Description ----------- Methylphenidate (Systemic) Methylphenidate (meth-ill-FEN-i-date) belongs to the group of medicines called central stimulants. It is used to treat children with attention- deficit hyperactivity disorder (ADHD). Methylphenidate works by increasing attention and decreasing restlessness in children who are overactive, cannot concentrate for very long or are easily distracted, and are emotionally unstable. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment. Methylphenidate is also used in the treatment of narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep). This medicine is available only with a doctor's prescription. Prescriptions cannot be refilled. A new written prescription must be obtained from your doctor each time you or your child needs this medicine. Methylphenidate is available in the following dosage forms: Oral o Tablets (U.S. and Canada) o Extended-release tablets (U.S. and Canada) Before Using This Medicine -------------------------- Methylphenidate (Systemic) Before you begin using any new medicine (prescription or nonprescription) or if you develop any new medical problem while you are using this medicine, check with your doctor, nurse, or pharmacist. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methylphenidate, the following should be considered: ALLERGIES: Tell your doctor if you have ever had any unusual or allergic reaction to methylphenidate. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes. PREGNANCY: Studies on effects in pregnancy have not been done in either humans or animals. BREAST-FEEDING: It is not known whether methylphenidate passes into breast milk. CHILDREN: Loss of appetite, trouble in leeping, stomach pain, and weight loss, may be especially likely to occur in children, who are usually more sensitive than adults to the effects of methylphenidate. Also, there have been reports of children's growth rate being slowed when methylphenidate was used for a long time. Some doctors recommend drug-free periods during treatment with methylphenidate. OLDER ADULTS: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of methylphenidate in the elderly with use in other age groups. OTHER MEDICINES: Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking methylphenidate, it is especially important that your doctor and pharmacist know if you are taking any of the following: o Amantadine (e.g., Symmetrel) or o Amphetamines or o Appetite suppressants (diet pills), except fenfluramine (e.g., Pondimin) or o Caffeine (e.g., NoDoz) or o Chlophedianol (e.g., Ulone) or o Cocaine or o Medicine for asthma or other breathing problems or o Medicine for colds, sinus problems, hay fever or other allergies (including nose drops or sprays) or o Nabilone (e.g., Cesamet) or o Pemoline (e.g., Cylert): Using these medicines with methylphenidate may cause severe nervousness, irritability, trouble in sleeping, or possibly irregular heartbeat or seizures o Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline at doses more than 10 milligrams a day [e.g., Eldepryl], tranylcypromine [e.g., Parnate]): Taking methylphenidate while you are taking or within 2 weeks of taking MAO inhibitors may cause sudden extremely high blood pressure and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other o Pimozide (e.g., Orap): The cause of tics may be masked OTHER MEDICAL PROBLEMS: The presence of other medical problems may affect the use of methylphenidate. Make sure you tell your doctor if you have any other medical problems, especially: o Alcohol abuse (or history of) or o Drug abuse or dependence (or history of): Dependence on methylphenidate may develop o Epilepsy or other seizure disorders: The risk of convulsions (seizures) may be increased o Gilles de la Tourette's disorder (or history of) or o Glaucoma or o High blood pressure or o Psychosis or o Severe anxiety, agitation, tension, or depression or o Tics (other than Tourette's disorder): Methylphenidate may make the condition worse Precautions While Using This Medicine ------------------------------------- Methylphenidate (Systemic) Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects. If you will be taking this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on methylphenidate are: o A strong desire or need to continue taking the medicine. o A need to increase the dose to receive the effects of the medicine. o Withdrawal side effects (for example, mental depression, unusual behavior, or unusual tiredness or weakness) occurring after he medicine is stopped. Side Effects of This Medicine ----------------------------- Methylphenidate (Systemic) Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor as soon as possible if any of the following side effects occur: More common Fast heartbeat Less common Bruising; chest pain; fever; joint pain; skin rash or hives; uncontrolled movements of the body Rare Blurred vision or any change in vision; convulsions (seizures); sore throat and fever; unusual tiredness or weakness With long-term use Mood or mental changes; weight loss Symptoms of overdose Agitation; confusion; convulsions (seizures); delirium or hallucinations; dryness of mouth; false sense of well-being; fast, pounding, or irregular heartbeat; fever an sweating; headache (severe); increased blood pressure; muscle twitching; trembling or tremors; vomiting Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome: More common Loss of appetite; nervousness; trouble in sleeping Less common Dizziness; drowsiness; headache; nausea; stomach pain After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects: Mental depression (severe); unusual behavior; unusual tiredness or weakness Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Proper Use of This Medicine --------------------------- Methylphenidate (Systemic) Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. Take this medicine about 30 to 45 minutes before meals. To do so will help it to work better. If you are taking the long-acting form of this medicine: o These tablets are to be swallowed whole. Do not break, crush, or chew before swallowing. To help prevent trouble in sleeping, take the last dose of this medicine for each day before 6 p.m., unless otherwise directed by your doctor. If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor. DOSING: The dose of methylphenidate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of methylphenidate. If your dose is different, do not change it unless your doctor tells you to do so. o The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using methylphenidate. o For short-acting oral dosage forms (tablets): Adults and adolescents: 5 to 20 milligrams two or three times a day, taken thirty to forty-five minutes before meals. Children 6 years of age and over: To start, 5 milligrams two times a day, before breakfast and lunch. Your doctor may increase your dose if needed by 5 to 10 milligrams a week until symptoms improve or a maximum dose is reached. Children up to 6 years of age: The dose must be determined by the doctor. o For long-acting oral dosage forms (extended-release tablets): Adults and adolescents: 20 milligrams one to three times a day, spaced eight hours apart, and taken on an empty stomach. Children 6 years of age and over: 20 milligrams one to three times a day, spaced eight hours apart, and taken on an empty stomach. Children up to 6 years of age: The dose must be determined by the doctor. MISSED DOSE: If you miss a dose of this medicine, take it as soon as possible. Then take any remaining doses for that day at regularly spaced intervals. Do not double doses. STORAGE: To store this medicine: o Keep out of the reach of children. o Store away from heat and direct light. o Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. o Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.