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- and 160-mg formulations in opiate-tolerant patients. These strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids. (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.
Do not take oxycodone with alcohol, other narcotic pain medications, sedatives,
tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your
breathing. Dangerous side effects may result.
Before taking oxycodone, tell your doctor if you are using pentazocine (Talwin),
nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are
using any of these drugs, you may not be able to use oxycodone, or you may need dosage
adjustments or special tests during treatment.
This list is not complete and there may be other drugs that can interact with oxycodone.
Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start
using a new medication without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
shallow breathing, slow heartbeat;
seizure (convulsions);
cold, clammy skin;
confusion;
severe weakness or dizziness; or
feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
nausea, vomiting, constipation, loss of appetite;
dizziness, headache, tired feeling;
dry mouth;
sweating; or
itching.
This list is not complete and other side effects may occur. Tell your
doctor about any unusual or bothersome side effect.
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