(meth il fen' i date)
[Posted 12/17/2013] ISSUE: FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. Based on a recent review of methylphenidate products, FDA updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. If not treated right away, priapism can lead to permanent damage to the penis.
Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Another ADHD drug, Strattera (atomoxetine), has also been associated with priapism in children, teens, and adults.
Priapism appears to be more common in patients taking atomoxetine than in those taking methylphenidate products; however, because of limitations in available information, FDA does not know how often priapism occurs in patients taking either type of product.
See the FDA Drug Safety Communication for additional information, including a Data Summary
BACKGROUND: Methylphenidate products are central nervous system (CNS) stimulants used to treat attention deficit hyperactivity disorder (ADHD).
RECOMMENDATION: Healthcare professionals should talk to male patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.
Encourage your patients to read the Medication Guide they receive with every filled prescription. Use caution when considering switching patients from methylphenidate to atomoxetine. Patients should not stop taking a methylphenidate product without first discussing it with your health care professional.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .
Methylphenidate can be habit-forming. Do not apply more patches, apply the patches more often, or leave the patches on for longer than prescribed by your doctor. If you use too much methylphenidate, you may find that the medication no longer controls your symptoms, you may feel a need to use large amounts of the medication, and you may experience unusual changes in your behavior. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
Do not stop using methylphenidate transdermal patches without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression if you suddenly stop using methylphenidate transdermal patches after overusing the medication. Your doctor may need to monitor you carefully after you stop using methylphenidate transdermal patches, even if you have not overused the medication, because your symptoms may worsen when treatment is stopped.
Do not sell, give away, or let anyone else use your methylphenidate transdermal patches. Selling or giving away methylphenidate transdermal patches may harm others and is against the law. Store methylphenidate transdermal patches in a safe place so no one else can use them accidentally or on purpose. Keep track of how many patches are left so you will know if any are missing.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with methylphenidate transdermal patches and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
Methylphenidate transdermal patches are used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Methylphenidate is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.
HOW should this medicine be used?
Transdermal methylphenidate comes as a patch to apply to the skin. It is usually applied once a day in the morning and left in place for up to 9 hours. Apply the methylphenidate patch at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use methylphenidate patches exactly as directed.
Your doctor will probably start you on a low dose of methylphenidate and gradually increase your dose, not more often than once every week.
Your doctor may tell you to stop using methylphenidate patches from time to time to see if the medication is still needed. Follow these directions carefully.
Apply the patch to the hip area. Do not apply the patch to an open wound or cut, to skin that is irritated, red, or swollen, or to skin that is affected by a rash or other skin problem. Do not apply to the patch to the waistline because it may be rubbed off by tight clothing. Do not apply a patch to the same spot two days in a row; each morning apply the patch to the hip that did not have a patch the day before.
Methylphenidate patches should remain attached during normal daily activities, including swimming, showering, and bathing. If a patch does fall off, ask your child how and when this happened. When you notice that a patch has fallen off, you may apply a new patch to a different area of the same hip. However, you should remove the new patch at the time that you were scheduled to remove the original patch.
While you are wearing the patch, keep that hip away from direct sources of heat such as heating pads, electric blankets, and heated waterbeds.
To apply the patch, follow these steps:
- Talk to your doctor about what time you should apply the patch. You should apply the patch 2 hours before the effects of the medication are needed.
- Wash and dry the skin in the area where you plan to apply the patch. Be sure that the skin is free of powders, oils, and lotions.
- Open the tray that contains the patches and throw away the drying agent that comes in the tray.
- Remove one pouch from the tray and cut it open with scissors. Be careful not to cut the patch. Never use a patch that has been cut or damaged in any way.
- Remove the patch from the pouch and hold it with the protective liner facing you.
- Peel off half of the liner. Be careful not to touch the sticky side of the patch with your fingers.
- Use the other half of the liner as a handle and apply the patch to the skin.
- Press the patch firmly in place and smooth it down.
- Hold the sticky half of the patch down with one hand. Use the other hand to pull back the other half of the patch and gently peel off the remaining piece of the protective liner.
- Use the palm of your hand to press the entire patch firmly in place for about 30 seconds.
- Go around the edges of the patch with your fingers to press them onto the skin. Be sure that the entire patch is firmly attached to the skin.
- Throw away the empty pouch and the protective liner in a closed trash can that is out of reach of children and pets. Do not flush the pouch or liner down the toilet.
- Wash your hands after you handle the patch.
- Record the time that you applied the patch on the administration chart that comes with the patches. Use the timetable in the patient information that comes with the patches to find the time that the patch should be removed. Do not follow these times if your doctor has told you to use the patch for less than 9 hours. Follow your doctor's instructions carefully and ask your doctor if you do not know when you should remove the patch.
- When it is time to remove the patch, use your fingers to peel it off slowly.
- Fold the patch in half with the sticky sides together and press firmly to seal it shut. Flush the patch down the toilet or throw it away in a closed trash can that is out of the reach of children and pets.
- If there is any adhesive left on the skin, gently rub the area with oil or lotion to remove it.
- Wash your hands.
- Record the time that you removed the patch and the way that you threw it away on the administration chart.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using methylphenidate,
- tell your doctor and pharmacist if you are allergic to methylphenidate, any other medications, any other skin patches, or any soaps, lotions, cosmetics, or adhesives that are applied to the skin.
- tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), rasagiline (Azilect), or selegiline (Eldepryl, Emsam, Zelapar), or if you have taken one of these medications during the past 14 days. Your doctor will probably tell you not to use methylphenidate patches until at least 14 days have passed since you last took an MAO inhibitor.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants such as clomipramine (Anafranil); desipramine (Norpramin) and imipramine (Tofranil); clonidine (Catapres); medications for high blood pressure; medications for seizures such as phenobarbital, phenytoin (Dilantin), and primidone (Mysoline); nonprescription medications used for colds, allergies, or nasal congestion; and selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you or anyone in your family has or has ever had Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words), motor tics (repeated uncontrollable movements), or verbal tics (repetition of sounds or words that is hard to control). Also tell your doctor if you have glaucoma (increased pressure in the eye that may cause vision loss), or feelings of anxiety, tension, or agitation. Your doctor will probably tell you not to use methylphenidate patches.
tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, heart or blood vessel disease, hardening of the arteries, or other heart problems. Your doctor will examine you to see if your heart and blood vessels are healthy. Your doctor will probably tell you not to use methylphenidate patches if you have a heart condition or if there is a high risk that you may develop a heart condition.
- tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Also tell your doctor if you have or have ever had seizures; an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain); mental illness; or a skin condition such as eczema (a condition that causes the skin to be dry, itchy, or scaly), psoriasis (a skin disease in which red scaly patches form on some areas of the body), or seborrheic dermatitis (condition in which flaky white or yellow scales form on the skin).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using methylphenidate, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using methylphenidate patches.
- you should know that methylphenidate should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
You may apply the missed patch as soon as you remember it. However, you should still remove the patch at your regular patch removal time. Do not apply extra patches to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Methylphenidate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- loss of appetite
- weight loss
- stuffed or runny nose
- swelling inside the nose
- redness or small bumps on the skin that was covered by the patch
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- fast, pounding, or irregular heartbeat
- chest pain
- shortness of breath
- excessive tiredness
- slow or difficult speech
- dizziness or faintness
- weakness or numbness of an arm or leg
- blurred vision
- changes in vision
- swelling or blistering of the skin that was covered by the patch
- motion tics or verbal tics
- believing things that are not true
- feeling unusually suspicious of others
- aggressive behavior
- changes in mood
- unusual sadness or crying
- hallucinations (seeing things or hearing voices that do not exist)
Methylphenidate patches may cause sudden death in children and teenagers, especially children and teenagers with heart defects or serious heart problems. This medication also may cause heart attack or stroke in adults, especially adults with heart defects or serious heart problems. Talk to your doctor about the risks of using this medication.
Methylphenidate patches may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is using this medication. Talk to your child's doctor about the risks of applying methylphenidate patches to your child.
Methylphenidate patches may cause an allergic reaction. Some people who have an allergic reaction to methylphenidate patches may not be able to take methylphenidate by mouth in the future. Talk to your doctor about the risks of using methylphenidate patches.
Methylphenidate may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any patches that are outdated or no longer needed by opening each pouch, folding each patch in half with the sticky sides together, and flushing the folded patches down the toilet or placing them in a closed trash can that is out of the reach of children and pets. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
If someone applies extra methylphenidate patches, remove the patches and clean the skin to remove any adhesive. Than call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- uncontrollable shaking of a part of the body
- coma (loss of consciousness for a period of time)
- extreme happiness
- hallucinations (seeing things or hearing voices that do not exist)
- fast, pounding, or irregular heartbeat
- wide pupils (black circles in the middle of the eyes)
- dry mouth and nose
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to methylphenidate.
Do not let anyone else use your medication. This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
- Methylphenidylacetate hydrochloride