Methohexital Sodium 500 mg/500mg Injection, 500 mg
Other active recalls for Methohexital Sodium (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Barbiturate class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 45P3261C7T
Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methohexital Sodium 500 mg/500mg 23155-0893-31 | Heritage | 1 vial | — | AP | FDA listed | — |
| Brevital Sodium 500 mg 42023-0105-01 | Par | 1 vial | — | AP | FDA listed | — |
| Methohexital Sodium 500 mg/500mgthis 83270-0003-01 | ONESOURCE | 500 mg | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83270-0003-01 You're viewing this | 500 mg in 1 VIAL (83270-003-01) | 2026-01-24 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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.)
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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. 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. 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.
⏱️ Dosage and Administration ▾
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 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.
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 Methohexital Sodium for Injection Vial For 1% methohexital solution (10 mg/mL) 500 mg 50 mL no further dilution needed FOR CONTINUOUS INTRAVENOUS ADMINISTRATION For continuous drip anesthesia, prepare a 0.2% solution by adding 500 mg of Methohexital Sodium for Injection 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 Methohexital Sodium for Injection 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 ADMINISTRATION The 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 Methohexital Sodium for Injection Vial For 5% methohexital solution (50 mg/mL) 500 mg 10 mL no further dilution needed Administration Dosage is highly individualized; the drug should be administered only by those completely familiar with its quantitative differences from other barbiturate anesthetics.
Adults 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 dri…
⛔ Contraindications ▾
CONTRAINDICATIONS 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.
⚠️ Warnings ▾
WARNINGS 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.
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 Methohexital Sodium for Injection may be additive with that of other CNS depressants, including ethyl alcohol and propylene glycol.
DANGER OF INTRA-ARTERIAL INJECTION—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: 1.
The extent of injury is related to concentration. Concentrations of 1% methohexital will usually suffice; higher concentrations should ordinarily be avoided. 2.
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.
Post injury arterial injection of vasodilators and/or arterial infusion of parenteral fluid…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 ▾
OVERDOSAGE 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.
Resuscitative measures should be initiated promptly. For hypotension, intravenous fluids should be administered and the patient’s legs raised. If desirable increase in blood pressure is not obtained, vasopressor and/or inotropic drugs may be used as dictated by the clinical situation.
For convulsions, diazepam intravenously and phenytoin may be required. If the seizures are refractory to diazepam and phenytoin, general anesthesia and paralysis with a neuromuscular blocking agent may be necessary. Protect the patient’s airway and support ventilation and perfusion.
Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed.
Safeguard the patient’s airway when employing gastric emptying or charcoal.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Compared with thiamylal and thiopental, methohexital is at least twice as potent on a weight basis, and its duration of action is only about half as long. Although the metabolic fate of methohexital in the body is not clear, the drug does not appear to concentrate in fat depots to the extent that other barbiturate anesthetics do. Thus, cumulative effects are fewer and recovery is more rapid with methohexital than with thiobarbiturates.
In experimental animals, the drug cannot be detected in the blood 24 hours after administration. Methohexital differs chemically from the established barbiturate anesthetics in that it contains no sulfur. Little analgesia is conferred by barbiturates; their use in the presence of pain may result in excitation.
Intravenous administration of methohexital results in rapid uptake by the brain (within 30 seconds) and rapid induction of sleep. Following intramuscular administration to pediatric patients, the onset of sleep occurs in 2 to 10 minutes. A plasma concentration of 3 mcg/mL was achieved in pediatric patients 15 minutes after an intramuscular dose (10 mg/kg) of a 5% solution.
Following rectal administration to pediatric patients, the onset of sleep occurs in 5 to 15 minutes. Plasma methohexital concentrations achieved following rectal administration tend to increase both with dose and with the use of more dilute solution concentrations when using the same dose. A 25 mg/kg dose of a 1% methohexital solution yielded plasma concentrations of 6.9 to 7.9 mcg/mL 15 minutes after dosing.
The absolute bioavailability of rectal methohexital sodium is 17%. With single doses, the rate of redistribution determines duration of pharmacologic effect. Metabolism occurs in the liver through demethylation and oxidation.
Side-chain oxidation is the most important biotransformation involved in termination of biologic activity. Excretion occurs via the kidneys through glomerular filtration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Methohexital Sodium for Injection is a white, freeze-dried plug/lyophilized cake, filled in Vials*: The 500 mg vials (with 30 mg anhydrous sodium carbonate) are available as follows: • NDC 83270-003-01– Multi-Dose Vial – Pack of 1 *In crystalline form.
📋 Description ▾
DESCRIPTION Methohexital Sodium for injection, 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 C 14 H 17 N 2 NaO 3 . 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 ). structure