ACETAMINOPHEN AND CODEINE (Page 3 of 3)

Overdosage

Following an acute overdosage, toxicity may result from codeine or acetaminophen.

Signs and Symptoms:

Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration and loss of consciousness. Convulsions may occur.

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

A single or multiple drug overdose with acetaminophen and codeine 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. For respiratory depression due to overdosage or unusual sensitivity to codeine phosphate, parenteral naloxone is a specific and effective antagonist.

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 then 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 severity of pain and response of the patient.

Codeine Phosphate 15mg to 60mg 360 mg

Acetaminophen 300 mg to 1000 mg 4000 mg

The usual dose of codeine phosphate in children is 0.5 mg/kg.

Doses may be repeated up to every 4 hours.

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription.

It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

Please view the drug manufacturer’s completedrug information at the FDA site:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bc4108b-314e-4a52-a37c-631c6b869b04

Label

NDC: 51655-802-54

Codeine Phosphate & APAP 30/300MG CIII

15 Tablets Rx Only

Lot: Exp:

Store at 20C to 25C (68-77F)

Keep out of reach of children. Dosage: See package insert

Manufacturered By: Amneal Pharmaceuticals of NY

Manufacture Address: Hauppage, NY 11788

Manufacture NDC: 65162-033-11 Mfg Lot:

Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256

Acetamin and Codeine 51655-802-54
(click image for full-size original)

NDC: 51655-802-53

Codeine Phosphate & APAP 30/300MG CIII

10 Tablets Rx Only

Lot: Exp:

Store at 20C to 25C (68-77F)

Keep out of reach of children. Dosage: See package insert

Manufacturered By: Amneal Pharmaceuticals of NY

Manufacture Address: Hauppage, NY 11788

Manufacture NDC: 65162-033-11 Mfg Lot:

Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-802-53
(click image for full-size original)
ACETAMINOPHEN AND CODEINE
codeine phosphate and apap tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-802(NDC:65162-033)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code IP;33
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-802-54 15 TABLET in 1 BOTTLE, DISPENSING None
2 NDC:51655-802-53 10 TABLET in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040779 07/18/2014
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
EPM Packaging 079124340 repack (51655-802)

Revised: 08/2014 Northwind Pharmaceuticals, LLC

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