OXYCODONE AND ACETAMINOPHEN CAPSULES USP

Rx only

Each capsule, for oral administration, contains:

Oxycodone Hydrochloride+............................................. 5 mg

Acetaminophen................................................................. 500 mg

(+5 mg Oxycodone HCl is equivalent to 4.4815 mg Oxycodone)

In addition, each capsule contains the following inactive ingredients: hard gelatin capsule (which contains FD&C Red #40, D&C Red #28, D&C Yellow #10, titanium dioxide, sodium lauryl sulfate, sodium propionate, edetate calcium disodium, benzyl alcohol, butylparaben, propylparaben, methylparaben, gelatin), starch (corn), croscarmellose sodium, colloidal silicon dioxide, sodium lauryl sulfate, stearic acid, magnesium stearate and printing ink (pharmaceutical glaze, synthetic black iron oxide, lecithin, SDA-3A alcohol, deionized water, ethylene glycol monoethyl ether, simethicone).

Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its structural formula is:

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 semi-synthetic 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 oxycodone 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.

Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.

For the relief of moderate to moderately severe pain.

Hypersensitivity to oxycodone or acetaminophen.

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 this drug, 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, this drug is subject to the Federal Controlled Substances Act (Schedule II).

• General:
•  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 products containing oxycodone or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
•  Special risk patients: Oxycodone and acetaminophen capsules 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’s disease, and prostatic hypertrophy or urethral stricture.
• Information for 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 this drug should be cautioned accordingly.
• Drug Interactions: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with oxycodone and acetaminophen may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
•  The concurrent use of anticholinergics with narcotics may produce paralytic-ileus.
• Pregnancy: Teratogenic Effects:
•  Pregnancy Category C. Animal reproductive studies have not been conducted with oxycodone and acetaminophen. It is also not known whether oxycodone and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and acetaminophen should not be given to a pregnant woman unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.
•  Nonteratogenic Effects: Use of narcotics during pregnancy may produce physical dependence in the neonate.
•  Labor and Delivery: As with all narcotics, administration of oxycodone and acetaminophen to the mother shortly before delivery may result in some degree of respiratory depression in the newborn and the mother, especially if higher doses are used.
• Nursing Mothers: It is not known whether the components of this drug are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxycodone and acetaminophen is administered to a nursing mother.
• Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

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, skin rash, and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

Oxycodone and Acetaminophen Capsules are a Schedule II controlled substance.

Oxycodone can produce drug dependence and has the potential for being abused. (See WARNINGS.)

Dosage should be adjusted accordingly to severity of pain and 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.

The usual adult dosage is one capsule every six hours as needed for pain.

Oxycodone and Acetaminophen Capsules USP

(Oxycodone Hydrochloride 5 mg and Acetaminophen 500 mg)

Capsules Identified 54 392

NDC 0054-2795-25: Bottles of 100 capsules.

Store at Controlled Room Temperature 15°-30°C (59°-86°F).

DEA Order Form Required

4073450//02

June 2001

© RLI, 2001