Acetaminophen And Codeine

Acetaminophen And Codeine

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Questions & Answers

Side Effects & Adverse Reactions

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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious skin reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine

Respiratory depression and death have occurred in children 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 2D6 of high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine [see Precautions, Nursing Mothers].

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see Overdosage].

Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain 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].

When prescribing codeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see Overdosage].

Hypersensitivity/ anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs include swelling of the face, mouth and throat, respiratory distress, urticaria, rash, pruritus and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Acetaminophen and Codeine Phosphate Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Acetaminophen and Codeine Phosphate Tablets, USP for patients with acetaminophen allergy.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Codeine is habit forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

Each tablet contains:

Acetaminophen, USP……………………………………………………..300 mg

Codeine Phosphate, USP…………………………………………………...30 mg

(Warning:  May be habit forming)

Inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.

Acetaminophen and codeine is supplied in tablet form for oral administration.

Acetaminophen, 4'-hydroxyacetanlllde, IS a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

9ba1db7f-figure-01

Codeine phosphate: 7,8-didehydro-4,5α-epoxy-3-methoxy-l7-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

9ba1db7f-figure-02

Acetaminophen And Codeine Manufacturers


  • Proficient Rx Lp
    Acetaminophen And Codeine Tablet [Proficient Rx Lp]
  • Proficient Rx Lp
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Proficient Rx Lp]
  • Direct Rx
    Acetaminophen And Codeine Tablet [Direct Rx]
  • Remedyrepack Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • Preferred Pharmaceuticals, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Preferred Pharmaceuticals, Inc.]
  • Rxchange Co.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Rxchange Co.]
  • Rxchange Co.
    Acetaminophen And Codeine Tablet [Rxchange Co.]
  • Keltman Pharmaceuticals Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Keltman Pharmaceuticals Inc.]
  • Redpharm Drug Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Redpharm Drug Inc.]
  • Contract Pharmacy Services-pa
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Contract Pharmacy Services-pa]
  • Dispensing Solutions, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Dispensing Solutions, Inc.]
  • H.j. Harkins Company, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [H.j. Harkins Company, Inc.]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Tablet [Remedyrepack Inc. ]
  • Aidarex Pharmaceuticals Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Aidarex Pharmaceuticals Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]
  • Unit Dose Services
    Acetaminophen And Codeine Tablet [Unit Dose Services]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Tablet [Remedyrepack Inc. ]
  • Aphena Pharma Solutions – Tennessee, Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Qualitest Pharmaceuticals
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Qualitest Pharmaceuticals]
  • Qualitest Pharmaceuticals
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Qualitest Pharmaceuticals]
  • Mutual Pharmaceutical Company, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Mutual Pharmaceutical Company, Inc.]
  • Amneal Pharmaceuticals, Llc
    Acetaminophen And Codeine Tablet [Amneal Pharmaceuticals, Llc]
  • Liberty Pharmaceuticals, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Liberty Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Qualitest Pharmaceuticals
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Solution [Qualitest Pharmaceuticals]
  • Pd-rx Pharmaceuticals, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Direct Rx
    Acetaminophen And Codeine Tablet [Direct Rx]
  • Blenheim Pharmacal, Inc.
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [Blenheim Pharmacal, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Acetaminophen And Codeine Tablet [Preferred Pharmaceuticals, Inc.]
  • Northwind Pharmaceuticals, Llc
    Acetaminophen And Codeine (Codeine Phosphate And Apap) Tablet [Northwind Pharmaceuticals, Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine (Acetaminophen And Codeine Phosphate) Tablet [A-s Medication Solutions Llc]

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