Generic Name: methylphenidate (oral) (METH il FEN i date)
Brand Name: Aptensio XR, Concerta, Cotempla XR-ODT, Metadate CD, Metadate ER, Methylin, QuilliChew ER, Quillivant XR, Ritalin
What is Cotempla XR-ODT?
Cotempla XR-ODT is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Cotempla XR-ODT may also be used for purposes not listed in this medication guide.
Cotempla XR-ODT 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.
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
Do not use Cotempla XR-ODT 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 Cotempla XR-ODT if you are allergic to it, or if you have:
a personal or family history of tics (muscle twitches) or Tourette's syndrome; or
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;
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;
problems with the esophagus, stomach, or intestines;
an abnormal brain wave test (EEG); or
drug or alcohol addiction.
It is not known whether Cotempla XR-ODT will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Cotempla XR-ODT is not approved for use by anyone younger than 6 years old.
How should I take Cotempla XR-ODT?
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.
Cotempla XR-ODT 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 Cotempla XR-ODT with or without food.
Swallow the 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.
Shake the oral suspension (liquid) before you measure a dose. 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. Cotempla XR-ODT is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Cotempla XR-ODT could be fatal.
What should I avoid while taking methylphenidate?
Avoid drinking alcohol. Alcohol may cause extended-release Cotempla XR-ODT to be released into the bloodstream too fast.
Avoid driving or hazardous activity until you know how Cotempla XR-ODT will affect you. Your reactions could be impaired.
Cotempla XR-ODT side effects
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;
a seizure (convulsions);
muscle twitches (tics);
changes in your vision; or
penis erection that is painful or lasts 4 hours or longer (rare).
Cotempla XR-ODT 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:
mood changes, feeling nervous or irritable, sleep problems (insomnia);
fast heart rate, increased blood pressure;
loss of appetite, weight loss;
nausea, stomach pain; or
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.
What other drugs will affect Cotempla XR-ODT?
Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs Cotempla XR-ODT, and may increase side effects.
Many drugs can affect Cotempla XR-ODT. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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More about Cotempla XR-ODT (methylphenidate)
- Side Effects
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- En Español
- 5 Reviews
- Drug class: CNS stimulants
- FDA Alerts (3)
- FDA Approval History