November 26, 2014
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OxyNEO

(oxycodone controlled release)

DIN (Drug Identification Number)

02372525 OXYNEO 10MG CONTROLLED-RELEASE TABLET
02372533 OXYNEO 15MG CONTROLLED-RELEASE TABLET
02372797 OXYNEO 20MG CONTROLLED-RELEASE TABLET
02372541 OXYNEO 30MG CONTROLLED-RELEASE TABLET
02372568 OXYNEO 40MG CONTROLLED-RELEASE TABLET
02372576 OXYNEO 60MG CONTROLLED-RELEASE TABLET
02372584 OXYNEO 80MG CONTROLLED-RELEASE TABLET

How does OxyNEO work? What will it do for me?

Oxycodone controlled release belongs to a group of medications known as opioid analgesics (narcotic pain relievers). It is used to relieve severe chronic pain which has not responded to other treatments. It decreases pain by acting on the central nervous system.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use OxyNEO?

The dose of oxycodone controlled release varies widely depending on the cause and severity of pain, individual medical history, and body weight.

For people who are not taking opioid pain medications when oxycodone is started, the usual starting dose of controlled-release tablets is 10 mg or 20 mg every 12 hours. Your doctor can adjust your dose until a dose that controls your pain with tolerable side effects is reached.

For people who are currently taking other opioid pain medications when oxycodone controlled release is started, the recommended starting dose will depend on the type and dose of opioid that is currently being taken. Your doctor will determine the appropriate dose for you.

Oxycodone controlled release should be taken with a glass of water. It can be taken with or without food.

The controlled-release tablets are for people who require continuous use of a pain killer for several days or more. It is taken every 12 hours (and is not taken "as needed"). The controlled-release tablets should be swallowed whole and should not be broken, cut, chewed, dissolved, or crushed. Taking broken, cut or chewed tablets can lead to the rapid release of oxycodone. This large amount of medication being absorbed into the body can be fatal.

To avoid difficulty swallowing, take only one tablet at a time and take the controlled-release tablet with enough water so that you are able to completely swallow the tablet immediately after placing it in your mouth. Do not lick, pre-soak, or wet the tablet before you place it in your mouth. You may notice what appears to be a tablet in your stool. This is normal and occurs because the tablet does not completely dissolve after all the medication has been released in the body.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose of the controlled-release tablets, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and protect it from moisture. Keep this medication in a safe place away from children or pets, and to prevent theft. Accidental use by a child or pet may result in death. If accidental use occurs, get immediate medical attention for the child or pet. Do not take this medication in front of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does OxyNEO come in?

OxyNEO tablets consist of a matrix with hydrogelling properties (i.e., particles or whole tablets become gel-like in water). The tablets are designed to be resistant to crushing.

10 mg
Each round, unscored, white, biconvex, controlled-release tablet, marked with "ON" on one side and "10" on the other, contains oxycodone hydrochloride 10 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, and titanium dioxide.

15 mg
Each round, unscored, grey, biconvex, controlled-release tablet, marked with "ON" on one side and "15" on the other, contains oxycodone hydrochloride 15 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: hypromellose; polyethylene glycol 400; red, yellow, and black iron oxides; and titanium dioxide.

20 mg
Each round, unscored, pink, biconvex, controlled-release tablet, marked with "ON" on one side and "20" on the other, contains oxycodone hydrochloride 20 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: hypromellose, polyethylene glycol 400, polysorbate 80, red iron oxide, and titanium dioxide.

30 mg
Each round, unscored, brown, biconvex, controlled-release tablet, marked with "ON" on one side and "30" on the other, contains oxycodone hydrochloride 30 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: hypromellose; polyethylene glycol 400; polysorbate 80; red, yellow, and black iron oxides; and titanium dioxide.

40 mg
Each round, unscored, yellow, biconvex, controlled-release tablet, marked with "ON" on one side and "40" on the other, contains oxycodone hydrochloride 40 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: hypromellose, polyethylene glycol 400, polysorbate 80, titanium dioxide, and yellow iron oxide.

60 mg
Each round, unscored, red, biconvex, controlled-release tablet, marked with "ON" on one side and "60" on the other, contains oxycodone hydrochloride 60 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: hypromellose, polyethylene glycol 400, polysorbate 80, red and black iron oxides, and titanium dioxide.

80 mg
Each round, unscored, green, biconvex, controlled-release tablet, marked with "ON" on one side and "80" on the other, contains oxycodone hydrochloride 80 mg. Nonmedicinal ingredients: tablet core: butylated hydroxytoluene, magnesium stearate, and polyethylene oxide; tablet coating: FD&C Blue No. 2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, titanium dioxide, and yellow iron oxide.

Who should NOT take OxyNEO?

Do not take oxycodone if you:

  • are allergic to oxycodone, other opioids (e.g., codeine, hydrocodone, morphine), or any ingredients of the medication
  • are pregnant or breast-feeding
  • are taking or have taken (within the last 14 days) MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • have a head injury
  • have a seizure disorder
  • have acute alcoholism
  • have acute asthma or other obstructive airway diseases (e.g., chronic bronchitis, emphysema)
  • have cor pulmonale (heart failure caused by chronic high blood pressure in the arteries of the lungs)
  • have delirium tremens (e.g., confusion, diarrhea, shaking, fever, hallucinations, disorientation) associated with alcohol withdrawal
  • have increased cerebral spinal fluid pressure
  • have increased levels of carbon dioxide in the blood
  • have or may have appendicitis or pancreatitis
  • have or may have bowel or digestive system problems (e.g., paralytic ileus)
  • have or may have a blockage in the digestive system
  • have respiratory depression (slowed breathing)
  • have severe central nervous system depression (slowed nervous system)

The controlled-release form of oxycodone should not be taken to manage acute pain nor for mild pain, intermittent pain, or pain of short duration that can be managed with other medications.

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