(methylphenidate HCl) Oral Solution 5 mg/5 mL and 10 mg/5 mL
Read the Medication Guide that
comes with Methylin Oral Solution before you or your child starts taking it and
each time you get a refill. There may be new information. This Medication Guide
does not take the place of talking to your doctor about your or your child's
treatment with Methylin Oral Solution.
What is the most important
information I should know about Methylin Oral Solution?
The following have been
reported with use of methylphenidate HCl oral solution and other stimulant
1. Heart-related problems:
- sudden death in patients who have heart problems or
- 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 Oral Solution.
Your doctor should check you or
your child's blood pressure and heart rate regularly during treatment with
Methylin Oral Solution.
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 Oral Solution.
2. Mental (Psychiatric) problems:
- 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 Oral Solution, especially seeing or hearing things that
are not real, believing things that are not real, or are suspicious.
3. Circulation problems in fingers and toes [Peripheral
vasculopathy, including Raynaud's phenomenon]: fingers or toes may feel numb,
cool, painful, and/or may change color from pale, to blue, to red.
- Tell your doctor if you have or your child has numbness,
pain, skin color change, or sensitivity to temperature in your fingers or toes.
- Call your doctor right away if you have or your child
has any signs of unexplained wounds appearing on fingers or toes while taking
What Is Methylin Oral Solution?
Methylin Oral Solution is a central nervous system
stimulant prescription medicine. Methylin Oral Solution is a liquid form of
medication that you take by mouth. It is used for the treatment of
Attention-Deficit Hyperactivity Disorder (ADHD). Methylin Oral Solution may
help increase attention and decrease impulsiveness and hyperactivity in
patients with ADHD.
Methylin Oral Solution should be used as a part of a
total treatment program for ADHD that may include counseling or other
Methylin Oral Solution is also used in the treatment of a
sleep disorder called narcolepsy.
Methylin Oral Solution is a federally controlled
substance (CII) because it can be abused or lead to dependence. Keep Methylin
Oral Solution in a safe place to prevent misuse and abuse. Selling or giving
away Methylin Oral Solution 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.
Who should not take Methylin Oral Solution?
Methylin Oral Solution should not be taken if you or
- 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
antidepression medicine called a monoamine oxidase inhibitor or MAOI.
- are allergic to anything in Methylin Oral Solution. See
the end of this Medication Guide for a complete list of ingredients.
Methylin Oral Solution should not be used in children
less than 6 years old because it has not been studied in this age group.
Methylin Oral Solution may not be right for you or
your child. Before startingMethylin Oral Solution 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)
- circulation problems in fingers and toes
Tell your doctor if you or your child is pregnant,
planning to become pregnant, or breastfeeding.
Can Methylin Oral Solution be taken with other
Tell your doctor about all of the medicines that you
or your child take including prescription and nonprescription medicines,
vitamins, and herbal supplements.
Methylin Oral Solution 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 Oral Solution.
Your doctor will decide whether Methylin Oral Solution
can be taken with other medicines.
Especially tell your doctor if you or your child
- antidepression 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
Oral Solution without talking to your doctor first.
How should Methylin Oral Solution be taken?
- Take Methylin Oral Solution exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Methylin Oral Solution is usually taken 2 to 3 times a
- Take Methylin Oral Solution 30 to 45 minutes before
- From time to time, your doctor may stop Methylin Oral
Solution treatment for awhile to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart,
and blood pressure while taking Methylin Oral Solution. Children should have
their height and weight checked often while taking Methylin Oral Solution.
Methylin Oral Solution treatment may be stopped if a problem is found during
- If you or your child takes too much Methylin Oral
Solution or overdoses, call your doctor or poison control center right away, or
get emergency treatment.
What are possible side effects of Methylin Oral
See “What is the most important information I should
know about Methylin Oral Solution?” for information on reported heart and
Other serious side effects include:
- 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 or your child develop priapism, seek medical help
right away. Because of the potential for lasting damage, priapism should be
evaluated by a doctor immediately.
Common side effects include:
- trouble sleeping
- decreased appetite
- stomach ache
- weight loss
- fast heart beat
Talk to your doctor if you or your child has side effects
that are bothersome or do not go away.
This is not a complete list of possible 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 FDA at 1-800-FDA-1088.
How should I store Methylin Oral Solution?
- Store Methylin Oral Solution in a safe place at room
temperature, 68° to 77°F (20° to 25°C).
- Keep Methylin Oral Solution and all medicines out of
the reach of children.
General information about Methylin Oral Solution
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use Methylin Oral Solution for
a condition for which it was not prescribed. Do not give Methylin Oral Solution
to other people, even if they have the same condition. It may harm them and it
is against the law.
This Medication Guide summarizes the most important
information about Methylin Oral Solution. If you would like more information,
talk with your doctor. You can ask your doctor or pharmacist for information
about Methylin Oral Solution that was written for healthcare professionals. For
more information, please contact Shionogi Inc. at 1-800-849-9707 or visit the
website at www.methylinrx.com.
What are the ingredients in Methylin Oral Solution?
Active Ingredient: methylphenidate hydrochloride
Inactive Ingredients: citric acid anhydrous,
glycerin, N&A grape flavor, PEG 1450, and purified water.
This Medication Guide has been approved by the U.S.
Food and Drug Administration.