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Butalbital

Generic Name
Butalbital
Brand Names
Allzital, Ascomp, Bupap, Butapap, Esgic, Fioricet, Fioricet With Codeine, Fiorinal, Orbivan, Tencon, Trianal, Trianal C, Vanatol, Vanatol S, Vtol
Drug Type
Small Molecule
Chemical Formula
C11H16N2O3
CAS Number
77-26-9
Unique Ingredient Identifier
KHS0AZ4JVK

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

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
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
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
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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