Hydrocodone Bitatrate And Acetaminophen

Hydrocodone Bitatrate And Acetaminophen

Hydrocodone Bitatrate And Acetaminophen Recall

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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.

Hypersensitivity/anaphylaxis

There have been post-marketing 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 NORCO® Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe NORCO® Tablets for patients with acetaminophen allergy.

Respiratory Depression:

At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure:

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions:

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

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

NORCO® is indicated for the relief of moderate to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

NORCO® (Hydrocodone bitartrate and acetaminophen) is supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Hydrocodone Bitartrate Structural Formula

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:

Acetaminophen Structural Formula

NORCO®, for oral administration is available in the following strengths:

                              Hydrocodone Bitartrate                   Acetaminophen
NORCO® 7.5/325                   7.5 mg                               325 mg
NORCO® 10/325                    10 mg                                325 mg

In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Meets USP Dissolution Test 1.

Hydrocodone Bitatrate And Acetaminophen Manufacturers


  • Rx Pak Division Of Mckesson Corporation
    Hydrocodone Bitatrate And Acetaminophen Tablet [Rx Pak Division Of Mckesson Corporation]
  • Actavis Pharma, Inc.
    Hydrocodone Bitatrate And Acetaminophen Tablet [Actavis Pharma, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Hydrocodone Bitatrate And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Products Llc]

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