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Oxycodone and Acetaminophen Tablets, USP
5mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg
and 10 mg*/325 mg

CII

Rx only

DESCRIPTION

Oxycodone hydrochloride and acetaminophen is supplied in tablet form for oral administration.

Each oxycodone and acetaminophen tablet, USP 5 mg*/325 mg tablet contains:

            Oxycodone Hydrochloride, USP 5 mg (*equivalent to 4.4815 mg Oxycodone)
            Acetaminophen, USP 325 mg

Each oxycodone and acetaminophen tablet, USP 7.5 mg*/325 mg tablet contains:

            Oxycodone Hydrochloride, USP 7.5 mg (*equivalent to 6.7228 mg Oxycodone)
            Acetaminophen, USP 325 mg

Each oxycodone and acetaminophen tablet, USP 7.5 mg*/500 mg tablet contains:

            Oxycodone Hydrochloride, USP 7.5 mg (*equivalent to 6.7228 mg Oxycodone)
            Acetaminophen, USP 500 mg

Each oxycodone and acetaminophen tablet, USP 10 mg*/325 mg tablet contains:

            Oxycodone Hydrochloride, USP 10 mg (*equivalent to 8.9637 mg Oxycodone)
            Acetaminophen, USP 325 mg

All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: crospovidone NF, microcrystalline cellulose NF, povidone USP, pregelatinized starch NF, silicon dioxide NF and stearic acid NF.

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. It may be represented by the following structural formula:

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine. Oxycodone hydrochloride may be represented by the following structural formula:

CLINICAL PHARMACOLOGY

The principal ingredient, oxycodone, is a semisynthetic opioid analgesic with multiple actions qualitatively similar to those of morphine; the most prominent involves the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in oxycodone and acetaminophen tablets 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 tablets, USP are indicated for the relief of moderate to moderately severe pain.

CONTRAINDICATIONS

This product should not be administered to patients who are hypersensitive to oxycodone, acetaminophen, or any other components of this product.

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 tablets, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid-containing medications. Like other opioid-containing medications, oxycodone and acetaminophen tablets 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 tablets should be cautioned accordingly.

Drug Interactions

Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with oxycodone and acetaminophen tablets 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 opioids may produce paralytic ileus.

Usage in Pregnancy

Nursing Mothers

It is not known whether the active 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 tablets 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 light-headedness, 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 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 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 opioids. Oxycodone and acetaminophen tablets are given orally. The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams (maximal daily dose of oxycodone and acetaminophen tablets 7.5 mg/325 mg and oxycodone and acetaminophen tablets 7.5 mg/500 mg is 8 tablets, and for oxycodone and acetaminophen tablets 10 mg/325 mg is 6 tablets).

HOW SUPPLIED

Each oxycodone and acetaminophen tablet, USP 5 mg/325 mg contains oxycodone hydrochloride 5 mg (equivalent to 4.4815 mg oxycodone) and acetaminophen 325 mg. It is available as a round, white scored tablet debossed with a 512 identification number.

            Bottles of 100.......................NDC No. 0406-0512-01
            Bottles of 500.......................NDC No. 0406-0512-05
            Unit Dose (10x10)...............NDC No. 0406-0512-62

Each oxycodone and acetaminophen tablet, USP 7.5 mg/325 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M522” on one side and “7.5/325” on the other side.

            Bottles of 100.......................NDC No. 0406-0522-01
            Unit Dose (10x10)...............NDC No. 0406-0522-62

Each oxycodone and acetaminophen tablet, USP 7.5 mg/500 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 500 mg. It is available as a white to off-white oval shaped tablet debossed with “M582” on one side and the other side is plain.

            Bottles of 100.......................NDC No. 0406-0582-01
            Unit Dose (10x10)...............NDC No. 0406-0582-62

Each oxycodone and acetaminophen tablet, USP 10 mg/325 mg contains oxycodone hydrochloride 10 mg (equivalent to 8.9637 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M523” on one side and “10/325” on the other side.

            Bottles of 100.......................NDC No. 0406-0523-01
            Unit Dose (10x10).......…....NDC No. 0406-0523-62

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

DEA Order Form Required.

Tyco

Healthcare

Mallinckrodt

Mallinckrodt Inc.

St. Louis, Missouri 63134, U.S.A.

Rev. 080206

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