Hydrocodone Bitatrate And Acetaminophen
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
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.
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.
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:
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:
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.
Sources
Hydrocodone Bitatrate And Acetaminophen Manufacturers
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Rx Pak Division Of Mckesson Corporation
![Hydrocodone Bitatrate And Acetaminophen Tablet [Rx Pak Division Of Mckesson Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrocodone Bitatrate And Acetaminophen | Rx Pak Division Of Mckesson Corporation
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 6 tablets.
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Actavis Pharma, Inc.
Hydrocodone Bitatrate And Acetaminophen | Actavis Pharma, Inc.
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
2.5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
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Lake Erie Medical Dba Quality Care Products Llc
Hydrocodone Bitatrate And Acetaminophen | Great Lakes Wholesale, Marketing, & Sales, Inc.
adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor do not give to children under 12 years of age
![Hydrocodone Bitatrate And Acetaminophen Tablet [Actavis Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a3fff41b-9eab-43b2-8e7f-cb1eaf9042bc&name=hydrocodone-bitartrate-25-mg-and-apap-325mg-tabs-3.jpg)
![Hydrocodone Bitatrate And Acetaminophen Tablet [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a1914355-2669-4010-a42a-e9ee54804f47&name=healthcare-44-386-1.jpg)
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