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Each PERCOLONE tablet contains:
Oxycodone Hydrochloride, USP ............ 5 mg*
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Inactive ingredients: Microcrystalline cellulose and stearic acid.
Oxycodone 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 analgesic ingredient, oxycodone, is a semisynthetic opioid 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 PERCOLONE are analgesia and sedation.
PERCOLONE is similar to codeine and methadone in that it retains at least one half of its analgesic activity when administered orally.
For the relief of moderate to moderately severe pain.
Hypersensitivity to PERCOLONE.
Drug Dependence: PERCOLONE 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 this drug, 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, this drug is subject to the Federal Controlled Substances Act.
Usage in Ambulatory Patients: PERCOLONE 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 this drug 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 PERCOLONE 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, this drug should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.
Pediatric Use: This drug should not be administered to pediatric patients.
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 of this drug or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Special Risk Patients: This drug 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 nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include euphoria, dysphoria, constipation, skin rash and pruritus.
The usual adult oral dose is 10 to 30 mg every 4 hours as needed for pain or as directed by physician. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 30 mg or more every 4 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in dosage may be required.
For control of severe, chronic pain in patients with certain terminal diseases, this drug should be administered on a regularly scheduled basis, every 4 hours, at the lowest dosage level that will achieve adequate analgesia.
The CNS depressant effects of PERCOLONE (oxycodone hydrochloride) may be additive with that of other CNS depressants. See .
Signs and Symptoms: Serious overdose of PERCOLONE 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.
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 is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including PERCOLONE. Therefore, an appropriate dose of naloxone (usual initial adult dose: 0.4 mg) should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of PERCOLONE 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.
An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
Gastric emptying may be useful in removing unabsorbed drug.
PERCOLONE is supplied as 5 mg white, round, biconvex tablets, bisected and debossed with "EPI" over "132" on one side and debossed with "5" on the other side as follows:
| Bottles of 100 | NDC 63481-132-70 |
| Blister Packs of 25 | NDC 63481-132-75 |
| (in units of 100 Tablets) |
DEA Order Form Required.
Dispense in a well-closed container as defined in the USP/NF. Protect from moisture. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
PERCOLONE® is a Registered Trademark of Endo Pharmaceuticals Inc.
Copyright © Endo Pharmaceuticals Inc. 1999
6450-02/Rev. September, 1999
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