methylphenidate (oral) (Adhansia XR, Aptensio XR, Concerta)

Brand Names: Adhansia XR, Aptensio XR, Concerta, Cotempla XR-ODT, Jornay PM, Metadate CD, Metadate ER, Methylin, Methylin ER, Methylphenidate Hydrochloride CD, Methylphenidate Hydrochloride LA, QuilliChew ER, Quillivant XR, Relexxii, Ritalin, Ritalin LA, Ritalin-SR

Generic Name: methylphenidate (oral)

• What is methylphenidate?
• What are the possible side effects of methylphenidate?
• What is the most important information I should know about methylphenidate?
• What should I discuss with my healthcare provider before taking methylphenidate?
• How should I take methylphenidate?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking methylphenidate?
• What other drugs will affect methylphenidate?
• Where can I get more information?

Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Methylphenidate may also be used for purposes not listed in this medication guide.

000780370_PB

capsule, white, imprinted with NVR R20

000780371_PB

capsule, yellow, imprinted with NVR R30

000780424_PB

capsule, yellow/white, imprinted with NVR, R10

000780440_PB

round, green, imprinted with CIBA, 3

000935292_PB

capsule, blue/white, imprinted with 93 5292, 93 5292

000935293_PB

capsule, white, imprinted with 93 5293, 93 5293

000935295_PB

capsule, green/white, imprinted with 93 5295, 93 5295

000935296_PB

capsule, blue/white, imprinted with 93 5296, 93 5296

000935297_PB

capsule, brown/white, imprinted with 93 5297, 93 5297

000935298_PB

capsule, brown/white, imprinted with 93 5298, 93 5298

004060136_PB

oval, white, imprinted with M 36

004060154_PB

oval, red, imprinted with M 54

004061473_PB

round, white, imprinted with M, 1451

005912715_PB

oblong, yellow, imprinted with Alza 18

005912717_PB

oblong, white, imprinted with Alza 36

005912718_PB

oblong, red, imprinted with Alza 54

005915884_PB

round, peach, imprinted with 5884, DAN 20

504580585_PB

oval, yellow, imprinted with alza 18

504580586_PB

oval, white, imprinted with alza 36

504580588_PB

oval, white, imprinted with alza 27

530140530_PB

round, turquoise, imprinted with 530, MD

530140531_PB

round, yellow, imprinted with 531, MD

530140532_PB

round, orange, imprinted with MD, 532

Concerta 18 mg

oblong, yellow, imprinted with alza 18

Concerta 36 mg

oblong, white, imprinted with alza 36

Concerta 54 mg

oblong, red, imprinted with alza 54

Methylin 10 mg

round, white, imprinted with 10, M

Methylin 20 mg

round, white, imprinted with 20, M

Methylin 5 mg

round, white, imprinted with 5, M inside square

Methylphenidate 10 mg 006034577

round, green, imprinted with 4577, V

Methylphenidate 10 mg 317220174

round, white, imprinted with T 174

Methylphenidate 10 mg-APH

round, blue, imprinted with MD, 530

Methylphenidate 10 mg-GG

round, yellow, imprinted with MD, 531

Methylphenidate 10 mg-WAT

round, green, imprinted with 5883, DAN 10

Methylphenidate 20 mg 006034578

round, yellow, imprinted with 4578, V

Methylphenidate 20 mg-APH

round, orange, imprinted with MD, 532

Methylphenidate 20 mg-GG

round, orange, imprinted with MD, 532

Methylphenidate 20 mg-WAT

round, peach, imprinted with 5884, DAN 20

Methylphenidate 5 mg 006034576

round, yellow, imprinted with 4576, V

Methylphenidate 5 mg-APH

round, yellow, imprinted with MD, 531

Methylphenidate 5 mg-GG

round, blue, imprinted with MD, 530

Methylphenidate 5 mg-WAT

round, lavender, imprinted with 5882, DAN 5

Methylphenidate Chewable 10 mg 317220928

round, white, imprinted with AT 262

Methylphenidate Chewable 2.5 mg 317220926

round, white, imprinted with 260, AT

Methylphenidate Chewable 5 mg 317220927

round, white, imprinted with 261, AT

Methylphenidate CR 10 mg 004061810

capsule, green/white, imprinted with 10 mg, M 1810

Methylphenidate CR 20 mg 004061820

capsule, blue/white, imprinted with 20 mg, M 1820

Methylphenidate CR 30 mg 004061830

capsule, maroon/white, imprinted with 30 mg, M 1830

Methylphenidate CR 40 mg 004061840

capsule, white/yellow, imprinted with 40 mg, M 1840

Methylphenidate CR 50 mg 004061850

capsule, purple/white, imprinted with 50 mg, M 1850

Methylphenidate CR 60 mg 004061860

capsule, white, imprinted with 60 mg, M 1860

Methylphenidate ER 10 mg 518620262

capsule, green/white, imprinted with LOGO 199, LOGO 199

Methylphenidate ER 18 mg 651620231

round, yellow, imprinted with 18

Methylphenidate ER 20 mg 518620263

capsule, white, imprinted with LOGO 200

Methylphenidate ER 20 mg 655800594

round, white, imprinted with 562 MD

Methylphenidate ER 20 mg-WAT

oval, white, imprinted with 3111, WPI

Methylphenidate ER 27 mg 651620233

round, gray, imprinted with 27

Methylphenidate ER 36 mg 651620235

round, white, imprinted with 36

Methylphenidate ER 54 mg 621750313

round, pink, imprinted with 54

Methylphenidate ER 54 mg 651620237

round, red, imprinted with 54

Methylphenidate ER 60 mg 518620267

capsule, yellow, imprinted with A602

Ritalin 10 mg

round, green, imprinted with CIBA, 3

Ritalin 5 mg

round, yellow, imprinted with CIBA, 7

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• excessive sweating;
• mood changes, feeling nervous or irritable, sleep problems (insomnia);
• fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
• loss of appetite, weight loss;
• dry mouth, nausea, stomach pain; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Methylphenidate may be habit-forming. 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 methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Methylphenidate 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.

Do not use methylphenidate if you have used 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.

You may not be able to use methylphenidate if you are allergic to it, or if you have:

• glaucoma;
• 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).

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.

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;
• problems with the esophagus, stomach, or intestines;
• an abnormal brain wave test (EEG); or
• drug or alcohol addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

Methylphenidate is not approved for use by anyone younger than 6 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Methylphenidate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

To prevent sleep problems, take this medicine in the morning.

Follow the directions on your medicine label about taking methylphenidate with or without food.

Swallow the extended-release capsule or tablet whole and do not crush, chew, or break it.

To make swallowing easier, you may open the capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use.

The chewable tablet must be chewed before you swallow it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

To take the orally disintegrating tablet (ODT):

• Remove a tablet from its blister pack only when you are ready to take the tablet. Use dry hands and take care not to damage a tablet while pushing it out of the blister.
• Place the tablet in your mouth and allow it to dissolve, without chewing or swallowing it whole. You may sip liquid if needed to help swallow the dissolved tablet.

Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using this medicine.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Methylphenidate is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.

SLIDESHOW

ADHD Symptoms in Children See Slideshow

Use the medicine as soon as you can, but skip the missed dose if it is later than 6:00 p.m. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal.

Avoid drinking alcohol. Alcohol may cause extended-release methylphenidate to be released into the bloodstream too fast.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Other drugs may affect methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about methylphenidate.

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