Percodan (Aspirin and Oxycodone HCl)


DuPont Pharma

Oxycodone HCl – ASA

Opioid Analgesic

Action And Clinical Pharmacology: 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 CNS 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. It has been suggested that less rapid biotransformation in the liver may be due to the protective effect of a methoxy group in the 3-position, the site of glucuronide conjugation in morphine.

Percodan also contains the nonopioid, anti-inflammatory and antipyretic analgesic, ASA.

Indications And Clinical Uses: The relief of mild to moderately severe pain, including conditions accompanied by fever and/or inflammation.

Contra-Indications: Status asthmaticus, pre-existing respiratory depression or convulsive states, gastrointestinal ulceration, hypersensitivity to oxycodone or ASA.

Manufacturers’ Warnings In Clinical States: Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential of 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 medication containing opioids.

Reye’s Syndrome: Reye’s syndrome is a rare but serious disease which can follow flu or chickenpox in children and teenagers. While the cause of Reye’s syndrome is unknown, some reports claim ASA (or salicylates) may increase the risk of developing this disease.

Occupational Hazards: 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 CNS Depressants: Patients receiving other opioid analgesics, general anesthetics, monoamine oxidase inhibitors, tricyclic antidepressants, 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.

Pregnancy: Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, Percodan should not be given to a pregnant woman unless, in the judgment of the physician, the potential benefits outweigh the possible hazards. The administration of Percodan to obstetrical patients in labor may be associated with respiratory depression of the newborn.

Children: The more potent formula, Percodan, should not be administered to infants or children. However, Percodan-Demi, containing half the amount of oxycodone, can be considered for children of 6 years of age or older.

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 elevated intracranial pressure. Futhermore, opioids may produce adverse reactions which can obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: The administration of Percodan 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, because of the danger of cardiac or respiratory depression, as well as to those patients with hemorrhage, severe impairment of hepatic, respiratory or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture.

Headache: Because headache often involves a significant psychological component, an opioid analgesic should only be employed for the treatment of headache when no other treatment is effective, in order to minimize the risk of psychological and physical dependence.

Coagulation Abnormalities: Salicylates should be used with caution in patients with coagulation abnormalities.

Drug Interactions: The CNS depressant effects of oxycodone may be additive with those of other CNS depressants (see Warnings).

Salicylates may enhance the effect of anticoagulants and inhibit the effect of uricosuric agents.

Other: Patients should be instructed to store Percodan, as for any medication, safely out of the reach of children.

Adverse Reactions: The most frequently observed adverse reactions include light-headedness, 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.

Symptoms And Treatment Of Overdose: 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. tag_Treatment

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 oxycodone. Therefore an appropriate dose of this antagonist should be administered, preferably by the i.v. 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. The instructions contained in package insert provided by the manufacturer should be carefully observed.

An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Oxygen, i.v. fluids, vasopressors and other supportive measures should be employed as indicated.

Gastric aspiration and lavage may be useful in removing unabsorbed drug.

Dosage And Administration: Adjust dosage according to the severity of the pain and the patient’s response. 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. The usual adult dose is 1 tablet every 6 hours as needed for pain.

Percodan: Adults: 1 tablet every 6 hours as needed for pain.

Percodan-Demi: Adults: 1 or 2 tablets every 6 hours. Children 12 years and older: one half tablet every 6 hours. Children 6 to 12 years: one quarter tablet every 6 hours. Not indicated for children under 6 years of age.

Availability And Storage: Percodan: Each yellow, scored tablet, embossed on one side with PERCODAN and on the other side with DuPont, contains: oxycodone HCl 5 mg and ASA 325 mg. Nonmedicinal ingredients: cornstarch, FD&C Yellow No. 6, D&C Yellow No. 10 and microcrystalline cellulose. Lactose-, sodium- and tartrazine-free. Bottles of 100 and 500 and blister packs of 25. Store at room temperature (15 to 30°C).

Percodan-Demi: Each pink, scored tablet, embossed on one side with PERCODAN-DEMI and on the other side with DuPont, contains: oxycodone HCl 2.5 mg and ASA 325 mg. Nonmedicinal ingredients: cornstarch, FD&C Red No. 3, FD&C Blue No. 2 and microcrystalline cellulose. Lactose-, sodium- and tartrazine-free. Bottles of 100. Store at room temperature (15 to 30°C). (Shown in Product Recognition Section)

PERCODAN® PERCODAN®-DEMI DuPont Pharma Oxycodone HCl – ASA Opioid Analgesic

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