Dongkook Pharm


Endure Medical
Full Prescribing Info
Propofol is white, oil-in-water isotonic emulsion for IV injection containing propofol 10 mg/mL. The vehicle contains glycerol, purified egg, lecithin, sodium hydroxide, soybean oil and water.
Pharmacology: Propofol is a short-acting anesthetic given IV for the induction and maintenance of general anesthesia. It is also used for sedation in adult patients undergoing surgery in conjunction with local or general anesthesia, induction is rapid, as is recovery. Propofol has no analgesic activity and supplementary analgesia may be required.
Pharmacokinetics: The pharmacokinetics of propofol is best described by a 3-compartment model. After single-bolus dose, 2 distribution phases are seen. The 1st phase has a t½ of 2-4 min. This is followed by a slow distribution phase with a t½ of 30-60 min. Significant metabolism of propofol occurs during the 2nd phase. The termination of anesthetic effect after a single IV bolus or maintenance infusion is due to extensive redistribution from the brain or other tissues and to metabolic clearance. Propofol is >95% bound to plasma proteins. It undergoes extensive hepatic metabolism to conjugates which are eliminated in the urine. The terminal t½ ranges from 3-12 hrs; with prolonged use, the terminal t½ may be longer. The pharmacokinetic of propofol does not appear to be altered by gender, chronic hepatic cirrhosis or chronic renal impairment. Propofol crosses the placental barrier and is distributed into breast milk.
Induction and maintenance of general anesthesia.
It may also be used for sedation of ventilated patients receiving intensive care for a period of up to 3 days; and for surgical and diagnostic procedures.
Dosage/Direction for Use
Propofol should only be administered through a filter with a pore size ≥5 micron.
Induction of General Anesthesia: Adults: In a non-premedicated and premedicated patients, it is recommended that propofol be titrated [approximately 4 mL (40 mg) every 10 sec in the average healthy adult] against the response of the patient until the clinical signs shows the onset of anesthesia. Most adult patients <55 years are likely to require 2-2.5 mg/kg of propofol. Above this age, the requirement will generally be less. In patients of ASA grades 3 and 4, lower rates of administration should be used [approximately 2 mL (20 mg) every 10 sec].
Elderly: Propofol should be titrated against the response of the patient. Patients >55 years may require lower doses of propofol for induction of anesthesia.
Children: Propofol is not recommended for induction of anesthesia in children, it is recommended that propofol be given slowly until the clinical signs show the onset of anesthesia. The dose should be adjusted for age and/or weight. Most patients > 8 years are likely to require approximately 2.5 mg/kg of propofol for induction of anesthesia. Under this age, the requirements may be more. Lower dosage is recommended for children of ASA grades 3 and 4.
Maintenance of General Anesthesia: Adults (including Elderly Patients): Anesthesia can be maintained by administering propofol either by continuous infusion or by a repeat bolus injection to prevent the clinical signs of light anesthesia. Recovery from anesthesia is typically rapid and it is therefore important to maintain propofol administration until the end of the procedure.
Continuous Infusion: The average rate of administration varies considerably between patients, but rates in the region of 4-12 mg/kg/hr usually maintain satisfactory anesthesia. Slightly higher rates of administration may be required for 10-20 min after induction of anesthesia.
Repeat Bolus Injections: If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 mL) to 50 mg (5 mL) may be given to clinical need. Propofol may be administered via Y-piece close to the injection site into infusion of dextrose 5%, sodium chloride 0.9% or dextrose 4% with sodium chloride 0.18%. Supplementary analgesic agents are generally required (nothing except 5% should be added) in addition to propofol. Nothing except dextrose 5% required should be used for total dilution of propofol.
Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen.
Cardiovascular depression would require lowering of the patient's head and with severe plasma expanders and pressor agents.
Propofol is not recommended for use in obstetrics including cesarian section.
Propofol should not be given to patients known to be allergic.
Special Precautions
Propofol should be administered with caution to patients with hypovolemia, epilepsy, lipid metabolism disorders and the elderly. Since there have been reports of delayed convulsions associated with the use of propofol, it is recommended that special care should be taken when propofol is used for day-case surgery. When used in patients with increased intracranial pressure, it should be administered slowly to avoid substantial decrease in mean arterial pressure and a resultant decrease in cerebral perfusion pressure. It is recommended that propofol should not be used with electroconvulsive therapy (ECT). Premedication with an antimuscarinic may be advisable since Propofol does not cause vagal inhibition.
Propofol is used to provide continuous sedation for ventilated adult patients under intensive care. Account should be taken on increasing the patient's lipid load. If the duration of sedation is in excess of 3 days, lipid concentrations should be monitored. Children ≤16 years should not be sedated in this manner of propofol.
Adverse Reactions
Cardiovascular System: Hypotension, bradycardia, hypertension, tachycardia, premature atrial contractions, syncope, abnormal ECG, ST segment depression.
Central Nervous System: Movement, convulsion, headache, dizziness, twitching, clonic/myoclonic movement, bucking/jerking/thrasing, amorous behavior, somnolence, hypertonia/dystonia and paresthesia, tremor, excitation, hallucination, delirium, euphoria, fatigue, moaning and rigidity.
Digestive System: Vomiting, nausea, abdominal cramping, hypersalivation, dry mouth and swallowing.
Respiratory System: Cough, hiccup, apnea, upper airway obstruction, bronchospasm, dyspnea, wheezing, decreased respiration, burning in throat, sneezing, tachypnea, hyperventilation and hypoxia.
Skin: Flushing, rash, pruritus and urticaria.
Injection Site: Burning, stinging or pain, frigidity, hyperesthesia, phlebitis, hives, itching, redness and discoloration.
Part of the Body: Fever, extremities, chest pain and neck rigidity stiffness.
Musculoskeletal System: Myalgia.
Urogenital System: Urine retention and green urine.
Others: Amblyopia, diplopia, eye pain, taste perversion, tinnitus, anaphylaxis and sexual discomfort.
Drug Interactions
The concurrent administration of Propofol with other CNS depressants including those used in premedication may increase the sedative, anesthetic and cardiorespiratory depressant effects of propofol. It is recommended that propofol is administered after opioids so that the dose of propofol can be carefully titrated against the response. The dosage of propofol should be reduced if given with nitrous oxide or halogenated anesthetics. Although propofol does not potentiate the effects of neuromuscular blockers, bradycardia and asystole have occurred after administration of propofol with atracurium or suxamethonium.
Store at temperatures not exceeding 30°C. Do not freeze.
ATC Classification
N01AX10 - propofol ; Belongs to the class of other general anesthetics.
Emulsion for inj (amp) 10 mg/mL x 20 mL x 5's.
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