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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Healthcare Professionals


Whether you're prescribing for a patient with ADHD or one who might benefit from a shorter-acting ADHD therapy for specific activities or weekends, Methylphenidate HCl Chewable Tablets offer flexible dosing you can tailor to fit your patient's needs.1, 2


Physicians

Methylphenidate HClPrescription for Physicians


Children (> 6 years)

• 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.


Directions - This product should be taken with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. Taking this product without adequate fluid may cause it to swell and block the patient's throat or esophagus and may cause choking. Patients should not take this product if they have difficulty in swallowing. If your patient experiences chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, they should seek immediate attention.


† See Prescribing Information for full Dosing and Administration instructions.


Methylphenidate HCl Chewable Tablets

LUPIN Pharmaceuticals Inc. believes that Methylphenidate HCl Chewable fills and important gap in the market. It is available in 2.5 mg, 5 mg and 10 mg doses. You can ensure that patients receive the generic chewable product by writing "Methylphenidate HCl Chewable" on their prescriptions. We are working with pharmacies nationwide to ensure adequate stock in stores. If there is a particular retailer in your area that you would like to carry this product, please contact us at 866.587.4617 so we can coordinate appropriate stocking levels at that store.


Provide Your Patients with Valuable Information

We are committed to helping physicians navigate the pathways of an ADHD diagnosis. As an added benefit, LUPIN Pharmaceuticals Inc. has developed a parent-friendly booklet for you to distribute to your patients. Inside, you'll find explanations of the different types of ADHD, lifestyle tips for raising a child with ADHD, as well as valuable resources for parents and family members. You can download the booklet below or fill out the form to order additional copies.


Download Booklet



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1 Clinical Practice guideline based on a review of evidence includes companion guide to implementation." Wolraich, Mark L., M.D., FAAP. What's New in ADHD Diagnosis, Treatment? The American Academy of Pediatrics, 2011.

2 "Using Stimulants for Attention-Deficit/Hyperactivity Disorder: Clinical Approaches and Challenges." Jonathan R. Stevens, MD, MPH, corresponding author Timothy E. Wilens, MD, and Theodore A. Stern, MD. Prim Care Companion CNS Disord. 2013; 15(2): PCC.12f01472. Published online 2013 Mar 28.




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