DEXMETHYLPHENIDATE (Systemic)?
Some commonly used brand names are:
In the U.S.?
Generic name product may be available in the U.S.
Other commonly used names are: D-methylphenidate and Ritadex.
? Not commercially available in Canada.
Category
- Central nervous system(CNS) stimulant
Description
Dexmethylphenidate (deks-meth-il-FEN-i-date) belongs to the group of medicines called central nervoussystem (CNS) stimulants. It is used to treat Attention Deficit HyperactivityDisorder (ADHD) in patients 6 years of age and older.
Dexmethylphenidate works in the treatment of ADHD by increasing attentionand decreasing restlessness in children and adults who are overactive, cannotconcentrate for very long or are easily distracted, and are impulsive. Thismedicine is used as part of a total treatment program that also includes social,educational, and psychological treatment.
This medicine is available only with your doctor's prescription. Prescriptionscannot be refilled. A new written prescription must be obtained from yourdoctor each time you or your child needs this medicine.
Dexmethylphenidate is available in the following dosage form:
Oral- Extended-release (long-acting) capsules (U.S.)
- Tablets (U.S.)
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For dexmethylphenidate,the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to dexmethylphenidate or methylphenidate (e.g., Concerta,Metadate CD, Ritalin, Ritalin SR). Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Dexmethylphenidate has not been studied in pregnantwomen. However, studies in animals have shown that dexmethylphenidate causessome problems. Before taking this medicine, make sure your doctor knows ifyou are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether dexmethylphenidate passesinto breast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.
Children?Side effects such as loss of appetite, stomachpain, weight loss (during prolonged treatment), trouble sleeping, and a fastheartbeat may be especially likely to occur in children, who are usually moresensitive than adults to the effects of dexmethylphenidate. Some childrenwho used medicines like dexmethylphenidate for a long time grew more slowlythan expected. It is not known whether long-term use of dexmethylphenidatecauses slowed growth. The doctor should regularly measure the height and weightof children who are taking methylphenidate. Studies on this medicine havebeen done only in children 6 years of age and older and there is no specificinformation comparing use of dexmethylphenidate in children less than 6 yearsof age with use in other age groups.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof dexmethylphenidate with use in other age groups.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingdexmethylphenidate, it is especially important that your doctor and pharmacistknow if you are taking any of the following:
- Antacids (medicines for indigestion or heartburn)?May alterthe release of dexmethylphenidate in the long-acting capsule formulation
- Anticonvulsants (medicine for seizures) including phenobarbital (e.g.,Luminal), phenytoin (e.g., Dilantin, Phenytek) or
- Coumarin anticoagulants (blood thinners) (e.g., warfarin [Coumadin])or
- Selective serotonin reuptake inhibitors (SSRIs) (citalopram [e.g.,Celexa], escitalopram [e.g., Lexapro], fluoxetine [e.g., Prozac], fluvoxamine[e.g., Luvox], nefazodone [e.g., Serzone], paroxetine [e.g., Paxil], sertraline[e.g., Zoloft], trazodone [e.g., Desyrel], venlafaxine [e.g., Effexor] or
- Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., pertofrane],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]?Useof these medicines with dexmethylphenidate has been shown to increase theeffects of dexmethylphenidate
- Clonidine or other centrally acting alpha-2 agonists (medicine forhigh blood pressure) (e.g., Catapres, Duraclon)?Serious problems havebeen reported but the safety of using methylphenidate in combination withclonidine has not been studied
- Monoamine oxidase (MAO) inhibitors (isocarboxazid [e.g., Marplan],phenelzine [e.g., Nardil], selegiline [e.g., Elderpyl], tranylcypromine [e.g.,Parnate])?Taking dexmethylphenidate while you are taking or within 2weeks of taking monoamine oxidase (MAO) inhibitors may cause high blood pressureproblems
- Pressor agents used for treatment of hypotension (check with yourdoctor for specific drugs)?Use of dexmethylphenidate with pressor agentsmay result in increased blood pressure.
Other medical problems?The presence of other medicalproblems may affect the use of dexmethylphenidate. Make sure you tell yourdoctor if you have any other medical problems, especially:
- Alcohol abuse (or history of) or
- Drug abuse or dependence (or history of)?Dependence on dexmethylphenidatemay be more likely to develop
- Agitation or
- Anxiety or
- Tension?Dexmethylphenidate may make the condition worse andshould NOT be used.
- Depression, severe or
- Glaucoma or
- Motor tics or
- Tourette's syndrome, family history or diagnosis?Dexmethylphenidateshould not be used when these conditions exist.
- Growth rate slowed, long-term?Reported with long-term use ofstimulant medicines similar to dexmethylphenidate
- Heart failure or
- Hypertension or
- Hyperthyroidism or
- Recent heart attack?May increase blood pressure or heart rate
- Psychosis?Dexmethylphenidate may make behavior problems andthought disorder symptoms in children worse.
- Seizures (history of) or
- EEG abnormalities or?The risk of having seizures may be increased.
Proper Use of This Medicine
Take this medicine only as directed by your doctor. Do not take moreof it, do not take it more often, and do not take it for a longer time thanyour doctor ordered. If too much is taken, it may become habit-forming.
Dexmethylphenidate may be taken with or without food or on a full or emptystomach. However, if your doctor tells you to take the medicine a certainway, take it exactly as directed.
You should take the extended-release capsule one time per day in the morning.
The extended-release capsule should be swallowed whole and not crushed,divided, or chewed.
If you are unable to swallow the capsule whole, you may sprinkle the contentsof the capsule. Open the capsule carefully and sprinkle the beads over a spoonfulof applesauce. The mixture of drug and applesauce should be taken immediatelyin its entirety. The drug and applesauce should not be stored for future use.
While your are taking dexmethylphenidate, your doctor may require differenttests for monitoring of your condition, such as blood pressure, heart rate,complete blood cell counts, and growth rates.
Dosing?The dose of dexmethylphenidate will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of dexmethylphenidate. If your doseis different, do not change it unless your doctor tells you to do so.
The number of tablets that you take depends on the strength of the medicine.
- For oral dosage form (long-acting capsules):
- For attention deficit hyperactivity disorder (ADHD):
- Adults and teenagers?
- Patients not taking dexmethylphenidate, methylphenidate, or takingother stimulant medicines other than methylphenidate?10 milligrams (mg)one time a day in the morning. If needed, your doctor may increase the doseonce a week by 10 mg a day until symptoms improve or a maximum dose is reached.
- Patients taking methylphenidate?Your doctor will start thedose at half the dose of methylphenidate you are taking, one time a day. Ifneeded, your doctor will adjust your dose once a week to a maximum dose of20 mg one time a day.
- Children 6 years of age and older?
- Patients not taking dexmethylphenidate, methylphenidate, or takingother stimulant medicines other than methylphenidate?5 milligrams (mg)one time a day in the morning. If needed, your doctor may increase the doseonce a week by 5 mg a day until symptoms improve or a maximum dose is reached.
- Patients taking methylphenidate?Your doctor will start thedose at half the dose of methylphenidate you are taking, one time a day. Ifneeded, your doctor will adjust your dose once a week to a maximum dose of20 mg one time a day.
- Children up to 6 years of age?Use and dose must be determinedby your doctor.
- For oral dosage form (tablets):
- For attention deficit hyperactivity disorder (ADHD):
- Adults, teenagers, and children 6 years of age and older?
- Patients not taking methylphenidate or taking other stimulant medicinesother than methylphenidate?2.5 milligrams (mg) two times a day, at least4 hours apart. If needed, your doctor may increase the dose once a week by2.5 to 5 mg a day until symptoms improve or a maximum dose is reached.
- Patients taking methylphenidate?Your doctor will start thedose at half the dose of methylphenidate you are taking, at least 4 hoursapart. If needed, your doctor will adjust your dose once a week to a maximumdose of 10 mg two times a day.
- Children up to 6 years of age?Use and dose must be determinedby your doctor.
Missed dose?If you miss a dose of this medicine, take itas soon as possible. Then take any remaining doses for that day at regularlyspaced intervals that are at least 4 hours apart for the tablets and 24 hoursapart for the extended-release capsules. Do not double doses.
Storage?To store this medicine:
- Keep out of the reach of children. Overdose of dexmethylphenidateis very dangerous in young children.
- Store away from direct light and heat
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Yourdoctor should check your progress at regular visits and make sure that yourdose is right and that the medicine is helping you.
Do not take other medicines unless they have been discussed with your doctor.This especially includes nonprescription medicines, such as aspirin, and medicinesfor appetite control, asthma, colds, cough, hay fever, or sinus problems.
This medicine may cause some people to become drowsy, dizzy, or less alertthan they are normally. Make sure you know how you reactto this medicine before you drive, use machines, or do anything else thatcould be dangerous if you are dizzy or are not alert.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Check with your doctor as soon as possibleif any of the following side effects occur:
Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you about ways to prevent or reducesome of these side effects. Check with your health care professional if anyof the following side effects continue or are bothersome or if you have anyquestions about them:
Symptoms of overdose
Get emergency help immediately if any of the followingsymptoms of overdose occur
Anxiety; bigger, dilated, or enlargedpupils (black part of eye); blurred vision; change in consciousness; chest painor discomfort; confusion as to time, place, or person; dizziness; dry mouth; dryness of mucous membranes; fainting; false or unusual sense of well-being; fast, slow, or irregular heartbeat ; feeling of warmth; fever; hallucinations; headache; holding false beliefs that cannot be changed by fact; hyperventilation; increased sensitivityof eyes to light; irregular heartbeats; irritability; lightheadedness; loss of consciousness; mood or mentalchanges; muscle twitching; nervousness; overactive reflexes; pounding in the ears; pounding or rapid pulse; redness of the face, neck, arms and occasionally upper chest; restlessness; shaking; seeing, hearing, or feeling things that are notthere; seizures; shortnessof breath; slow or fast heartbeat; sweating; tremors such as shakiness; trouble sleeping; unusualexcitement; vomiting
Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.
Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.
Developed: 11/21/2002
Revised: 07/13/2005
