Butalbital And Acetaminophen
PrescriptionBrand names: BUTALBITAL AND ACETAMINOPHEN
About This Medication
DESCRIPTION Each Butalbital and acetaminophen tablets, 50 mg/ 325 mg for oral administration contains: *Butalbital, USP………...….. 50 mg Acetaminophen, USP..……. 325 mg Each Butalbital and acetaminophen tablets, 50 mg/ 300 mg for oral administration contains: *Butalbital, USP………...….. 50 mg Acetaminophen, USP..……. 300 mg * Habit forming ingredient In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Silicified Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Pregelatinized Starch, Povidone, Crospovidone and Stearic Acid. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 M.W.=224.26 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: C 8 H 9 NO 2 M.W.=151.16 Image Image
Active Ingredients
| Ingredient | Strength |
|---|---|
| Acetaminophen | - |
| Butalbital | - |
Indications & Usage
Dosage & Administration
Side Effects Overview
Warnings & Precautions
WARNINGS Butalbital 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. 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 butalbital and acetaminophen tablets immediately and seek medical care if they experience these symptoms. Do not prescribe butalbital and acetaminophen tablets for patients with acetaminophen allergy.
Contraindications
CONTRAINDICATIONS This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product. Patients with porphyria
Frequently Asked Questions
INDICATIONS AND USAGE Butalbital and acetaminophen tablets 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.
DOSAGE AND ADMINISTRATION 50 mg/325 mg: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets. 50 mg/300 mg : One or two tablets every four hours. Total daily dosage should not exceed six tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
WARNINGS Butalbital 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 …
CONTRAINDICATIONS This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product. Patients with porphyria
Butalbital And Acetaminophen is a prescription medication. You will need a valid prescription from a licensed healthcare provider.
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- • DailyMed — Butalbital And Acetaminophen drug label (National Library of Medicine)
- • openFDA — Butalbital And Acetaminophen label data (U.S. Food & Drug Administration)
- • RxNorm — RXCUI 197426 (NLM Normalized Drug Names)
- • NDC Directory — Butalbital And Acetaminophen (FDA National Drug Code)
Medical Disclaimer
The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.
Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.
Data sources: DailyMed (NLM), openFDA, MFDS