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.
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.
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 .
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found for this drug
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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ORAL | 50 mg in 1 1 | 2019/09/10 | 13107-075 | ||
ORAL | 50 mg in 1 1 | 2023/02/03 | 68071-2927 | ||
ORAL | 50 mg in 1 1 | 2021/09/21 | 63629-2087 | ||
ORAL | 50 mg in 1 1 | 2011/09/20 | 68258-2012 | ||
ORAL | 50 mg in 1 1 | 2023/03/30 | 61919-022 | ||
ORAL | 50 mg in 1 1 | 2024/01/30 | 0527-1552 | ||
ORAL | 50 mg in 1 1 | 2020/08/12 | 79739-7028 | ||
ORAL | 50 mg in 1 1 | 2022/07/27 | 64380-157 | ||
ORAL | 50 mg in 1 1 | 2021/03/31 | 0591-2641 | ||
ORAL | 50 mg in 1 1 | 2020/04/30 | 0095-3000 |
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No EMA products found for this drug
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No HSA products found for this drug
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No NMPA products found for this drug
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No PPB products found for this drug
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No TGA products found for this drug