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| |  OxyContin Tablets Hailed by World Pain-Care Community VANCOUVER, B.C., Sept. 27, 1996 -- OxyContin(TM) generated a groundswell of international support at this year's meeting of the International Association of the Study of Pain (IASP). The enthusiasm of IASP members parallels the powerful U.S. response to the launch of OxyContin -- enabling the drug to achieve its entire expected first-year sales in only eight months. OxyContin, a unique, controlled-release form of oxycodone, fits the profile of opioids hailed by experts at IASP. As Stephen Long, MD, Pain Specialist at the Virginia Commonwealth University/Medical College of Virginia, declared: "Now, thanks to controlled-release opioids, we can give our patients around-the-clock, opioid pain control for both cancer and non- cancer pain." Dr. Long's opinion echoed through the 3-day meeting. Many IASP members shared the opinion that OxyContin is an excellent opioid for moderate to severe pain requiring opioid therapy for more than a few days. For instance, OxyContin may be appropriate for pain of back injury, arthritis, and other types of noncancer pain, as well as for cancer pain. In the past, other opioid drugs, such as morphine, were generally reserved for only cancer pain. OxyContin reached total U.S. sales of $26 million, four months earlier than projected by Purdue Pharma L.P. -- the company that developed and patented OxyContin. Abbott Laboratories now copromotes OxyContin with Purdue Pharma. By year's end, sales will range from $130,000 to $150,000 for each Purdue or Abbott sales representative, bringing total sales to more than $40 million. OxyContin is the only oral oxycodone that acts for a full 12 hours to relieve pain -- making it the longest-lasting oxycodone ever. Unlike Percodan(R)*, Percocet(R)* and other combination products, it contains no aspirin or acetaminophen that may be potentially toxic in maximal daily doses. With OxyContin, analgesic onset occurs within 1 hour in most patients. There is no ceiling effect to analgesia, allowing physicians to titrate the dosage upward when needed for pain control. Common opioid side effects, except for constipation, often diminish over time for many patients taking OxyContin. Please read the accompanying prescribing information for OxyContin Tablets. OxyContin 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. The most serious risk associated with opioids, including OxyContin, is respiratory depression. Common opioid side effects are constipation, nausea, sedation, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and weakness. * Registered trademark, DuPont Merck Pharmaceutical Co. q12h Warning -- May be habit forming 10 mg * 20 mg * 40 mg Brief Summary on OxyContin(TM) (oxycodone hydrochloride controlled-release) Tablets. Before prescribing, see complete prescribing information, including DOSAGE AND ADMINISTRATION. INDICATIONS AND USAGE: For the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days. CONTRAINDICATIONS: OxyContin is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. OxyContin is contraindicated in any patient who has or is suspected of having paralytic ileus. WARNINGS: OxyContin TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED OxyContin TABLETS COULD LEAD TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY TOXIC DOSE OF OXYCODONE. Respiratory Depression Respiratory depression, the chief hazard from all opioid agonist preparations, occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose. Head Injury The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure. Oxycodone produces effects which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. Hypotensive Effect 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 patients. OxyContin, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. PRECAUTIONS: General -- OxyContin tablets are intended for use in patients who require oral pain therapy with an opioid agonist of more than a few days duration. As with any opioid analgesic, it is critical to adjust the dosing regimen individually for each patient. Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar controlled-release opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Physicians should individualize treatment in every case, using non-opioid analgesics, prn opioids and/or combination products, and chronic opioid therapy with drugs such as OxyContin in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society. Use of OxyContin is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis. The administration of oxycodone, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings. Interactions with other CNS Depressants OxyContin, like all opioid analgesics, should be used with caution and started in a reduced dosage (1/3 to 1/2 of the usual dosage) in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers and alcohol. Interactive effects resulting in respiratory depression, hypotension, profound sedation or coma may result if these drugs are taken in combination with the usual doses of OxyContin. Interactions with Mixed Agonist/Antagonist Opioid Analgesics Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients. Ambulatory Surgery OxyContin is not recommended pre-operatively (preemptive analgesia) or for the management of pain in the immediate post-operative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Patients who are already receiving OxyContin tablets as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given and the temporary changes in physiology caused by the surgical intervention (see PRECAUTIONS: Drug-Drug Interactions). Use in Pancreatic/Biliary Tract Disease Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level. Tolerance and Physical Dependence Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is the occurrence of withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy. Significant tolerance should not occur in most of the patients treated with the lowest doses of oxycodone. It should be expected, however, that a fraction of cancer patients will develop some degree of tolerance and require progressively higher dosages of OxyContin to maintain pain control during chronic treatment. Regardless of whether this occurs as a result of increased pain secondary to disease progression or pharmacological tolerance, dosages can usually be increased safely by adjusting the patient's dose to maintain an acceptable balance between pain relief and side effects. The dosage should be selected according to the patient's individual analgesic response and ability to tolerate side effects. Tolerance to the analgesic effect of opioids is usually paralleled by tolerance to side effects, except for constipation. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug or may be precipitated through the administration of drugs with opioid antagonist activity (see OVERDOSAGE). If OxyContin is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. This is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate or heart rate.
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