IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate or effective for you. Consult your healthcare professional before using this drug.
Table of Contents
- Uses and How to Use
- Dosage and Storage
- Precautions and Side Effects
- Drug Interactions
- Drug Images
Pronounced: (dex-meth-ill-FEN-eh-date)
Focalin XR Oral Warning
Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.
Dexmethylphenidate may be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Such patients may be more likely to increase their dose of this drug unnecessarily or take this medication too often. With prolonged use or abuse of this medication, drug dependence and abnormal behavior may occur. Withdrawal symptoms may occur after stopping the drug. Consult your doctor or pharmacist for more details. (See also How to Use section.)
Focalin XR Oral Side Effects
Trouble sleeping, dizziness, dry mouth, heartburn, nausea, stomach pain, headache, nervousness, loss of appetite, or weight loss may occur. If any of these effects persist or worsen, notify your doctor.
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.
Tell your doctor immediately if any of these unlikely but serious side effects occur:
- high fever
- uncontrolled muscle movements (e.g., stiffness, twitching, shaking)
- mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal behavior/thoughts)
- outbursts of words/sounds
- severe sweating
- swelling of the ankles/feet
- extreme tiredness
- blurred vision
Seek immediate medical attention if any of these rare but very serious side effects occur:
- shortness of breath
- fainting
- blurred vision
- slurred speech
- confusion
- easy bleeding/bruising
- chest/jaw/left arm pain
- severe headache
- fast/irregular/pounding heartbeat
- signs of infection (fever, persistent sore throat)
- seizures
- weakness
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:
- 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.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Focalin XR Oral Precautions
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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:
- certain mental/mood conditions (e.g., agitation, psychosis)
- heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy)
- problems with heart structure (e.g., valve problems)
- history of heart attack or stroke
- severe anxiety/tension
- certain eye problem (glaucoma)
- personal or family history of uncontrolled muscle movements (motor tics, Tourette's syndrome)
- seizures
Tell your doctor your medical history, especially of:
- history of alcohol/drug abuse
- family history of sudden death/irregular heartbeat/rhythm
- heart problems (e.g., recent heart attack, heart failure, abnormal heartbeat)
- high blood pressure
- family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts)
- history of seizure disorders
- overactive thyroid (hyperthyroidism)
This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height and consult your doctor or pharmacist for more details.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.
Previous Section
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.
