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.

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.

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.

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.

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.

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.

Methylphenidate is a controlled substance (CII), because it can be abused or lead to dependence. As a result, your doctor will have use a special type of prescription pad which may look different.

Since it is a controlled substance (CII),  you can not refill this medication. You will need to obtain another prescription from your doctor. Based on some state laws, you may only be able to obtain 30 day supply.

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems since Heart-related problems have been reported with use of methylphenidate and other stimulant medicines.

The most common side effects of methylphenidate include:

• poor appetite
• weight loss
• nausea/vomiting
• trouble sleeping
• mood swings