See also:
What is the most important information I should know about Fiorinal C 1 / 2?
Fiorinal C 1 / 2 (Fiorinal C 1 / 2 1 / 2) is contraindicated under the following conditions:
Post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
Hypersensitivity or intolerance to Fiorinal C 1 / 2, Caffeine (Fiorinal C 1 / 2 1 / 2), Butalbital (Fiorinal C 1 / 2) or Codeine (Fiorinal C 1 / 2 1 / 2).
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 Fiorinal C 1 / 2 or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patients.
Peptic ulcer or other serious gastrointestinal lesions.
Patients with porphyria.
See also:
What are the possible side effects of Fiorinal C 1 / 2?
Frequently Observed
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
Infrequently Observed
All adverse events tabulated below are classified as infrequent.
Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of Butalbital (Fiorinal C 1 / 2).
Autonomic Nervous: dry mouth, hyperhidrosis.
Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.
Cardiovascular: tachycardia.
Musculoskeletal: leg pain, muscle fatigue.
Genitourinary: diuresis.
Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
The following adverse reactions have been voluntarily reported as temporally associated with Butalbital (Fiorinal C 1 / 2), Fiorinal C 1 / 2, Caffeine (Fiorinal C 1 / 2 1 / 2), and Codeine (Fiorinal C 1 / 2 1 / 2) Phosphate Capsules, USP, a related product containing Fiorinal C 1 / 2, Butalbital (Fiorinal C 1 / 2), Caffeine (Fiorinal C 1 / 2 1 / 2), and Codeine (Fiorinal C 1 / 2 1 / 2).
Central Nervous: abuse, addiction, anxiety, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.
Autonomic Nervous: epistaxis, flushing, miosis, salivation.
Gastrointestinal: anorexia, appetite increased, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasms, hiccup, mouth burning, pyloric ulcer.
Cardiovascular: chest pain, hypotensive reaction, palpitations, syncope.
Skin: erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.
Urinary: kidney impairment, urinary difficulty.
Miscellaneous: allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.
The following adverse drug events may be borne in mind as potential effects of the components of Butalbital (Fiorinal C 1 / 2), Acetaminophen, Caffeine (Fiorinal C 1 / 2 1 / 2), and Codeine (Fiorinal C 1 / 2 1 / 2) Phosphate Capsules. Potential effects of high dosage are listed in the OVERDOSAGE section.
Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Caffeine (Fiorinal C 1 / 2 1 / 2): cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.
Codeine (Fiorinal C 1 / 2 1 / 2): nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Butalbital (Fiorinal C 1 / 2), Acetaminophen, and Caffeine (Fiorinal C 1 / 2 1 / 2) Tablets, USP.
Fiorinal C 1 / 2 (Fiorinal C 1 / 2 1 / 2) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy of Fiorinal C 1 / 2 (Fiorinal C 1 / 2 1 / 2) is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: Butalbital (Fiorinal C 1 / 2), Fiorinal C 1 / 2, Caffeine (Fiorinal C 1 / 2 1 / 2), and Codeine (Fiorinal C 1 / 2 1 / 2) Phosphate Capsules, USP, and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital (Fiorinal C 1 / 2), Fiorinal C 1 / 2, Caffeine (Fiorinal C 1 / 2 1 / 2), and Codeine (Fiorinal C 1 / 2 1 / 2) Phosphate Capsules, USP proved statistically significantly superior to each of its components (Butalbital (Fiorinal C 1 / 2), Fiorinal C 1 / 2, and Caffeine (Fiorinal C 1 / 2 1 / 2) Capsules, USP and Codeine (Fiorinal C 1 / 2 1 / 2)) and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of Fiorinal C 1 / 2 (Fiorinal C 1 / 2 1 / 2) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because Codeine (Fiorinal C 1 / 2 1 / 2) and Butalbital (Fiorinal C 1 / 2) are habit-forming and potentially abusable.
Fiorinal C 1 / 2 is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.
Butalbital (Fiorinal C 1 / 2) is a barbiturate. It relaxes muscle contractions involved in a tension headache.
Caffeine (Fiorinal C 1 / 2 1 / 2) is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
Codeine (Fiorinal C 1 / 2 1 / 2) is an opioid pain medication. An opioid is sometimes called a narcotic.
Fiorinal C 1 / 2, Butalbital (Fiorinal C 1 / 2), Caffeine (Fiorinal C 1 / 2 1 / 2), and Codeine (Fiorinal C 1 / 2 1 / 2) is a combination medicine used to treat tension headaches. This medicine is not for treating headaches that come and go.
This medication may also be used for purposes not listed in this medication guide.
Use Fiorinal C 1 / 2 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Fiorinal C 1 / 2.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsTension or muscle contraction headache: Management of the symptom complex of tension (muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Limitations of use: Reserve for use in patients for whom alternative treatment options (eg, nonopioid, non-barbiturate analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule,
Oral:Fiorinal C 1 / 2 (Fiorinal C 1 / 2 1 / 2): Butalbital (Fiorinal C 1 / 2) 50 mg, Fiorinal C 1 / 2 325 mg, Caffeine (Fiorinal C 1 / 2 1 / 2) 40 mg, and Codeine (Fiorinal C 1 / 2 1 / 2) phosphate 30 mg
Fiorinal/Codeine (Fiorinal C 1 / 2 1 / 2) #3: Butalbital (Fiorinal C 1 / 2) 50 mg, Fiorinal C 1 / 2 325 mg, Caffeine (Fiorinal C 1 / 2 1 / 2) 40 mg, and Codeine (Fiorinal C 1 / 2 1 / 2) phosphate 30 mg [DSC]
Fiorinal/Codeine (Fiorinal C 1 / 2 1 / 2) #3: Butalbital (Fiorinal C 1 / 2) 50 mg, Fiorinal C 1 / 2 325 mg, Caffeine (Fiorinal C 1 / 2 1 / 2) 40 mg, and Codeine (Fiorinal C 1 / 2 1 / 2) phosphate 30 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]
Generic: Butalbital (Fiorinal C 1 / 2) 50 mg, Fiorinal C 1 / 2 325 mg, Caffeine (Fiorinal C 1 / 2 1 / 2) 40 mg, and Codeine (Fiorinal C 1 / 2 1 / 2) phosphate 30 mg
Dosing: Adult
Note: Limit Butalbital (Fiorinal C 1 / 2) use to ≤3 days per month to avoid medication overuse headache (Garza 2006); studies have found increased risk with use of ≥5 days per month (Da Silva 2014).
Tension or muscle contraction headache:
Oral: 1 to 2 capsules (Butalbital (Fiorinal C 1 / 2) 50 mg/Fiorinal C 1 / 2 325 mg/Caffeine (Fiorinal C 1 / 2 1 / 2) 40 mg/Codeine (Fiorinal C 1 / 2 1 / 2) 30 mg) every 4 hours as needed; maximum: 6 capsules (Butalbital (Fiorinal C 1 / 2) 300 mg/Fiorinal C 1 / 2 1,950 mg/Caffeine (Fiorinal C 1 / 2 1 / 2) 240 mg/Codeine (Fiorinal C 1 / 2 1 / 2) 180 mg) per day.
Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of opioid withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018). For low Butalbital (Fiorinal C 1 / 2) doses or less frequent use, consider abrupt discontinuation of therapy or a gradual taper over 2 to 4 weeks. If use is frequent or at high doses or if a patient has developed chronic migraine, discontinuing the Butalbital (Fiorinal C 1 / 2)-containing product and replacing with a gradual (eg, over 2 to 4 weeks) phenobarbital taper is advised to avoid withdrawal symptoms (ie, worsened headache, nausea/vomiting, restlessness, anxiety, diaphoresis, disturbed sleep, seizures). Consider providing bridge therapy with a medication to treat acute headaches and optimizing a preventative regimen to avoid rebound headache (Boes 2006; Garza 2019).
Dosing: Geriatric
Avoid use (Beers Criteria [AGS 2019]).
See also:
What other drugs will affect Fiorinal C 1 / 2?
Beta-blockers (eg, propranolol), doxycycline, estrogens (including oral contraceptives), felodipine, griseofulvin, nifedipine, phenylbutazone, quinidine, theophylline
Effects of these drugs may be increased.
Corticosteroids
May enhance renal Cl of Fiorinal C 1 / 2; sudden discontinuation of corticosteroids may result in symptoms of salicylism; effects of corticosteroids may be decreased.
Insulin, oral antidiabetic agents
Hypoglycemic effects may be increased.
MAOIs
May increase CNS effects.
Methotrexate, 6-mercaptopurine
Bone marrow toxicity may occur.
NSAIDs
Increased GI ulceration or bleeding may occur.
Other CNS depressants (eg, ethanol, narcotics, general anesthetics, tranquilizers, sedative-hypnotics)
Increased drowsiness, dizziness, and other CNS depressive effects may occur.
Sulfinpyrazone, probenecid
Uricosuric effects may be decreased.
Tricyclic antidepressants
Antidepressant levels/effect may decrease.
Warfarin
Anticoagulant effects may be increased or decreased.
Laboratory Test Interactions
Blood tests
Serum amylase; fasting blood glucose; cholesterol; protein; serum hepatic aminotransferase (ALT); uric acid; prothrombin time.
Urine tests
Glucose, 5-hydroxyindoleacetic acid; Gerhardt ketone, vanillylmandelic acid; uric acid; diacetic acid; spectrophotometric detection of barbiturates.
