Metadate ER

Metadate ER is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (a chronic sleep disorder that causes overwhelming daytime drowsiness). Metadate ER belongs to a group of drugs called central nervous system (CNS) stimulants. These work by changing the amount of natural substances in the brain to decrease impulsiveness and hyperactivity.

This medication comes as a extended release (long-acting) tablet, and the effects of each dose last up to 8 hours. Metadate ER is usually taken 1 or 2 times a day. The dose should be individualized on the basis of how a patient responds to the medication.

Do not crush, chew, or divide Metadate ER tablets. Swallow Metadate ER whole.

Common side effects of Metadate ER include headache, decreased appetite, and stomachache.

Metadate ER can cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Metadate ER affects you.

Metadate ER is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD)and narcolepsy (a chronic sleep disorder that causes overwhelming daytime drowsiness).

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

• Celltech Pharmaceuticals, Inc.

• UCB Manufacturing, Inc.

• UCB, Inc.

Serious side effects have been reported with Metadate ER. See the “Metadate ER Precautions” section.

Common side effects of Metadate ER include the following:

• headache
• decreased appetite
• nausea and vomiting
• stomach pain
• diarrhea
• heartburn
• nervousness
• restlessness
• trouble falling asleep or staying asleep
• dizziness
• nausea
• changes in heart rate or blood pressure
• rapid or flutter heart rate (palpitations)

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including the prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antidepressants such as clomipramine (Anafranil), desipramine (Norpramin), and imipramine (Tofranil)
• decongestants (cough and cold medications)
• medications for high blood pressure
• medications for seizures such as phenobarbital, phenytoin (Dilantin), and primidone (Mysoline)
• methyldopa (Aldomet)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)
• venlafaxine (Effexor)

This is not a complete list of Metadate ER drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Metadate ER including the following:

Heart-related problems. Sudden death has been reported in patients who have heart probelms or heart defects; stroke and heart attacks in adults and increased blood pressure and heart rate may also occur with Metadate ER. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Metadate ER.

Mental (psychiatric) problems.Tell your doctor about any mental problems you have or about any 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 Metadate ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. All patients should monitor for the following symptoms of psychiatric problems:

• new or worsening behavior and thought problems
• new or worsening bipolar illness
• new or worsening aggressive behavior or hostility

Circulation problems. Tell your healthcare provider right away if you have some or all of the following symptoms of circulation problems:

• fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red
• unexplained wounds appearing on fingers and toes

Other serious side effects have been reported with Metadate ER:

• 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 develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Do not take Metadate ER if you:

• are allergic to Metadate ER or to any of its ingredients
• 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
• have severe high blood pressure or a heart problem
• have overproduction of a hormone by the butterfly-shaped gland in the neck (hyperthyroidism)
• are taking or have taken a monoamine oxidase inhibitor (MAOI) within the past 14 days

Metadate ER should not be used in children 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 Metadate ER, there are no specific foods that you must exclude from your diet when receiving Metadate ER.

Before taking Metadate ER, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Metadate ER or to any of its ingredients
• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression
• have tics or Tourette's syndrome
• have or have had seizures or have had an abnormal brain wave test (EEG)
• have or have had circulation problems in fingers or toes
• are 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.

Metadate ER falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Metadate ER should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Metadate ER crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Metadate ER.

Take Metadate ER exactly as prescribed. Follow the directions on your prescription label carefully.

This medication comes as a extended release (long-acting) tablet, and the effects of each dose last up to 8 hours. Metadate ER is usually taken 1 or 2 times a day. The dose should be individualized on the basis of how a patient responds to the medication.

Do not chew or crush Metadate ER tablets. Swallow Metadate ER tablets whole with water or other liquids. Tell your doctor if you cannot swallow Metadate ER whole.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking Metadate ER. Children should have their height and weight checked often while taking Metadate ER. Metadate ER treatment may be stopped if a problem is found during these check-ups.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Metadate ER is usually taken once or twice a day, in the morning and sometimes in the early afternoon 30 to 45 minutes before a meal.

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

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this and all medicines out of the reach of children.
• Store Metadate ER at room temperature.
• Protect it from exposure to excess heat, light, and moisture.

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

Drug Dependence

Metadate ER 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.