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Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Musculoskeletal | Family Medicine

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OxyContin (oxycodone HCl controlled-release)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Purdue Pharma
Approval Status: Approved May 1996
Treatment Area: pain associated with musculoskeletal conditions

General Information

OxyContin has been approved for the treatment of moderate to severe pain, which requires treatment for more than a few days, such as the pain associated with musculoskeletal conditions.

OxyContin tablets are taken every 12 hours. Most pain medications must be taken every three to six hours.

OxyContin is available in four tablet strengths (10, 20, 40, and 80 mg).

OxyContin tablets are available by prescription only. The tablets are to be taken whole. Taking broken, chewed, or crushed tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone.

OxyContin is contraindicated in subjects with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes subjects with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and subjects with acute or severe bronchial asthma or hypercarbia. OxyContin is contraindicated in any subjects who has or is suspected of having paralytic ileus.

OxyContin, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. OxyContin may produce orthostatic hypotension in ambulatory subjects. OxyContin, like all opioid analgesics, should be administered with caution to subjects in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Clinical Results

In clinical trials of OxyContin tablets, involving more than 700 subjects, onset of pain relief occurred within one hour for most subjects.

Side Effects

The most serious risk associated with opioids, including OxyContin, is respiratory depression. Common opioid side effects are constipation, nausea, sedation, dizziness, vomiting, pruritis, headache, dry mouth, sweating, and weakness.

Additional Information

Among the most common causes of persistent, debilitating pain are arthritis, lower back conditions, injuries, and cancer. For example, more than eight million Americans are permanently disabled by back pain--with 65,000 new cases diagnosed each year.

In advanced stages of cancer, nearly 75% of cancer subjects have pain that is moderate, severe, or very severe. In earlier stages, 30% to 45% of cancer subjects experience moderate to severe pain.