Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is 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 capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; 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.
Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief.Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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.
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is contraindicated under the following conditions:Hypersensitivity or intolerance to aspirin, caffeine, butalbital or codeine.Patients with a 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 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 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is not recommended.Results from epidemiologic studies indicate an association between aspirin and Reye’s Syndrome.Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.