Focalin XR

Focalin XR is a prescription medication used to treat attention deficit and hyperactivity disorder (ADHD). Focalin XR belongs to a group of drugs called stimulants. It is believed to work by balancing certain chemicals in the brain.

Focalin XR is available in an extended-release (long-acting) capsule that is usually taken once a day, with or without food. Do not chew or crush the extended-release capsules. Swallow the capsules whole.

Common side effects include headache, upset stomach, and trouble sleeping.

Focalin XR is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

• Novartis Pharmaceutical Corporation

See "Drug Precautions" for serious side effects.

Other serious side effects of Focalin XR include:

• serious allergic reactions
• 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 of Focalin XR include:

• headache
• upset stomach
• trouble sleeping
• anxiety
• decreased appetite
• dry mouth
• dizziness
• nervousness

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

Tell your doctor about all of the medicines that you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Focalin XR 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 XR.

Your doctor will decide whether Focalin XR can be taken with other medicines.

Especially tell your doctor if you take:

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

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

The following have been reported with use of Focalin XR 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 have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you carefully for heart problems before starting Focalin XR.
Your doctor should check your blood pressure and heart rate regularly during treatment with Focalin XR.
Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Focalin XR.

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 have, or about a family history of suicide, bipolar illness, or depression. 
Call your doctor right away if you have any new or worsening mental symptoms or problems while taking Focalin XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Focalin XR should not be taken if you:

• 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 XR
• are a child less than 6 years old because it has not been studied in this age group

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Focalin XR there are no specific foods that you must exclude from your diet when receiving Focalin XR.

Before starting Focalin XR tell your 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)
• if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Tell your doctor about all of the medicines that you take including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding. It is not known if Focalin XR is excreted in human breast milk or if it will harm your nursing baby.

• Take Focalin XR exactly as prescribed. Your doctor may adjust the dose until it is right for you.
• Take Focalin XR capsules once each day in the morning with or without food.
• Swallow Focalin XR capsules whole with water or other liquids. Do not chew, crush, or divide the capsules or the beads in the capsule. If you cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing.
• From time to time, your doctor may stop Focalin XR treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Focalin XR. Children should have their height and weight checked often while taking Focalin XR. Focalin XR treatment may be stopped if a problem is found during these check-ups.

Take Focalin XR exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

Capsules:

• For patients new to methylphenidate: Begin treatment with Focalin XR (dexmethylphenidate) at 5 mg/day for children and 10 mg/day for adults, increasing the dose weekly in 5 mg increments for children and in 10 mg increments for adults. Doses above 30 mg/day in children and 40 mg/day in adults have not been studied. 
• For patients already using methylphenidate: Start Focalin XR (dexmethylphenidate) therapy with half (1/2) the current total daily dose of methylphenidate.
• Patients already using Focalin XR  immediate-release tablets: Switch to the same daily dose of Focalin XR extended-release capsules.

If you take too much Focalin XR call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store in a safe place at room temperature, 59 to 86° F (15 to 30° C). 
• Keep and all medicines out of the reach of children.
• Medicines are sometimes prescribed for purposes other than those descibed here. Do not use this medication for a condition for which it was not prescribed. Do not give Focalin XR to other people, even if they have the same condition. It may harm them and it is against the law.

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

WARNING: DRUG DEPENDENCE

Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.