Metadate CD

Metadate CD is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (a chronic sleep disorder that causes overwhelming daytime drowsiness). Metadate CD 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 in extended release (long acting) capsule and is usually taken once each day in the morning before breakfast. Metadate CD can be taken with or without food.

Do not crush, chew, or divide Metadate CD capsules. Swallow Metadate CD whole.

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

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

Metadate CD 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.

• UCB, Inc.

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

The most common side effects of Metadate CD include:

• 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 CD 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 CD drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Metadate CD 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 CD:

• 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 CD if you:

• are allergic to Metadate CD 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 CD 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 CD, there are no specific foods that you must exclude from your diet when receiving Metadate CD.

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

• are allergic to Metadate CD 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 CD falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Metadate CD 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 CD 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 CD.

Take Metadate CD exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Take Metadate CD once a day in the morning before breakfast Metadate CD is an extended-release capsule. It releases medicine into your body throughout the day.

Metadate CD can be taken with or without food.

Swallow Metadate CD capsules whole with water or other liquids. If you cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid. Never chew or crush the capsule or the medicine inside the capsule.

Metadate CD should not be taken with alcohol. This may result in a more rapid release of the dose of Metadate CD.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking Metadate CD. Children should have their height and weight checked often while taking Metadate CD. Metadate CD 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

​The recommended starting dose of Metadate CD is 20 mg once daily. The dosage may be adjusted in weekly 10-20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed.

​If improvement is not seen after dose is adjusted over a one-month period, the drug should be discontinued.

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 CD at room temperature.
• Protect it from exposure to excess heat, light, and moisture.

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