Acetaminophen And Codeine (Page 3 of 3)

Pediatric Use:

Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS and WARNINGS).

ADVERSE REACTIONS

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, 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 allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis.

At higher doses codeine has most of the disadvantages of morphine including respiratory depression.

DRUG ABUSE AND DEPENDENCE

Controlled Substance:

Acetaminophen and Codeine Phosphate tablets are classified as a Schedule III controlled substance.

Abuse and Dependence:

Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

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, 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 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 severity of pain and response of the patient. The usual adult dosage is:

Single Doses (range) Maximum 24 Hour Dose
Codeine Phosphate 15 mg to 60 mg 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.

HOW SUPPLIED

Repackaged by A-S Medication Solutions — Libertyville, IL
See REPACKAGING INFORMATION for available configurations.

A-S Medication Solutions
(click image for full-size original)

Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed “2064″ and “V” on one side and debossed “3″ on the reverse side. They are supplied in bottles of 30, 50, 60, 90, 100, 120, 180, 500 and 1000.

Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed “2065″ and “V” on one side and debossed “4″ on the reverse side. They are supplied in bottles of 100, 500 and 1000.

Dispense in a tight, light resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8182436
Rev 10/13
R8

REPACKAGING INFORMATION

Please reference the HOW SUPPLIED section listed above for a description of individual tablets or capsules. This drug product has been received by A-S Medication Solutions — Libertyville, IL in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from A-S Medication Solutions are listed below:

NDC#Count Strength
50090-0009-015300 mg / 30 mg

Repackaged by:

A-S Medication Solutions
(click image for full-size original)

Libertyville, IL 60048

PRINCIPAL DISPLAY PANEL

NDC 50090-0009-0

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048

//medlibrary.org/lib/images-rx/acetaminophen-and-codeine-5/50090-0009-0-300x132.jpg
(click image for full-size original)
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0009(NDC:0603-2338)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
STARCH, CORN
SODIUM METABISULFITE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 2064;V;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0009-0 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089805 09/30/1988
Labeler — A-S Medication Solutions LLC (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions LLC 830016429 repack (50090-0009)

Revised: 12/2014 A-S Medication Solutions LLC

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