Generic Name: methylphenidate (METH-il-FEN-i-date)
Brand Name: Daytrana
Use methylphenidate system with caution if you have a history of mental or mood problems or alcohol or substance abuse or dependence. Abuse of methylphenidate system may cause it to not work as well. Abuse may also lead to addiction and mental or mood changes. Do not suddenly stop using methylphenidate system. Depression or other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.
Methylphenidate system is used for:
Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.
Methylphenidate system is a central nervous system stimulant. Exactly how it works to treat ADHD is not known.
Do NOT use methylphenidate system if:
- you are allergic to any ingredient in methylphenidate system
- you have severe anxiety, agitation, or tension
- you have glaucoma
- you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
- you have serious heart problems (eg, heart defect, irregular heartbeat)
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using methylphenidate system:
Some medical conditions may interact with methylphenidate system. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction to dexmethylphenidate
- if you have skin inflammation, a cut, or a skin wound; skin problems (eg, eczema, psoriasis); or an allergy or sensitivity to soap, lotion, cosmetics, or adhesives
- if you have circulation problems in your hands or feet (eg, Raynaud phenomenon, thromboangiitis obliterans)
- if you have a history of high blood pressure, heart problems (eg, heart failure, heart defects, fast or irregular heartbeat), blood vessel problems, or heart attack, or if a family member has a history of any of these problems or sudden death
- if you have a history of seizures or abnormal electroencephalograms (EEGs)
- if you have a history of an overactive thyroid, chronic fatigue, cystic fibrosis, or stomach or bowel problems (eg, blockage, inflammation, narrowing)
- if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a member of your family has had any of these problems
Some MEDICINES MAY INTERACT with methylphenidate system. Tell your health care provider if you are taking any other medicines, especially any of the following:
- MAOIs (eg, phenelzine) because severe high blood pressure may occur
- Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by methylphenidate system
- Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by methylphenidate system
This may not be a complete list of all interactions that may occur. Ask your health care provider if methylphenidate system may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use methylphenidate system:
Use methylphenidate system as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Methylphenidate system comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get methylphenidate system refilled.
- Do not remove the patch from the pouch until you are ready to apply it.
- Do NOT use the patch if the pouch seal is open or damaged or if the patch is cut or damaged in any way.
- Do NOT apply the patch to skin that is oily, damaged, or irritated, or skin that has lotion or powder on it. Do NOT apply to an open wound or cut skin.
- Do NOT apply the patch to the waistline or anywhere that tight clothing may rub it or cause it to fall off.
- Apply the patch 2 hours before the effect is needed, unless your doctor tells you otherwise.
- Gently wash and completely dry the application area before you apply the patch. Open the pouch. Remove the protective liner from the patch. Apply the patch to a clean, dry area on the hip. Hold it in place for 30 seconds. Be sure the edges are firmly attached to the skin. Choose a new area on the opposite hip each day when you apply the patch.
- Wash your hands immediately after handling methylphenidate system.
- Remove the patch 9 hours after it is applied, unless your doctor tells you otherwise.
- Remove the patch slowly. If the patch is difficult to remove, apply an oil-based product (eg, petroleum jelly, mineral oil) to the patch edges, gently working it underneath the edges. Oil or lotion may be used to remove any glue that remains on the skin after the patch has been removed.
- After removing the used patch, fold it in half with the sticky sides together. Throw the patch away in a container with a lid. You may also ask your doctor or pharmacist for other ways to dispose of methylphenidate system. Be sure it is out of the reach of children and away from pets.
- Do NOT flush the pouches or protective liners down the toilet. Throw these items away in a container with a lid, out of the reach of children and away from pets.
- If the patch falls off during the day, be sure you know when and how the patch came off. Choose a different site on the same hip and apply a new patch. Remove the patch at the regularly scheduled time.
- Do not wear the patch any longer than 9 hours in a 24-hour period.
- Use the administration chart that comes with methylphenidate system to monitor the date and time that you apply and remove the patch. Also record how you dispose of it.
- Throw away any unused patches as soon as they are no longer needed. Remove the patches from the pouch and remove the protective liners. Fold the patches in half with the sticky sides together. Throw the patches away in a container with a lid, or ask your doctor or pharmacist for other ways to properly dispose of methylphenidate system. Be sure they are out of the reach of children and away from pets. Wash your hands after throwing away methylphenidate system.
- If you miss a dose of methylphenidate system, apply the missed patch if you remember that day, then remove the patch at the regularly scheduled time. If it is close to the time that you would regularly remove the patch or if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule the next day. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use methylphenidate system.
Important safety information:
- Methylphenidate system may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use methylphenidate system with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Methylphenidate system should not be used to treat depression or to prevent or treat normal fatigue.
- Do NOT use more than the recommended dose without checking with your doctor.
- Methylphenidate system should be used as a part of an ADHD treatment program that includes a variety of treatment measures (eg, psychological, educational, social).
- If your condition does not get better within 1 month or if it gets worse, check with your doctor.
- Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition.
- Methylphenidate system may cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Methylphenidate system may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
- Tell your doctor or dentist that you take methylphenidate system before you receive any medical or dental care, emergency care, or surgery.
- Check with your doctor if methylphenidate system causes persistent loss of appetite or persistent sleeping problems. You may need to remove the patch earlier in the day, or you may need a different dose. Do not change your dose or stop using methylphenidate system without checking with your doctor.
- Contact your doctor if you develop redness, swelling, or blisters that do not improve within 48 hours after the patch is removed or that spread beyond the patch site.
- If you develop an allergic reaction to methylphenidate system, talk to your doctor before taking any other form of methylphenidate system (eg, tablets). You may also be allergic to the other forms of methylphenidate system.
- Do not expose the patch site to heating pads, electric blankets, hot water beds, or any other external heat source. It may increase the amount of medicine released from the patch, which may increase your risk of side effects.
- The patch should not come off during swimming, bathing, or showering if it has been applied properly. If the patch does come off during the day, apply a new patch as directed.
- Methylphenidate system may cause harm if it is chewed on or swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
- Before you start any new medicine, check the label to see if it has a decongestant in it. If it does or if you are not sure, check with your doctor or pharmacist.
- Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use methylphenidate system. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- It is not known if methylphenidate system may affect growth rate in CHILDREN and teenagers. They may need regular growth checks while they use methylphenidate system.
- Caution is advised when using methylphenidate system in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
- Methylphenidate system should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using methylphenidate system while you are pregnant. It is not known if methylphenidate system is found in breast milk. If you are or will be breast-feeding while you use methylphenidate system, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, methylphenidate system may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if methylphenidate system stops working well. Do not take more than prescribed.
Some people who use methylphenidate system for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking methylphenidate system. If you stop taking methylphenidate system suddenly, you may have WITHDRAWAL symptoms. These may include depression or other mental problems.
Possible side effects of methylphenidate system:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth; headache; indigestion; loss of appetite; mild sore throat; nausea; nervousness; redness, mild itching, or small bumps on the skin at the application site; stomach pain; stuffy nose; trouble sleeping; vomiting; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; joint pain; purple or brownish red spots on the skin; unusual hoarseness); blurred vision or other vision problems; chest, jaw, or arm pain; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; new or worsening mental, mood, or behavior changes (eg, abnormal thoughts, aggression, agitation, anxiety, depression, hostility, irritability, panic attacks, persistent crying, restlessness, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; sudden, severe nausea or vomiting; suicidal thoughts or attempts; swelling or blisters at the application site; tremor; uncontrolled speech or muscle movements; unusual sweating; unusual tiredness or weakness; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dilated pupils; exaggerated reflexes; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; mental or mood changes (eg, agitation); muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.Proper storage of methylphenidate system:
Store methylphenidate system at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store the patch in its sealed pouch in the tray provided. Do not store the patches outside the pouch. Throw away any unused patches within 2 months of opening the tray. Store away from heat, moisture, and light. Do not store in the bathroom. Keep methylphenidate system out of the reach of children and away from pets.
- If you have any questions about methylphenidate system, please talk with your doctor, pharmacist, or other health care provider.
- Methylphenidate system is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take methylphenidate system or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about methylphenidate system. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to methylphenidate system. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using methylphenidate system.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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