OXYCODONE AND ACETAMINOPHEN (Page 5 of 5)

Treatment

A single or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Oxycodone

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 hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone. 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. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Acetaminophen

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

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. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and acetaminophen tablets are given orally.

The total daily dose of acetaminophen should not exceed 4 grams.

Strength UsualAdult Dosage MaximalDaily Dose
Oxycodone and acetaminophen tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 Tablets

Cessation of Therapy

In patients treated with oxycodone and acetaminophen tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

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 30 . . . . . . . . . . . . . . . . . . . . . NDC 21695-233-30
Bottles of 60 . . . . . . . . . . . . . . . . . . . . . NDC 21695-233-60
Bottles of 90 . . . . . . . . . . . . . . . . . . . . . NDC 21695-233-90

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.

Mallinckrodt Inc.
Hazelwood, MO 63042 USA

Printed in U.S.A.

Rev 05/2011

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Mallinckrodt
COVIDIEN™

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 7.5 mg*/325 mg Bottle

Multiple strengths. Do not dispense unless strength is stated.
NDC 21695-233-90
90 TABLETS
OXYCODONE AND ACETAMINOPHEN TABLETS USP
CII
7.5 mg*/325 mg
Rx only
Each tablet contains:
Oxycodone Hydrochloride USP . . . . . . 7.5 mg*
Acetaminophen USP . . . . . . . . . . . . . . .325 mg

Oxycodone/Acetaminophen 7.5mg/325mg
(click image for full-size original)
OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-233(NDC:0406-0522)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 7.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
SILICON DIOXIDE
STEARIC ACID
Product Characteristics
Color white (off-white) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code M522;7;5;325
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-233-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:21695-233-60 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:21695-233-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040545 03/08/2011
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 07/2011 Rebel Distributors Corp

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