Methylin

Methylin is a prescription medication used to treat Attention-Deficit Hyperactivity Disorder (ADHD). Methylin belongs to a group of drugs called central nervous system (CNS) stimulants, which works by changing the amount of natural substances in the brain to decrease impulsiveness and hyperactivity.

This medication comes in chewable tablet and solution forms. It is usually taken 2 to 3 times a day. The chew tablets and oral solution should be taken 30 to 45 minutes before a meal.

Common side effects of Methylin are headache, decreased appetite, and stomach ache.

Methylin 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.

• Mallinckrodt, Inc.

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

Methylin may cause serious side effects, including:

• seizures, mainly in patients with a history of seizures
• slowing of growth (weight and height)
• eyesight changes or blurred vision

The most common side effects of Methylin include:

• poor appetite
• nausea
• vomiting
• stomach pain
• weight loss
• tics
• trouble sleeping
• mood swings
• dizziness

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

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 of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylin 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 Methylin.

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

Especially tell your doctor if you or your child takes:

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

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

Do not start any new medicine while taking Methylin without talking to your doctor first.

The following have been reported with use of Methylin and other stimulant medicines.

• 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 or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Methylin.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Methylin.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Methylin.

• 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 or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Methylin, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Do not take Methylin if you or your child:

• 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 Methylin

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

Before starting Methylin, tell your or your child's 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)
• skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives/glues (patch form)

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

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

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Methylin will harm your unborn baby.

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.

Methylin falls into category C. There are no adequate animal or human studies; or studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women.

This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Methylin is excreted in human breast milk or if it will harm your nursing baby.

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

Methylin comes in as a chewable tablet and solution forms. It is usually taken 2 to 3 times a day.

Take Methylin 30 to 45 minutes before meals.

Your doctor may adjust the dose until it is right for you or your child.

From time to time, your doctor may stop Methylin treatment for awhile to check ADHD symptoms.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking Methylin. Children should have their height and weight checked often while taking Methylin. Methylin 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
• your weight
• your height
• your age
• your gender

​Methylin (regular release tablets)

• Adults:
  • Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily.
  • In others adults, 10 to 15 mg daily will be adequate.
  • Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
• Children (6 years and older):
  • Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
  • Methylin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

Methylin Oral Solution

Adults: The average dosage of Methylin (methylphenidate) is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children (6 years and older): Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. A daily dose above 60 mg is not recommended. 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.

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

Methylin 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.