OXYCODONE AND ACETAMINOPHEN TABLETS, USP

Rx only

Code 984Z00                                                                                                                   Rev. 03/06

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:

Oxycodone Hydrochloride      2.5 mg*

Acetaminophen, USP            400 mg

*2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.

The Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid.

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. The molecular formula for acetaminophen is C₈H₉NO₂ and the molecular weight is 151.16. It may be represented by the following structural formula:

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic pure opioid agonist which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C₁₈H₂₁NO4•HCl and the molecular weight is 351.82. It 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 involves the central nervous system and organs composed of smooth muscle. The principle actions of therapeutic value of the oxycodone in Oxycodone and Acetaminophen Tablets, USP 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.

Oxycodone and Acetaminophen Tablets, USP is indicated for the relief of moderate to moderately severe pain.

Oxycodone and Acetaminophen Tablets, USP should not be administered to patients who are hypersensitive to oxycodone, acetaminophen, or any other components of this product.

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 Oxycodone and Acetaminophen Tablets, USP 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, Oxycodone and Acetaminophen Tablets, USP is subject to the Federal Controlled Substances Act (Schedule II).

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 oxycodone and acetaminophen tablets should be cautioned accordingly.

Patient receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Oxycodone and Acetaminophen Tablets, USP 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 opioids may produce paralytic ileus.

It is not known whether Oxycodone and Acetaminophen Tablets, USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxycodone and Acetaminophen Tablets, USP is are administered to a nursing woman.

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 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. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

Oxycodone and Acetaminophen Tablets, USP is 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 opioids. Oxycodone and Acetaminophen Tablets, USP is given orally.

The usual adult dosage is one or two tablets every six hours (maximal daily dose of Oxycodone and Acetaminophen Tablets, USP 2.5 mg/400 mg is 10 tablets). The total daily dose of acetaminophen should not exceed 4 grams.

Oxycodone and Acetaminophen Tablets, USP 2.5mg/400 mg are supplied as follows:

Store at 20 to 25°C (68 to 77°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.