Oxycodone Acetaminophen 2.5/400

Generic Name: oxycodone and acetaminophen
Dosage Form: Tablets, usp 2.5mg/400mg

Rx only

Code 984Z00                                                                                                                   Rev. 03/06

Oxycodone Acetaminophen 2.5/400 Description

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:

Oxycodone Hydrochloride      2.5 mg*

Acetaminophen, USP            400 mg

*2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.

The Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, 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. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula:

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic pure opioid agonist which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4•HCl and the molecular weight is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

Oxycodone Acetaminophen 2.5/400 - 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 principle actions of therapeutic value of the oxycodone in Oxycodone and Acetaminophen Tablets, USP 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 Oxycodone Acetaminophen 2.5/400

Oxycodone and Acetaminophen Tablets, USP is indicated for the relief of moderate to moderately severe pain.

Contraindications

Oxycodone and Acetaminophen Tablets, USP 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, USP 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, USP is subject to the Federal Controlled Substances Act (Schedule II).

Precautions

General

Head Injury and Increased Intracranial Pressure:

The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions:

The administration of Oxycodone and Acetaminophen Tablets, USP or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients:

Oxycodone and acetaminophen tablets should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.

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

Patient receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Oxycodone and Acetaminophen Tablets, USP 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

Teratogenic Effects; Pregnancy Category C:

Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen Tablets, USP. It is also not known whether oxycodone and acetaminophen tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and acetaminophen tablets should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

Nonteratogenic Effects:

Use of opioids during pregnancy may produce physical dependence in the neonate.

Labor and Delivery:

As with all opioids, administration of Oxycodone and Acetaminophen Tablets, USP 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 Oxycodone and Acetaminophen Tablets, USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxycodone and Acetaminophen Tablets, USP is 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 Tablets, USP is a Schedule II controlled substance.

Oxycodone can produce drug dependence and has the potential for being abused (See WARNINGS).

Overdosage

Acetaminophen

Signs and Symptoms:

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.

In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment:

The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patient’s estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals.

The antidote, N-acetylcysteine, should be administered as early as possible, preferably within 16 hours of the overdose ingestion for optimal results, but in any case, within 24 hours. Following recovery, there are no residual, structural, or functional hepatic abnormalities.

Oxycodone

Signs and Symptoms:

Serious overdosage with oxycodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment:

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including oxycodone. Therefore, an appropriate dose of naloxone hydrochloride (usual initial adult dose 0.4 mg to 2 mg) should be administered preferably by the intravenous route, and simultaneously with efforts at respiratory resuscitation (see package insert). Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.

An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

Gastric emptying may be useful in removing unabsorbed drug.

Oxycodone Acetaminophen 2.5/400 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, USP is given orally.

The usual adult dosage is one or two tablets every six hours (maximal daily dose of Oxycodone and Acetaminophen Tablets, USP 2.5 mg/400 mg is 10 tablets). The total daily dose of acetaminophen should not exceed 4 grams.

How is Oxycodone Acetaminophen 2.5/400 Supplied

Oxycodone and Acetaminophen Tablets, USP 2.5mg/400 mg are supplied as follows:

White, capsule shaped tablets, debossed “2.5/400” on one side and “ADG” on the other side.

Bottles of 100 Bottles of 500

NDC# 46672-828-10 NDC# 46672-828-50

Store at 20 to 25°C (68 to 77°F). [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.

Manufactured by:

MIKART, INC.

Atlanta, Georgia 30318

Code 984Z00                                                                                                                     Rev. 03/06

Oxycodone and Acetaminophen (Oxycodone and Acetaminophen)

PRODUCT INFO Product Code 46672-828 Dosage Form TABLET Route Of Administration ORAL DEA Schedule CII

INGREDIENTS Name (Active Moiety) Type Strength oxycodone hydrochloride (oxycodone) Active 2.5 MILLIGRAM  In 1 TABLET acetaminophen (acetaminophen) Active 400 MILLIGRAM  In 1 TABLET croscarmellose sodium Inactive   crospovidone Inactive   microcrystalline cellulose Inactive   povidone Inactive   pregelatinized starch Inactive   silicon dioxide Inactive   stearic acid Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (WHITE) Score 1 Shape OVAL (CAPSULE) Symbol false Imprint Code ADG;2.5/400 Coating false Size 14mm

PACKAGING # NDC Package Description Multilevel Packaging 1 46672-828-10 100 TABLET In 1 BOTTLE, PLASTIC None 2 46672-828-50 500 TABLET In 1 BOTTLE, PLASTIC None

Revised: 05/2006