Methylin ER

Methylin ER is a prescription medication used to control symptoms of attention deficit hyperactivity disorder.

Methylin ER belongs to a group of drugs called central nervous system stimulants. These work by changing the amounts of certain natural substances in the brain.

This medication comes in a long-acting tablet form and is taken once a day in the morning. It may be taken with or without food.

Do not chew, divide, or break Methylin ER tablets. Swallow the tablets whole.

Common side effects of Methylin ER include nervousness and insomnia.

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

Methylin ER is a prescription medication used to control symptoms of attention deficit hyperactivity disorder in children aged 6 years and older, adolescents, and adults.

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

• Mallinckrodt, Inc.

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

Common side effects of Methylin ER include the following:

• upper abdominal pain
• decreased appetite
• headache
• dry mouth
• nausea
• insomnia
• anxiety
• dizziness
• weight loss
• irritability
• increased sweating

This is not a complete list of Methylin 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 prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or have stopped taking them during the past 14 days
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antidepressants such as clomipramine (Anafranil), desipramine (Norpramin), and imipramine (Tofranil)
• decongestants such as pseudoephedrine (Sudafed, others) or phenylephrine (Sudafed PE, others)
• 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); and venlafaxine (Effexor)

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

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

• Cardiovascular events. Sudden death, stroke, and heart attack have been reported in patients taking stimulants such as Methylin ER. Caution should be used in patients with known cardiac abnormalities or heart problems. Tell your healthcare provider right away if you have some or all of the following symptoms of cardiovascular problems:
  • Changes in heart rate or blood pressure
  • Chest pain
  • Heart palpitations
  • Fainting
• Psychiatric events. Stimulants such as Methylin ER can make symptoms of psychiatric conditions worse. It may also lead to aggression or hostility in some patients. Caution should be used in patients with known psychiatric illnesses such as bipolar disorder or depression.

Methylin ER may also make it easier for patients with seizure disorders to have seizures.

Tell your doctor right away if you have any of the following signs or symptoms while taking Methylin ER:

• fast, pounding, or irregular heartbeat
• chest pain
• shortness of breath
• excessive tiredness
• slow or difficult speech
• fainting
• weakness or numbness of an arm or leg
• seizures
• changes in vision or blurred vision
• agitation
• believing things that are not true
• feeling unusually suspicious of others
• hallucinating (seeing things or hearing voices that do not exist)
• motor tics or verbal tics
• depression
• abnormally excited mood
• mood changes
• frequent, painful erections
• erection that lasts longer than 4 hours
• numbness, pain, or sensitivity to temperature in the fingers or toes
• skin color change from pale to blue to red in the fingers or toes
• unexplained wounds on the fingers or toes
• fever
• hives
• rash
• blistering or peeling skin
• itching
• swelling of the eyes, face, lips, mouth, tongue, or throat
• hoarseness
• difficulty breathing or swallowing

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

Do not take Methylin ER if you:

• are allergic to allergic to Methylin ER or to any of its ingredients
• have marked anxiety, tension, and agitation
• have glaucoma
• have motor tics or a family history of Tourette’s syndrome
• are taking or have taken a monoamine oxidase inhibitor within 14 days

Medications 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 Methylin ER, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Methylin ER or to any of its ingredients
• have or have a family history of tics or Tourette’s syndrome
• have glaucoma
• have an overactive thyroid gland
• have feelings of anxiety, tension, or agitation
• have any condition that prevents you from digesting sugar, starch, or dairy products
• have liver problems
• have or have a family history of heart problems
• have or have family history of depression, bipolar disorder, mania, or suicidal thoughts
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription 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.

Methyiln ER 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 or plan to breastfeed.

It is not known if Methylin 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 Methylin ER.

Take Methylin ER exactly as prescribed.

Methylin ER comes in long-acting tablet form and is taken once a day in the morning. It may be taken with or without food.

Do not chew, divide, or break Methylin ER tablets. Swallow tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Methylin ER at the same time.

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
• your age

The recommended starting dose of Methylin ER for children and adolescents is 18 mg/day. The recommended starting dose of Methylin ER for adults is 18 or 36 mg/day. The dose may be increased slowly according to patient response and tolerability.

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

If Methylin ER 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.

• Store Methylin ER at room temperature.
• Protect from exposure to light.
• Keep this and all medicines out of the reach of children.

WARNING: DRUG DEPENDENCE

Methylphenidate hydrochloride extended-release tablets 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.