Hydrocodone Bitartate And Acetaminophen
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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.
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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
History
There is currently no drug history available for this drug.
Other Information
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:
Each tablet contains:
Hydrocodone Bitartrate...... 5 mg
Acetaminophen.................. 325 mg
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, and FD&C Yellow #6. Meets USP Dissolution Test 1.
Sources
Hydrocodone Bitartate And Acetaminophen Manufacturers
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Major Pharmaceuticals
![Hydrocodone Bitartate And Acetaminophen Tablet [Major Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrocodone Bitartate And Acetaminophen | Major Pharmaceuticals
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 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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Aidarex Pharmaceuticals Llc
Hydrocodone Bitartate And Acetaminophen | Aidarex Pharmaceuticals Llc
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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H.j. Harkins Company, Inc.
Hydrocodone Bitartate And Acetaminophen | H.j. Harkins Company, 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.
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 12 tablets.
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Rebel Distributors Corp
Hydrocodone Bitartate And Acetaminophen | Rebel Distributors Corp
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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A-s Medication Solutions Llc
Hydrocodone Bitartate And Acetaminophen | A-s Medication Solutions Llc
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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Preferred Pharmaceuticals, Inc.
Hydrocodone Bitartate And Acetaminophen | Preferred Pharmaceuticals, 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.
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 12 tablets.
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Kle 2, Inc.
Hydrocodone Bitartate And Acetaminophen | Kle 2, 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.
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 12 tablets.
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Unit Dose Services
Hydrocodone Bitartate And Acetaminophen | Unit Dose Services
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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Northwind Pharmaceuticals
Hydrocodone Bitartate And Acetaminophen | Northwind Pharmaceuticals
Dosage should be adjusted according to the severity of the pain and 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.
Product Strength Usual Adult Dosage AS NEEDED FOR PAIN The total daily dosage should not exceed
5 mg/325 mg One or two tablets every four to six hours 12 tablets
7.5 mg/325 mg One tablet every four to six hours 6 tablets
10 mg/325 mg One tablet every four to six hours 6 tablets -
Bryant Ranch Prepack
Hydrocodone Bitartate And Acetaminophen | Bryant Ranch Prepack
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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Actavis Pharma, Inc.
Hydrocodone Bitartate 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.
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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Bryant Ranch Prepack
Hydrocodone Bitartate And Acetaminophen | Bryant Ranch Prepack
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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Lake Erie Medical Dba Quality Care Products Llc
Hydrocodone Bitartate And Acetaminophen | Lake Erie Medical Dba Quality Care Products Llc
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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Aidarex Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03aea0d1-c808-40ae-9605-166733202166&name=hydrocodone-apap-tab-kle2-3.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [H.j. Harkins Company, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4f505b2a-45a2-4d34-96f6-dedb574cb508&name=HydrocodoneLabel.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a05c255c-6e0b-4e86-b907-738b777fc524&name=a05c255c-6e0b-4e86-b907-738b777fc524-03.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d9ebc427-9e52-4627-a59d-0e1a4fe80165&name=6362-0.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6f367d9b-7141-46d8-a3a3-5a241e167259&name=be430d5e-0007-431c-922f-29a546432d86-03.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Kle 2, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cb805564-d418-4339-aaf2-646800dd4161&name=HydrocodoneLabel.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Unit Dose Services]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f410ba48-2c6c-42e0-9802-ecc733cad9b0&name=50436-3912.jpg)
![Hydrocodone Bitartate And Acetaminophen Tablet [Northwind Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b32a79b-ab42-4020-9c13-064284d95258&name=51655-900-20.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3345ecf5-5250-4005-9658-81a60ddbc01c&name=47311.jpg)
![Hydrocodone Bitartate And Acetaminophen Tablet [Actavis Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fa32969f-7210-47ec-bbd1-f62bea8989a7&name=hydrocodone-bitartrate-and-acetaminophen-5mg-325mg-3.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=06cd8ce6-8416-4747-b563-d88814539e12&name=54281.jpg)
![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=44ed0a3b-1614-42f0-8a28-c836686167aa&name=scan0005.jpg)
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