Pregnancy Category C

Uses. The drug is a potent sedative. Butalbital's primary medical use is for headache relief, and a product containing butalbital has also been found effective in treating pain of oral surgery.

Drawbacks. In excessive amounts butalbital can interfere with breathing and induce coma. The drug can increase body temperature, cause reddening of the skin, slow manual dexterity, and bring on confusion and glumness, all rather reminiscent of what alcohol can do. Compared to other barbiturates butalbital is rather short acting, which can have the advantage of lessening the time that users experience unwanted effects.

Abuse factors. Excessive use can cause problems both when actively taking the drug and when the drug is stopped. A case is reported when butalbital was suspected of promoting periods of wandering with the person having no recollection of what happened during those times. A single dose of one thousand milligrams (mg) is considered a poisonous dose, and a woman who took 900 mg daily for more than two years developed hallucinations, seizures, and delirium when she stopped the drug; hospitalization was needed to cure those symptoms. Two individuals taking 1,500 mg daily for months became confused, experienced hallucinations, and needed medical help to wean themselves from the drug. Persons taking butalbital for migraine have had grand mal brain seizures upon stopping the drug. Some medical practitioners feel that drug abuse is a cause of chronic headache, a belief that may make prescribing a controlled substance such as butalbital a touchy issue if a patient complains of daily headache.

Drug interactions. Monoamine oxidase inhibitors (MAOIs) can boost the effects of butalbital. Like other barbiturates, butalbital can increase the effects of alcohol and tranquilizers. Butalbital is suspected of decreasing the blood levels of imipramine, so persons taking tricyclic antidepressants such as imip-ramine may need to have blood levels monitored.

Cancer. Not enough scientific information to report.

Pregnancy. Animal experiments apparently do not indicate butalbital's potential for causing birth defects, but a large study of human pregnancy outcomes found no link between the drug and birth defects. In one case when a pregnant woman using butalbital gave birth, the child experienced seizures identified as butalbital withdrawal symptoms. Those symptoms disappeared when the infant received another barbiturate on a gradually decreasing dose that weaned the child off the drug.

Combination products. Fiorinal is a headache remedy that has had several formulations but is typically butalbital, aspirin, and caffeine. The product has been found useful for pain relief among women who have recently given birth, apparently more effective than propoxyphene. Also oral surgery patients have received good pain relief from Fiorinal and codeine. Fiorinal is known to produce a false positive for phenobarbital in body fluid testing. Abuse of the butalbital, aspirin, and caffeine (BAC) combination headache remedy can in itself cause rebound headaches. Although most persons feel no particular attraction to that combination when they take it, a minority of users experience elevation of physical energy and psychic mood, which makes the tablets attractive. Persons have been known to take from 150 to 420 BAC tablets a month for years, habits requiring hospitalization and psychological help to overcome. Substituting acetaminophen for aspirin in this combination has been found to be just as good for treating headache and less likely to cause unwanted effects. This latter combination, under the brand name Fioricet, has been found to have the additional effect of relieving tension.

Sedapap and Phrenilin (both with butalbital and acetaminophen) are remedies for headaches produced by tension or muscle contraction. The combination is not recommended for preadolescents or for persons suffering from porphyria, a condition involving disturbances in body chemistry and abnormal sensitivity to light. Potential for causing cancer or birth defects is unknown, and the combination is assigned to Pregnancy Category C. The combination passes into the milk supply of nursing mothers with unknown effect.

Additional scientific information may be found in:

Forbes, J.A. "Analgesic Effect of an Aspirin-Codeine-Butalbital-Caffeine Combination and an Acetaminophen-Codeine Combination in Postoperative Oral Surgery Pain." Pharmacotherapy 6 (1986): 240-47. Friedman, A.P., and F.J. DiSerio. "Symptomatic Treatment of Chronically Recurring Tension Headache: Placebo-Controlled, Multicenter Investigation of Fioricet and Acetaminophen with Codeine." Clinical Therapeutics 10 (1987): 69-81. Good, M.I. "Organic Dissociative Syndrome Associated with Antimigraine Pharmacotherapy." Canadian Journal of Psychiatry 36 (1991): 597-99. Preskorn, S.H., R.L. Schwin, and W.V. McKnelly. "Analgesic Abuse and the Barbiturate Abstinence Syndrome." Journal of the American Medical Association 244 (1980): 369-70.

Raja, M. "Severe Barbiturate Withdrawal Syndrome in Migrainous Patients." Headache 36 (1996): 119-21.

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