butalbital, aspirin, and caffeine

INDICATIONS Butalbital, Aspirin, and Caffeine Capsules 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 in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

WARNINGS 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 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. Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus Avoid use of NSAIDs, including Butalbital, Aspirin, and Caffeine Capsules, in pregnant women at about 30 weeks gestation and later. NSAIDs including Butalbital, Aspirin, and Caffeine Capsules, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs, including Butalbital, Aspirin, and Caffeine Capsules, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit Butalbital, Aspirin, and Caffeine Capsules use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Butalbital, Aspirin, and Caffeine Capsules treatment extends beyond 48 hours. Discontinue Butalbital, Aspirin, and Caffeine Capsules if oligohydramnios occurs and follow up according to clinical practice [ see PRECAUTIONS; Pregnancy ]. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Butalbital, Aspirin, and Caffeine Capsules. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Butalbital, Aspirin, and Caffeine Capsules and evaluate the patient immediately.