Pofol

Pofol

propofol

Manufacturer:

Dong Kook

Distributor:

AA Medical
Full Prescribing Info
Contents
Propofol.
Description
Each mL contains propofol 10 mg. Pofol injection is a white, aqueous and isotonic emulsion for IV injection.
Action
Pharmacology: Propofol is an IV anaesthetic which is chemically unrelated to other anaesthetics. Induction of anaesthesia with propofol is rapid and maintenance can be achieved by either continuous infusion or intermittent bolus injections with either nitrous oxide or opioids used to provide analgesia.
Indications/Uses
Induction and maintenance of general anaesthesia, sedation of ventilated patients receiving intensive care.
Dosage/Direction for Use
Induction of General Anaesthesia: Adults: It is recommended that Pofol be titrated [approximately 40 mg (4 mL) every 10 sec in an average healthy adult] against the response of the patient until the clinical signs show the onset of anaesthesia.
Most adult patients <55 years are likely to require Pofol 1.5-2.5 mg/kg; reduce rates of administration (20-50 mg/min) to decrease total amount administered. The total dose required can be reduced by lower rates of administration [20-50 mg/min (2-5 mL/min)].
Over 55 years, the requirement will generally be less. In patients of American Society of Anaesthesiologists (ASA) grades 3 and 4, lower rates of administration should be used [approximately 20 mg (2 mL) every 10 sec].
Children >3 Years: It is recommended that Pofol be given slowly until the clinical signs show the onset of anaesthesia. The dose should be adjusted for age and/or weight. Most patients >8 years are likely to require approximately 2.5 mg/kg of Pofol for induction of anaesthesia. Under this age, the requirements may be >2.5 mg/kg. Lower dosage is recommended for children of ASA grades 3 and 4.
Maintenance of General Anaesthesia: Adults: Anaesthesia can be maintained by administering Pofol either by continuous infusion or repeat IV injection to prevent the clinical signs of light anaesthesia.
Continuous Infusion: The required rate of administration varies considerably between patients, but rates in the region of 4-12 mg/kg/hr usually maintain satisfactory anaesthesia.
Repeat Bolus Injection: If a technique involving repeat bolus injection is used, increments of 25-50 mg may be given according to clinical need.
Children >3 Years: The required rate of administration varies considerably between patients, but rates in the region of 9-15 mg/kg/hr usually maintain satisfactory anaesthesia.
Sedation During Intensive Care: Adults: When used to provide sedation for ventilated patients undergoing intensive care, it is recommended that Pofol be titrated for a period of up to 3 days, given by continuous infusion. The infusion rate should be adjusted according to the depth of sedation required but rates in the region of 0.3-4 mg/kg/hr should achieve satisfactory sedation. Rates of infusion >4 mg/kg/hr are not recommended. Pofol may be diluted with dextrose 5% IV infusion (see Cautions for Usage).
Overdosage
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 if severe, use of plasma expanders and pressor agents.
Contraindications
Hypersensitivity to propofol and to any of the components of Pofol.
Use in pregnancy & lactation: The migration of Pofol to foetus was reported; Pofol should not be used in pregnancy and lactation.
Pofol crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia.
Excretion of Pofol in milk was reported and safety to the neonates has not been established. The use of Pofol in lactation is not recommended and if necessary, lactation should be discontinued.
Use in children: The safety and efficacy of Pofol in children is not established; use in children <3 years is not recommended. Pofol is not recommended for sedation in children, and for maintenance of anaesthesia in children <3 years.
Special Precautions
Pofol should be used with caution in patients of ASA grades 3 and 4, debilitated patients and elderly patients. Patients with circulatory or respiratory impairment, hypovolaemic patients; renal or hepatic impairment; epileptics or with epileptic history; drug dependency and hypersensitivity history; with disorders of fat metabolism (primary leucosis, diabetic hyperlipidemia, pancreatitis, etc) or in other conditions where lipid emulsions must be used cautiously. [It is recommended that blood lipid levels be monitored when Pofol is administered to patients thought to be at particular risk of fat overload. Administration of Pofol should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other IV lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the Pofol formulation; Pofol 10 mg (1 mL) contains approximately 0.1 g of fat].
General: For anaesthesia, patients should be abstained from food as a rule and pre-anaesthetic medication should be carried out.
During anaesthesia, respiratory and circulatory system should be observed.
The depth of anaesthesia is considered as lowest depth needed for operation or test.
Pofol should be given by those trained in anaesthesia or intensive care and after administration, the anaesthesiologist should observe the state of patients until completely awakened.
Before anaesthesia, facilities for artificial ventilation eg, aerobic respiratory apparatus, intubatory apparatus, aspirator, etc should be available.
Patients must not have alcohol at least 8 hrs before/after administration of Pofol.
In case Pofol is used to provide sedation for ventilated patients undergoing intensive care, it should be limited for a period of up to 3 days.
Sufficient recovery time should be given to patients after general anaesthesia until the recovery is sure.
The risk of relative vagal overactivity may be increased because Pofol lacks vagolytic activity; it has been associated with reports of bradycardia, occasionally profound and also asystole. The IV administration of an anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal time is likely to predominate or when Pofol is used in conjunction with other agents likely to cause bradycardia.
Effects on the Ability to Drive or Operate Machinery: Patients should be advised that performance of skilled tasks eg, driving may be impaired for some time after general anaesthesia.
Use in the elderly: As with other IV anaesthetic agents, caution should be applied in elderly patients with renal or hepatic impairment, baroreceptor reflex depression.
Use In Pregnancy & Lactation
The migration of Pofol to foetus was reported; Pofol should not be used in pregnancy and lactation. Pofol crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia.
Excretion of Pofol in milk was reported and safety to the neonates has not been established. The use of Pofol in lactation is not recommended and if necessary, lactation should be discontinued.
Adverse Reactions
Cardiovascular System: Bradycardia, hypotension, hypertension, premature ventricular contractions, premature atrial contractions, syncope, arrhythmia, atrial fibrillation, ventricular fibrillation, atrioventricular heart block, bigeminal pulses, haemorrhage, cardioplegy, abnormal ECG, edema, extrasystole, cardiac infarction, cardiac ischemia, ST segment depression, tachycardia, cardiac output decrement, heart block, etc.
Central Nervous System: Hypertonia/dystonia, paraesthesia, chafe, amorous behavior, anxiety, bucking, jerking, chill, clonic/myoclonic movement, confusion, delirium, dejection, vertigo, euphoria, fatigue, hallucination, analgesia, hysteria, sleeplessness, moaning, neurosis, episthotonos, epilepsy, drowsiness, tremor, twitching, increased intracranial pressure, acute/delayed convulsion, epileptic shock, chorea, excitation, aphrodisiac disorders, rigidity, bellicosity, etc.
Digestive System: Hypersalivation, abdominal cramping, diarrhoea, xerostomia, glandular parotid extension, vomiting, nausea, etc.
Respiratory System: Cough, hiccup, apnea, upper airway obstruction, bronchospasm, dyspnea, wheezing, decreased respiration, burning in throat, sneezing, tachypnea, hyperventilation, hypoxia, pharyngitis, pulmonary insufficiency, pulmonary edema, respiratory acidosis during lactation, etc.
Skin: Flushing, rash, pruritus, urticaria, conjunctival congestion, diaphoresis, erythema, etc.
Systemic Symptoms: Anaphylaxis, anaphylactoid response, perinatal disorders, torpidity, arousal, pectoralgia, acroesthesia, fever, cervical ankylosis, septicaemia, body pain, weakness, etc.
Musculoskeletal System: Myalgia, etc.
Urogenital System: Urinary retention; green, red or turbid urine; oliguria; urine discoloration, etc.
Haematologic System: Coagulopathy, leukocytosis, etc.
Sensory System: Amblyopia, ambiopia, otic pain, ocular pain, nystagmus, cacogeusia, sonitus, etc.
Others: Musculi linguae depression, hyperpotassemia, hyperlipemia, blood urea nitrogen (BUN) increment, creatinine increment, dehydration, hyperglycemia, metabolic acidosis, molal osmotic concentration increment, renal/hepatic function disorders, etc.
Injection Site: Burning, irritation, rubor, urticaria, pruritus, discoloration, hemal pain, percussion, frigidity, insensibility, phlebitis (sometimes), thrombosis, paretic sense (rarely), etc.
Drug Interactions
The combined treatment with narcotics (morphine, meperidine, fentanyl), opioids and tranquilizer (benzodiazepines, barbitals, chloral hydrate, droperidol, etc) is likely to decrease the inducing dosage. These preparations are likely to increase anaesthetic effect of Pofol and to decrease systolic, diastolic, average blood pressure and cardiac output.
In case adjuvants of anaesthesia (nitrous oxide, opioids) are used, the rates of infusion of Pofol should be decreased or controlled during maintenance of anaesthesia. Powerful inhalation anaesthetics (isoflurane, enflurane, halothane) may increase the anaesthetic effect of Pofol and its effect on cardiac and respiratory system.
Pofol has not caused any clinical changes on the action, maintenance degree of the neuromuscular blockers (suxamethonium and nondepolarizing muscle relaxants).
Caution For Usage
Pofol contains no antimicrobial preservatives, the vehicle is prevented from growth of microorganisms.
When Pofol is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both Pofol and infusion equipment throughout the infusion period.
Any drug or fluid added to the Pofol line must be administered close to the cannula site.
Pofol must not be administered via a microbiological filter.
Pofol and any syringe containing Pofol is for single use in an individual patient.
According to the guide established in connection with the other fat emulsions, infusion period of this medication should not exceed 12 hrs. After operation or 12 hrs passage, any unused portion of Pofol and the giving set must be discarded. Any portion of the contents remaining after use must also be discarded.
Pofol has no analgesic properties and therefore, supplementary analgesic agents are required in addition to Pofol. Pofol has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular-blocking drugs, inhalation agents and analgesic agents.
Pofol can be used for injection undiluted or diluted with 5% dextrose only. For mix-dilution, dextrose 5% IV infusion and lignocaine (lidocaine) injection fluids should be used.
When Pofol is administered diluted with dextrose 5% IV infusion in PVC bags or glass infusion bottles, dilutions which must not exceed ⅕ (propofol 2 mg/1 mL solution) should be prepared aseptically immediately before administration and must be used within 6 hrs of preparation. Usually, it is recommended that Pofol is mixed into the needed amount of dextrose 5% IV infusion. The dilution may be used with a variety of infusion control technique, but a giving set used alone will not avoid the risk of accidents eg, uncontrolled infusion of large volumes of diluted Pofol; thus, a burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of Pofol in the burette. When Pofol is used undiluted to maintain anaesthesia, it is recommended that equipment eg, syringe pumps or volumetric infusion pump should always be used to control infusion rates.
Pofol may be administered via a Y-piece close with dextrose 5% IV infusion, sodium chloride 0.9% IV infusion, dextrose 4% with sodium chloride 0.18% IV infusion.
The local pain which may occur during the induction phase of Pofol anaesthesia can be minimized by the co-administration of lignocaine and by the use of the larger veins of the forearm and antecubital fossa.
Container should be shaken well before use.
See table.

Click on icon to see table/diagram/image
Storage
Store between 2°C and 25°C. Do not freeze.
ATC Classification
N01AX10 - propofol ; Belongs to the class of other general anesthetics.
Presentation/Packing
Inj (amp) (white to almost white emulsion) 10 mg/mL x 20 mL x 5's.
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