|Drug Name:||Butalbital, Aspirin, Caffeine and Codeine Phosphate|
|Manufacturer:||Jerome Stevens Pharmaceuticals|
|Other Info:||Butalbital: toxic dose 1 g (adult); lethal dose 2 g to 5 g Aspirin: toxic blood level greater than 30 mg/100 mL; lethal dose 10 to 30 g (adult)Caffeine: toxic dose greater than 1 g; lethal dose unknownCodeine: lethal dose 0.5 to 1 g (adult)|
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: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) 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 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 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.
This combination product is contraindicated under the following conditions:Hypersensitivity or intolerance to aspirin, caffeine, butalbital or codeine.Patients with hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand's disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage.)Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs.Anaphylactoid reactions have occurred in such patients.Peptic ulcer or other serious gastrointestinal lesions.Patients with porphyria.
Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions.
It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders.Aspirin administered pre-operatively may prolong the bleeding time.In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure.
Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries.Codeine or other narcotics may obscure the signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.Butalbital and codeine are both habit-forming and potentially abusable.
Consequently, the extended use of this product is not recommended.Results from epidemiologic studies indicate an association between aspirin and Reye Syndrome.Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.