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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Pharmacists

Lupin Pharmaceuticals Inc.'s 120 representatives are calling on pediatricians to promote the availability of Methylphenidate HCl Chewable Tablets, so please ensure that you stock up now for your customers.


Methylphenidate HClPrescription Available for Pharmacists


Ensure adequate retail supply by checking with your distribution center or wholesaler, or by calling LUPIN Pharmaceuticals Inc. directly at 866.587.4617.


Stocking Information

Methylphenidate HCl Chewable Tablets are available through these major wholesalers:



For more information on LUPIN Pharmaceuticals Inc., please visit us at www.lupinpharmaceuticals.com.



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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.


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