Dexmethylphenidate HCL ER

COMMON BRAND(S): Focalin XR

GENERIC NAME(S): Dexmethylphenidate

WARNINGS:

Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

This medication can be habit-forming and should be used cautiously by people who have mental/mood disorders or a substance use disorder (such as overuse of or addiction to drugs/alcohol). Before using this medication, tell your doctor if you have a personal or family history of a substance use disorder. Do not increase your dose, use it more often, or use it for a longer time or in a different way than prescribed. Doing so may result in a decrease in the effect of this drug, drug dependence, or abnormal thoughts/behavior.

Your doctor may monitor you for a while after the medication is stopped, especially if you have taken this drug for a long time or in high doses. (See also How to Use section.

Who should not take Dexmethylphenidate HCL ER?

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Uses

Uses

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 Dexmethylphenidate HCL ER

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.

Side Effects

Side Effects

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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

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.

Interactions

Interactions

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.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, agitation, confusion, sweating, flushing, muscle twitching, hallucinations, seizures, loss of consciousness.

Notes

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (such as blood pressure, complete blood count, height/weight monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near bedtime or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.

Images
dexmethylphenidate ER 5 mg capsule,extended release biphasic50-50
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NVR, D40
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color
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color
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TEVA, 5552
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color
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color
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oblong
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TEVA, 5045
This medicine is a aqua blue white, oblong, capsule imprinted with "TEVA" and "5045".
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dexmethylphenidate ER 35 mg capsule,extended release biphasic50-50

color
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shape
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TEVA, 5046
This medicine is a aqua blue ivory, oblong, capsule imprinted with "TEVA" and "5046".
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color
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TEVA, 5553
This medicine is a white, oblong, capsule imprinted with "TEVA" and "5553".
dexmethylphenidate ER 40 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 40 mg capsule,extended release biphasic50-50

color
white,blue-green
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TEVA, 5562
This medicine is a white blue-green, oblong, capsule imprinted with "TEVA" and "5562".
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dexmethylphenidate ER 5 mg capsule,extended release biphasic50-50

color
white,light purple
shape
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This medicine is a white light purple, oblong, capsule imprinted with "logo and 804" and "logo and 804".
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color
light brown
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oblong
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MYLAN DE 10, MYLAN DE 10
This medicine is a light brown, oblong, capsule imprinted with "MYLAN DE 10" and "MYLAN DE 10".
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dexmethylphenidate ER 15 mg capsule,extended release biphasic50-50

color
gray
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oblong
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MYLAN DE 15, MYLAN DE 15
This medicine is a gray, oblong, capsule imprinted with "MYLAN DE 15" and "MYLAN DE 15".
dexmethylphenidate ER 40 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 40 mg capsule,extended release biphasic50-50

color
white,gray
shape
oblong
imprint
MYLAN DE 40, MYLAN DE 40
This medicine is a white gray, oblong, capsule imprinted with "MYLAN DE 40" and "MYLAN DE 40".
dexmethylphenidate ER 5 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 5 mg capsule,extended release biphasic50-50

color
dark blue
shape
oblong
imprint
MYLAN DE 5, MYLAN DE 5
This medicine is a dark blue, oblong, capsule imprinted with "MYLAN DE 5" and "MYLAN DE 5".
dexmethylphenidate ER 30 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 30 mg capsule,extended release biphasic50-50

color
white,light brown
shape
oblong
imprint
MYLAN DE 30, MYLAN DE 30
This medicine is a white light brown, oblong, capsule imprinted with "MYLAN DE 30" and "MYLAN DE 30".
dexmethylphenidate ER 30 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 30 mg capsule,extended release biphasic50-50

color
white,light caramel
shape
oblong
imprint
NVR, D30
This medicine is a white light caramel, oblong, capsule imprinted with "NVR" and "D30".
dexmethylphenidate ER 35 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 35 mg capsule,extended release biphasic50-50

color
light blue,light caramel
shape
oblong
imprint
NVR, D35
This medicine is a light blue light caramel, oblong, capsule imprinted with "NVR" and "D35".
dexmethylphenidate ER 40 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 40 mg capsule,extended release biphasic50-50

color
green,white
shape
oblong
imprint
NVR, D40
This medicine is a green white, oblong, capsule imprinted with "NVR" and "D40".
dexmethylphenidate ER 5 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 5 mg capsule,extended release biphasic50-50

color
light blue
shape
oblong
imprint
NVR, D5
This medicine is a light blue, oblong, capsule imprinted with "NVR" and "D5".
dexmethylphenidate ER 10 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 10 mg capsule,extended release biphasic50-50

color
caramel
shape
oblong
imprint
NVR, D10
This medicine is a caramel, oblong, capsule imprinted with "NVR" and "D10".
dexmethylphenidate ER 15 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 15 mg capsule,extended release biphasic50-50

color
green
shape
oblong
imprint
NVR, D15
This medicine is a green, oblong, capsule imprinted with "NVR" and "D15".
dexmethylphenidate ER 20 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 20 mg capsule,extended release biphasic50-50

color
white
shape
oblong
imprint
NVR, D20
This medicine is a white, oblong, capsule imprinted with "NVR" and "D20".
dexmethylphenidate ER 25 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 25 mg capsule,extended release biphasic50-50

color
light blue,white
shape
oblong
imprint
NVR, D25
This medicine is a light blue white, oblong, capsule imprinted with "NVR" and "D25".
dexmethylphenidate ER 15 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 15 mg capsule,extended release biphasic50-50

color
white
shape
oblong
imprint
par, 428
This medicine is a white, oblong, capsule imprinted with "par" and "428".
dexmethylphenidate ER 30 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 30 mg capsule,extended release biphasic50-50

color
white
shape
oblong
imprint
par, 430
This medicine is a white, oblong, capsule imprinted with "par" and "430".
dexmethylphenidate ER 25 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 25 mg capsule,extended release biphasic50-50

color
yellow,white
shape
oblong
imprint
par, 333
This medicine is a yellow white, oblong, capsule imprinted with "par" and "333".
dexmethylphenidate ER 35 mg capsule,extended release biphasic50-50
dexmethylphenidate ER 35 mg capsule,extended release biphasic50-50

color
yellow,white
shape
oblong
imprint
par, 339
This medicine is a yellow white, oblong, capsule imprinted with "par" and "339".

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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.