Common Myths About OxyContin® (Oxycodone HCl Controlled-Release) Tablets CII
The terms oxycodone and OxyContin are not interchangeable. involves OxyContin. The facts are:
- Oxycodone is an opioid analgesic drug substance that was introduced in the U.S. in the late 1930s and is now used in more than 50 different drug formulations, manufactured by over 30 companies.
- Oxycodone is frequently combined with aspirin or acetaminophen in immediate-release (also known as short acting) pain medications available as generics and brands such as Percodan®, Percocet®, and Tylox®. Oxycodone is also available alone in other formulations, many of which are generic formulations, but also includes the brand Roxicodone®. OxyContin is the brand name of Purdue Pharma’s controlled-release (also known as long acting) formulation of oxycodone approved by FDA in December 1995.
- Of total number of oxycodone prescriptions from 2004 through 2009, less than 18 percent were for OxyContin. In other words, more than 7 out of 10 oxycodone prescriptions were written for medicines other than OxyContin. In 2010, less than 12 percent were written for OxyContin.1
For many years, news reports have incorrectly referred to oxycodone problems as if they involved only OxyContin, even when other medications containing oxycodone were specifically named by authorities and in court records. News reporting on Florida pill mills incorrectly referred to the distribution of oxycodone as if it only related to OxyContin. Correcting that mistaken belief, the Drug Enforcement Administration in March 16, 2011 testimony before the House Appropriations Subcommittee on Commerce, Justice, Science and Related Agencies made the following statement about oxycodone and Florida pill mills:
DEA Administrator Michele Leonhart: “It’s a little bit different than the OxyContin problem, and a lot of people think that the drug that is the number one drug out of the pill mills of Florida, they think it’s OxyContin, and that’s not correct.”
Congressman Frank Wolf: “What is it?”
DEA Administrator Michele Leonhart: “It’s the generic form. It’s Oxycodone.”
Congressman Frank Wolf: “Who makes that?”
DEA Administrator Michele Leonhart: “And a number of companies…”
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE
OxyContin® contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse
liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin.The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OxyContin for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of OxyContin, even when the drug has
been used as recommended and not misused or abused [seeWarnings and Precautions (5.2)]. Proper dosing and titration are essential and OxyContin should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OxyContin or following a dose increase. Instruct patients to swallow OxyContin tablets intact. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of oxycodone.
Accidental ingestion of OxyContin, especially in children, can result in a fatal overdose of oxycodone
[seeWarnings and Precautions (5.3)].
INDICATIONS AND USAGE
OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Use
OxyContin is not for use:
- As an as-needed (prn) analgesic
- For pain that is mild or not expected to persist for an extended period of time
- For acute pain
- In the immediate postoperative period (the first 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
- For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time
OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
OxyContin is contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus and gastrointestinal obstruction
- Hypersensitivity (e.g., anaphylaxis) to oxycodone
Please read the full Prescribing Information for OxyContin Tablets, available at http://app.purduepharma.com/xmlpublishing/pi.aspx?id=o
1. IMS Health data