Methylphenidate

What it is used for

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age. Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.

The most important thing to know

Methylphenidate transdermal may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate transdermal system has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate transdermal system, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death.

The risk of overdose and death is increased with higher doses of methylphenidate transdermal system or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate transdermal system and will monitor your child during treatment.

o Methylphenidate transdermal system may lead to physical dependence after prolonged use, even if used as directed by your healthcare provider. o Do not give methylphenidate transdermal system to anyone else. See “ What is methylphenidate transdermal system? ” for more information. o Keep methylphenidate transdermal system in a safe place and properly dispose of any unused medicine.

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Side effects, and when to stop

Methylphenidate transdermal system may cause serious side effects, including: Seizures. Your child’s healthcare provider may stop treatment with methylphenidate transdermal system if your child has a seizure. Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate.

If your child develops priapism, get medical help right away. Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include: o fingers or toes may feel numb, cool, or painful o fingers and toes may change color from pale, to blue, to red Tell your child’s healthcare provider if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with methylphenidate transdermal system. Slowing of growth (height and weight) in children. Your child should have their height and weight checked often during treatment with methylphenidate transdermal system.

Your healthcare provider may stop your child’s methylphenidate transdermal system treatment if they are not growing or gaining weight as expected. Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.

New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with methylphenidate transdermal system. Loss of skin color. Methylphenidate transdermal system may cause a persistent loss of skin-color where the patch is applied or around the patch application site.

Loss of skin-color, in some cases, has been reported at locations on the skin far from any application site. The loss of skin-color may be permanent even after removing the patch or methylphenidate transdermal system is stopped. Call your healthcare provider right away if your child has changes in skin-color. Methylphenidate transdermal system treatment may be stopped if your child has changes in skin color.

Allergic skin rash (contact sensitization). Stop using methylphenidate transdermal system and tell your child’s healthcare provider right away if your child develops swelling or blisters at or around the application site. Your child may have a skin allergy to methylphenidate transdermal system. People who have skin allergies to methylphenidate transdermal system may develop an allergy to all medicines that contain methylphenidate, even methylphenidate medicines taken by mouth.

The most common side effects of methylphenidate transdermal system in children 6 to 12 years old include: decreased appetite trouble sleeping nausea vomiting weight loss tics changes in mood trouble eating The most common side effects of methylphenidate transdermal system in children 13 to 17 years old include: decreased appetite nausea trouble sleeping weight loss dizziness stomach pain trouble eating Methylphenidate transdermal system may also cause skin problems where it is applied (redness, small bumps, itching).

Your child’s doctor may do certain blood tests while your child uses methylphenidate transdermal system. These are not all the possible side effects of methylphenidate transdermal system. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store methylphenidate transdermal system?

Store methylphenidate transdermal system at room temperature between 20° to 25°C (68° to 77°F). Store methylphenidate transdermal system in a safe place, like a locked cabinet. Do not store

Storing it

” for more information. o Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your child’s healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using methylphenidate transdermal system.

Tell your child’s healthcare provider if your child has any heart problems, heart disease or heart defects. Remove the methylphenidate transdermal system (patch) and call your child’s healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with methylphenidate transdermal system.

Increased blood pressure and heart rate. Your child’s healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with methylphenidate transdermal system. Mental (psychiatric) problems, including: o new or worse behavior or thought problems o new or worse bipolar illness o new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or manic symptoms Tell your child’s healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression.

Call your child’s healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with methylphenidate transdermal system, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms. What is methylphenidate transdermal system? Methylphenidate transdermal system is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age.

Methylphenidate transdermal system may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD. Methylphenidate transdermal system is not recommended for use in children under 6 years of age with ADHD. Methylphenidate transdermal system is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.

Keep methylphenidate transdermal system in a safe place to protect it from theft. Never give your methylphenidate transdermal system to anyone else because it may cause death or harm them. Selling or giving away methylphenidate transdermal system may harm others and is against the law. Do not use methylphenidate transdermal system if your child: is allergic to methylphenidate or any of the ingredients in methylphenidate transdermal system.

See the end of this Medication Guide for a complete list of ingredients in methylphenidate transdermal system. is taking, or has stopped taking withing the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI) Before using methylphenidate transdermal system, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child: has heart problems, heart disease, heart defects, or high blood pressure has mental problems including psychosis, mania, bipolar illness, or depression, or has a family history of suicide bipolar illness, or depression has seizures or have had an abnormal brain wave test (EEG) has circulation problems in fingers or toes has skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues) has a history of vitiligo or a family history of vitiligo has eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness) has or had repeated movements or sounds (tics) or Tourette’s s