All FDA warnings are at the end of this fact sheet. Please consult them before taking this medication.
Methylphenidate/dexmethylphenidate is a prescription medication that is used to treat children over 6 years old, adolescents, and adults with attention-deficit hyperactivity disorder (ADHD).
ADHD is associated with severe inattention, hyperactivity, and impulsivity that interfere with an individual's ability to function in school, at work, or in social settings. Examples of ADHD symptoms include making careless mistakes, losing things necessary for tasks, the inability to sit still and focus, and interrupting or intruding on others.
Adults have similar symptoms, but display less hyperactivity compared to children. Adults with ADHD may be more prone to procrastination, becoming easily frustrated and taking on many tasks at once while accomplishing none of them. A person may have severe inattention without hyperactivity or impulsivity and still meet criteria for the diagnosis of ADHD.
Methylphenidate/dexmethylphenidate is used in addition to non-medication treatments to manage ADHD symptoms.
Although some symptoms may improve within days of starting methylphenidate/dexmethylphenidate, it may take several weeks before you notice the full benefits of the medication.
In order for methylphenidate/dexmethylphenidate to work properly, it should be taken as ordered by your healthcare provider
Do not stop taking methylphenidate/dexmethylphenidate or change your dose without talking to with your healthcare provider first.
Methylphenidate/dexmethylphenidate should not be used at the same time or within 2 weeks of monoamine oxidase inhibitors (MAOIs), usually used to treat depression. MAOIs include phenelzine (Nardil®), tranylcypromine (Parnate®), selegiline (EMSAM®) and isocarboxazid (Marplan®). Some medications also have MAOI-like activity, such as the antibiotic linezolid (Zyvox®), and should be avoided as well. Using methylphenidate/dexmethylphenidate within 2 weeks of, or at the same time as, MAOIs can result in dangerously high blood pressure that can be fatal.
If you are planning on becoming pregnant, notify your healthcare provider so that he/she can best manage your medications. People living with ADHD who wish to become pregnant face important decisions, each with risks and benefits as they relate to how the illness, medications, and risks to the fetus may interact. This is a complex decision as untreated ADHD has risks to the fetus as well as the mother. Therefore, it is important to discuss this with your doctor and caregivers.
Regarding breast-feeding, caution is advised since there is limited information available about the safety of methylphenidate/dexmethylphenidate while breastfeeding.
Methylphenidate/dexmethylphenidate is usually taken one to three times per day with our without food.
While the dose usually varies, your healthcare provider will determine the dose that is right for you based upon your response.
If you miss a dose of methylphenidate/dexmethylphenidate, take it as soon as you remember it, if it is not too close to when your next dose is due-discuss this with your health care provider. Do not double your next dose or take more than what is prescribed. Do not take a missed dose after 5:00 PM, as this may interfere with sleep.
Avoid drinking alcohol or using illegal drugs while you are taking methylphenidate/dexmethylphenidate the beneficial effects of the medication may be decreased and adverse effects may be increased.
If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).
Overdosing with methylphenidate/dexmethylphenidate may lead to nausea and vomiting, rapid heart beat, abnormal heart rhythms, paranoia, hallucinations and seizures.
Upset stomach, loss of appetite, insomnia, and mild anxiety
Methylphenidate and dexmethylphenidate should be avoided in individuals who have a heart defect (structural abnormalities), uncontrolled high blood pressure, or a disorder of the heart or blood vessels.
Methylphenidate/dexmethylphenidate are rarely associated with clinically significant increases in blood pressure or heart rate. Blood pressure and heart rate should be monitored before starting medication, and then weekly while adjusting the dose and then every 1 to 3 months or when side effects like "racing heart", shortness of breath or exercise fatigue become problematic.
Severe anxiety, panic attacks, mania, hallucinations, paranoia and delusions are all possible. If they occur, the medication should be discontinued, and the individual should be evaluated by their health care provider.
Talk to your prescriber if you have concerns. Young males who have not yet reached puberty may not recognize the problem or may embarrassed to tell anyone. Know the signs and symptoms of priapism and seek immediate medical treatment if it occurs.
Methylphenidate/dexmethylphenidate is a Schedule II controlled substance, similar to other stimulant medications, such as amphetamine, mixed amphetamine salts, dextroamphetamine and lisdexamfetamine. There is a risk of physical and/or emotional dependence (addiction) when it is taken for long periods of time.
Although treatment with these medications can slow growth, many studies have shown that these changes are small, and children may catch-up with growth over time, therefore should not be a concern for most children. Height, weight, and eating habits should be discussed before treatment starts and regularly during treatment. If you are concerned about a child's growth, discuss other possible treatments with your child's doctor.
Medications used to treat depression such as tricyclic antidepressants (TCA) and monoamine oxidase inhibitors can interact with these medications resulting in serious reactions, including high body temperature, high blood pressure, and seizures (convulsions). Tell your healthcare provider if you are beginning or have recently discontinued any of these medications.
MAOIs, including phenelzine (Nardil®), Tranylcypromine (Parnate®), and selegiline (Emsam®), should not be taken with or within 2 weeks of taking these medications. Using these medications together can be fatal.
Medications that may increase the effects and adverse effects of methylphenidate/dexmethylphenidate include:
These medications may increase the blood level of some seizure medications such as phenobarbital or phenytoin. If you are taking any of these medications, tell your healthcare provider.
These medications may decrease response to some blood pressure medications such as clonidine, guanfacine, guanethidine and guanadrel. Tell your healthcare provider if you are taking any of these medications.
Urinary alkalinizers (e.g. sodium bicarbonate) may increase the effects of these medications, while urinary acidifiers (citrus beverages) may decrease the effects.
Although you may experience beneficial effects from methylphenidate/dexmethylphenidate within a few days of starting the medication, it often takes several weeks to get the full effect of the medication. Your healthcare provider may also need to adjust gradually the dose to find the dose that works best for you.
College of Psychiatric and Neurologic Pharmacists
FDA ALERT [02/2006] Sudden Unexplained Death, Cardiac/Cardiovascular, and Psychiatric Adverse Events Associated with Stimulant Therapy for ADHD.
In February of 2006, FDA warned of serious cardiac and cardiovascular risks including sudden unexplained death (SUD) associated with the use of methylphenidate or dexmethylphenidate in children, adolescents and adults. Individuals with structural heart abnormalities are at a greater risk for these adverse cardiac/cardiovascular effects although those without structural cardiac abnormalities are also at risk. In addition, psychiatric adverse events including hallucinations, increased aggression, and mania have been reported in individuals taking methylphenidate or dexmethylphenidate. The risk of these effects is greater in those with existing psychiatric illness.
Rarely, sudden unexplained death has been associated with stimulant use. Tell your prescriber about any history of heart disease in yourself or family member as it could increase the risk. These drugs also increase blood pressure and heart rate. Stimulants have a high potential for abuse and long term use may lead to dependence. Use or misuse may cause sudden death and serious cardiovascular events or stroke.
Stimulant medications have been associated with serious psychiatric adverse reactions including worsening psychosis, mania, panic attacks and severe anxiety.
FDA ALERT (12/2013) Risk of Long-Lasting Erections with Methylphenidate ADHD Medications
In December of 2013, the FDA warned that methylphenidate-containing products may in rare instances cause prolonged and sometimes painful erections known as priapism. Priapism may 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.
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