Home > Medical Reference > Encyclopedia (English)

Please install flash player to see this video.

Hospital Virtual Tour

Related Content

Pronunciation:

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

U.S. Brand Names:

Fiorinal® With Codeine; Phrenilin® With Caffeine and Codeine

Synonyms:

Butalbital Compound and Codeine; Codeine and Butalbital Compound; Codeine, Butalbital, Aspirin, and Caffeine

Generic Available:

Yes

Canadian Brand Names:

Fiorinal®-C 1/2; Fiorinal®-C 1/4; Tecnal C 1/2; Tecnal C 1/4

Use:

Mild to moderate pain when sedation is needed

Restrictions:

C-III

Pregnancy Risk Factor:

C/D (prolonged use or high doses at term)

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to butalbital, codeine, aspirin, or any component of the formulation; opium derivatives; hemorrhagic diathesis (eg, hemophilia, hypoprothrombinemia, von Willebrand disease, the thrombocytopenias, thrombasthenia, and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency, and severe liver damage); peptic ulcer or other serious GI lesions; porphyria; pregnancy (prolonged use or high doses at term)

Warnings/Precautions:

Habit-forming, potentially abusable; patients on anticoagulant therapy

Adverse Reactions:

>10%:

Central nervous system: Dizziness, lightheadedness, drowsiness

Gastrointestinal: Nausea, heartburn, stomach pain, dyspepsia, epigastric discomfort

1% to 10%:

Central nervous system: Confusion, mental depression, unusual excitement, nervousness, faint feeling, insomnia, nightmares, intoxicated feeling

Dermatologic: Rash

Gastrointestinal: Constipation, GI ulceration

<1% (Limited to important or life-threatening): Tachycardia, chest pain, palpitation, syncope, hallucinations, nervousness, jitters, exfoliative dermatitis, Stevens-Johnson syndrome, agranulocytosis, megaloblastic anemia, thrombocytopenia, occult bleeding, prolongation of bleeding time, leukopenia, iron-deficiency anemia, hepatotoxicity, thrombophlebitis, impaired renal function, respiratory depression, bronchospasm, epistaxis, allergic reaction

Overdosage/Toxicology:

Symptoms of 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.

Drug Interactions:

Aspirin: Substrate of CYP2C8/9 (minor)

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

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Dosage:

Adults: Oral: 1-2 capsules every 4 hours as needed for pain; up to 6/day

Patient Education:

If self-administered, use exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. Take with food or milk. While using this medication, do not use alcohol and other prescription or OTC medications (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 - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); heartburn or epigastric discomfort (frequent mouth care, frequent sips of fluids, chewing gum, or sucking lozenges may help); or constipation (increased exercise, fluids, fruit, or fiber may help; if unresolved, consult prescriber about use of stool softeners). Report chest pain or palpitations; persistent dizziness; confusion, nightmares, excitation, or changes in mentation; shortness of breath or respiratory difficulty; skin rash, unusual bleeding or bruising; or unusual fatigue and weakness. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Nursing Implications:

Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

Drowsiness is common; may cause depression, nervousness, insomnia, and nightmares; rare reports of hallucinations

Mental Health: Effects on Psychiatric Treatment:

Rare reports of agranulocytosis; use caution with clozapine and carbamazepine; CNS depressant effects of psychotropics may be enhance by barbiturates; enzyme induction effects of barbiturates may decrease effects of psychotropics

Dosage Forms:

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

Fioricet® with Codeine: Butalbital 50 mg, caffeine 40 mg, acetaminophen 325 mg, and codeine phosphate 30 mg [may contain benzyl alcohol]

Phrenilin® with Caffeine and Codeine: Butalbital 50 mg, caffeine 40 mg, acetaminophen 325 mg, and codeine phosphate 30 mg [contains benzyl alcohol and lactose]

International Brand Names:

Fiorinal®-C 1/2 (CA); Fiorinal®-C 1/4 (CA); Tecnal C 1/2 (CA); Tecnal C 1/4 (CA)

References

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

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997- A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.