Attention, chocolate lovers: You may not be able to help yourselves. Swiss and British scientists have linked the widespread love of chocolate to a chemical "signature" that may be programmed into our metabolic systems.
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OXYCODONE AND ACETAMINOPHEN
CAPSULES
5 mg/500 mg
CII
Rx only
Analgesic For Oral Use
DESCRIPTION
Each Oxycodone and Acetaminophen Capsule USP 5 mg/500 mg contains:
*5 mg Oxycodone Hydrochloride USP is equivalent to 4.4815 mg oxycodone.
In addition, each capsule contains the following inactive ingredients: Gelatin NF, Magnesium Stearate NF, Silicon Dioxide NF, Sodium Lauryl Sulfate NF, Pregelatinized Starch NF, Stearic Acid NF, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, and Titanium Dioxide USP.
The oxycodone component is 14-hydroxydihydrocodeinone, a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid and thebaine. Oxycodone hydrochloride may be represented by the structural formula shown below:
Acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder with a slightly bitter taste. It has the following structural formula:
CLINICAL PHARMACOLOGY
The principal ingredient, oxycodone, is a semisynthetic 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 this product 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.
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Capsules are indicated for the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
This product should not be administered to patients who are hypersensitive to any components.
WARNINGS
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 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, oxycodone and acetaminophen capsules are subject to the Federal Controlled Substances Act (Schedule II).
PRECAUTIONS
General
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 oxycodone and acetaminophen capsules 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 capsules 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
Labor and Delivery
As with all narcotics, administration of oxycodone and acetaminophen capsules 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 product are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxycodone and acetaminophen capsules are administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
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 allergic reactions, euphoria, dysphoria, constipation, skin rash and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.
DRUG ABUSE AND DEPENDENCE
Oxycodone and acetaminophen capsules are a Schedule II controlled substance.
Oxycodone can produce drug dependence and has the potential for being abused (see WARNINGS).
OVERDOSAGE
Acetaminophen
Oxycodone
DOSAGE AND ADMINISTRATION
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. Oxycodone and acetaminophen capsules are given orally.
The usual adult dosage is one capsule every 6 hours as needed for pain.
HOW SUPPLIED
Each OXYCODONE AND ACETAMINOPHEN USP capsule contains Oxycodone Hydrochloride 5 mg (equivalent to 4.4815 mg oxycodone) and Acetaminophen 500 mg. It is available as a Red/Beige hard gelatin capsule imprinted with 
532 identification number.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.
Protect from moisture.
DEA Order Form Required.
is a registered trademark of Mallinckrodt Inc.
Mallinckrodt Inc.
St. Louis, Missouri 63134, U.S.A.
tyco
Healthcare
Mallinckrodt
Printed in U.S.A.
Rev 101706