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OXYCODONE AND ACETAMINOPHEN CAPSULES, USP CII
AnalgesicFor Oral Use
1006580102
Rx only
Description:
Each oxycodone and acetaminophen capsule USP, for oral administration, contains:
Oxycodone Hydrochloride, USP 5 mg†
Acetaminophen, USP 500 mg
Inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
The oxycodone component is 14-hydroxydihydrocodeinone, a white, odorless crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine. Oxycodone Hydrochloride has the molecular formula of C18H21NO4•HCl, a molecular weight of 351.83 and may be represented by the following structural formula:
†5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone.
Acetaminophen occurs as a white, odorless crystalline powder, possessing a slightly bitter taste. It has the molecular formula C8H9NO2 and a molecular weight of 151.17. Acetaminophen 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 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 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 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, 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 oxycodone and acetaminophen capsules 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 non-ambulatory 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 oxycodone and acetaminophen capsule every 6 hours as needed for pain.
How Supplied:
Oxycodone and Acetaminophen Capsules, USP are available as:
5 mg / 500 mg: Red opaque cap and white opaque body filled with white powder.
Imprinted in black ink stylized barr 658.
Available in bottles of:
| 100 | NDC 0555-0658-02 |
| 500 | NDC 0555-0658-04 |
Dispense in a tight, light-resistant container as defined in the USP/NF.
Store at controlled room temperature 15°-30°C (59°-86°F) [see USP].
Protect from moisture.
MANUFACTURED BY
BARR LABORATORIES, INC.
POMONA, NY 10970
BR-658