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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Child playing baseball



What You Can Do


There are steps you can take as a parent in order to ensure your child's success with managing ADHD. And proper treatment of ADHD through medication and behavioral counseling can help family members, teachers and others see the true potential of your child.


  • Help yourself understand ADHD. There are a number of reputable ADHD-related websites and sources that contain useful information. While there is currently no cure for ADHD, there are many things you can do in order to make the symptoms manageable for both your child and your family.


  • Help your child understand ADHD. It's important that you help your child understand the diagnosis in words that make sense to him or her. Help your child understand that by cooperating and participating in different methods of treatment, life will become easier for the whole family, both at school and at home.



  • For Your Child...

    While life with a child with ADHD can be stressful for everyone, it's important to remember that it's most difficult for him or her.


    • Acknowledge and support the things your child is good at. When your child finds something he or she is good at, encourage participation and allow him or her to experience accomplishment and success.

    • Help build his or her social skills. It's important to encourage activities that will help your child learn how to behave well, cooperate and make friends.

    • Accept that there will be bad days. You should be prepared for them, and find ways to deal with them in a way that minimizes the negative impact on your child.

  • At Home...

    Taking care of another family member with ADHD can be stressful at times. It's important that you take care of yourself, because if you become ill due to stress or lack of sleep, you can no longer be of support to your child.


    • Join a community support group. There are support groups all over the world that exist to help parents who have children with ADHD. It's important to choose one that you're comfortable with, as you will benefit most from being around people you can trust and speak openly with.

    • Consider getting psychiatric help for your child, yourself — and possibly your other family members. Professional counseling can help relieve stress and provide guidance on how to handle the challenges that may arise.

    • Don't depend on trial and error. Have a plan, and develop and present your child with a program that suits his or her individual needs. You can work with your physician, attend parent-training classes or consult specialized books to help.

    • Consistency ensures success. Once a plan is developed, make sure that everyone who is in your child's life on a regular basis follows it. Consistency is key in effectively managing ADHD.

    • Make sure your other children do not feel neglected. Your child requires a lot of attention and support in order to live a productive life. It's not unusual for siblings to feel like they do not receive enough attention as a result. Make sure you set aside some one-on-one time to ensure all of your children receive the attention they deserve.

  • At School...

    You are the most important support member in your child's life — no one understands him or her the way you do. So it's important to stick up for your child, especially in environments where you can't always be present, such as school.


    • Educate yourself about educational rights for children with ADHD. The Individuals with Disabilities Education Act (IDEA) and Section 504 of the Rehabilitation Act will help you maximize your child's educational opportunities.

    • Become your child's record keeper and advocate. You are the only one who will have access to crucial information, such as evaluations, test results, behavior records, medical history and more. It's important that you manage and share it with the right people in order to maximize the effectiveness of treatment.

    • Work with your child's teacher to put together and keep track of a behavioral record. Your child's teacher spends a large amount of time with him or her. This makes teachers a valuable ally when it comes to tracking your child's behavior and progress.


How a Balanced Diet Can Help




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