Focalin

Generic Name: dexmethylphenidate (Oral route)

dex-meth-il-FEN-i-date

Oral route(Capsule, Extended Release;Tablet)

Give cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur .

Commonly used brand name(s)

In the U.S.

• Focalin


• Focalin XR

Available Dosage Forms:

• Tablet


• Capsule, Extended Release

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Focalin

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.

Before Using Focalin

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

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with 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 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

Interactions with Food/Tobacco/Alcohol

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) 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, or a family history of or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Psychosis (mental illness), history of or


• Seizures, history of or


• Stroke, history of or


• Tachycardia (increased heart rate)—May make these conditions worse.

Proper Use of dexmethylphenidate

This section provides information on the proper use of a number of products that contain dexmethylphenidate. It may not be specific to Focalin. Please read with care.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

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.

The extended-release capsule should be swallowed whole and not crushed, divided, or chewed.

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 not taking dexmethylphenidate, methylphenidate, or patients taking stimulant medicines other than methylphenidate—10 milligrams (mg) once a day in the morning. If needed, your doctor may increase the dose once a week by 10 mg per day until symptoms improve or a maximum dose of 20 mg is reached.
      
      
      • Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, once a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 20 mg once a 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 not taking dexmethylphenidate, methylphenidate, or patients taking stimulant medicines other than methylphenidate—5 milligrams (mg) once a day in the morning. If needed, your doctor may increase the dose once a week by 5 mg per day until symptoms improve or a maximum dose of 20 mg is reached.
      
      
      • Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, once a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 20 mg once a 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 not taking methylphenidate or patients taking 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 or 5 mg per day until symptoms improve or a maximum dose of 10 mg two times a day is reached.
      
      
      • Patients 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 While Using Focalin

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 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.

Focalin 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:

Less common

• Fast, pounding, or irregular heartbeat or pulse

Rare

• Blurred vision


• change in near or distance vision


• difficulty in focusing the eyes

Incidence not known

• 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:

Symptoms of overdose

• 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


• dryness of the 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 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 such as shakiness


• trouble with 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:

More common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• loss of appetite


• nausea


• stomach discomfort, upset, or pain


• throat pain


• weight loss

Less common

• 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.

See also: Focalin side effects (in more detail)

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More Focalin resources

• Focalin Side Effects (in more detail)
• Focalin Use in Pregnancy & Breastfeeding
• Focalin Drug Interactions
• Focalin Support Group
• 26 Reviews for Focalin - Add your own review/rating

• Focalin Prescribing Information (FDA)


• Focalin Consumer Overview


• Focalin Monograph (AHFS DI)


• Focalin MedFacts Consumer Leaflet (Wolters Kluwer)


• Dexmethylphenidate Prescribing Information (FDA)


• Focalin XR Prescribing Information (FDA)


• Focalin XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Focalin with other medications

• ADHD
• Auditory Processing Disorder