Fiorinal

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butalbital, aspirin, and caffeine†

(byoo-tal-bi-tal, as-pir-in, & kaf-een) ,

Fiorinal

(trade name),

Tecnal

(trade name),

Trianal

(trade name)

Classification

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

Indications

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).

Action

Contains an analgesic (aspirin) 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.

Pharmacokinetics

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); aspirin and caffeine primarily metabolized by liver.
Half-life: Butalbital = 35 hr; aspirin = 3 hr; caffeine = 3 hr.

Time/action profile

ROUTEONSETPEAKDURATION
PO15–30 min1–2 hr30 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to individual components (cross-sensitivity may occur with NSAIDS); Bleeding disorders, thrombocytopenia, or vitamin K deficiency; Severe hepatic disease; Peptic ulcer disease; Porphyria; Pregnancy or lactation; Children (safety and effectiveness not established).
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; Patients concomitantly receiving warfarin therapy; Severe renal disease; Head injury; Elevated intracranial pressure; Hypothyroidism; Addison's disease; Benign prostatic hyperplasia; Asthma; Geriatric: Appears on Beers list. Geriatric patients are at increased risk for side effects (dosage reduction recommended).

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

  • respiratory depression

Cardiovascular

  • palpitations
  • tachycardia

Gastrointestinal

  • bleeding
  • constipation
  • dry mouth
  • dysphagia
  • epigastric distress
  • flatulence
  • heartburn

Dermatologic

  • dermatitis
  • pruritis
  • rash
  • sweating

Musculoskeletal

  • leg pain
  • muscle weakness

Miscellaneous

  • fever
  • physical dependence
  • psychological dependence
  • tolerance

Interactions

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.May increase the effect of warfarin, oral antidiabetic agents, insulin, 6–mercaptopurine, methotrexate, and NSAIDS.May decrease the effect of probenecid.St. John’s wort may decrease barbiturate effect.Concurrent use of kava kava, valerian, skullcap, chamomile, or hops can increase CNS depression.

Route/Dosage

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 aspirin/40 mg caffeine
Capsules: 50 mg butalbital/325 mg aspirin/40 mg caffeine
In combination with: codeine. 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)

Implementation

  • 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.
  • Oral: Should be administered with food, milk, or a full glass of water to minimize GI irritation.

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 aspirin 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 report any signs of bleeding, bruising, or ringing in ears to a health care professional.
  • 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.

Fiorinal

a trademark for a group of fixed-combination drugs containing a sedative-hypnotic (butalbital); an analgesic, antipyretic, and antiinflammatory (aspirin); and a central nervous system stimulant (caffeine).

butalbital

A sedative/ hypnotic of intermediate duration of action, which may be used for tension headaches.

Adverse effects
Dizziness, drowsiness, nausea, sedation, euphoria, addiction, diarrhoea, constipation, memory loss.