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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ROXICET 5/500™ CAPLETS
(Oxycodone and Acetaminophen Tablets USP)
Rx only.
DESCRIPTION
Each caplet contains:
Oxycodone Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 mg+
(+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mg
Inactive Ingredients:
The caplets contain: colloidal silicon dioxide, microcrystalline cellulose, starch (corn), croscarmellose sodium, pregelatinized starch, and stearic acid.
Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its structure is as follows:
C6H9NO2 M.W. 151.16
The oxycodone component is 14-hydroxydihydrocodeinone, a white, odorless crystalline powder which is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:
C18H21NO4•HCl M.W. 351.83
CLINICAL PHARMACOLOGY
The principal ingredient, oxycodone, is a semi-synthetic narcotic 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 oxycodone 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
For the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
Hypersensitivity to oxycodone or acetaminophen.
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, this drug is 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 taking this drug 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 may exhibit additive CNS depression. When such 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:
Nursing Mothers:
It is not known whether the components of this drug are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxycodone and acetaminophen is administered to a nursing mother.
Pediatric Use:
Safety and effectiveness in children 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 non-ambulatory 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 tablets 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 severity of pain and 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.
Tablets:
The usual adult dose is one caplet every six hours as needed for pain.
HOW SUPPLIED
ROXICET 5/500™ Caplets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 500 mg) white scored capsule-shaped tablets (Identified 54 730).
NDC 0054-8784-24: Unit dose, 25 caplets per card (reverse numbered), 4 cards per shipper.
NDC 0054-4784-25: Bottles of 100 caplets.
Store at Controlled Room Temperature 15°-30°C (59°-86°F).
DEA Order Form Required.
4073401 098
© RLI, 1998
