Butalbital 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.
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
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 high 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.
Rarely, acetaminophen can 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.
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 Butalbital, Acetaminophen and Caffeine Capsules, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen, and Caffeine Capsules, USP for patients with acetaminophen allergy.
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 high 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 reactionsRarely, acetaminophen can 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/ anaphylaxisThere 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 Butalbital, Acetaminophen and Caffeine Capsules, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen, and Caffeine Capsules, USP for patients with acetaminophen allergy.
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
Butalbital, Acetaminophen, and Caffeine Capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
History
There is currently no drug history available for this drug.
Other Information
Butalbital, Acetaminophen, and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital, USP……………………50 mg
Acetaminophen, USP…………….300 mg
Caffeine, USP……………………..40 mg
Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, FD&C red # 40, titanium dioxide, FD&C blue # 1,FD&C yellow # 6, gelatin.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:
Sources
Butalbital And Acetaminophen Manufacturers
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Qualitest Pharmaceuticals
![Butalbital And Acetaminophen Tablet [Qualitest Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Butalbital And Acetaminophen | Avkare, Inc.
1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Stat Rx Usa Llc
Butalbital And Acetaminophen | Stat Rx Usa Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Nexgen Pharma, Inc.
Butalbital And Acetaminophen | Nexgen Pharma, Inc.
Butalbital and Acetaminophen Tablets 50 mg/300 mg: One or two tablets every four hours. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of these products is not recommended because of the potential for physical dependence.
![Butalbital And Acetaminophen Tablet [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=be1b8109-725e-4427-9cd9-b468a71a48bd&name=BUTAL_APAP50-650mgLabel42549.jpg)
![Butalbital And Acetaminophen Tablet [Nexgen Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=669e3bd0-fbd9-423c-8654-a78fe650e3e2&name=0feca9fa-fde3-4d5d-bb6a-2886572933a0-03.jpg)
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