butalbital, acetaminophen, caffeine

butalbital, acetaminophen, caffeine†

(byoo-tal-bi-tal, a-seet-a-min-oh-fen, kaf-een) ,


(trade name),


(trade name)


Therapeutic: nonopioid analgesics
Pharmacologic: barbiturates
Pregnancy Category: C
† For information on acetaminophen component in formulation, see acetaminophen monograph


Relief of the symptom complex of tension (or muscle contraction) headaches (use should be short-term only as the butalbital component may be habit-forming).


Contains an analgesic (acetaminophen) for relief of pain, a barbiturate (butalbital) for its sedative effect, and caffeine, which may be of benefit in tension headaches.

Therapeutic effects

Decreased severity of pain with some sedation.


Absorption: Well absorbed.
Distribution: Widely distributed; crosses the placenta and enters breast milk.
Metabolism and Excretion: Butalbital primarily eliminated by kidneys as unchanged drug or metabolites (59–88% of dose); acetaminophen and caffeine primarily metabolized by liver.
Half-life: Butalbital = 35 hr; acetaminophen = 1–3 hr; caffeine = 3 hr.

Time/action profile

PO15–30 min1–2 hr30 hr


Contraindicated in: Hypersensitivity to individual components; Lactation; Porphyria.
Use Cautiously in: History of suicide attempt or drug addiction; Chronic alcohol use; Severe hepatic or renal disease; Severe cardiovascular disease; Patients concomitantly receiving other CNS depressants; Geriatric: Appears on Beers list. Geriatric patients are at increased risk for side effects (dosage reduction recommended); Children <12 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • drowsiness (most frequent)
  • confusion
  • delirium
  • depression
  • dizziness
  • excitation
  • headache (with chronic use)
  • insomnia
  • irritability
  • lethargy
  • nervousness
  • numbness
  • tingling

Ear, Eye, Nose, Throat

  • earache
  • nasal congestion
  • tinnitus


  • respiratory depression


  • palpitations
  • tachycardia


  • constipation
  • dry mouth
  • dysphagia
  • flatulence
  • heartburn


  • dermatitis
  • pruritis
  • rash
  • sweating


  • leg pain
  • muscle weakness


  • fever
  • physical dependence
  • psychological dependence
  • tolerance


Drug-Drug interaction

Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, and sedative/hypnotics.May increase the liver metabolism and decrease the effectiveness of other drugs including amiodarone, benzodiazepines, bupropion, calcium channel blockers, carbamazepine, citalopram, clarithromycin, cyclosporine, erythromycin, fluoxetine, fluvoxamine, glipizide, hormonal contraceptives, losartan, methadone, mirtazapine, nateglinide, nefazodone, nevirapine, phenytoin, pioglitazone, promethazine, propranolol, protease inhibitors, proton pump inhibitors, rifampin, ropinirole, rosiglitazone, selegiline, sertraline, tacrolimus, theophylline, venlafaxine, voriconazole, warfarin, and zafirlukast.MAO inhibitors, felbamate, primidone, and valproic acid may prevent metabolism and increase the effectiveness of butalbital.St. John’s wort may ↓ barbiturate effect.Concurrent use of kava kava, valerian, skullcap, chamomile, or hops can increase CNS depression.


Oral (Adults) 1–2 capsules or tablets (50–100 mg butalbital) every 4 hr as needed for pain (should not exceed 6 tablets or capsules/24 hr).

Availability (generic available)

Tablets: 50 mg butalbital/325 mg acetaminophen/40 mg caffeine, 50 mg butalbital/500 mg acetaminophen/40 mg caffeine, 50 mg butalbital/750 mg acetaminophen/40 mg caffeine Cost: Generic — 50 mg/325 mg/40 mg $64.15 / 100, 50 mg/500 mg/40 mg $119.99 / 100
Capsules: 50 mg butalbital/300 mg acetaminophen/40 mg caffeine, 50 mg butalbital/325 mg acetaminophen/40 mg caffeine, 50 mg butalbital/500 mg acetaminophen/40 mg caffeine Cost: Generic — 50 mg/325 mg/40 mg $119.95 / 100
In combination with: codeine Rx. See combination drugs.

Nursing implications

Nursing assessment

  • Assess type, location, and intensity of pain before and 60 min following administration.
  • Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Most patients who receive butalbital compound for pain do not develop psychological dependence.
  • Assess frequency of use. Frequent, chronic use may lead to daily headaches in headache-prone individuals because of physical dependence on caffeine and other components. Chronic headaches from overmedication are difficult to treat and may require hospitalization for treatment and prophylaxis.

Potential Nursing Diagnoses

Acute pain (Indications)
Risk for injury (Side Effects)


  • Do not confuse Fiorinal with Fioricet.
  • Explain therapeutic value of medication before administration to enhance the analgesic effect.
  • Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
  • Medication should be discontinued gradually after long-term use to prevent withdrawal symptoms.

Patient/Family Teaching

  • Instruct patient to take medication exactly as directed. Do not increase dose because of the habit-forming potential of butalbital. If medication appears less effective after a few weeks, consult health care professional. The dose of acetaminophen should not exceed the maximum recommended daily dose of 4 g/day. Chronic excessive use of >4 g/day (2 g in chronic alcoholism) may lead to hepatotoxicity, renal or cardiac damage.
  • Advise patients with tension headaches to take medication at first sign of headache. Lying down in a quiet, dark room may also be helpful. Medications taken for prophylaxis should be continued.
  • May cause drowsiness or dizziness. Advise patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants.
  • Advise patient to use an additional nonhormonal method of contraception while taking butalbital compound.

Evaluation/Desired Outcomes

  • Decrease in severity of pain without a significant alteration in level of consciousness.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
Breckenridge markets additional ANDA products, including estradiol/norethindrone acetate tablets 1 mg/0.5 mg (generic version of Activella); oxcarbazepine tablets (generic version of Trileptal); meloxicam tablets (generic version of Mobic); Ascomp w/ codeine (generic version of Fiorinal with codeine); butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with codeine); cyclobenzaprine (generic version of Flexeril); methylprednisolone (generic version of Medrol); polyethylene glycol powder (generic version of Miralax); folic acid tablets; and Vitamin D capsules (generic of Drisdol).
Breckenridge also currently markets Ascomp with codeine (Fiorinal with codeine), butalbital, acetaminophen, caffeine and codeine phosphate (Fioricet with codeine), cyclobenzaprine (Flexeril), folic acid 1 mg, methylprednisolone (Medrol), polyethylene glycol powder (Miralax), prednisone 1-mg tablets, and prochlorperazine (Compazine).
The company has introduced several products after their abbreviated new drug applications (ANDAs) won approval from the Food and Drug Administration, including meloxicam tablets (a generic version of Mobic), ascomp with codeine (generic version of Fiorinal with codeine), methylprednisolone (generic version of Medrol), prochlorperazine (generic version of Compazine), butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with Codeine), and folic acid, 1 mg.