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Each tablet of PERCODAN-Demi contains:
Oxycodone hydrochloride ....... 2.25 mg*
Oxycodone terephthalate ........ 0.19 mg**
Aspirin, USP ........................... 325 mg
* 2.25 mg oxycodone HCl is equivalent to 2.0169 mg of oxycodone.
** 0.19 mg oxycodone terephthalate is equivalent to 0.1504 mg of oxycodone.
PERCODAN-Demi Tablets also contain: microcrystalline cellulose and starch.
The oxycodone component is 14-hydroxydihydrocodeinone, a white odorless crystalline powder which is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:
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The principal ingredient, oxycodone, is a semisynthetic narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in PERCODAN-Demi are analgesia and sedation.
Oxycodone is similar to codeine and methadone in that it retains at least one half of its analgesic activity when administered orally.
PERCODAN-Demi also contains the non-narcotic antipyretic-analgesic, aspirin.
For the relief of moderate to moderately severe pain.
Hypersensitivity to oxycodone or aspirin.
Drug Dependence: Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of PERCODAN-Demi, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, PERCODAN-Demi is subject to the Federal Controlled Substances Act.
Usage in ambulatory patients: Oxycodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using PERCODAN-Demi should be cautioned accordingly.
Interaction with other central nervous system depressants: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with PERCODAN-Demi may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Usage in pregnancy: Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, PERCODAN-Demi should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.
Reye Syndrome is a rare but serious disease which can follow flu or chicken pox in children and teenagers. While the cause of Reye Syndrome is unknown, some reports claim aspirin (or salicylates) may increase the risk of developing this disease.
Salicylates should be used with caution in the presence of peptic ulcer or coagulation abnormalities.
Head injury and increased intracranial pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute abdominal conditions: The administration of PERCODAN-Demi (oxycodone and aspirin) or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Special risk patients: PERCODAN-Demi should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison' disease, and prostatic hypertrophy or urethral stricture.
The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include euphoria, dysphoria, constipation and pruritus.
PERCODAN-Demi tablets are a Schedule II controlled substance. Oxycodone can produce drug dependence and has the potential for being abused (See WARNINGS ).
Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of narcotics. PERCODAN-Demi is given orally.
Dosage: Adults--One or two tablets every six hours.
Children 12 years and older--One-half tablet every six hours.
Children 6 to 12 years--One-quarter tablet every six hours.
PERCODAN-Demi is not indicated for children under 6 years of age.
The CNS depressant effects of PERCODAN-Demi may be additive with that of other CNS depressants (See WARNINGS ).
Aspirin may enhance the effect of anticoagulants and inhibit the uricosuric effect of uricosuric agents.
Signs and Symptoms: Serious overdose with PERCODAN-Demi is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. The ingestion of very large amounts of PERCODAN-Demi may, in addition, result in acute salicylate intoxication.
Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride (NARCAN®) is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics including oxycodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered (usual initial adult dose 0.4 mg-2 mg) preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
Gastric emptying may be useful in removing unabsorbed drug.
As white, scored tablets available in:
Bottles of 100 NDC 63481-166-70
Store at controlled room temperature 15°-30°C (59°-86°F).
DEA Order Form Required.
Rx only
PERCODAN® is a Registered Trademark of Endo Pharmaceuticals Inc.
NARCAN® is a Registered Trademark of Endo
Pharmaceuticals Inc.
Copyright © Endo Pharmaceuticals Inc. 1998
6484-00/April, 1998
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