Sodium oxibate (Solution) Instructions for Use

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

ATC Code

N01AX (Other drugs for general anesthesia)

Active Substance

Sodium oxybutyrate (Grouping name)

Dosage Form

Sodium oxibate

Solution for intravenous and intramuscular injection 200 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular injection transparent, colorless or with a slight yellowish tint, with a specific odor.

Excipients: hydrochloric acid or sodium hydroxide – to adjust pH to 7.7-9.0, water for injection – up to 1 ml.

5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Agent for non-inhalation anesthesia

Pharmacotherapeutic Group

Agent for non-inhalation general anesthesia

Pharmacological Action

A drug affecting cerebral metabolism. It is used for non-inhalation anesthesia. It activates metabolism in tissues, particularly in the brain, heart, and retina. It increases tissue resistance to hypoxia. It has a sedative and central muscle relaxant effect. It possesses antihypoxic activity. It improves myocardial contractility, microcirculation, glomerular filtration (stabilizes kidney function under blood loss conditions). In high doses, it induces a state of sleep and anesthesia (within 5-7 minutes after intravenous administration).

Pharmacokinetics

Clinical data on the pharmacokinetics of sodium oxybate are limited. It easily penetrates the blood-brain barrier and other histohematic barriers. After intravenous administration, 70% is eliminated from the blood within 2-3 hours.

Indications

Neurotic and neurosis-like conditions caused by psychogenic influences, intoxications, and traumatic injuries of the CNS, sleep disorders (as part of combination therapy). An agent for non-inhalation anesthesia for minor surgical interventions, for induction anesthesia, for general anesthesia in obstetric practice during operative delivery, for rest of women in labor, for increasing the resistance of the mother and fetus to hypoxia. Heart surgery. Primary open-angle glaucoma (to activate oxidative processes in the retina).

ICD codes

Dosage Regimen

Determine the dosage individually based on the clinical indication, patient status, and route of administration.

For intravenous administration to adults, administer a single dose of 30-120 mg/kg body weight. Inject slowly to prevent respiratory depression and convulsive muscle twitching.

For intramuscular administration to adults, use a single dose of 100-150 mg/kg body weight.

For oral administration, the single dose range is 40-200 mg/kg body weight.

When used for non-inhalation anesthesia, precede administration with standard premedication. Adjust the dose for patients with hypokalemia, as the drug may exacerbate this condition.

Monitor respiratory function and potassium levels during and after administration, especially with high or repeated doses. Avoid daytime use in patients requiring rapid psychomotor reactions.

Adverse Reactions

From the digestive system nausea, vomiting (upon emergence from general anesthesia).

From the CNS motor and speech excitation upon emergence from anesthesia; in some cases – daytime sleepiness; with rapid intravenous administration – convulsive twitching of the tongue and limb muscles, convulsions.

From metabolism hypokalemia (with long-term use in high doses without potassium chloride administration).

From the respiratory system respiratory disturbance up to arrest (with rapid intravenous administration).

Contraindications

Hypokalemia, myasthenia gravis, severe toxicosis of pregnancy accompanied by arterial hypertension, hypersensitivity to sodium oxybate.

Use in Pregnancy and Lactation

Contraindicated in late toxicosis of pregnancy.

Special Precautions

When using sodium oxybate as an anesthetic agent, standard premedication (promedol, atropine, diphenhydramine) is preliminarily administered. Overdose may lead to respiratory arrest.

Effect on ability to drive vehicles and operate machinery

It should not be used during daytime hours in patients whose activities require rapid psychomotor reactions.

Drug Interactions

Sodium oxybutyrate enhances the effect of narcotic and analgesic agents and general anesthetics. It has a pronounced antagonism with bemegride.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.