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.

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:

• 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

• 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