TYLOX^®
(oxycodone and acetaminophen capsules usp)
analgesic

CII

For Oral Use

Each capsule of TYLOX (oxycodone and acetaminophen capsules USP) contains:

Inactive ingredients: docusate sodium, gelatin, magnesium stearate, sodium benzoate, sodium metabisulfite†, corn starch, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, and titanium dioxide.

Acetaminophen occurs as a white, odorless crystalline powder, possessing a slightly bitter taste.

The oxycodone component is 14-hydroxy-dihydrocodeinone, a white, odorless crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone

†See WARNINGS

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 the oxycodone in TYLOX (oxycodone and acetaminophen capsules) 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.

TYLOX (oxycodone and acetaminophen capsules) are indicated for the relief of moderate to moderately severe pain.

TYLOX (oxycodone and acetaminophen capsules) should not be administered to patients who are hypersensitive to any component.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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 TYLOX (oxycodone and acetaminophen capsules), 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, TYLOX is subject to the Federal Control 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 TYLOX should be cautioned accordingly.

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with TYLOX 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 Category C. Animal reproductive studies have not been conducted with TYLOX. It is also not known whether TYLOX can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TYLOX should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

As with all narcotics, administration of TYLOX 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.

It is not known whether the components of TYLOX are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TYLOX is administered to a nursing woman.

Safety and effectiveness in children 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 allergic reactions, euphoria, dysphoria, constipation, skin rash and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

TYLOX 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 according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to oxycodone can develop with continued use and that the incidence of untoward effects is dose related. This product is inappropriate even in high doses for severe or intractable pain.

TYLOX (oxycodone and acetaminophen capsules) are given orally. The usual adult dosage is one TYLOX capsule every 6 hours as needed for pain.

TYLOX (oxycodone and acetaminophen capsules USP): (colored red, imprinted “TYLOX”“McNEIL”) NDC 0045-0526 - bottles of 100 and unit dose 100's.

•  Dispense in tight, light-resistant container as
  defined in the official compendium.
  Store at controlled room temperature
  (15°-30°C, 59°-86°F). Protect from moisture.

OMP DIVISION
ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869
Printed in U.S.A.

© OMP 2000    7518500