Butalbital/Aspirin/Caffeine/Codeine/

DEA Class;  Rx, schedule III

Common Brand Names; Fiorinal with Codeine 

Analgesic and opioids combos

Salicylate analgesic (aspirin), short-to-intermediate acting barbiturate (butalbital), CNS stimulant (caffeine), and opiate agonist (codeine)

Used together to treat mild to moderate pain and headaches, especially when antianxiety or relaxant effects are needed

Codeine metabolism is highly variable and unpredictable; use in patients younger than 12 years is contraindicated

Indicated For the treatment of occasional tension headache, occasional migraine† or co-existing migraine† and tension-type headaches.

Hypersensitivity

Children <12 years (increased risk of death from opioid)

Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy

Children <16 years because of potential for Reye syndrome

Postoperative use in children following tonsillectomy and/or adenoidectomy 

Bronchospastic reaction to aspirin

Syndrome of asthma, rhinitis, and nasal polyps

Significant respiratory depression

Peptic ulcer disease

Known allergy to NSAIDs

Within 14 days of taking MAOIs

Hemophilia

Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease

Porphyria

>10%

Codeine

Constipation

Drowsiness

1-10%

Codeine

Hypotension, tachycardia or bradycardia, confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, rash, urticaria, anorexia, nausea, vomiting, xerostomia, ureteral spasm, urination decreased, LFT’s increased, weakness, blurred vision, dyspnea, histamine-release

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

Particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders

Avoid driving car or operating machinery

Avoid in severe renal impairment (ie, CrCl <10 mL/min)

Avoid use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms

May increase respiratory depressant effects; caution with head injury, COPD, or other conditions with decreased respiratory drive

As butalbital, aspirin, caffeine, and codeine phosphate drug dosage forms 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

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

Withdrawal seizures reported in two-day-old male infant whose mother had taken a butalbital-containing drug during the last 2 months of pregnancy; butalbital was found in infant’s serum; the infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms

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

Adults

6 capsules/day PO.

Geriatric

6 capsules/day PO.

Adolescents

Safety and efficacy have not been established.

Children

12 years: Safety and efficacy have not been established.

1 to 11 years: Use is contraindicated.

Infants

Use is contraindicated.

butalbital/aspirin/caffeine/codeine

Capsule: Schedule III

50mg/325mg/40mg/30mg