Focalin
Generic Name: dexmethylphenidate (Oral route)
dex-meth-il-FEN-i-date
Dexmethylphenidate hydrochloride should be given 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. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up .
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:
- Capsule, Extended Release
- Tablet
Therapeutic Class: CNS Stimulant
Chemical Class: Amphetamine Related
Compare with other drugs.
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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 overactive, 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 pediatrics-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
No information is available on the relationship of age to the effects of dexmethylphenidate in geriatric patients .
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
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 .
- Blood vessel problems or
- Depression, severe or
- Heart disease or failure or
- Heart rhythm problems or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid) or
- Psychosis (mental illness) or
- Seizures, history of or
- Tachycardia (rapid 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 one time each 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 drug 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) 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 of 20 mg is reached.
- Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, 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 patients taking 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 of 20 mg is reached.
- Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, 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 younger than 6 years of age—Use and dose must be determined by your doctor .
- Adults:
- 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 a 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 .
- Adults, teenagers, and children 6 years of age and older:
- For oral dosage form (extended-release capsules):
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
Your doctor should check your progress at regular visits and make sure that your dose is right and that the medicine is helping you. Your doctor will need to check your blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine .
You should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days .
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 that could be dangerous if you are dizzy or are not alert .
Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely 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 notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you 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
- Blurred vision
- change in near or distance vision
- difficulty in focusing eyes
- Convulsions
- muscle spasm or jerking of 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 eye)
- blurred vision
- change in consciousness
- chest pain or discomfort
- confusion as to time, place, or person
- dizziness
- dry mouth
- dryness of 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 eyes to light
- irregular heartbeats
- 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
- slow or fast heartbeat
- sweating
- tremors such as 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:
More common- Acid or sour stomach
- belching
- dry mouth
- headache
- heartburn
- indigestion
- loss of appetite
- nausea
- stomach discomfort, upset, or pain
- throat pain
- weight loss
- Fever
- sleeplessness
- trouble sleeping
- 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.
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More Focalin resources
Focalin XR Extended-Release Capsules
Compare Focalin with other medications for the treatment of:
Attention Deficit Hyperactivity Disorder, Auditory Processing Disorder
