TYLOX

TYLOX- acetaminophen and oxycodone hydrochloride capsule
Ortho-McNeil-Janssen Pharmaceuticals, Inc.

For Oral Use

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 (see WARNINGS).

DESCRIPTION

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

*
5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone
Oxycodone Hydrochloride USP5 mg *
Warning — May be habit forming.
Acetaminophen USP 500 mg

Inactive ingredients: docusate sodium, gelatin, magnesium stearate, sodium benzoate, sodium metabisulfite 1, 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:

Chemical Structure
(click image for full-size original)

1
See WARNINGS

CLINICAL PHARMACOLOGY

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 Indications and Usage

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

CONTRAINDICATIONS

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

WARNINGS

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).

PRECAUTIONS

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 preexisting 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 TYLOX® (oxycodone and acetaminophen capsules) or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients

TYLOX® 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

  • Do not take TYLOX® if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing, stop taking TYLOX® and contact your healthcare provider immediately.
  • Do not take more than 4,000 milligrams of acetaminophen per day. Call your healthcare provider if you took more than the recommended dose.
  • 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. Exercise caution until you are reasonably certain that TYLOX® does not adversely affect your ability to engage in such activities.

Drug Interactions

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.

Usage in Pregnancy

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.

Nonteratogenic Effects

Use of narcotics during pregnancy may produce physical dependence in the neonate.

Labor and Delivery

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.

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