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Butalbital, Aspirin, And Caffeine is a brand name for Butalbital. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: INDICATIONS Butalbital, aspirin, and caffeine capsules are 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…
Verbatim from this product's FDA label. Tap a section to expand.
DOSAGE AND ADMINISTRATION
One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
ADVERSE REACTIONS
The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of butalbital, aspirin, and caffeine capsules.
Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported. Butalbital, aspirin, and caffeine capsules may also cause exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and fixed drug eruption (FDE) ( see WARNINGS ).
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.
CONTRAINDICATIONS
Butalbital, aspirin, and caffeine capsules are contraindicated under the following conditions: • Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. , 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Butalbital in United States of America.
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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 ]. Serious Skin Reactions NSAIDs, including aspirin, a component of butalbital, aspirin, and caffeine capsules, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of butalbital, aspirin, and caffeine capsules at the first appearance of skin rash or any other sign of hypersensitivity.
Butalbital, aspirin, and caffeine capsules are contraindicated in patients with previous serious skin reactions to NSAIDs [ see CONTRAINDICATIONS ]. 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.