Butalbital: Short- to intermediate-acting barbiturate. ASA: Analgesic, antipyretic, and anti-inflammatory. Caffeine: CNS stimulant. Codeine: Narcotic analgesic and antitussive. The role each component plays in the relief of the complex of symptoms known as tension headache is incompley understood.
Adults: 1 or 2 caps q4h. Max: 6 caps/day. Elderly: Start at lower end of dosing range. Oral route.
May enhance effects of PO anticoagulants. If treatment exceeds max daily dose, may cause hypoglycemia with PO antidiabetic agents and insulin. May cause bone marrow toxicity and blood dyscrasias with 6-mercaptopurine and methotrexate. Increased risk of peptic ulceration and bleeding with NSAIDs. Increased CNS depression with other narcotic analgesics, alcohol, general anesthetics, tranquilizers (eg, chlordiazepoxide), sedative-hypnotics, or other CNS depressants. May diminish effects of uricosuric agents (eg, probenecid, sulfinpyrazone). Withdrawal of corticosteroids may cause salicylism with chronic ASA use. Enhanced CNS effects of butalbital with MAOIs.
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Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Hemorrhagic diathesis (eg, hemophilia, hypoprothrombinemia, von Willebrand's disease, thrombocytopenias, thrombasthenia and other ill-defined hereditary plaet dysfunctions, severe vitamin K deficiency, severe liver damage), peptic ulcer or other serious GI lesions, and porphyria. Syndrome of nasal polyps, angioedema and bronchospastic reactivity to ASA or other NSAIDs.
Extended and repeated use is not recommended; may be habit-forming and potentially abusable. Caution with severe renal/hepatic impairment, coagulation disorders, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, prostatic hypertrophy, peptic ulcer, and in elderly/debilitated patients. May interfere with certain lab tests. ASA: Therapeutic doses may cause anaphylactic shock and other severe allergic reactions. Significant bleeding may result in patients with bleeding disorders, peptic ulcers, or other GI lesions. Preoperative administration may prolong bleeding time. Reye's syndrome reported; caution in children, including teenagers, with chickenpox or flu. Caution with underlying hemostatic defects. Caution when administering salicylates to persons with known allergies. Increased risk of ASA hypersensitivity in patients with nasal polyps or asthma. Codeine: Respiratory depressant effects and CSF pressure elevation capacity may be enhanced with head injury or other intracranial lesions. May obscure diagnosis or clinical course of head injuries or acute abdominal conditions. Ultra-rapid metabolizers, due to specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN), may have life-threatening or fatal respiratory depression or experience signs of overdose. Children with obstructive sleep apnea treated with codeine for post-tonsillectomy and/or -adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Use lowest effective dose for the shortest period.
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Absorption: ASA: (650mg dose) C max =8.8mcg/mL, T max =40 min. Codeine: Readily absorbed; (60mg dose) C max =198ng/mL, T max =1 hr. Butalbital: Well-absorbed; (100mg dose) C max =2020ng/mL, T max =1.5 hrs. Caffeine: Rapid; (80mg dose) C max =1660ng/mL, T max =<1 hr. Distribution: Found in breast milk. ASA: Plasma protein binding (50-80%). Butalbital: Plasma protein binding (in vitro) (45%); crosses placenta. Metabolism: ASA: Liver; salicyluric acid, phenolic/acyl glucuronides of salicylate, and gentisic and gentisuric acid (major metabolites). Codeine: Glucuronidation. Caffeine: Liver; 1-methylxanthine and 1-methyluric acid. Elimination: ASA: Urine; T 1/2 =12 min (ASA), 3 hrs (salicylic acid and/or total salicylate). Codeine: Urine (90%), feces; T 1/2 =2.9 hrs. Butalbital: Urine (59-88% unchanged or metabolites); T 1/2 =35 hrs. Caffeine: Urine (70%, 3% unchanged); T 1/2 =3 hrs.
Advise not to take medication if allergic to ASA. Inform that therapy may impair mental/physical abilities; instruct to avoid potentially hazardous tasks (eg, operating machinery/driving). Advise to avoid alcohol and other CNS depressants. Inform that drug may be habit-forming; instruct to take ud. Advise that a genetic variation may lead to life-threatening or fatal respiratory depression or signs of overdose. Instruct nursing mothers to monitor their infants for signs of morphine toxicity; instruct to seek immediate medical attention if these signs develop.
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Ascomp with Codeine Analgesic/barbiturate CIII.
Category C, not for use in nursing.
Cap: (Butalbital-Aspirin -Caffeine-Codeine Phosphate) 50mg-325mg-40mg-30mg.
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Relief of the symptom complex of tension (or muscle contraction) headache.
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Drowsiness, dizziness, nausea, abdominal pain.
<25°C (77°F); tight container. Protect from moisture.
Monitor for anaphylactic shock and other severe allergic reactions, bleeding episodes, drug abuse/dependence, signs of CNS depression, and other adverse reactions. Monitor effects of therapy with serial LFTs and/or renal function tests in patients with severe hepatic/renal disease.
Assess for previous hypersensitivity/intolerance to drug's ingredients, hemorrhagic diathesis, peptic ulcer, serious GI lesions, porphyria, renal/hepatic impairment, any other conditions where treatment is cautioned or contraindicated, pregnancy/nursing status, and possible drug interactions.
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Codeine brand names