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TABLETS USP(300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only · Aphena Pharma Solutions - Tennessee, LLC
Dosage Form
TABLETS USP(300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
WARNING: Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
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 |
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.
Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
The most frequently observed adverse reactions include 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, and agranulocytosis.
At higher doses, codeine has most of the disadvantages of morphine including respiratory depression.
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 or more hours 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.
Acetaminophen and codeine phosphate is supplied in tablet form for oral administration.
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
[image: MM1]Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:
[image: MM2]Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP . . . . . . . . . . . . . 15 mg
(Warning: May be habit forming)
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP . . . . . . . . . . . . . 30 mg
(Warning: May be habit forming)
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP . . . . . . . . . . . . . 60 mg
(Warning: May be habit forming)
In addition, each Acetaminophen and Codeine Phosphate Tablet USP contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.
NDC 67544-001 - Codeine Phosphate/APAP 15/300mg - Rx Only
[image: mm001]
NDC 67544-002 - Codeine Phosphate/APAP 30/300mg - Rx Only
[image: mm002]
NDC 67544-003 - Codeine Phosphate/APAP 60/300mg - Rx Only
[image: mm003]
|
Repackaged by Aphena Pharma Solutions - TN. |
| [image: mmAphena] |
Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with “2” on one side and an M on the other side.
Bottles of 100......................................... NDC 0406-0483-01
Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with “3” on one side and an M on the other side.
Bottles of 20........................................... NDC 0406-0484-20
Bottles of 30........................................... NDC 0406-0484-03
Bottles of 50........................................... NDC 0406-0484-50
Bottles of 100......................................... NDC 0406-0484-01
Bottles of 1000....................................... NDC 0406-0484-10
Unit Dose (10 x 10)............................... NDC 0406-0484-62
Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an M on the other side.
Bottles of 100......................................... NDC 0406-0485-01
Bottles of 500......................................... NDC 0406-0485-05
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistant container as defined in the USP.
Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a Mallinckrodt company.
© 2013 Mallinckrodt.
Mallinckrodt Inc.
Hazelwood, MO 63042 USA
Rev 10/2013
Mallinckrodt™
Pharmaceuticals
Photos of the product and/or packaging supplied by the manufacturer.
This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.
Pharmacokinetics
The behavior of the individual components is described below.
Codeine – Codeine is rapidly absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues.
The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces.
At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours.
Acetaminophen – Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within
24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.
Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 15/300mg | 30/300mg | 60/300mg |
| 9000 | - | 67544-002-09 | - |
| 15 | - | 67544-002-15 | - |
| 20 | - | 67544-002-20 | - |
| 30 | - | 67544-002-30 | - |
| 40 | - | 67544-002-40 | - |
| 45 | - | 67544-002-45 | - |
| 50 | - | 67544-002-50 | - |
| 56 | - | 67544-002-46 | - |
| 60 | - | 67544-002-53 | 67544-003-53 |
| 75 | - | 67544-002-55 | - |
| 84 | - | 67544-002-54 | - |
| 90 | 67544-001-60 | 67544-002-60 | 67544-003-60 |
| 60 | - | 67544-002-53 | 67544-003-53 |
| 112 | - | 67544-002-72 | - |
| 150 | - | 67544-002-75 | - |
| 180 | - | 67544-002-80 | 67544-003-80 |
| 200 | - | 67544-002-85 | - |
| 240 | - | 67544-002-90 | 67544-003-90 |
| 300 | - | 67544-002-93 | - |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
[image: mmAphena]
Cookeville, TN 38506
20140505SC
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