Focalin (Dexmethylphenidate Hydrochloride) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Focalin

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What is attention deficit hyperactivity disorder (ADHD)?

ADHD refers to a chronic biobehavioral disorder that initially manifests in childhood and is characterized by hyperactivity, impulsivity, and/or inattention. Not all of those affected by ADHD manifest all three behavioral categories. These symptoms can lead to difficulty in academic, emotional, and social functioning. The diagnosis is established by satisfying specific criteria and may be associated with other neurological, significant behavioral, and/or developmental/learning disabilities. Therapy may consider the use of medication, behavioral therapy, and adjustments in day-to-day lifestyle activities.

Studies in the United States indicates approximately 8%-10% of children satisfy diagnostic criteria for ADHD. ADHD is, therefore, one of the most common disorders of childhood. ADHD occurs two to four times more commonly in boys than girls (male to female ratio 4:1 for the predominant...

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PATIENT INFORMATION

MEDICATION GUIDE

FOCALIN®
(dexmethylphenidate hydrochloride) tablets

Read the Medication Guide that comes with FOCALIN® (dexmethylphenidate hydrochloride) before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with FOCALIN® (dexmethylphenidate hydrochloride) .

What is the most important information I should know about FOCALIN® (dexmethylphenidate hydrochloride) ?

The following have been reported with use of dexmethylphenidate hydrochloride 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 FOCALIN® (dexmethylphenidate hydrochloride) .

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with FOCALIN® (dexmethylphenidate hydrochloride) .

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 FOCALIN® (dexmethylphenidate hydrochloride) .

2. Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems
new or worse bipolar illness
new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things that are not true, 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 FOCALIN® (dexmethylphenidate hydrochloride) , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is FOCALIN® (dexmethylphenidate hydrochloride) ?

FOCALIN® (dexmethylphenidate hydrochloride) is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). FOCALIN® (dexmethylphenidate hydrochloride) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

FOCALIN® (dexmethylphenidate hydrochloride) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

FOCALIN® (dexmethylphenidate hydrochloride) is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN® (dexmethylphenidate hydrochloride) in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN® (dexmethylphenidate hydrochloride) 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 FOCALIN® (dexmethylphenidate hydrochloride) ?

FOCALIN® (dexmethylphenidate hydrochloride) 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 anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
are allergic to anything in FOCALIN® (dexmethylphenidate hydrochloride) . See the end of this Medication Guide for a complete list of ingredients.

FOCALIN® (dexmethylphenidate hydrochloride) should not be used in children less than 6 years old because it has not been studied in this age group.

FOCALIN® (dexmethylphenidate hydrochloride) may not be right for you or your child. Before starting FOCALIN® (dexmethylphenidate hydrochloride) tell your or your child's doctor about all health conditions (or a family history of) including:

heart problems, heart defects, high blood pressure
mental problems including psychosis, mania, bipolar illness, or depression
tics or Tourette's syndrome
seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can FOCALIN® (dexmethylphenidate hydrochloride) be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. FOCALIN® (dexmethylphenidate hydrochloride) and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking FOCALIN® (dexmethylphenidate hydrochloride) .

Your doctor will decide whether FOCALIN® (dexmethylphenidate hydrochloride) can be taken with other medicines.

Especially tell your doctor if you or your child takes:

anti-depression medicines including MAOIs
seizure medicines
blood thinner medicines
blood pressure medicines
cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking FOCALIN® (dexmethylphenidate hydrochloride) without talking to your doctor first.

How should FOCALIN® (dexmethylphenidate hydrochloride) be taken?

Take FOCALIN (dexmethylphenidate hydrochloride) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
Take FOCALIN® (dexmethylphenidate hydrochloride) twice a day, at least 4 hours apart.
FOCALIN® (dexmethylphenidate hydrochloride) can be taken with or without food.
From time to time, your doctor may stop FOCALIN® (dexmethylphenidate hydrochloride) treatment for a while to check ADHD symptoms.
Your doctor may do regular checks of the blood, heart, and blood pressure while taking FOCALIN® (dexmethylphenidate hydrochloride) . Children should have their height and weight checked often while taking FOCALIN® (dexmethylphenidate hydrochloride) . FOCALIN® (dexmethylphenidate hydrochloride) treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much FOCALIN® (dexmethylphenidate hydrochloride) or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of FOCALIN® (dexmethylphenidate hydrochloride) ?

See “What is the most important information I should know about FOCALIN® (dexmethylphenidate hydrochloride) ?” for information on reported heart and mental problems.

Other 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

Common side effects include:

stomach ache
nausea

decreased appetite
fever

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store FOCALIN® (dexmethylphenidate hydrochloride) ?

Store FOCALIN® (dexmethylphenidate hydrochloride) in a safe place at room temperature, 59 to 86° F (15 to 30° C).
Keep FOCALIN® (dexmethylphenidate hydrochloride) and all medicines out of the reach of children.

General information about FOCALIN® (dexmethylphenidate hydrochloride)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOCALIN® (dexmethylphenidate hydrochloride) for a condition for which it was not prescribed. Do not give FOCALIN® (dexmethylphenidate hydrochloride) to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about FOCALIN® (dexmethylphenidate hydrochloride) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOCALIN® (dexmethylphenidate hydrochloride) that was written for healthcare professionals. For more information about FOCALIN® (dexmethylphenidate hydrochloride) call 1-888-669-6682.

What are the ingredients in FOCALIN®?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 1/27/2011
This monograph has been modified to include the generic and brand name in many instances.