Precautions

General—All routes of administration of Brevital^® Sodium are often associated with hiccups, coughing, and/or muscle twitching, which may also impair pulmonary ventilation.

Following induction, temporary hypotension and tachycardia may occur.

Recovery from methohexital anesthesia is rapid and smooth. The incidence of postoperative nausea and vomiting is low if the drug is administered to fasting patients. Postanesthetic shivering has occurred in a few instances.

The usual precautions taken with any barbiturate anesthetic should be observed with Brevital^® Sodium. The drug should be used with caution in patients with asthma, obstructive pulmonary disease, severe hypertension or hypotension, myocardial disease, congestive heart failure, severe anemia, or extreme obesity.

Methohexital sodium should be used with extreme caution in patients in status asthmaticus. Caution should be exercised in debilitated patients or in those with impaired function of respiratory, circulatory, renal, hepatic, or endocrine systems.

Information for Patients—When appropriate, patients should be instructed as to the hazards of drowsiness that may follow use of Brevital^® Sodium. Outpatients should be released in the company of another individual, and no skilled activities, such as operating machinery or driving a motor vehicle, should be engaged in for 8 to 12 hours.

Laboratory Tests—BSP and liver function studies may be influenced by administration of a single dose of barbiturates.

Drug Interactions—Prior chronic administration of barbiturates or phenytoin (e.g. for seizure disorder) appears to reduce the effectiveness of Brevital^® Sodium. Barbiturates may influence the metabolism of other concomitantly used drugs, such as phentyoin, halothane, anticoagulants, corticosteroids, ethyl alcohol, and propylene glycol-containing solutions.

Carcinogenesis, Mutagenesis, Impairment of Fertility—Studies in animals to evaluate the carcinogenic and mutagenic potential of Brevital^® Sodium have not been conducted. Reproduction studies in animals have revealed no evidence of impaired fertility.

Usage in Pregnancy—Pregnancy Category B—Reproduction studies have been performed in rabbits and rats at doses up to 4 and 7 times the human dose respectively and have revealed no evidence of harm to the fetus due to methohexital sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery—Brevital^® Sodium has been used in cesarean section delivery but, because of its solubility and lack of protein binding, it readily and rapidly traverses the placenta.

Nursing Mothers—Caution should be exercised when Brevital^® Sodium is administered to a nursing woman.

Pediatric Use—The safety and effectiveness of methohexital sodium in pediatric patients below the age of 1 month have not been established. Seizures may be elicited in subjects with a previous history of convulsive activity, especially partial seizure disorders. Apnea has been reported following dosing with methohexital regardless of the route of administration used. Studies using methohexital sodium intravenously in pediatric patients have been reported in the published literature. This literature is not adequate to establish the safety and effectiveness of intravenous administration of methohexital sodium in pediatric patients. Due to a variety of limitations such as study design, biopharmaceutic issues, and the wide range of effects observed with similar doses of intravenous methohexital, additional studies of intravenous methohexital in pediatric patients are necessary before this route can be recommended in pediatric patients. (See WARNINGS)

Geriatric Use—Clinical studies of Brevital^® Sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Elderly subjects may commonly have conditions in which methohexital should be used cautiously such as obstructive pulmonary disease, severe hypertension or hypotension, preexisting circulatory depression, myocardial disease, congestive heart failure, or severe anemia. Caution should be exercised in debilitated patients or in those with impaired function of respiratory, circulatory, renal, hepatic, or endocrine systems (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS). Barbiturates may influence the metabolism of other concomitantly used drugs that are commonly taken by the elderly, such as anticoagulants and corticosteroids. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS—Drug Interactions).