pharmacopeia

Boxed warning

Methohexital Sodium for Injection 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. (See WARNINGS.)

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • 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; Methohexital Sodium for Injection may be given by infusion or intermittent injection.

Contraindications

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  • Methohexital Sodium for Injection is contraindicated in patients in whom general anesthesia is contraindicated, in those with latent or manifest porphyria, or in patients with a known hypersensitivity to barbiturates.contraindicated

Dosage & administration

Sourced from openFDA

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 Methohexital Sodium for Injection. Age- and size- appropriate resuscitative equipment (i.e., 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. Methohexital Sodium for Injection may be used with any of the recognized preanesthetic medications. Preparation of Solution FOLLOW DILUTION INSTRUCTIONS EXACTLY. Freshly prepare solutions of Methohexital Sodium for Injection and use promptly. Reconstituted solutions of Methohexital Sodium for Injection are chemically stable at room temperature for 24 hours. Diluents ONLY USE BACTERIOSTATIC-FREE DILUENT - Recommended diluents are based on route of administration (see Dilution Instructions ). Incompatible diluents: Lactated Ringer's Injection Dilution Instructions 1% 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 ADMINISTRATION The preferred diluent for intermittent intravenous and rectal administration is Sterile Water for Injection.

Warnings & precautions

Sourced from openFDA

As with all potent anesthetic agents and adjuncts, Methohexital Sodium for Injection 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.

Adverse reactions

Sourced from openFDA

Side effects associated with Methohexital Sodium for Injection are extensions of pharmacologic effects and include: Cardiovascular Circulatory depression, thrombophlebitis, hypotension, tachycardia, peripheral vascular collapse, and convulsions in association with cardiorespiratory arrest. Respiratory Respiratory depression (including apnea), cardiorespiratory arrest, laryngospasm, bronchospasm, hiccups, and dyspnea Neurologic Skeletal muscle hyperactivity (twitching), injury to nerves adjacent to injection site, and seizures Psychiatric Emergence delirium, restlessness, and anxiety may occur, especially in the presence of postoperative pain Gastrointestinal Nausea, emesis, abdominal pain, and liver function tests abnormal Allergic Erythema, pruritus, urticaria, and cases of anaphylaxis have been reported rarely Other Other adverse reactions include pain at injection site, salivation, headache, and rhinitis For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Onesource at 1-888-217-8103 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Sourced from openFDA

Signs and Symptoms The onset of toxicity following an overdose of intravenously administered methohexital will be within seconds of the infusion. If methohexital is administered rectally or is ingested, the onset of toxicity may be delayed. The manifestations of an ultrashort-acting barbiturate in overdose include central nervous system depression, respiratory depression, hypotension, loss of peripheral vascular resistance, and muscular hyperactivity ranging from twitching to convulsive-like movements. Other findings may include convulsions and allergic reactions. Following massive exposure to any barbiturate, pulmonary edema, circulatory collapse with loss of peripheral vascular tone, and cardiac arrest may occur. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Establish an airway and ensure oxygenation and ventilation.

Approval history

Sourced from openFDA
  • Jun 27, 1960NDANDA011559Ph Health
  • Oct 3, 2024ANDAANDA215488Onesource Specialty

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
122 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective6352%
  2. 2Product Quality Issue2520%
  3. 3Off Label Use86.6%
  4. 4Drug Effect Decreased75.7%
  5. 5Vomiting75.7%
  6. 6Nausea64.9%
  7. 7Drug Effect Less Than Expected54.1%
  8. 8Maternal Exposure During Pregnancy54.1%
  9. 9Unwanted Awareness During Anaesthesia54.1%
  10. 10Hypotension43.3%
  11. 11Airway Complication Of Anaesthesia32.5%
  12. 12Blood Pressure Decreased32.5%
  13. 13Bradycardia32.5%
  14. 14Dyspnoea32.5%
  15. 15Ventricular Extrasystoles32.5%

Literature

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Recent PubMed references pinned to Methohexital as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Methohexital as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Methohexital work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Methohexital used for?
According to FDA labeling, Methohexital carries indications including: 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; Methohexital Sodium for Injection may be given by infusion or intermittent injection.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methohexital?
Methohexital is classified as Barbiturates, plain, Barbiturate, Unknown Cellular or Molecular Interaction, Decreased Medullary Respiratory Drive, General Anesthesia, Increased Central Nervous System GABA Activity, Vasodilation.
What are the brand names for Methohexital?
Methohexital is marketed under brand names including Brevital.
What are the contraindications for Methohexital?
Methohexital labeling lists contraindications including: Methohexital Sodium for Injection is contraindicated in patients in whom general anesthesia is contraindicated, in those with latent or manifest porphyria, or in patients with a known hypersensitivity to barbiturates.. Always consult the full prescribing information and a clinician.
Note. Data for methohexital is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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