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|Focalin

DEXMETHYLPHENIDATE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Focalin
• Focalin XR

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 nervous system (CNS) stimulants. It is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Dexmethylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long or are easily distracted, and are impulsive. This medicine 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. Prescriptions cannot be refilled. A new written prescription must be obtained from your doctor 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 will do. 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 unusual or allergic reaction to dexmethylphenidate or methylphenidate (e.g., Concerta, Metadate CD, Ritalin, Ritalin SR). Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Dexmethylphenidate has not been studied in pregnant women. However, studies in animals have shown that dexmethylphenidate causes some problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether dexmethylphenidate passes into 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 taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Side effects such as loss of appetite, stomach pain, weight loss (during prolonged treatment), trouble sleeping, and a fast heartbeat may be especially likely to occur in children, who are usually more sensitive than adults to the effects of dexmethylphenidate. Some children who used medicines like dexmethylphenidate for a long time grew more slowly than expected. It is not known whether long-term use of dexmethylphenidate causes slowed growth. The doctor should regularly measure the height and weight of children who are taking methylphenidate. Studies on this medicine have been done only in children 6 years of age and older and there is no specific information comparing use of dexmethylphenidate in children less than 6 years of age with use in other age groups.

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 dexmethylphenidate with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two 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 dexmethylphenidate, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antacids (medicines for indigestion or heartburn)—May alter the 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]—Use of these medicines with dexmethylphenidate has been shown to increase the effects of dexmethylphenidate

• Clonidine or other centrally acting alpha-2 agonists (medicine for high blood pressure) (e.g., Catapres, Duraclon)—Serious problems have been reported but the safety of using methylphenidate in combination with clonidine 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 2 weeks of taking monoamine oxidase (MAO) inhibitors may cause high blood pressure problems

• Pressor agents used for treatment of hypotension (check with your doctor for specific drugs)—Use of dexmethylphenidate with pressor agents may result in increased blood pressure.

Other medical problems—The presence of other medical problems may affect the use of dexmethylphenidate. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on dexmethylphenidate may be more likely to develop

• Agitation or
• Anxiety or
• Tension—Dexmethylphenidate may make the condition worse and should NOT be used.

• Depression, severe or
• Glaucoma or
• Motor tics or
• Tourette"s syndrome, family history or diagnosis—Dexmethylphenidate should not be used when these conditions exist.

• Growth rate slowed, long-term—Reported with long-term use of stimulant 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 and thought 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 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.

Dexmethylphenidate may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, 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 contents of the capsule. Open the capsule carefully and sprinkle the beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken immediately in its entirety. The drug and applesauce should not be stored for future use.

While your are taking dexmethylphenidate, your doctor may require different tests 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 different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of dexmethylphenidate. If your dose is 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 taking other stimulant medicines other than methylphenidate—10 milligrams (mg) one time a day in the morning. If needed, your doctor may increase the dose once a week by 10 mg a day until symptoms improve or a maximum dose is reached.
      • Patients taking methylphenidate—Your doctor will start the dose at half the dose of methylphenidate you are taking, one time a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 20 mg one time a day.
    • Children 6 years of age and older—
      • Patients not taking dexmethylphenidate, methylphenidate, or taking other stimulant medicines other than methylphenidate—5 milligrams (mg) one time a day in the morning. If needed, your doctor may increase the dose once a week by 5 mg a day until symptoms improve or a maximum dose is reached.
      • Patients taking methylphenidate—Your doctor will start the dose at half the dose of methylphenidate you are taking, one time a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 20 mg one time a day.
    • Children up to 6 years of age—Use and dose must be determined by 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 medicines other than methylphenidate—2.5 milligrams (mg) two times a day, at least 4 hours apart. If needed, your doctor may increase the dose once a week by 2.5 to 5 mg a day until symptoms improve or a maximum dose is reached.
      • Patients taking methylphenidate—Your doctor will start the dose at half the dose of methylphenidate you are taking, at least 4 hours apart. If needed, your doctor will adjust your dose once a week to a maximum dose of 10 mg two times a day.
    • Children up to 6 years of age—Use and dose must be determined by your 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 that are at least 4 hours apart for the tablets and 24 hours apart for the extended-release capsules. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children. Overdose of dexmethylphenidate is very dangerous in young children.
• Store away from direct light and heat
• 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.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits and make sure that your dose 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 medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Side Effects of This Medicine

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.

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

Developed: 11/21/2002
Revised: 07/13/2005

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