Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Musculoskeletal | Family Medicine
View By:YearCompanyConditionsTherapeutic AreasDrug Names
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
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
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.
In clinical trials of OxyContin tablets, involving more than 700
subjects, onset of pain relief occurred within one hour for most
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.
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