Classes
DEA Class; Rx
Common Brand Names; Fioricet with Codeine
- Analgesics, Opioid Combos
Description
Codeine: Opioid agonist; analgesia
Acetaminophen: Acts on hypothalamus to produce analgesia and antipyresis
Butalbital: Barbiturate; elicits generalized CNS depressant effects
Caffeine: Vasoconstrictive properties of cerebral blood vessels may be helpful when treating headaches
Indications
For the treatment of Tension Headache (Off-label)
Contraindications
Hypersensitivity to drug or components
Hepatitis or severe hepatic/renal impairment
Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease porphyria
Children <12 years
Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy (see Black Box Warnings)
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
Significant respiratory depression
Known or suspected gastrointestinal obstruction, including paralytic ileus
Adverse Effects
>10%
Codeine
Drowsiness
Constipation
1-10%
Codeine
Bradycardia, hypotension, tachycardia
Confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, weakness
Rash, urticaria
Anorexia, nausea, vomiting, xerostomia
LFT’s increased
Ureteral spasm, urination decreased
Dyspnea
Burning at injection site, blurred vision, histamine release
Acetaminophen
Angioedema, laryngeal edema
Pruritic maculopapular rash, urticaria
Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
Hepatotoxicity
Anaphylactoid reaction
Butalbital
Drowsiness, dizziness, intoxicated feeling, lightheadedness, sedation
Abdominal pain, nausea, vomiting
Shortness of breath
Caffeine
Tachycardia, palpitations (dose dependent)
Insomnia, irritability restlessness, nervousness, tremor, tinnitus
Diarrhea, nausea, vomiting
Diuresis
Warnings
As Butalbital, acetaminophen, caffeine, and codeine phosphate capsules contain butalbital and codeine, they expose users to the risks of addiction, abuse, and misuse; assess each patient’s risk for addiction, abuse, or misuse prior to prescribing therapy, and monitor all patients receiving drug for development of addiction behaviors and conditions
Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)
Acetaminophen may cause rare serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), which can be fatal; discontinued at the first appearance of skin rash
Use caution in patients withG6PD deficiency
Avoid driving car or operating machinery
May increase respiratory depressant effects; caution with head injury, COPD, or other conditions with decreased respiratory drive
Codeine may cause tolerance/dependency
Pregnancy and Lactation
Pregnancy
Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage
Lactation:
Codeine and its active metabolite, morphine, are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk; women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants; in women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent
There is no information on effects of codeine milk production; because of potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, breastfeeding is not recommended during treatment
Withdrawal seizures in newborns whose mothers had taken butalbital-containing drug during pregnancy reported
Maximum Dosage
1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day
To discontinue therapy, decrease dose by 25% to 50% every 2-4 days; monitor for symptoms/signs of withdrawal; if withdrawal symptoms occur, raise dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both; do not abruptly discontinue therapy in a physically dependent patient
Pediatric
<12 years: Safety and efficacy not established
≥12 years: 1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day (not to exceed acetaminophen 4 g/day); to discontinue therapy, decrease dose by 25% to 50% every 2-4 days; monitor for symptoms/signs of withdrawal; if withdrawal symptoms occur, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both; do not abruptly discontinue therapy in a physically dependent patient