Important Safety Information

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Methylphenidate Hydrochloride Chewable Tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate Hydrochloride Chewable tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate Hydrochloride Chewable Tablets may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Methylphenidate Hydrochloride Chewable Tablets?


Methylphenidate Hydrochloride Chewable Tablets should not be taken if you or your child:

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Signs, Symptoms, Diagnosis and Treatment

 
Chewable ADHD Treatment for Children

Understanding ADHD1


ADHD is a neurodevelopmental disorder that affects people at all stages of life, but is most often identified in young children. 11% of US children had been diagnosed with ADHD in 2011.2 Some children may appear to "grow out" of ADHD, but symptoms do change over time and can tend more towards inattentiveness and impulsivity than hyperactivity as children get older. Individuals with severe childhood ADHD symptoms and those with other psychiatric disorders are more likely to have ADHD that persists into adulthood. ADHD can cause problems in school, at home, or in social situations.3


 

Signs of ADHD in Children4


Most children will experience some inattention, unfocused motor activity, and impulsivity, but ADHD is marked by ongoing patterns of these symptoms that are severe, frequent, and interfere with their lives.

Children living with ADHD might5:

  • Be easily distracted

  • Be forgetful or tend to lose things

  • Avoid lengthy tasks when concentration is needed.

  • Fidget or squirm

  • Be overly talkative

  • Make careless mistakes and miss details

  • Have difficulty staying seated and feel restless

  • Have difficulty taking turns in games, activities, or conversations                           

Chewable ADHD Treatment for Children
 
Chewable ADHD Treatment for Children

Symptoms and Diagnosis of ADHD in Children5

Diagnosing someone with ADHD is a multi-step process. No single test can diagnose ADHD. Patients with other conditions such as anxiety, sleep disorders, depression and some learning disabilities, may present with similar symptoms. Mental health professionals, such as psychologists or psychiatrists, and primary care providers, like pediatricians, can make an ADHD diagnosis.

The American Academy of Pediatrics recommends that information be collected on the child's symptoms and functioning from parents, school and other sources - preferably before visiting the clinician. In children under 17, the diagnostic process includes the identification of at least six core symptoms of ADHD in the Inattention Dimension, the Hyperactivity-Impulsivity Dimension or in a combination of both.6


 

Dimensions and Core Symptoms of ADHD6


Inattention Dimension

  • Careless mistakes

  • Difficulty sustaining attention

  • Seems not to listen

  • Fails to finish tasks

  • Difficulty organizing

  • Avoids tasks that require sustained attention

  • Loses things

  • Easily distracted

  • Forgetful

Hyperactivity-Impulsivity Dimension

  • Fidgety

  • Unable to stay seated

  • Moves excessively (restless)

  • Difficulty engaging in leisure activities quietly

  • "On the go"

  • Talks excessively

  • Blurts answers before questions are completed

  • Difficulty awaiting turn

  • Interrupts/intrudes on others






In addition to identifying the required symptoms above, all of the following criteria must also be met and documented6:


Chewable ADHD Treatment for Children
  • The core symptoms must have persisted for at least 6 months

  • They must be inconsistent to a degree with the child's developmental age

  • They should be present before the age of 125

  • There must also be the presence of some impairment in two or more major settings for at least 6 months (for example, home and school)

  • There must be evidence of significant clinical impairment in social, academic, or occupational functioning because of the behaviors


The evaluation and diagnosis of a child with ADHD is a complex process. We encourage you to contact your healthcare provider if you have any questions regarding this process or to obtain more information on obtaining a diagnosis of ADHD.

 

Treating ADHD

There isn't a simple solution for ADHD, and treatment can sometimes be complicated. The best form of treatment for your child might involve a combination of several important elements. These various methods work together to provide a unified approach for children diagnosed with ADHD, including:

  • Behavior Management

  • Education about Diagnosis/Treatment

  • Educational Programs and Support

  • Medication

Chewable ADHD Treatment for Children



 

Behavior Management

Helping your child learn appropriate behavior both at home and at school is a key aspect of treating ADHD. While there is a wealth of helpful information available on parenting a child with ADHD, it's important that you consult your child's physician and school counselor for additional direction on how to best handle behavioral issues with your child.


Education about Diagnosis/Treatment

The more you know about your child's condition, the more you can help. Visit our ADHD Support page for additional information. Forums, wikis and e-books are all freely accessible with an Internet connection, and local communities like CHAAD (Children and Adults with Attention-Deficit/Hyperactivity Disorder) chapters or independent support groups can offer resources as well.


Educational Programs and Support

Support and fellowship are available through CHAAD chapters and local support groups to help you and your child adjust to living with ADHD. In addition, he or she may qualify for Section 504 or IDEA (Individuals with Disabilities Education Act) services through the government. Searching for support groups in your area through sites like Psychology Today and CHAAD can lead you to other parents and children who are going through similar experiences with ADHD and provide you with a valuable support system when things get stressful.


Medication

The most common type of medication used for treating ADHD is called a stimulant, and there are many types of stimulants available.7 A few other ADHD medications are non-stimulants and work differently than stimulants.4 For many children, stimulant medications like Methylphenidate Hydrochloride (HCl) Chewable Tablets reduce hyperactivity and impulsivity and improve their ability to focus.7


Questions to Ask Your Child's Doctor

How is ADHD diagnosed?

  • What are some common symptoms?

  • How are distraction and hyperactivity different in a healthy child vs. one with ADHD?

  • Will ADHD go away when he or she becomes an adult?

  • Is there a cure for ADHD?

  • Could Methylphenidate HCl Chewable Tablets help with any of the symptoms and are they right for my child?

  • What are the risks associated with treatment with Methylphenidate HCl Chewable Tablets?






References


  1. Centers for Disease Control and Prevention. "Facts about ADHD." Accessed 2/17/17. www.cdc.gov/ncbddd/adhd/facts.html.

  2. Centers for Disease Control and Prevention. "Data and Statistics." Accessed 6/16/17. www.cdc.gov/ncbddd/adhd/data.html.

  3. Child Mind Institute. "Can You Grow out of ADHD?." Accessed 7/18/17. www.childmind.org/guide/what-parents-should-know-about-adhd/outgrow/

  4. National Institute of Mental Health. "Attention Deficit Hyperactivity Disorder." Accessed 3/7/17. www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder- adhd/index.shtml

  5. Centers for Disease Control and Prevention. "ADHD Symptoms and Diagnosis" www.cdc.gov/ncbddd/adhd/diagnosis.html. Accessed 3/7/2017

  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. WebMD. "Stimulant Drugs for ADHD." Accessed 2/17/17. www.webmd.com/add-adhd/adhd- stimulant-therapy#1




Important Safety Information

Methylphenidate Hydrochloride Chewable Tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate Hydrochloride Chewable tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate Hydrochloride Chewable Tablets may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Methylphenidate Hydrochloride Chewable Tablets?


Methylphenidate Hydrochloride Chewable Tablets should not be taken if you or your child:

  • are very anxious, tense, or agitated
  • have an eye problem called glaucoma
  • have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
  • are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitory or MAOI.
  • are allergic to anything in Methylphenidate Hydrochloride Chewable Tablets. See the Medication Guide for a complete list of ingredients.


Methylphenidate Hydrochloride Chewable Tablets should not be used in children less than 6 years old.


CAUTION PHENYLKETONURICS: Methylphenidate Hydrochloride Chewable Tablets contain phenylalanine.


What is the most important information I should know about Methylphenidate Hydrochloride Chewable Tablets?

The following have been reported with use of methylphenidate HCl and other stimulant medicines:


1. Heart-related problems

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Methylphenidate Hydrochloride Chewable Tablets, and should check you or your child's blood pressure and heart rate regularly during treatment. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Methylphenidate Hydrochloride Chewable Tablets.


2. Mental (Psychiatric) problems

In All Patients:

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility In Children and Teenagers:
  • new psychotic symptoms (such as hearing voices, believing things that are not true or are suspicious) or new manic symptoms.

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Methylphenidate Chewable Tablets, especially psychotic symptoms.


3. Circulation problems in fingers and toes

  • Fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
  • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
  • Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate Hydrochloride Chewable Tablets

What are the side effects of Methylphenidate Hydrochloride Chewable Tablets?


Serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
  • painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
 

Common side effects include:

  • nervousness
  • trouble sleeping
  • headache
  • stomach ache
  • fast heartbeat
  • nausea
  • decreased appetite
  • dizziness
  • weight loss

What Are Methylphenidate Hydrochloride Chewable Tablets?


Methylphenidate Hydrochloride Chewable Tablets are a central nervous system stimulant prescription medicine. They are used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in adults and children over six years of age. They are also used in the treatment of a sleep disorder called narcolepsy. Methylphenidate Hydrochloride Chewable Tablets should be used as part of a total treatment program for ADHD that may include counseling or other therapies.


Please note this information is not complete and does not take the place of talking to your or your child's doctor. For additional safety information please see the Medication Guide and the full Prescribing Information.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561.