Dosing and uses of Fiorinal (butalbital/aspirin/caffeine)
Adult dosage forms and strengths
butalbital/aspirin/caffeine
tablet/capsule: Schedule III
- 50mg/325mg/40mg
Tension Headache
1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day
Renal Impairment
Reduce dosing
Hepatic Impairment
Reduce dosing
Pediatric dosage forms and strengths
capsule: Schedule III
- 50mg/325mg/40mg
Tension Headache
<16 years: Safety & efficacy not established
>16 years: As adults; 1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day
Geriatric dosage forms and strengths
Nor recommended
Fiorinal (butalbital/aspirin/caffeine) adverse (side) effects
Frequency not defined
ButalbitaL
- Dizziness, drowsiness, feeling of intoxication, lightheadedness, sedation
- Abdominal pain, nausea, vomiting
- Shortness of breath
Aspirin
- Dyspepsia, heartburn, nausea, vomiting, stomach pain
- Tinnitus (high or chronic dose)
- Rash
- Urticaria
Caffeine
- Tachycardia, palpitations (dose dependent)
- Insomnia, irritability, nervousness, restlessness, tinnitus, tremor
- Diarrhea, nausea, vomiting
- Diuresis
Warnings
Contraindications
Hypersensitivity
Children younger than 16 years old because of potential for Reye syndrome
Bronchospastic reaction to aspirin
Peptic ulcer disease
Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease
Porphyria
Cautions
Gastrointestinal bleeding; particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders
Avoid driving car or operating machinery
Reye syndrome may occur in children because of aspirin component; do not use for chickenpox or flu symptoms
Avoid in severe renal impairment (ie, CrCl <10 mL/min)
Pregnancy and lactation
Pregnancy category: D; avoid during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus because of aspirin component
Lactation: excreted in breast milk; do not breast feed
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Fiorinal (butalbital/aspirin/caffeine)
Mechanism of action
Butalbital: Barbiturate; elicits generalized CNS depressant effects
Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties attributed to prostaglandin synthetase inhibition resulting in decreased formation of thromboxane A2
Caffeine: Vasoconstrictive properties of cerebral blood vessels may be helpful when treating headaches
Butalbital Pharmacokinetics
Protein binding: 45%
Absorption: Well absorbed
Half-life elimination: 35 hr
Excretion: Urine (59-88%)
