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OXYCODONE*
AND
ACETAMINOPHEN
CAPSULES, USP
CII
Rx only
DESCRIPTION
Each capsule, for oral administration, contains:
Oxycodone Hydrochloride, USP..................................5 mg
(equivalent to 4.4815 mg Oxycodone)
* WARNING– May be habit forming
Acetaminophen, USP....................................................500 mg
In addition each capsule contains the following inactive ingredients: croscarmellose sodium, FD&C Red #40, gelatin, magnesium stearate, povidone, pregelatinized starch, stearic acid and titanium dioxide.
The acetaminophen component is 4’-hydroxyacetanilide, a white, odorless, crystalline powder, possessing a slightly bitter taste, and having the following structural formula:
The oxycodone component is 14-hydroxydihydrocodeinone, 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:
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
Oxycodone and Acetaminophen Capsules should not be administered to patients who are hypersensitive to any component.
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 Substance 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
Teratogenic Effects:
Pregnancy Category C: Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen Capsules. It is also not known whether Oxycodone and Acetaminophen Capsules can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and Acetaminophen Capsules should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
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 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. 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 narcotics.
Oxycodone and Acetaminophen Capsules are given orally. The usual adult dosage is one Oxycodone and Acetaminophen Capsule every 6 hours as needed for pain.
HOW SUPPLIED
Oxycodone Hydrochloride and Acetaminophen Capsules, USP, 5 mg/500 mg, supplied as a red capsule, imprinted 4832/V in bottles of 100, 500 and 1000. Dispense in tight, light-resistant container as defined in the official USP.
Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
Manufactured by:
VINTAGE PHARMACEUTICALS, INC.
Charlotte, NC 28206
8180827
Rev 7/06
R4