METHYLPHENIDATE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Concerta
• Daytrana
• Metadate CD
• Ritalin
• Ritalin LA
• Ritalin-SR

In Canada?

• PMS-Methylphenidate
• Riphenidate
• Ritalin
• Ritalin SR

Generic name product may be available in the U.S.

Category

• Central nervous system stimulant

Description

Methylphenidate (meth-il-FEN-i-date)belongs to the group of medicines called central nervous system (CNS) stimulants.It is used to treat attention-deficit hyperactivity disorder (ADHD), narcolepsy(uncontrollable desire for sleep or sudden attacks of deep sleep), and otherconditions as determined by the doctor.

Methylphenidate 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 a doctor's prescription. Prescriptionscannot be refilled. A new written prescription must be obtained from yourdoctor each time you or your child needs this medicine.

Methylphenidate is available in the following dosage forms:

Oral
• Tablets (U.S. and Canada)
• Extended-release tablets (U.S. and Canada)
• Extended-release capsules (U.S.)

Topical
• Transdermal (stick-on) skin patch (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 methylphenidate,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to methylphenidate. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein humans. However, it has been found to cause birth defects and other problemsin animals at doses many times the human dose.

Breast-feeding?It is not known whether methylphenidate 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 the doctor.

Children?Loss of appetite, trouble in sleeping, stomach pain,fast heartbeat, and weight loss may be especially likely to occur in children,who are usually more sensitive than adults to the effects of methylphenidate.Some children who used medicines like methylphenidate for a long time grewmore slowly than expected. It is not known whether long-term use of methylphenidatecauses slowed growth. The doctor should regularly measure the height and weightof children who are taking methylphenidate. Some doctors recommend stoppingtreatment with methylphenidate during times when the child is not under stress,such as on weekends.

This medicine should not be used in children under 6 years of age.

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 methylphenidate in the elderly 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 takingmethylphenidate, it is especially important that your health care professionalknow if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills) or
• Bupropion (e.g., Wellbutrin, Zyban) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Clonidine (e.g., Catapres)
• Cocaine or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, hay fever or other allergies(including nose drops or sprays) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert)?Using these medicines with methylphenidatemay cause severe nervousness, irritability, trouble in sleeping, or possiblyirregular heartbeat or seizures

• Guanethidine (e.g., Ismelin) ? Methylphenidate may reduce theeffects of this medicine

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline[e.g., Eldepryl], tranylcypromine [e.g., Parnate])?Taking methylphenidatewhile you are taking or less than 2 weeks after taking an MAO inhibitor maycause sudden extremely high blood pressure and severe convulsions; at least14 days should be allowed between stopping treatment with an MAO inhibitorand starting treatment with methylphenidate

• Pimozide (e.g., Orap)?Pimozide is not used to treat tics thatare caused by medicines. Before tics are treated with pimozide, the doctorshould find out if the tics are caused by methylphenidate

Other medical problems?The presence of other medicalproblems may affect the use of methylphenidate. Make sure you tell your doctorif you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)?Dependence on methylphenidatemay be more likely to develop

• Epilepsy or other seizure disorders?The risk of having convulsions(seizures) may be increased

• Gilles de la Tourette's disorder (or family history of) or
• Glaucoma or
• Heart failure or
• High blood pressure or
• Psychosis or
• Severe anxiety, agitation, tension, or depression or
• Thyroid (overactive) or
• Tics (other than Tourette's disorder)?Methylphenidate may makethe condition worse

• Heart problems or
• Family history of heart problems?May make the condition worseand cause serious problems

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.

This medicine may be taken with or without food, depending on which brandis used.

To help prevent trouble in sleeping, take the last dose of the short-actingtablets before 6 p.m., unless otherwise directed by your doctor.

If you think this medicine is not working properly after you have takenit for several weeks, do not increase the dose.Instead, check with your doctor.

If you are taking the long-acting form of this medicine:

• These tablets or capsules are to be swallowed whole. Do not break,open, crush, or chew before swallowing.
• If you are taking Concerta brand of methylphenidate extended-releasetablets, you may sometimes notice what looks like a tablet in your stool.This is just the empty shell that is left after the medicine has been absorbedinto your body.

For patients using the transdermal system (skin patch):

• Methylphenidate patches come with patient instructions. Read them carefully before using this medicine. Methylphenidate patches willwork only if applied correctly.
• Do not remove the patch from its sealed pouchuntil you are ready to put it on your skin. The patch may not workas well if it is unwrapped too soon.
• Apply the patch 2 hours before the desired effect.
• Do not try to trim or cut the adhesive patchto adjust the dosage. Check with your healthcare professional if youthink the medicine is not working as it should.
• Apply the patch to a clean, dry area of skin on your hip. Choosean area that is not very oily, has little or no hair, and is free of scars,cuts, burns, or any other skin irritations. A different place on either hipshould be chosen each day. The patch should not be applied to the waistline,or where tight clothing may rub it.
• Press the patch firmly in place with the palm of your hand for about10 seconds. Make sure there is good contact with your skin, especially aroundthe edges of the patch.
• The patch should stay in place even when you are showering, bathing,or swimming. Apply a new patch if one falls off. However, the total time ofwearing a patch for that day should not exceed the total amount of time inone day that your doctor prescribed for you to wear the patch.
• Remove the patch approximately 9 hours after it has been applied, as directed by your doctor.
• After removing a used patch, fold the patch in half with the stickysides together. Place the folded, used patch in its protective pouch or inaluminum foil. Make sure to dispose of it out of the reach of children andpets.

Dosing?The dose of methylphenidate will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of methylphenidate. If your dose isdifferent, do not change it unless your doctor tells you to do so.

The number of tablets or capsules that you take depends on the strengthof the medicine. Also, the number of doses you take eachday, the time allowed between doses, and the length of time you take the medicinedepend on the medical problem for which you are using methylphenidate.

• For attention-deficit hyperactivity disorder:
  • For short-acting oral dosage form (tablets):
    • Adults and teenagers?5 to 20 milligrams (mg) two or three timesa day, taken with or after meals.
    • Children 6 years of age and older?To start, 5 mg two timesa day, taken with or after breakfast and lunch. If needed, your doctor mayincrease the dose once a week by 5 to 10 mg a day until symptoms improve ora maximum dose is reached.
    • Children up to 6 years of age?The dose must be determined bythe doctor.
  • For long-acting oral dosage form (extended-releasetablets):
    • Adults, teenagers , and children?The dose must be determinedby the doctor.
  • For long-acting oral dosage form (extended-releasecapsules):
    • Adults, teenagers, and children over 6 years of age?The recommendedstarting dose is 20 mg a day, taken in the morning before breakfast. Yourdoctor may increase the dose once a week as needed up to 60 mg a day.
    • Children up to 6 years of age?The dose must be determined bythe doctor.
  • For the transdermal (stick-on) skin patch:
    • Adults, teenagers, and children over 6 years of age?The doseyou receive will be determined by your doctor on an individual basis.
    • Children up to 6 years of age?The dose must be determined byyour doctor
• For narcolepsy:
  • For short-acting oral dosage form (tablets):
    • Adults and teenagers?5 to 20 mg two or three times a day, takenwith or after meals.
  • For long-acting oral dosage form (extended-releasetablets):
    • Adults and teenagers?The dose must be determined by the doctor.

Missed dose?If you miss a dose of this medicine, contact yourhealthcare professional for instructions.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• 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 thismedicine does not cause unwanted effects, such as high blood pressure.

Methylphenidate may cause dizziness, drowsiness, or changes in vision.Do not drive a car, ride a bicycle, operate machinery, or do other thingsthat might be dangerous until you know how this medicine affects you.

If you take this medicine in large doses and/or 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 takingbefore you stop completely. This is to help reduce unwanted effects.

If you think you may have become mentally or physicallydependent on this medicine, check with your doctor. Some signs of dependenceon methylphenidate are:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to receive the effects of the medicine.
• Withdrawal side effects (for example, mental depression, unusualbehavior, or unusual tiredness or weakness) occurring after the medicine isstopped.

If you are using the methylphenidate transdermal patches and you experienceany swelling or blistering where the patch has been, you should be seen byyour doctor.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possibleif any of the following side effects occur:

More common

Fast heartbeat; increased blood pressure

Less common

Chest pain; fever; joint pain; skin rash or hives; uncontrolled movements of the body

Rare

Black, tarry stools; blistering, burning,itching, peeling, skin rash, redness, or other signs of irritation; blood in urine or stools; blurred visionor other changes in vision; convulsions (seizures); crusting, dryness, flaking of skin; muscle cramps; pinpoint red spots onskin; scaling, severe redness, soreness, swellingof skin; uncontrolled vocal outbursts and/or tics(uncontrolled and repeated body movements); unusualbleeding or bruising

Incidence unknown

Abnormal liver function; black, tarrystools ; confusion; cracksin the skin; hives or welts; loss of heat from the body; numbness of hands; painful or difficult urination ; paleskin ; red, irritated eyes; red, swollen, scaly skin; severe or sudden headache; shortness of breath; sore throat; sores, ulcers, or white spots onlips or in mouth; sudden loss of coordination; sudden slurring of speech; swollenglands; troubled breathing with exertion ; unusual bleeding or bruising; unusualtiredness or weakness

With long-term use or at high doses

Changes in mood; confusion; delusions (false beliefs); depersonalization(feeling that self or surroundings are not real); hallucinations (seeing, hearing, or feeling things that are not there); weight loss

Symptoms of overdose

Agitation; confusion (severe); convulsions (seizures); dryness of mouthor mucous membranes; false sense of well-being; fast, pounding, or irregular heartbeat; fever; flushing; hallucinations(seeing, hearing, or feeling things that are not there); headache (severe); increased blood pressure; increased sweating; large pupils; muscle twitching; overactive reflexes; sweating; trembling orshaking; vomiting

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

More common

Blisters under the skin; flushing, rednessof skin; loss of appetite; nervousness; small, rounded bumps rising from theskin; stuffy nose; swellingat site of patch application; trouble in sleeping; unusually warm skin

Less common

Anger; dizziness; drowsiness; fear; headache; irritability; muscle aches; nausea; nervousness; runny nose; scalp hair loss; sleeplessness; stomach pain; talking, feeling, and acting with excitement; trouble sleeping; unable to sleep

After youstop using this medicine, your body may need time to adjust. The length oftime this takes depends on the amount of medicine you were using and how longyou used it. During this period of time check with your doctor if you noticeany of the following side effects:

Mental depression (severe); unusualbehavior; unusual tiredness or weakness

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although not specifically included in productlabeling, methylphenidate may be used in certain patients with the followingcondition:

• Depressive disorder secondary to physical illness in patients whocannot take antidepressant medicines.

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.