Pofol (Emulsion) Instructions for Use

Instructions
Dosage forms

ATC Code

N01AX10 (Propofol)

Active Substance

Propofol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Intravenous anesthesia preparation

Pharmacotherapeutic Group

Non-inhalation anesthetic agent

Pharmacological Action

A non-inhalation anesthetic agent. When administered intravenously, the state of anesthesia occurs within approximately 30 seconds, without pronounced signs of excitation.

After administration, Propofol is distributed throughout the body tissues and undergoes biotransformation primarily in the liver with the formation of inactive conjugates.

The onset of anesthesia under the influence of propofol is apparently due to a nonspecific effect on the lipid membranes of CNS neurons, resulting in disruption of ion channel function, particularly sodium channels.

Furthermore, it has been shown that propofol enhances GABA-ergic processes in the brain. Propofol has virtually no analgesic effect.

Recovery of function after cessation of propofol’s action occurs quickly.

Indications

For induction of anesthesia and for maintenance of general anesthesia. For providing a sedative effect during mechanical ventilation.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Emulsion

For induction of anesthesia in adult patients with average body weight, administer intravenously 40 mg every 10 seconds until clinical signs of anesthesia appear.

In most cases, the total dose is 2-2.5 mg/kg. For children over 8 years of age, administer slowly intravenously until clinical signs of anesthesia appear.

The dose should be adjusted according to age and/or body weight; the average dose is 2.5 mg/kg. For children under 8 years of age, drug doses may be higher.

For adults and children over 3 years of age with ASA grades 3 and 4, Propofol should be administered in smaller doses.

For maintenance of anesthesia by continuous infusion, adults are administered 4-12 mg/kg/h. For children, the infusion rate is 9-15 mg/kg/h.

Repeated administration as a bolus in doses necessary to maintain adequate anesthesia is also possible.

To provide a sedative effect during artificial ventilation of the lungs in adults, Propofol is administered at a dose of 300 mcg/kg/h.

Adverse Reactions

When used for induction of anesthesia, arterial hypotension, bradycardia, and transient apnea are possible.

Rarely convulsions, opisthotonus, pulmonary edema. During awakening, headache, nausea, and vomiting may occur.

In some cases postoperative fever.

In isolated cases angioedema, bronchospasm, erythema, sexual disinhibition; at doses exceeding 4 mg/kg/h, isolated cases of rhabdomyolysis have been reported.

Local reactions phlebitis, thrombosis.

Contraindications

Allergic reactions to propofol administration in history, children under 1 month of age, children and adolescents under 16 years of age (for providing a sedative effect during mechanical ventilation).

Use in Pregnancy and Lactation

Should not be used in obstetric practice as an anesthetic agent, as Propofol crosses the placental barrier and can cause neonatal depression. It can be used as a general anesthetic during termination of pregnancy in the first trimester.

Propofol is excreted in small amounts in breast milk. It is believed that this is not dangerous for the child, provided that the mother does not breastfeed the child for several hours after propofol administration.

Use in Hepatic Impairment

Propofol should be used with caution in liver diseases.

Use in Renal Impairment

Propofol should be used with caution in kidney diseases.

Pediatric Use

Contraindicated in children under 1 month of age, children and adolescents under 16 years of age (for providing a sedative effect during mechanical ventilation).

Geriatric Use

Propofol should be used with caution in elderly patients.

Special Precautions

Propofol should be used with caution in concomitant hypovolemia, epilepsy, lipid metabolism disorders, diseases of the cardiovascular system, respiratory organs, liver and kidneys, and in elderly patients. To prevent bradycardia, it is advisable to include m-cholinolytics in the premedication complex.

Drug Interactions

With simultaneous use of propofol with muscle relaxants, inhalational anesthetics, and analgesics, an enhancement of the depressant effect on respiration and a decrease in blood pressure is possible, which potentiates the effect of propofol.

With simultaneous use of propofol and opioid analgesics, the risk of respiratory depression increases.

After fentanyl administration, the plasma level of propofol may temporarily increase.

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.

Medical Disclaimer