Each tablet of PERCODAN contains:

 Oxycodone Hydrochloride ......... 4.50 mg*

 Oxycodone Terephthalate .......... 0.38 mg**

 Aspirin, USP .............................. 325 mg

*   4.50 mg oxycodone HCl is equivalent to 4.0338 mg of oxycodone.
** 0.38 mg oxycodone terephthalate is equivalent to 0.3008 mg of oxycodone.

PERCODAN Tablets also contain: D&C Yellow 10, FD&C Yellow 6, 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:

The principal ingredient, oxycodone, is a semisynthetic opioid 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 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 also contains the non-opioid antipyretic-analgesic, aspirin.

INDICATIONS

For the relief of moderate to moderately severe pain.

CONTRAINDICATIONS

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, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid-containing medications. Like other opioid-containing medications, PERCODAN 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 should be cautioned accordingly.

Interaction with Other Central Nervous System Depressants:   Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with PERCODAN 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 should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Pediatric Use:   PERCODAN should not be administered to pediatric patients. PERCODAN®-Demi, containing half the amount of oxycodone, can be considered. (See product prescribing information for PERCODAN-Demi.)

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.

PRECAUTIONS

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of opioids 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions:   The administration ofPERCODAN or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients:   PERCODAN 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.

ADVERSE REACTIONS

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include euphoria, dysphoria, constipation and pruritus.

DRUG ABUSE AND DEPENDENCE

PERCODAN (oxycodone and aspirin) tablets are a Schedule II controlled substance. Oxycodone can produce drug dependence and has the potential for being abused (See ).

DOSAGE AND ADMINISTRATION

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 opioids. PERCODAN is given orally. The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of aspirin should not exceed 4 grams or 12 tablets.

DRUG INTERACTIONS

The CNS depressant effects of PERCODAN may be additive with that of other CNS depressants (See ).

Aspirin may enhance the effect of anticoagulants and inhibit the uricosuric effects of uricosuric agents.

MANAGEMENT OF OVERDOSAGE

Signs and Symptoms:   Serious overdose with PERCODAN 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 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 opioid antagonist naloxone hydrochloride (NARCAN®) is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids 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.

HOW SUPPLIED

PERCODAN (4.50 mg oxycodone hydrochloride, 0.38 mg oxycodone terephthalate, 325 mg Aspirin, USP), supplied as a yellow tablet, with one face scored and inscribed"PERCODAN" and plain on the other side is available in:

 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

DEA Order Form Required.

PERCODAN® is a Registered Trademark of Endo Pharmaceuticals Inc.

NARCAN® is a Registered Trademark of Endo Pharmaceuticals Inc.

Copyright © Endo Pharmaceuticals Inc. 1999

6483-01/Rev. November, 1999

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