Schedule II controlled substance with abuse liability similar to morphine.
Potential for abuse in a manner similar to other legal or illicit opiates. Consider abuse potential when prescribing or dispensing oxycodone extended-release tablets (e.g., OxyContin®) in situations where the clinician or pharmacist is concerned about increased risk of misuse, abuse, or diversion.
Intended Uses of Extended-release Tablets (e.g., OxyContin®)
Oxycodone hydrochloride extended-release tablets (e.g., OxyContin®) are a controlled-release oral formulation indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
Oxycodone hydrochloride extended-release tablets (e.g., OxyContin®) are not intended for use as a prn analgesic.
Only use the 80-mg formulation in opiate-tolerant patients. This strength may cause fatal respiratory depression when administered to patients not previously exposed to opiates. (See Dosage and Administration.)
Overdose Risk with Improper Administration of Extended-release Tablets (e.g., OxyContin®)
Oxycodone hydrochloride extended-release tablets are to be swallowed whole and are not to be broken.
Chewing, crushing, or dissolving the extended-release tablets could result in rapid release and absorption of a potentially fatal dose of oxycodone hydrochloride.
REMS:
FDA approved a REMS for oxycodone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of oxycodone and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth. Use a specially marked spoon or dropper to measure your dose. Ask your pharmacist if you do not have one. Do not use a household spoon. If you are allergic to latex or rubber, do not use the dropper that comes with the product. If the medicine upsets your stomach, take it with food or milk. You may mix the medicine with food or juice if you will immediately eat or drink. Do not store food or drink with medicine added. Follow the directions on the prescription label. Do not take more than you are told to take.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.
Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.
You may get drowsy or dizzy when you first start taking this medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.
This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.
Your mouth may get dry. Drinking water, chewing sugarless gum, or sucking on hard candy may help. See your dentist every 6 months.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
breathing difficulties, wheezing
confusion
light headedness or fainting spells
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
itching
nausea, vomiting
Where should I keep my medicine?
Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date or 90 days after opening the bottle, whichever comes first.
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.
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