Acetaminophen And Codeine Phosphate

Acetaminophen And Codeine Phosphate

Acetaminophen And Codeine Phosphate Recall

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Questions & Answers

Side Effects & Adverse Reactions

  • 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.

    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 or 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 postmarketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included 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.

    Alcohol Information

    Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

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 are indicated for the relief of mild to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

  • Acetaminophen and codeine 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 description

    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 description

    Each tablet contains:

    acetaminophen...........................300 mg

    codeine phosphate.......................15 mg

    (Warning: May be habit forming)

    OR

    acetaminophen...........................300 mg

    codeine phosphate....................... 30 mg

    (Warning: May be habit forming)

    OR

    acetaminophen...........................300 mg

    codeine phosphate....................... 60 mg

    (Warning: May be habit forming)

    In addition, each tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 300 mg/60 mg strength tablets also contain crospovidone, povidone, pregelatinized starch, and stearic acid.

Acetaminophen And Codeine Phosphate Manufacturers


  • Direct Rx
    Acetaminophen And Codeine Phosphate Tablet [Direct Rx]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Phosphate Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Phosphate Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Tablet [Cardinal Health]
  • Preferred Pharmaceuticals, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Preferred Pharmaceuticals, Inc.]
  • Andrx Pharmaceuticals, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Andrx Pharmaceuticals, Inc.]
  • Contract Pharmacy Services-pa
    Acetaminophen And Codeine Phosphate Tablet [Contract Pharmacy Services-pa]
  • Blenheim Pharmacal, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Blenheim Pharmacal, Inc.]
  • Redpharm Drug Inc.
    Acetaminophen And Codeine Phosphate Tablet [Redpharm Drug Inc.]
  • Dispensing Solutions, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Dispensing Solutions, Inc.]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Tablet [Cardinal Health]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Acetaminophen And Codeine Phosphate Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Rebel Distributors Corp
    Acetaminophen And Codeine Phosphate Tablet [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Acetaminophen And Codeine Phosphate Tablet [Rebel Distributors Corp]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Tablet [Cardinal Health]
  • Physicians Total Care, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Physicians Total Care, Inc.]
  • Mckesson Contract Packaging
    Acetaminophen And Codeine Phosphate Tablet [Mckesson Contract Packaging]
  • Bryant Ranch Prepack
    Acetaminophen And Codeine Phosphate Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Acetaminophen And Codeine Phosphate Tablet [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Phosphate Tablet [Remedyrepack Inc. ]
  • Apotheca, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Apotheca, Inc.]
  • Mallinckrodt, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Mallinckrodt, Inc.]
  • Aurolife Pharma, Llc
    Acetaminophen And Codeine Phosphate Tablet [Aurolife Pharma, Llc]
  • Mikart, Inc.
    Acetaminophen And Codeine Phosphate Liquid [Mikart, Inc.]
  • American Health Packaging
    Acetaminophen And Codeine Phosphate Tablet [American Health Packaging]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Acetaminophen And Codeine Phosphate Tablet [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Ranbaxy Pharmaceuticals Inc.
    Acetaminophen And Codeine Phosphate Tablet [Ranbaxy Pharmaceuticals Inc.]
  • Preferred Pharmaceuticals, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Preferred Pharmaceuticals, Inc.]
  • Teva Pharmaceuticals Usa Inc
    Acetaminophen And Codeine Phosphate Tablet [Teva Pharmaceuticals Usa Inc]
  • Aphena Pharma Solutions – Tennessee, Llc
    Acetaminophen And Codeine Phosphate Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Mylan Institutional Inc.
    Acetaminophen And Codeine Phosphate Tablet [Mylan Institutional Inc.]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Tablet [Cardinal Health]
  • Preferred Pharmaceuticals, Inc.
    Acetaminophen And Codeine Phosphate Tablet [Preferred Pharmaceuticals, Inc.]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Tablet [Cardinal Health]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Tablet [Cardinal Health]
  • Bryant Ranch Prepack
    Acetaminophen And Codeine Phosphate Tablet [Bryant Ranch Prepack]
  • Proficient Rx Lp
    Acetaminophen And Codeine Phosphate Tablet [Proficient Rx Lp]
  • Preferred Pharmaceuticals Inc.
    Acetaminophen And Codeine Phosphate Tablet [Preferred Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Phosphate Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Acetaminophen And Codeine Phosphate Tablet [Remedyrepack Inc. ]
  • Directrx
    Acetaminophen And Codeine Phosphate Tablet [Directrx]

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