SUMMARY
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP
C-III
Revised: January 2007
Rx only
Each capsule, for oral administration, contains:Codeine Phosphate, USP.
Butalbital, aspirin, caffeine, and codeine phosphate capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate; codeine; butalbital, aspirin, and caffeine; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine, and codeine phosphate, proved statistically significantly superior to each of its components and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine, and codeine phosphate capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
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NEWS HIGHLIGHTS RELATED TO BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE
Media Articles Related to Butalbital, Aspirin, Caffeine, and Codeine (Codeine / Butalbital / Caffeine / Aspirin)
Headache
Source: MedicineNet Brain Aneurysm Specialty [2008.09.30]
Children With Hay Fever More Likely To Experience Headaches, Facial Pain
Source: Allergy News From Medical News Today [2008.09.23]
Phase II Results Of COL-144 Presented At European Headache And Migraine Trust International Congress 2008
Source: Headache / Migraine News From Medical News Today [2008.09.08]
New Scientific Review Shows That Zolmitriptan ('Zomig(TM)') Nasal Spray Provided Efficacious Relief From Cluster Headache
Source: Headache / Migraine News From Medical News Today [2008.09.08]
FDA Approves First Generic Divalproex Sodium To Treat Seizures, Migraine Headaches And Bipolar Disorder
Source: Bipolar News From Medical News Today [2008.08.01]
Published Studies Related to Butalbital, Aspirin, Caffeine, and Codeine (Codeine / Butalbital / Caffeine / Aspirin)
Comparison of butorphanol nasal spray and fiorinal with codeine in the treatment of migraine. [1998.07]
Fiorinal with codeine in the treatment of tension headache--the contribution of components to the combination drug. [1988]
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