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Pronunciation:

(byoo TAL bi tal, a seet a MIN oh fen, KAF een, & KOE deen)

U.S. Brand Names:

Fioricet® with Codeine

Synonyms:

Acetaminophen, Caffeine, Codeine, and Butalbital; Caffeine, Acetaminophen, Butalbital, and Codeine; Codeine, Acetaminophen, Butalbital, and Caffeine

Generic Available:

Yes

Use:

Relief of symptoms of complex tension (muscle contraction) headache

Restrictions:

C-III

Pregnancy Risk Factor:

C (per manufacturer); D (prolonged use or high doses at term)

Pregnancy Implications:

Reproduction studies have not been conducted. Butalbital, codeine, and caffeine cross the placenta and can be found in fetal tissue. Butalbital may cause withdrawal seizures in newborns when taken during pregnancy. Should be administered to a pregnant woman only when clearly indicated, and for as short a period as possible. Use of codeine during labor and delivery may lead to respiratory depression in the neonate.

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity to butalbital, codeine, caffeine, acetaminophen, or any component of the formulation; porphyria; known G6PD deficiency; pregnancy (prolonged use or high doses at term)

Warnings/Precautions:

Limit acetaminophen to <4 g/day. May cause severe hepatic toxicity in acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients. Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (eg, morphine, hydrocodone, oxycodone). Use caution with Addison's disease, severe renal or hepatic impairment. Use caution in patients with head injury or other intracranial lesions, acute abdominal conditions, urethral stricture of BPH, or in patients with respiratory diseases. Elderly and/or debilitated patients may be more susceptible to CNS depressants, as well as constipating effects of narcotics. Tolerance or drug dependence may result from extended use. Safety and efficacy in pediatric patients have not been established.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Tachycardia, palpitation, hypotension, edema, syncope

Central nervous system: Drowsiness, fatigue, mental confusion, disorientation, nervousness, hallucination, euphoria, depression, seizure, headache, agitation, fainting, excitement, fever

Dermatologic: Rash, erythema, pruritus, urticaria, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis

Gastrointestinal: Nausea, xerostomia, constipation, gastrointestinal spasm, heartburn, flatulence

Genitourinary: Urinary retention, diuresis

Neuromuscular & skeletal: Leg pain, weakness, numbness

Otic: Tinnitus

Miscellaneous: Allergic reaction, anaphylaxis

Note: Potential reactions associated with components of Fioricet® with Codeine include agranulocytosis, irritability, nausea, thrombocytopenia, tremor, vomiting

Overdosage/Toxicology:

Symptoms of opiate overdose include unsteady gait, slurred speech, confusion, respiratory depression, hypotension, and coma. Opioid symptoms may be reversed by naloxone, 2 mg I.V., with repeated doses as necessary up to a total of 10 mg. Barbiturate treatment is symptomatic and supportive.

Symptoms of acetaminophen overdose include hepatic necrosis, transient azotemia, renal tubular necrosis with acute toxicity, anemia, and GI disturbances with chronic toxicity. Treatment consists of acetylcysteine 140 mg/kg orally (loading) followed by 70 mg/kg every 4 hours for 17 doses; therapy should be initiated based upon laboratory analysis suggesting a high probability of hepatotoxic potential. Activated charcoal is very effective at binding acetaminophen. Intravenous acetylcysteine should be reserved for patients unable to take oral forms.

Drug Interactions:

Acetaminophen: Substrate of (minor) CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)

Caffeine: Substrate of CYP1A2 (major), 2C8/9 (minor), 2D6 (minor), 2E1 (minor), 3A4 (minor); Inhibits CYP1A2 (weak), 3A4 (moderate)

Also see individual monographs for Acetaminophen and Codeine.

Butalbital: Refer to Phenobarbital monograph.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Stability:

Store below 30°C (86°F).

Mechanism of Action:

Combination product for the treatment of tension headache. Contains codeine (narcotic analgesic), butalbital (barbiturate), caffeine (CNS stimulant), and acetaminophen (nonopiate, nonsalicylate analgesic).

Dosage:

Oral: Adults: 1-2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

Dosing adjustment/comments in hepatic impairment: Use with caution. Limited, low-dose therapy usually well tolerated in hepatic disease/cirrhosis. However, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.

Test Interactions:

Acetaminophen may produce false positive tests for urinary 5-hydroxyindoleacetic acid.

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take oral medication as directed with chilled liquids. Use exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. Take with food or milk. Do not use alcohol, other prescriptions, OTC medications, or herbal products (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause dizziness, lightheadedness, confusion, or drowsiness (use caution when driving, climbing stairs, or changing position sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); heartburn, nausea (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); or constipation (increased exercise, fluids, fruit, or fiber may help; if unresolved, contact prescriber). Report chest pain or palpitation; persistent dizziness; confusion; nightmares; excitation or changes in mentation; shortness of breath or respiratory difficulty; skin rash or irritation; unusual muscle weakness or leg pain; or ringing in ears. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause confusion, disorientation, nervousness, hallucinations, euphoria, agitation, irritability, depression, or drowsiness

Mental Health: Effects on Psychiatric Treatment:

May cause severe hepatic toxicity in overdose, use caution in patients with alcoholic liver disease. May cause agranulocytosis, use caution with clozapine and carbamazepine. May cause thrombocytopenia, use caution with valproate.

Dosage Forms:

Capsule: Butalbital 50 mg, caffeine 40 mg, acetaminophen 325 mg, and codeine phosphate 30 mg

References

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922.

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