Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable.Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Butalbital, Aspirin, and Caffeine Capsules, USP is contraindicated under the following conditions: Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. 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 preoperatively may prolong the bleeding time.
Butalbital is habit-forming and potentially abusable.
Consequently, the extended use of Butalbital, Aspirin, and Caffeine 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.