Drug Guide
Butalbital; Acetaminophen; Caffeine; Codeine Phosphate
Classification
Therapeutic: Analgesic, sedative, and antipyretic combination
Pharmacological: Barbiturate (butalbital), opioid (codeine), analgesic (acetaminophen), stimulant (caffeine)
FDA Approved Indications
- Moderate to severe pain management
Mechanism of Action
Butalbital depresses sensory cortex, alters spinal reflexes, and produces generalized CNS depression; Acetaminophen inhibits prostaglandin synthesis; Caffeine blocks adenosine receptors, leading to CNS stimulation; Codeine binds to opioid receptors, inhibiting ascending pain pathways.
Dosage and Administration
Adult: As prescribed, typically one tablet every 4 hours as needed, not exceeding 6 tablets per day.
Pediatric: Not recommended for children under 12 due to risk of respiratory depression and metabolic issues.
Geriatric: Use with caution; start at lower end of dosing range due to increased sensitivity and risk of side effects.
Renal Impairment: Adjust dose accordingly; use with caution to avoid accumulation of toxic metabolites.
Hepatic Impairment: Use with caution; may require dose adjustments due to metabolism.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Widely distributed, crosses blood-brain barrier.
Metabolism: Metabolized in liver; codeine via CYP2D6 to morphine, acetaminophen via conjugation.
Excretion: Renal excretion of metabolites.
Half Life: Butalbital ~4-6 hours; codeine ~3 hours; acetaminophen ~2-3 hours; caffeine ~3-7 hours.
Contraindications
- Hypersensitivity to components
- Respiratory depression
- Porphyria
Precautions
- Use with caution in patients with hepatic impairment, respiratory depression, or a history of substance abuse; monitor for potential dependence and abuse.
Adverse Reactions - Common
- Drowsiness (Common)
- Dizziness (Common)
- Nausea (Common)
Adverse Reactions - Serious
- Respiratory depression (Rare)
- Hypersensitivity reactions (Rare)
- Severe allergic reactions (Rare)
- Addiction, dependence (Potential)
Drug-Drug Interactions
- Other CNS depressants, alcohol, MAO inhibitors, CYP2D6 inhibitors
Drug-Food Interactions
- Alcohol enhances CNS depression.
Drug-Herb Interactions
N/ANursing Implications
Assessment: Assess pain characteristics and response; monitor for signs of CNS depression, respiratory depression, and allergic reactions.
Diagnoses:
- Pain, acute
- Risk for respiratory depression
- Risk for dependency
Implementation: Administer with food if gastrointestinal upset occurs; monitor vital signs; avoid alcohol and other CNS depressants.
Evaluation: Evaluate pain relief and monitor for adverse effects.
Patient/Family Teaching
- Take exactly as prescribed; do not increase dose.
- Avoid alcohol and sedatives.
- Report signs of allergic reactions or respiratory difficulty.
- Caution against operating machinery or driving until response is known.
Special Considerations
Black Box Warnings:
- Addiction potential, respiratory depression, hepatotoxicity (from acetaminophen in overdose).
Genetic Factors: CYP2D6 polymorphisms can affect codeine metabolism, influencing efficacy and safety.
Lab Test Interference: May alter liver function tests; monitor as indicated.
Overdose Management
Signs/Symptoms: Respiratory depression, somnolence, cyanosis, hypotension, coma.
Treatment: Provide airway support, administer narcotic antagonists like naloxone, manage symptoms supportively, induce vomiting or gastric lavage if early and appropriate.
Storage and Handling
Storage: Store at room temperature, away from moisture and heat.
Stability: Stable for 2-3 years under proper storage conditions.