Tylox

• Janssen Pharmaceuticals, Inc.

• Ortho-McNeil Pharmaceutical Corporation

• Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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 nonopiate, nonsalicylate analgesic and antipyretic.

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

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products (see Boxed Warning).

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/Anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Tylox® immediately and seek medical care if they experience these symptoms. Do not prescribe Tylox® for patients with acetaminophen allergy.

Tylox® 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.

Drug Dependence

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).

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) contains 5 mg oxycodone and 500 mg acetaminophen. The capsules are red and imprinted with "Tylox" "McNEIL". Tylox® is available as follows:

Bottles of 100 capsules - NDC 50458-526-60

Hospital Unit Dose 100 capsules – NDC 50458-526-79

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.

Manufactured by:
Janssen Ortho, LLC
Gurabo, Puerto Rico 00778

Manufactured for:
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, NJ 08869

Revised October 2011

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2000
10187201

You should not use Tylox if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Tylox and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Tylox may be habit forming. Never share acetaminophen and oxycodone with another person, especially someone with a history of drug abuse or addiction.

You should not use Tylox if you are allergic to acetaminophen (Tylenol) or oxycodone, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure Tylox is safe for you, tell your doctor if you have:

• liver disease, cirrhosis, or if you drink more than 3 alcoholic beverages per day;

• a history of alcoholism or drug addiction;

• diarrhea, inflammatory bowel disease;

• bowel obstruction, severe constipation;

• a colostomy or ileostomy;

• kidney disease;

• low blood pressure, or if you are dehydrated;

• a history of head injury, brain tumor, or stroke; or

• asthma, COPD, sleep apnea, or other breathing disorders.

Oxycodone may be habit forming. Never share Tylox with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take Tylox, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen and oxycodone may pass into breast milk and could harm a nursing baby. You should not breast-feed while using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Tylox can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

Get emergency medical help if you have any of these signs of an allergic reaction to Tylox: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat;

• a light-headed feeling, like you might pass out;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• problems with urination; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Tylox side effects include:

• drowsiness;

• upset stomach, constipation;

• blurred vision; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.