WHAT IS FOCALIN XR?
Focalin XR is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.
Focalin XR is used to treat attention deficit hyperactivity disorder (ADHD).
Focalin XR may also be used for purposes not listed in this medication guide.
You should not use Focalin XR if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.
Focalin XR may be habit-forming, and Focalin XR is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.
Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.
Do not use Focalin XR if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Focalin XR may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.
You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.
Call your doctor right away if you have: signs of heart problems–chest pain, feeling light-headed or short of breath; signs of psychosis–paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems–unexplained wounds on your fingers or toes.
Before taking this medicine
You should not take this medicine if you are allergic to Focalin XR or methylphenidate (Ritalin, Concerta), or if you have:
a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).
Do not use Focalin XR if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Some medicines can interact with Focalin XR and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:
heart problems or a congenital heart defect;
high blood pressure; or
a family history of heart disease or sudden death.
To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:
depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
motor tics (muscle twitches) or Tourette’s syndrome;
blood circulation problems in the hands or feet;
seizures or epilepsy;
an abnormal brain wave test (EEG); or
a history of drug or alcohol addiction.
Taking this medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether dexmethylphenidate passes into breast milk or if it could harm nursing baby. Tell your doctor if you are breast-feeding.
Focalin XR is not approved for use by anyone younger than 6 years old.
This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.
How to use Focalin XR
Read the Medication Guide provided by your pharmacist before you start taking dexmethylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily in the morning, with or without food. Taking this medication late in the day may cause trouble sleeping (insomnia).
The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor.
Do not break, crush, or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Swallow the capsules whole. If you have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a spoonful of cool applesauce. Swallow all of the mixture right away without chewing it. Then drink a glass of cool liquid to make sure you have swallowed all of the dose. Do not prepare the mixture ahead of time.
Methylphenidate and dexmethylphenidate are different medications and do not provide the same amount of medicine. Do not switch between products unless your doctor tells you to.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your condition does not improve or if it worsens.
See also Warning section.
Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood circulation problems (such as Raynaud’s disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal/family history of uncontrolled muscle movements (motor tics, Tourette’s syndrome), overactive thyroid (hyperthyroidism), seizure disorder.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
If used for a long time, this drug may affect a child’s growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child’s weight and height regularly, and consult your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping, weight loss, or chest pain.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Dexmethylphenidate is very similar to methylphenidate. Do not use medications containing methylphenidate while using dexmethylphenidate.
This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson’s disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Trouble sleeping, nervousness, dizziness, dry mouth, heartburn, nausea, stomach pain, headache, loss of appetite, or weight loss may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts, thoughts of suicide), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control, vision changes (such as blurred vision).
Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).
Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
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