Rx Drugs Info

roxicet 5/500 (Oxycodone hydrochloride and Acetaminophencapsule 
[Roxane Laboratories, Inc.]

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:

Image from Drug Label Content

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:

Image from Drug Label Content

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:

Head Injury and Increased Intracranial Pressure:

The respiratory depressant effects of narcotics 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, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions:

The administration of products containing oxycodone or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients:

Oxycodone and Acetaminophen 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 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:

Teratogenic Effects: Pregnancy Category C.

Animal reproductive studies have not been conducted with oxycodone and acetaminophen. It is also not known whether oxycodone and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and acetaminophen 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 narcotics during pregnancy may produce physical dependence in the neonate.

Labor and Delivery:

As with all narcotics, administration of oxycodone and acetaminophen 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 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:

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 overdosage 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. Patients’ 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 overdose 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 narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, 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.

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

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ROXICET 5/500 (Oxycodone hydrochloride and Acetaminophen)
PRODUCT INFO
Product Code 0054-8784 Dosage Form CAPSULE
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
oxycodone hydrochloride (oxycodone) Active 5 MILLIGRAM  In 1 CAPSULE
acetaminophen (acetaminophen) Active 500 MILLIGRAM  In 1 CAPSULE
colloidal silicon dioxide Inactive  
croscarmellose sodium Inactive  
microcrystalline cellulose Inactive  
pregelatinized starch Inactive  
starch (corn) Inactive  
stearic acid Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color WHITE (WHITE) Score 2
Shape CAPSULE (CAPSULE) Symbol false
Imprint Code 54;730 Coating false
Size 18mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0054-8784-24 100 CAPSULE In 1 BLISTER PACK None
2 0054-4784-25 100 CAPSULE In 1 BOTTLE, PLASTIC None

Revised: 03/2006Roxane Laboratories, Inc.

Data are from FDA and U.S. National Library of Medicine.