Overview
Butalbital, or 5-allyl-5-isobutylbarbituric acid, is a derivative of barbituric acid which the hydrogens at position 5 are substituted by an allyl group and an isobutyl group. It is a short-to-intermediate acting member of barbiturates that exhibit muscle-relaxing and anti-anxiety properties that produce central nervous system (CNS) depression that ranges from mild sedation to general anesthesia. Butalbital has a low degree of selectivity and a narrow therapeutic index. Typically indicated to manage tension (or muscle contraction) headaches, butalbital is often combined with one or more therapeutic agents, such as acetylsalicylic acid, acetaminophen, aspirin, and caffeine. There have not been clinical trials that evaluate the clinical efficacy of butalbital in migraines thus it is not indicated for such condition. As with other barbiturates, butalbital carries a risk of abuse or misuse potential, intoxication, hangover, tolerance, dependence, and overdosage possibly leading to death. Butalbital‐containing analgesics can also produce a drug‐induced headache in addition to tolerance and dependence. Due to these risks, the use of butalbital-containing combination products is typically limited for use only in cases where other medications are deemed ineffective and such usage is advised to be carefully monitored.
Indication
Indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate, in various combinations with acetaminophen, aspirin, caffeine, and codeine .
Associated Conditions
- Tension Headache
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
LGM Pharma Solutions, LLC | 79739-7075 | ORAL | 50 mg in 1 1 | 8/13/2020 | |
RxChange Co. | 33358-059 | ORAL | 50 mg in 1 1 | 11/6/2014 | |
Preferred Pharmaceuticals Inc. | 68788-8137 | ORAL | 50 mg in 1 1 | 3/13/2024 | |
AvPAK | 50268-553 | ORAL | 50 mg in 1 1 | 8/29/2022 | |
Actavis Pharma, Inc. | 52544-082 | ORAL | 50 mg in 1 1 | 3/1/2021 | |
Proficient Rx LP | 63187-933 | ORAL | 50 mg in 1 1 | 2/1/2022 | |
Cardinal Health 107, LLC | 55154-7147 | ORAL | 50 mg in 1 1 | 4/21/2021 | |
Dispensing Solutions, Inc. | 66336-619 | ORAL | 50 mg in 1 1 | 9/1/2011 | |
STAT Rx USA LLC | 42549-553 | ORAL | 50 mg in 1 1 | 3/29/2012 | |
El Dorado Distributors LLC | 11584-0030 | ORAL | 50 mg in 1 1 | 1/9/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PRONAL TABLETS | PRO DOC LIMITEE | 02229736 | Tablet - Oral | 50 MG | 6/25/2009 |
TRIANAL C¼ | laboratoire riva inc. | 02242406 | Capsule - Oral | 50 MG | 12/22/2006 |
FIORINAL TAB | novartis pharmaceuticals canada inc | 00275328 | Tablet - Oral | 50 MG | 12/31/1973 |
TEVA-TECNAL C 1/2 | teva canada limited | 00608181 | Capsule - Oral | 50 MG | 12/31/1984 |
TEVA-TECNAL C 1/4 | teva canada limited | 00608203 | Capsule - Oral | 50 MG | 12/31/1984 |
TRIANAL TABLET | laboratoire riva inc. | 01971409 | Tablet - Oral | 50 MG | 2/7/1997 |
PRONAL C1/4 CAPSULES | PRO DOC LIMITEE | 02229735 | Capsule - Oral | 50 MG | 6/25/2009 |
FIORINAL-C 1/2 | aralez pharmaceuticals canada inc | 00176206 | Capsule - Oral | 50 MG | 12/31/1970 |
TRIANAL C½ | laboratoire riva inc. | 01971387 | Capsule - Oral | 50 MG | 3/9/1998 |
PRONAL CAPSULES | PRO DOC LIMITEE | 02229733 | Capsule - Oral | 50 MG | 6/23/2009 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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