Brevital Sodium (methohexital sodium for injection) can be used in adults as follows:

1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents.
2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; Brevital Sodium (methohexital sodium for injection) may be given by infusion or intermittent injection.
3. For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures.
4. As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS).
5. As an agent for inducing a hypnotic state.

Brevital Sodium (methohexital sodium for injection) can be used in pediatric patients older than 1 month as follows:

1. For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents.
2. For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures.
3. As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.

Facilities for assisting ventilation and administering oxygen are necessary adjuncts for all routes of administration of anesthesia. Since car-diorespiratory arrest may occur, patients should be observed carefully during and after use of Brevital Sodium (methohexital sodium for injection) . Age- and size-appropriate resuscitative equipment (ie, intubation and cardioversion equipment, oxygen, suction, and a secure intravenous line) and personnel qualified in its use must be immediately available.

Preanesthetic medication is generally advisable. Brevital Sodium (methohexital sodium for injection) may be used with any of the recognized preanesthetic medications.

Preparation of Solution-FOLLOW DILUTING INSTRUCTIONS EXACTLY.

Solutions of Brevital Sodium (methohexital sodium for injection) should be freshly prepared and used promptly. Reconstituted solutions of Brevital Sodium (methohexital sodium for injection) are chemically stable at room temperature for 24 hours.

Diluents-DO NOT USE DILUENTS CONTAINING BACTERIOSTATS. Preferred diluent: Sterile Water for Injection

Acceptable diluents: 5% Dextrose Injection, 0. 9% Sodium Chloride Injection

Incompatible diluents: Lactated Ringer's Injection

Dilution Instructions-1% solutions (10 mg/mL) should be prepared for intravenous use. Contents of vials should be diluted as follows:

When the first dilution is made with the 2. 5 g, the solution in the vial will be yellow. When further diluted to make a 1% solution, it must be clear and colorless or should not be used.

For continuous drip anesthesia, prepare a 0. 2% solution by adding 500 mg of Brevital Sodium (methohexital sodium for injection) to 250 mL of diluent. For this dilution, either 5% glucose solution or isotonic (0. 9%) sodium chloride solution is recommended instead of distilled water in order to avoid extreme hypotonicity. For intramuscular administration, contents of the vials should be diluted as follows:

FOR INTRAMUSCULAR ADMINISTRATION

For rectal administration, contents of the vials should be diluted as follows:

FOR RECTAL ADMINISTRATION

Administration-Dosage is highly individualized; the drug should be administered only by those completely familiar with its quantitative differences from other barbiturate anesthetics.

Adults-Brevital Sodium (methohexital sodium for injection) is administered intravenously in a concentration of no higher than 1%. Higher concentrations markedly increase the incidence of muscular movements and irregularities in respiration and blood pressure.

Induction of anesthesia-For induction of anesthesia, a 1% solution is administered at a rate of about 1 mL/5 seconds. Gaseous anesthetics and/or skeletal muscle relaxants may be administered concomitantly. The dose required for induction may range from 50 to 120 mg or more but averages about 70 mg. The usual dosage in adults ranges from 1 to 1. 5 mg/kg. The induction dose usually provides anesthesia for 5 to 7 minutes.

Maintenance of anesthesia-Maintenance of anesthesia may be accomplished by intermittent injections of the 1% solution or, more easily, by continuous intravenous drip of a 0. 2% solution. Intermittent injections of about 20 to 40 mg (2 to 4 mL of a 1% solution) may be given as required, usually every 4 to 7 minutes. For continuous drip, the average rate of administration is about 3 mL of a 0. 2% solution/minute (1 drop/second). The rate of flow must be individualized for each patient. For longer surgical procedures, gradual reduction in the rate of administration is recommended (see discussion of prolonged administration in WARNINGS). Other parenteral agents, usually narcotic analgesics, are ordinarily employed along with Brevital Sodium (methohexital sodium for injection) during longer procedures.

Pediatric Patients-Brevital Sodium (methohexital sodium for injection) is administered intramuscularly in a 5% concentration and administered rectally as a 1% solution.

Induction of anesthesia-For the induction of anesthesia by the intramuscular route of administration, the usual dose ranges from 6. 6 to 10 mg/kg of the 5% concentration. For rectal administration, the usual dose for induction is 25 mg/kg using the 1% solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Compatibility Information

Solutions of Brevital Sodium (methohexital sodium for injection) should not be mixed in the same syringe or administered simultaneously during intravenous infusion through the same needle with acid solutions, such as atropine sulfate, metocurine iodide, and succinylcholine chloride. Alteration of pH may cause free bar-bituric acid to be precipitated. Solubility of the soluble sodium salts of barbiturates, including Brevital Sodium (methohexital sodium for injection) , is maintained only at a relatively high (basic) pH.

Because of numerous requests from anesthesiologists for information regarding the chemical compatibility of these mixtures, the following chart contains information obtained from compatibility studies in which a 1% solution of Brevital Sodium (methohexital sodium for injection) was mixed with therapeutic amounts of agents whose solutions have a low (acid) pH.

Store at controlled room temperature (20° to 25°C) (68° to 77°F) [see USP].

The expiration period for the vials is 2 years.

Brevital®Sodium Vials*:

500 mg (with 30 mg anhydrous sodium carbonate) are available as follows:

50-mL size, multiple dose-1's (NDC 42023-105-01)

The 2. 5 g vials (with 150 mg anhydrous sodium carbonate) are available as follows:

50-mL size, multiple dose-1's (NDC 42023-106-01)

*In crystalline form.

Prescribing Information as of January 2008., Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307. FDA revision date: 5/5/2008

Last reviewed on RxList: 6/14/2008
This monograph has been modified to include the generic and brand name in many instances.