Important Safety Information

Read More

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:

style2
Family watching TV


What are Methylphenidate HCl Chewable Tablets?

 


A physician may have prescribed Methylphenidate Hydrochloride (HCl) Chewable Tablets to help you or your child with ADHD. Methylphenidate is a stimulant medication that has been prescribed for decades and has been very well-studied.1 It is one of the most widely used prescription stimulants for the treatment of ADHD.2 Methylphenidate provides relief from ADHD symptoms and helps improve behavior.2

Lupin's Methylphenidate HCl Chewable Tablets are a short-acting, immediate-release, chewable formulation that provide an appropriate option for patients who only need medication during certain parts of their day.1 Patients ages 6-18 may prefer the chewable formulation over others.3 And portable, precise dosing makes administration more convenient for those on the go.4

 
 

Methylphenidate HCl Chewable Tablets

  • Provide a choice of formulation that some patients ages 6-18 may prefer3

  • Convenient, precise dosing for those on the go4

  • Grape flavor

  • AB-rated to Methylin®* (Methylphenidate HCl Chewable tablets)

  • Generic pricing

 
 

How It Works Chewable ADHD Medication

 
 

Children living with ADHD often have more difficulty paying attention or tend to be more impulsive or hyperactive compared with other children the same age.5 Methylphenidate HCl Chewable Tablets are a stimulant medication that, along with other corrective measures, can help to reduce some of the symptoms seen in ADHD, such as inattentiveness, hyperactivity and impulsivity.2,6 Because of the extensive evidence of efficacy and safety, stimulants are considered a first-choice medication for ADHD by the American Academy of Pediatrics.7

Physicians typically begin by prescribing low doses of stimulants and then increase the dose gradually until reaching a therapeutic effect.1 Stimulants like Methylphenidate HCl Chewable Tablets are prescription medications and should be taken under medical supervision and monitored by a physician. The American Academy of Pediatrics also recommends that medication be accompanied by behavior therapy, as studies have shown that this combination can result in using lower stimulant doses.8

 


*Methylin® is a registered trademark of Mallinckrodt LLC.


References


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

  2. "Prescription stimulants in individuals with and without attention deficit hyperactivity disorder: misuse, cognitive impact, and adverse effects." Lakhan, S and Kirchgessner, A. Brain and Behavior (2012), vol. 2, no. 5.

  3. 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).

  4. "Safety of Chewable Tablets for Children." Michele Th., Knorr B., Vada E., Reiss Th. Journal of Asthma (2002), vol. 39, No. 5.

  5. "Role of Aberrant Striatal DopamineD1 Receptor/cAMP/Protein Kinase A/DARPP32 Signaling in the Paradoxical Calming Effect of Amphetamine." Napolitano, F. The Journal of Neuroscience (2010), vol. 30, no. 33.

  6. "ADHD & Pharmacotherapy: Past, Present and Future: A Review of the Changing Landscape of Drug Therapy for Attention Deficit Hyperactivity Disorder." Connolly, J et al. Therapeutic Innovation & Regulatory Science (2015), vol. 49, no. 5.

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

  8. "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.




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.