEPENDENCE
Methylphenidate Hydrochloride Chewable Tablets should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances.
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Physicians

 

Methylphenidate Hydrochloride (HCl) Chewable Tablets offer prescribers a flexible alternative that may be appropriate across a range of clinical applications and patient profiles.1,2

 

Chewable ADHD Treatment for Children

Flexibility

Suitable for a broad range of patients—both children and adults.1,3*
*Methylphenidate HCl Chewable Tablets should not be used in children less than 6 years old.

Methylphenidate HCl Chewable Tablets may be appropriate across a range of clinical applications, including:

As a primary medication therapy for some patients who:

  • Are just beginning ADHD therapy4,5

  • Are undergoing behavior therapy and may respond to a lower dosage ADHD medication2,5


As an adjunct medication for patients who are currently on a long-acting therapy and:

  • Do not like to take an all day ADHD medication on weekends5

  • Might benefit from a shorter-acting ADHD therapy for extracurricular or family activities4,6

  • Might benefit from a shorter-acting ADHD therapy for evenings*4,5

  • * Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

 

Pharmacokinetic Parameters

Methylphenidate HCl Chewable Tablet 10 mg


Chewable ADHD Treatment for Children

  • Rapid onset of action†7#

  • Readily absorbed†‡

  • Bioequivalent to Methylin†§ (Methylphenidate HCl Chewable Tablets)


GAVIS Pharmaceuticals. [Bioequivalence Study for Methylphenidate 10mg chewable tablets BE fasting/fed studies 16020/09-10; 16021/09-10]. Unpublished raw data. #When compared to a non-chewable formulation. Methylphenidate Hydrochloride Chewable Tablets [package insert]. Somerset, NJ: GAVIS Pharmaceuticals, LLC; 2015. §Other pharmacokinetic parameters, such as Cmax and AUC, were found to be within the preset FDA acceptance limits on bioequivalence. Methylphenidate HCI Chewable Tablets are AB-rated to Methylin®. *Methylin® is a registered trademark of Mallinckrodt LLC.

 
Chewable ADHD Treatment for Children

Safety & Efficacy


  • Methylphenidate is recognized as having an extensive record for safety and efficacy by the AAP.6


  • While the initial stimulant medication trial may focus on normalizing core symptoms of ADHD, the AAP recommends a longer-term comprehensive plan that includes individualized and specific behavioral, academic and social target goals and treatments.6

 

Methylphenidate has a documented and well-characterized safety record.6,8

In a double-blind study involving 33 participants and 68 controls, methylphenidate was well tolerated, with appetite suppression, insomnia, tics and anxiety being the most common side effects.8

In a 2015 meta-analysis involving 9 parallel group trials, methylphenidate was not associated with an overall increase in total number of serious adverse events (risk ratio 0.98, 95% confidence interval 0.44 to 2.22, 1532 participants). However, methylphenidate was associated with a 29% increase in the risk of non-serious adverse events (risk ratio 1.29, 95% confidence interval 1.10 to 1.51). The most common non-serious events were decreased appetite and sleep problems.9





 

Advantages of a Chewable Formulation

  • Children ages 6-18 may prefer chewable tablets10

  • Precise dosing alternative to liquids11

  • Portable and convenient dosage form in a grape flavor11

 

Chewable ADHD Medication: Dosage and Administration


Methylphenidate HCl Chewable Tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.12

Children (> 6 years)1

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

  • Initiate in small doses, with gradual weekly increments.

  • Daily dosage above 60 mg is not recommended.

  • Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.


  • Adults1

    • Administer in divided doses 2 or 3 times daily, preferably 30 to 45 min before meals

    • Average dosage is 20 to 30 mg daily.

    • Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate.



    Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

    Directions - This product should be taken with at least 8 ounces (a full glass) of water or other fluid.

    See Prescribing Information for more dosing and administration instructions, including warnings about a potential choking hazard, the risk of priapism and circulation problems, and the presence of phenylalanine in the chewable tablet. Always advise patients and caregivers to refer to the patient Medication Guide and help them understand its contents.

 

Helpful Resources


Provide your patients with useful information.

We are committed to working with you to help your patients navigate a new ADHD diagnosis. To help your patients get started, we've developed a fact-based and easy-to-read guide. It discusses diagnosis, available treatments, lifestyle tips for raising a child with ADHD, support strategies, school tips and more.

Download a free PDF copy of Growing Up With ADHD now or complete the form to obtain print booklets for your patients.


Download Booklet



Chewable ADHD Treatment for Children
 

Not recommended for children under 6 years of age.4

 

References


  1. Methylphenidate Hydrochloride Chewable Tablets [package insert]. Somerset, NJ: GAVIS Pharmaceuticals, LLC.; 2015.

  2. "ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention- Deficit/Hyperactivity Disorder in Children and Adolescents." Pediatrics (2011), vol. 128, no. 5.

  3. "European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD" Kooij S., Bejerot S., Blackwell A., Caci H., et al. BMC Psychiatry (2010), vol 10, no. 67.

  4. "A Review of Pharmacological Management of Attention-Deficit/Hyperactivity Disorder." Briars L. and Todd T. The Journal of Pediatric Pharmacology and Therapeutics (2016) vol. 21, no. 3.

  5. "ADHD Parents Medication Guide." American Academy of Child & Adolescent Psychiatry and American Psychiatric Association (2013).

  6. "ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention- Deficit/Hyperactivity Disorder in Children and Adolescents." Pediatrics (2015), vol. 128 (Supplement).

  7. "Advanced Drug Formulation Design to Optimize Therapeutic Outcomes." eds. Robert Williams, III, David Taft, and Jason McConville (Boca Raton: CRC Press, 2008), 227.

  8. "The Efficacy and Tolerability of Methylphenidate and Behavior Modification in Children with Attention-Deficit/Hyperactivity Disorder and Severe Mood Dysregulation." Waxmonsky J. et al. Journal of Child and Adolescent Psychopharmacology (2008), vol. 18, no. 6.

  9. "Methylphenidate for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Cochrane Systematic Review with Meta-Analyses and Trial Sequential Analyses of Randomised Clinical Trials." Storeb ø O. et al. British Medical Journal (2015) 351:h5203.

  10. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Reflection Paper: Formulations of Choice for the Paediatric Population (EMEA/CHMP/PEG/194810/2005).

  11. "Safety of Chewable Tablets for Children." Michele Th., Knorr B., Vada E., Reiss Th. Journal of Asthma (2002), vol. 39, No. 5, p: 391-403.

  12. "Clinical Practice: Adult Attention Deficit-Hyperactivity Disorder." Volkow, ND, Swanson, JM. The New England Journal of Medicine (2013), vol. 369, no. 20.




INDICATION
ATTENTION DEFICIT DISORDERS, NARCOLEPSY
Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.


Important Safety Information

DRUG ABUSE AND DEPENDENCE
  • Methylphenidate Hydrochloride Chewable Tablets should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
  • Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances.


CONTRAINDICATIONS
  • Children less than 6 years of age - Methylphenidate Hydrochloride Chewable Tablets should not be used in children under six years, since safety and efficacy in this age group have not been established.
  • Monoamine Oxidase Inhibitors - Methylphenidate Hydrochloride Chewable Tablets are 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).
  • Anxiety, Tension, and Agitation - Marked anxiety, tension, and agitation are contraindications to Methylphenidate Hydrochloride Chewable Tablets, since the drug may aggravate these symptoms.
  • Hypersensitivity - Methylphenidate Hydrochloride Chewable Tablets are also contraindicated in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.

    • WARNINGS AND PRECAUTIONS

      CARDIOVASCULAR

      • Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems
        Stimulant products generally should not be used in children, adolescents, or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems. Stroke, and myocardial infarction have been reported in adults taking stimulant drugs.
      • Hypertension and other Cardiovascular Conditions
        Stimulant medications can cause modest changes in blood pressure and heart rate. Use caution when 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).
      • Peripheral Vasculopathy, Including Raynaud's Phenomenon - Stimulants, including Methylphenidate Hydrochloride Chewable Tablets, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown.

      PSYCHIATRIC

      • 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.
      • 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.
      • Aggression - Aggressive behavior or hostility is often observed in children and adolescents with ADHD. Patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
      • 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.

      GENITOURINARY

      • Priapism - Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients.

      ENDOCRINE

      • Long-Term Suppression of Growth - 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.

      VISUAL DISTURBANCE

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

      ADVERSE REACTIONS

      • Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening.
      • Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolysis.

      Please see Prescribing Information, including Boxed Warning regarding risk of drug abuse and dependence, as well as Medication Guide