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Dexmethylphenidate (Oral Route)

US Brand Names

Description

Dexmethylphenidate 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 increases attention and decreases restlessness in children and adults who are hyperactive, cannot concentrate for very long, or are easily distracted and 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.

This product is available in the following dosage forms:

• Tablet
• Capsule, Extended Release

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dexmethylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of dexmethylphenidate have not been performed in the geriatric population.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Toloxatone
• Tranylcypromine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Agitation, severe or
• Anxiety, severe or
• Glaucoma or
• Motor tics (repeated muscle movements), history of or
• Tension, severe or
• Tourette's syndrome, or family history of—Should not be used in patients with these conditions.

• Alcohol abuse, history of or
• Drug abuse and dependence, history of—Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or
• Blood vessel problems or
• Coronary artery disease or
• Depression, or a family history of or
• Heart attack, recent or
• Heart disease (e.g., cardiomyopathy) or
• Heart failure or
• Heart rhythm problems (e.g., ventricular arrhythmia), or a family history of or
• Hypertension (high blood pressure) or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Stroke, history of or
• Tachycardia (increased heart rate)—Use with caution. May make these conditions worse.

Proper Use

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 be habit-forming. If you or your child feel that the medicine is not working properly after you have taken it for several weeks, check with your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

This medicine may be taken with or without food.

You should take the extended-release capsule only once a day and in the morning. If you take this medicine in the afternoon or evening, it might be harder for you to fall asleep. If your doctor tells you to take the medicine at a certain time, take it exactly as directed.

Swallow the extended-release capsule whole. Do not crush, divide, or chew it.

If you or your child are unable to swallow the capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The medicine and applesauce can not be stored for future use.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 the medicine.

• For attention deficit hyperactivity disorder (ADHD):
  • For oral dosage form (extended-release capsules):
    • Adults:
      • Patients new to dexmethylphenidate—At first, 10 milligrams (mg) once a day in the morning. If needed, your doctor may increase your dose once a week by 10 mg per day until symptoms improve or a maximum dose of 40 mg per day is reached.
      • Patients currently taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, given once a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 40 mg per day.
      • Patients using the regular dexmethylphenidate tablets will use the same number of milligrams per day as a single dose for the extended-release capsules.
    • Children 6 years of age and older:
      • Patients new to dexmethylphenidate—At first, 5 milligrams (mg) once a day in the morning. If needed, your doctor may increase your dose once a week by 5 mg per day until symptoms improve or a maximum dose of 30 mg per day is reached.
      • Patients currently taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, given once a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 30 mg per day.
      • Patients using the regular dexmethylphenidate tablets will use the same number of milligrams per day as a single dose for the extended-release capsules.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults, teenagers, and children 6 years of age and older:
      • Patients new to methylphenidate—At first, 2.5 milligrams (mg) two times a day, at least 4 hours apart. If needed, your doctor may increase your dose once a week by 2.5 or 5 mg per day until symptoms improve or a maximum dose of 10 mg two times a day is reached.
      • Patients currently taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, divided and taken two times a day 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 younger than 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure the dose is right and the medicine is helping you. Your doctor might need to check your blood, heart, and blood pressure for any unwanted effects.

You or your child should not use this medicine if you have used a medicine for depression called a monoamine oxidase inhibitor (MAOI) in the past 14 days. Some examples of MAOI are isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®, Zelapar®), or tranylcypromine (Parnate®).

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, allergies, or sinus problems.

This medicine may cause some people to have vision changes or 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, not alert, or not able to see well.

Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, shortness of breath, or fainting while taking this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

Side Effects

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 immediately if any of the following side effects occur:

• Fast, pounding, or irregular heartbeat or pulse

• Blurred vision
• Change in near or distance vision
• Difficulty in focusing the eyes

• Convulsions
• Muscle spasm or jerking of the arms and legs
• Sudden loss of consciousness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Anxiety
• Bigger, dilated, or enlarged pupils (black part of the eye)
• Blurred vision
• Change in consciousness
• Chest pain or discomfort
• Confusion as to time, place, or person
• Dizziness
• Dry mouth
• Fainting
• Fast, slow, or irregular heartbeat
• Feeling of warmth
• Fever
• Hallucinations
• Headache
• Hyperventilation
• Increased sensitivity of the eyes to light
• Irritability
• Lightheadedness
• Loss of consciousness
• Mood or mental changes
• Muscle twitching
• Nervousness
• Overactive reflexes
• Pounding in the ears
• Pounding or rapid pulse
• Redness of the face, neck, arms, and occasionally, upper chest
• Restlessness
• Seeing, hearing, or feeling things that are not there
• Seizures
• Shaking
• Shortness of breath
• Sweating
• Tremors or shakiness
• Trouble sleeping
• Unusual excitement
• Vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• Belching
• Heartburn
• Indigestion
• Loss of appetite
• Nausea
• Stomach discomfort, upset, or pain
• Throat pain
• Weight loss

• Sleeplessness
• Twitching
• Unable to sleep

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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