Aptensio XR

Name: Aptensio XR

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom). Store methylphenidate in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules or how much liquid is left so you will know if any medication is missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What Is Aptensio XR?

Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

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.

You should not use methylphenidate if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation.

Do not use methylphenidate if you have taken an MAO inhibitor in the past 14 days, including isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Methylphenidate may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

Using this medicine improperly can cause death or serious side effects on the heart.

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 should not 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).

Some stimulants have caused 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.

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

It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Aptensio XR Interactions

Avoid drinking alcohol, especially if you take extended-release methylphenidate. Alcohol may cause the medicine to be released into the bloodstream too fast.

Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antidepressant;
  • blood pressure medication;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine; or
  • seizure medicine.

This list is not complete. Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Indications

APTENSIO XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies].

Warnings

Included as part of the "PRECAUTIONS" Section

Patient information

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

Administration

Instructions

QuilliChew ER

  • Extended-release chewable tablet
  • Take once in morning
  • May take with or without food
  • Switching from other methylphenidate products
    • If switching from other methylphenidate products, discontinue that treatment, and titrate with QuilliChew ER using the titration schedule (see Pediatric Dosing)
    • Do not substitute for other methylphenidate products on an mg-per-mg basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles

Methylin

  • Chewable tablet: Take with at least 8 ounces (a full glass) of water or other fluid; taking without enough liquid may cause choking
  • Methylin ER tablet: Swallow whole; do not crush or chew
  • Take all formulations 30-45 minutes before meals

Ritalin

  • Ritalin, Ritalin SR tablets: Swallow whole, do not crush or chew
  • Ritalin LA capsule: Swallow whole, do not crush or chew; may open capsule and sprinkle contents on applesauce and consumed immediately
  • Take all formulations 30-45 minutes before meals

Metadate

  • Metadate ER: Swallow whole, do not crush or chew; administer twice daily before breakfast and lunch
  • Metadate CD: Swallow whole, do not crush or chew; may open capsule and sprinkle contents on applesauce and consumed immediately; administer once daily in AM

Quillivant XR

  • Oral extended-release suspension
  • Shake bottle vigorously for at least 10 seconds before measuring dose
  • May take with or without food

Aptensio XR

  • May take with or without food
  • Advise patients to establish a routine pattern with regard to meals
  • Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce and consume immediately

Daytrana

  • Apply patch on hip 2 hr before desired onset; remove after 9 hr; alternate application site

Cotempla XR-ODT

  • Take consistently with or without food
  • Use dry hands when opening the blister pack
  • Do not remove the tablet from the blister pack until just prior to dosing
  • Remove tablet by peeling back foil on blister pack; do not push the tablet through the foil
  • Do not store tablet for future use
  • Administer immediately after opening by placing the tablet on the patient’s tongue and letting it dissolve; do not chew or crush
  • Tablet will disintegrate in saliva so that it can be swallowed; no liquid is needed to take the tablet

Uses For Aptensio XR

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Methylphenidate is also used to treat narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing 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.

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.

Breastfeeding

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.

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