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Brevital (Methohexital Sodium) - Indications and Dosage

 



INDICATIONS AND USAGE

Brevital Sodium 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 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 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.

DOSAGE AND ADMINISTRATION

Facilities for assisting ventilation and administering oxygen are necessary adjuncts for all routes of administration of anesthesia. Since cardiorespiratory arrest may occur, patients should be observed carefully during and after use of Brevital Sodium. 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 may be used with any of the recognized preanesthetic medications.

Preparation of Solution

FOLLOW DILUTING INSTRUCTIONS EXACTLY.

Solutions of Brevital Sodium should be freshly prepared and used promptly. Reconstituted solutions of Brevital Sodium 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 (for IV or rectal administration only), 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:

FOR INTRAVENOUS ADMINISTRATION
Strength Amount of Diluent to Be Added to the Contents of the Vial For 1% methohexital solution
500 mg 50 mL no further dilution needed
2.5 g 15 mL add to 235 mL for 250 mL total volume

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 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
Strength Amount of DiluentSterile water for injection or 0.9% sodium chloride injection only. to Be Added to the Contents of the Vial Methohexital Concentration after Dilution
500 mg vial 10 mL 5% Solution (50 mg/mL)
2.5 g vial 50 mL 5% Solution (50 mg/mL)

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

FOR RECTAL ADMINISTRATION
Strength Amount of Diluent to Be Added to the Contents of the Vial Methohexital Concentration after Dilution
500 mg vial 50 mL 1% Solution (10 mg/mL)
2.5 g vial
(larger vial needed)
250 mL 1% Solution (10 mg/mL)

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 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 during longer procedures.

Pediatric Patients

Brevital Sodium 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 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 barbituric acid to be precipitated. Solubility of the soluble sodium salts of barbiturates, including Brevital Sodium, 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 was mixed with therapeutic amounts of agents whose solutions have a low (acid) pH.

Active Ingredient Potency per mL Volume Used Immediate 15 min Physical Change
30 min
1 h
Brevital Sodium 10 mg 10 mL CONTROL
Atropine Sulfate 1/150 gr 1 mL None Haze
Atropine Sulfate 1/100 gr 1 mL None Ppt Ppt
Succinylcholine chloride 0.5 mg 4 mL None None Haze
Succinylcholine chloride 1 mg 4 mL None None Haze
Metocurine Iodide 0.5 mg 4 mL None None Ppt
Metocurine Iodide 1 mg 4 mL None None Ppt
Scopolamine hydrobromide 1/120 gr 1 mL None None None Haze
Tubocurarine chloride 3 mg 4 mL None Haze

HOW SUPPLIED

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

Brevital® Sodium VialsIn crystalline form.:

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)

Rx Only.

Prescribing Information as of January 2009.

JHP Pharmaceuticals
Manufactured and Distributed by:
JHP Pharmaceuticals, LLC.
Rochester, MI 48307

3003014B

Page last updated: 2009-07-20

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