BUTALBITAL COMPOUND

General

byoo-TAL-bi-tal [Pronunciation]

butalbital, acetaminophen

• Axocet

• Bucet, Bupap

• Butex Forte

• Dolgic

• Marten-Tab

• Phrenilin

• Phrenilin Forte

• Repap CF

• Sedapap

• Tencon

• Triaprin

butalbital, acetaminophen, caffeine

• Endolor

• Esgic

• Esgic-Plus

• Fioricet

• Margesic

• Medigesic

• Repan

• Triad

butalbital, aspirin, caffeine

• Fiorinal

• Fiortal

• Tecnal [Canada]

Controlled Substance Schedule
III(products with aspirin only)

Pregnancy Category
Category D

Ther. class.
nonopioid analgesics
(combination with barbiturate)

Pharm. class.
barbiturates

†For information on acetaminophen component in formulation, see acetaminophen monograph‡For information on aspirin component in formulation, see salicylates monograph

Indications

Management of mild to moderate pain

Action

Contain an analgesic (aspirin or acetaminophen) for relief of pain, a barbiturate (butalbital) for its sedative effect, and some contain caffeine, which may be of benefit in vascular headaches

Therapeutic Effect(s):
Decreased severity of pain with some sedation

Pharmacokinetics

Absorption: Well absorbed

Distribution: Widely distributed; cross the placenta and enter breast milk

Metabolism and Excretion: Mostly metabolized by the liver

Half-life: 35 hr

TIME/ACTION PROFILE

ROUTE	ONSET	PEAK	DURATION
PO	15–30 min	1–2 hr	2–6 hr

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to individual components

• Cross-sensitivity may occur

• Comatose patients or those with pre-existing CNS depression

• Uncontrolled severe pain

• Aspirin should be avoided in patients with bleeding disorders or thrombocytopenia

• Acetaminophen should be avoided in patients with severe hepatic or renal disease

• Caffeine should be avoided in patients with severe cardiovascular disease

• Pregnancy or lactation

• Porphyria

Use Cautiously in:

• History of suicide attempt or drug addiction

• Chronic alcohol use/abuse (for aspirin and acetaminophen content)

• Geri: Appears on Beers list. Geriatric patients are at increased risk for side effects (dosage reduction recommended)

• Use should be short-term only

• Children (safety not established)

Adverse Reactions/Side Effects

CNS: caffeine—drowsiness, hangover, delirium, depression, excitation, headache (with chronic use), insomnia, irritability, lethargy, nervousness, vertigo.

Resp: respiratory depression.

CV: caffeine—palpitations, tachycardia.

GI: caffeine—constipation, diarrhea, epigastric distress, heartburn, nausea, vomiting.

Derm: dermatitis, rash.

Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANGIOEDEMA AND SERUM SICKNESS , physical dependence, psychological dependence, tolerance.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• 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 hormonal contraceptives , chloramphenicol , acebutolol , propranolol , metoprolol , timolol , doxycycline , corticosteroids , tricyclicantidepressants , phenothiazines , phenylbutazone , and quinidine

• MAO inhibitors , primidone , and valproic acid may prevent metabolism and increase the effectiveness of butalbital

• May enhance the hematologic toxicity of cyclophosphamide

Drug-Natural Products

• St. John's wort may decrease barbiturate effect

• Concurrent use of kava-kava , valerian , skullcap , chamomile , or hops can increase CNS depression

Route/Dosage

• PO (Adults): 1–2 capsules or tablets (50–100 mg butalbital) every 4 hr as needed for pain (not to exceed 4 g acetaminophen or aspirin/24 hr).

Availability

• Tablets and capsules: 50 mg

• In combination with: aspirin, acetaminophen, caffeine, and codeine Rx. See combination drugs

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

• PO: Oral doses 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. Doses of acetaminophen or aspirin should not exceed the maximum recommended daily dose. Chronic excessive use of >4 g/day (2 g in chronic alcoholism) may lead to hepatotoxicity, renal or cardiac damage

• Advise patients with vascular 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