Brevital Sodium
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Questions & Answers
Side Effects & Adverse Reactions
See boxed Warning.
As with all potent anesthetic agents and adjuncts, Brevital should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient.
Maintenance of a patent airway and adequacy of ventilation must be ensured during induction and maintenance of anesthesia with methohexital sodium solution. Laryngospasm is common during induction with all barbiturates and may be due to a combination of secretions and accentuated reflexes following induction or may result from painful stimuli during light anesthesia. Apnea/hypoventilation may be noted during induction, which may impair pulmonary ventilation; the duration of apnea may be longer than that produced by other barbiturate anesthetics. Cardiorespiratory arrest may occur.
This prescribing information describes intravenous use of methohexital sodium in adults. It also discusses intramuscular and rectal administration in pediatric patients older than one month. Although the published literature discusses intravenous administration in pediatric patients, the safety and effectiveness of intravenous administration of methohexital sodium in pediatric patients have not been established in well-controlled, prospective studies. (See PRECAUTIONS— Pediatric Use)
Seizures may be elicited in subjects with a previous history of convulsive activity, especially partial seizure disorders.
Because the liver is involved in demethylation and oxidation of methohexital and because barbiturates may enhance preexisting circulatory depression, severe hepatic dysfunction, severe cardiovascular instability, or a shock-like condition may be reason for selecting another induction agent.
Prolonged administration may result in cumulative effects, including extended somnolence, protracted unconsciousness, and respiratory and cardiovascular depression. Respiratory depression in the presence of an impaired airway may lead to hypoxia, cardiac arrest, and death.
The CNS-depressant effect of Brevital Sodium may be additive with that of other CNS depressants, including ethyl alcohol and propylene glycol.
Unintended intra-arterial injection of barbiturate solutions may be followed by the production of platelet aggregates and thrombosis, starting in arterioles distal to the site of injection. The resulting necrosis may lead to gangrene, which may require amputation. The first sign in conscious patients may be a complaint of fiery burning that roughly follows the distribution path of the injected artery; if noted, the injection should be stopped immediately and the situation reevaluated. Transient blanching may or may not be noted very early; blotchy cyanosis and dark discoloration may then be the first sign in anesthetized patients. There is no established treatment other than prevention. The following should be considered prior to injection:
- The extent of injury is related to concentration. Concentrations of 1% methohexital will usually suffice; higher concentrations should ordinarily be avoided.
- Check the infusion to ensure that the catheter is in the lumen of a vein before injection. Injection through a running intravenous infusion may enhance the possibility of detecting arterial placement; however, it should be remembered that the characteristic bright-red color of arterial blood is often altered by contact with drugs. The possibility of aberrant arteries should always be considered.
Postinjury arterial injection of vasodilators and/or arterial infusion of parenteral fluids are generally regarded to be of no value in altering outcome. Animal experiments and published individual case reports concerned with a variety of arteriolar irritants, including barbiturates, suggest that 1 or more of the following may be of benefit in reducing the area of necrosis:
- Arterial injection of heparin at the site of injury, followed by systemic anticoagulation.
- Sympathetic blockade (or brachial plexus blockade in the arm).
- Intra-arterial glucocorticoid injection at the site of injury, followed by systemic steroids.
- A case report (nonbarbiturate injury) suggests that intra-arterial urokinase may promote fibrinolysis, even if administered late in treatment.
If extravasation is noted during injection of methohexital, the injection should be discontinued until the situation is remedied. Local irritation may result from extravasation; subcutaneous swelling may also serve as a sign of arterial or periarterial placement of the catheter.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Brevital Sodium can be used in adults as follows:
- For intravenous induction of anesthesia prior to the use of other general anesthetic agents.
- 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.
- 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.
- As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS).
- As an agent for inducing a hypnotic state.
Brevital Sodium can be used in pediatric patients older than 1 month as follows:
- For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents.
- For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures.
- As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.
History
There is currently no drug history available for this drug.
Other Information
Brevital® Sodium (Methohexital Sodium for Injection, USP) is 2,4,6 (1H, 3H, 5H)-Pyrimidinetrione, 1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt and has the empirical formula C14H17N2NaO3. Its molecular weight is 284.29.
The structural formula is as follows:
Methohexital sodium is a rapid, ultrashort-acting barbiturate anesthetic. Methohexital sodium for injection is a freeze-dried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. It contains not less than 90% and not more than 110% of the labeled amount of methohexital sodium. It occurs as a white, freeze-dried plug that is freely soluble in water.
This product is oxygen sensitive. The pH of the 1% solution is between 10 and 11; the pH of the 0.2% solution in 5% dextrose is between 9.5 and 10.5.
Methohexital sodium may be administered by direct intravenous injection or continuous intravenous drip, intramuscular or rectal routes (see PRECAUTIONS—Pediatric Use). Reconstituting instructions vary depending on the route of administration (see DOSAGE AND ADMINISTRATION).
Sources
Brevital Sodium Manufacturers
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A-s Medication Solutions Llc
![Brevital Sodium (Methohexital Sodium) Injection, Powder, Lyophilized, For Solution [A-s Medication Solutions Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Brevital Sodium | A-s Medication Solutions Llc
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 SolutionFOLLOW DILUTION 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.
DiluentsDO 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 Instructions1% 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 200 mg 20 mL no further dilution needed 500 mg 50 mL no further dilution needed 2.5 g 15 mL add to 235 mL diluent for 250 mL total volumeWhen 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 Diluent* to Be Added to the Contents of the Vial Methohexital Concentration after Dilution * Sterile Water for Injection or 0.9% Sodium Chloride Injection only. 200 mg 4 mL 5% Solution (50 mg/mL) 500 mg 10 mL 5% Solution (50 mg/mL) 2.5 g vial 50 mL 5% Solution (50 mg/mL)For rectal 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 200 mg vial 20 mL 1% Solution (10 mg/mL) 500 mg vial 50 mL 1% Solution (10 mg/mL) 2.5 g vial
(larger vial needed) 250 mL 1% Solution (10 mg/mL) AdministrationDosage is highly individualized; the drug should be administered only by those completely familiar with its quantitative differences from other barbiturate anesthetics.
AdultsBrevital 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 anesthesiaFor 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 anesthesiaMaintenance 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 PatientsBrevital Sodium is administered intramuscularly in a 5% concentration and administered rectally as a 1% solution.
Induction of anesthesiaFor 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.
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Jhp Pharmaceuticals Llc
Brevital Sodium | Par Pharmaceutical, Inc.
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 SolutionFOLLOW DILUTION 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.
DiluentsONLY USE BACTERIOSTATIC-FREE DILUENT – Recommended diluents are based on route of administration (see dilution instructions).
Incompatible diluents: Lactated Ringer's Injection
Dilution Instructions1% solutions (10 mg/mL) should be prepared for intermittent intravenous and rectal administration; 0.2% solutions (2 mg/mL) should be prepared for continuous intravenous drug administration; 5% solutions (50 mg/mL) should be prepared for intramuscular administration. .
Contents of vials should be diluted as follows:
FOR INTERMITTENT INTRAVENOUS and RECTAL ADMINISTRATIONThe preferred diluent for intermittent intravenous and rectal administration is Sterile Water for Injection. 5% Dextrose Injection, or 0.9% Sodium Chloride Injection are also acceptable diluents.
Strength Amount of Diluent to Be Added to the Contents of the Brevital Vial For 1% methohexital solution (10 mg/mL)500 mg
50 mL
no further dilution needed
2.5 g
15 mL
add to 235 mL diluent 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 INTRAVENOUS ADMINISTRATIONFor 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 ONLY is recommended as the diluent instead of sterile water for injection in order to avoid extreme hypotonicity.
Strength Amount of Diluent to Be Added to the Contents of the Brevital Vial For 0.2% methohexital solution (2 mg/mL)500 mg
15 mL
add to 235 mL diluent for 250 mL total volume
FOR INTRAMUSCULAR ADMINISTRATIONThe preferred diluent for intramuscular administration is Sterile Water for Injection. 0.9% Sodium Chloride Injection is also an acceptable diluent.
Strength Amount of Diluent to Be Added to the Contents of the Brevital Vial For 5% methohexital solution (50 mg/mL)500 mg
10 mL
no further dilution needed
2.5 g
50 mL
no further dilution needed
AdministrationDosage is highly individualized; the drug should be administered only by those completely familiar with its quantitative differences from other barbiturate anesthetics.
AdultsBrevital 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 anesthesiaFor 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 anesthesiaMaintenance 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 PatientsBrevital Sodium is administered intramuscularly in a 5% concentration and administered rectally as a 1% solution.
Induction of anesthesiaFor 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.
![Brevital Sodium (Methohexital Sodium) Injection, Powder, Lyophilized, For Solution [Jhp Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eccd8340-ead3-4363-8902-0c19d33aa2ac&name=brevital-03.jpg)
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