Butalbital, aspirin, caffeine, and codeine

• It is used to treat tension headaches.

• If you have an allergy to butalbital, aspirin, caffeine, codeine, or any other part of this medicine.
• If you have an allergy to aspirin or NSAIDs.
• If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have hemophilia.
• If you have Reye's syndrome.
• If you have kidney disease.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking butalbital, aspirin, caffeine, and codeine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you are taking probenecid.
• If you are taking any other NSAID.
• If you are pregnant or may be pregnant. Do not take this medicine if you are in the third trimester of pregnancy. You may also need to avoid butalbital, aspirin, caffeine, and codeine at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this medicine during pregnancy.
• If you are breast-feeding. Do not breast-feed while you take butalbital, aspirin, caffeine, and codeine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take butalbital, aspirin, caffeine, and codeine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

(byoo TAL bi tal, AS pir in, KAF een, & KOE deen)

• Aspirin, Caffeine, Codeine, and Butalbital
• Butalbital Compound and Codeine
• Codeine and Butalbital Compound
• Codeine, Butalbital, Aspirin, and Caffeine
• Codeine/Butalbital/Asa/Caffeine

• Analgesic Combination (Opioid)
• Analgesic, Opioid
• Barbiturate

Aspirin: Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors, acts on the hypothalamic heat-regulating center to reduce fever, blocks thromboxane synthetase action which prevents formation of the platelet-aggregating substance thromboxane A2.

Butalbital: A short- to intermediate-acting barbiturate. Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, hypnosis, and dose-dependent respiratory depression.

Caffeine: A cranial vasoconstrictor to enhance the vasoconstrictor effect; also used as a central stimulant for relief of headache.

Codeine: Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression.

Store below 25°C (77°F). Protect from moisture.

1% to 10%:

Central nervous system: Dizziness (3%), drowsiness (2%), intoxicated feeling (1%)

Gastrointestinal: Gastrointestinal distress (4%; abdominal pain, nausea)

<1% (Limited to important or life-threatening): Adenocarcinoma (cholangiocarcinoma), agitation, anaphylactic shock, anorexia, chest pain, depression, disorientation, diuresis, dysphagia, dysuria, edema, epistaxis, erythema multiforme, esophagitis, exfoliative dermatitis, gastroenteritis, gastrointestinal spasm, gastrointestinal ulcer due to Helicobacter pylori, hallucination, hypersensitivity reaction, hypogonadism (Brennan, 2013; Debono, 2011), hypotension, loss of consciousness, nervousness, neuropathy, numbness, palpitations, psychosis, renal insufficiency, skin rash, slurred speech, syncope, tachycardia, tinnitus, toxic epidermal necrolysis, urticaria, vertigo, vomiting

Note: Potential reactions associated with components of Fiorinal® with Codeine include acute airway obstruction, anemia, bleeding time prolonged, cardiac stimulation, dependence, hemolytic anemia, hepatitis, hyperglycemia, irritability, nephrotoxicity, occult blood loss, peptic ulcer, pruritus, renal toxicity (high doses, prolonged therapy) thrombocytopenia, tremor, urate excretion impaired

Use exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing butalbital/aspirin/caffeine/codeine and monitor all patients regularly for the development of these behaviors and conditions.

Serious, life-threatening, or fatal respiratory depression may occur with use. Monitor for respiratory depression, especially during initiation of therapy or following a dose increase.

Accidental ingestion of even one dose, especially by children, can result in a fatal overdose of codeine.

Prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

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.

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with butalbital/aspirin/caffeine/codeine requires careful consideration of the effects on codeine, and the active metabolite, morphine.

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of butalbital/aspirin/caffeine/codeine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.