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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 21.05.2022
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Profast Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below.
Table 3. Indications for Profast Injectable Emulsion
Safety, effectiveness and dosing guidelines for Profast Injectable Emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use.
Profast Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
In the Intensive Care Unit (ICU), Profast Injectable Emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Profast Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established.
Profast Injectable Emulsion is not recommended for obstetrics, including Cesarean section deliveries. Profast Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of Profast Injectable Emulsion may be associated with neonatal depression.
Profast Injectable Emulsion is not recommended for use in nursing mothers because Profast has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of Profast are not known.
Profast (Profast) slows the activity of your brain and nervous system.
Profast is used to help you relax before and during general anesthesia for surgery or other medical procedures. Profast is also used in critically ill patients who require a breathing tube connected to a ventilator (a machine that moves air in and out of the lungs when a person cannot breathe on their own).
Profast may also be used for purposes not listed in this medication guide.
General Instructions: Profast-Lipuro must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (eg, ECG, pulse oxymeter) and facilities for maintenance of patent airways, artificial ventilation and other resuscitation facilities should always be immediately available. For sedation during surgical or diagnostic procedures, Profast-Lipuro should not be given by the same person that carries out the surgical or diagnostic procedure.
Supplementary analgesic drugs are generally required in addition to Profast-Lipuro.
Profast-Lipuro is given IV. The dosage is adjusted individually according to the patient's response.
Adults: Induction of General Anaesthesia: For induction of anaesthesia, Profast-Lipuro should be titrated (Profast 20-40 mg every 10 sec) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients <55 years are likely to require 1.5-2.5 mg/kg body weight of Profast. In older patients and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Profast-Lipuro may be reduced to a minimum of 1 mg/kg body weight of Profast. In these patients, lower rates of administration should be applied (approximately 2 mL, corresponding to 20 mg every 10 sec).
Maintenance of General Anaesthesia: Anaesthesia can be maintained by administering Profast-Lipuro either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25-50 mg (Profast-Lipuro 2.5-5 mL) may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion, the dosage requirements usually are in the range of 4-12 mg/kg body weight/hr. In the elderly, in patients of poor general condition, in patients of ASA grade III and IV and in hypovolaemic patients, the dosage may be reduced further depending on the severity of the patient's condition and on the performed anaesthetic technique.
Children >1 month: Induction of General Anaesthesia: For induction of anaesthesia, Profast-Lipuro should be titrated slowly against the response of the patient until the clinical signs show the onset of anaesthesia. The dosage should be adjusted according to age and/or body weight.
Most patients >8 years are likely to require approximately 2.5 mg/kg body weight of Profast-Lipuro for induction of anaesthesia.
Below this age, the dose requirement may be higher (2.5-4 mg/kg). Due to the lack of clinical experience, lower dosages are recommended for young patients at increased risk (ASA grades III and IV).
Maintenance of General Anaesthesia: For maintenance of general anaesthesia, a satisfactory level of anaesthesia is usually achieved by continuous infusion with a dosage regimen in the range of 9-15 mg/kg body weight/hr.
Children <3 years may need higher doses within the range of recommended dosages, when compared with older paediatric patients. Dosage should be adjusted individually and particular attention paid to the need for adequate analgesia.
Duration of use in maintenance studies in children <3 years was mostly about 20 min, with a maximum duration of 75 min. A maximum duration of use of approximately 60 min should therefore not be exceeded except where there is a specific indication for longer use eg, malignant hyperthermia where volatile agents must be avoided.
Profast-Lipuro must not be used for induction and maintenance of anaesthesia in children <1 month.
Sedation of Adults During Intensive Care: When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Profast-Lipuro be given by continuous infusion. The infusion rate should be adjusted according to the required depth of sedation. Usually, satisfactory sedation is achieved with administration rates in the range of 0.3-4 mg/kg body weight/hr.
Profast-Lipuro must not be used for sedation in intensive care of children <16 years.
Sedation for Diagnostic and Surgical Procedures in Adult Patients: To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response. Most patients will require 0.5-1 mg/kg body weight over 1-5 min for onset of sedation. Maintenance of sedation may be accomplished by titrating Profast-Lipuro infusion to the desired level of sedation. Most patients will require 1.5-4.5 mg/kg body weight/hr. The infusion may be supplemented by bolus administration of 10-20 mg (Profast-Lipuro 1-2 mL) if a rapid increase of the depth of sedation is required. In patients >55 years and in patients of ASA grade III and IV, lower doses of Profast-Lipuro may be required and the rate of administration may need to be reduced.
Profast-Lipuro must not be used for sedation for diagnostic and surgical procedures in children <16 years.
Administration: Profast-Lipuro is administered IV by injection or continuous infusion either undiluted or diluted with 5% w/v glucose solution or 0.9% w/v sodium chloride solution as well as in a 0.18% w/v sodium chloride and 4% w/v glucose solution.
Containers should be shaken before use.
Before use, the neck of the ampoule or the surface of the rubber stopper or the bottle should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded.
Profast-Lipuro contains no antimicrobial preservatives and supports growth of microorganisms. Therefore, Profast-Lipuro is to be drawn up aseptically into a sterile syringe or an infusion set immediately after opening the ampoule or breaking the bottle seal. Administration must commence without delay. Asepsis must be maintained for both Profast-Lipuro and the infusion equipment throughout the infusion period.
Any drugs or fluids added to a running Profast-Lipuro infusion must be administered close to the cannula site. Profast-Lipuro must not be administered via infusion sets with microbiological filters. The contents of 1 ampoule or bottle of Profast-Lipuro and any syringe containing Profast-Lipuro are for single use in 1 patient. Any portion of the contents remaining after use must be discarded.
Infusion of Undiluted Profast-Lipuro: When administering Profast-Lipuro by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps, should always be used to control the infusion rates. As established for the parenteral administration of all kinds of fat emulsions, the duration of continuous infusion of Profast-Lipuro from 1 infusion system must not exceed 12 hrs. The infusion line and the reservoir of Profast-Lipuro must be discarded and replaced after 12 hrs at the latest. Any portion of Profast-Lipuro remaining after the end of infusion or after replacement of the infusion system must be discarded.
Infusion of Diluted Profast-Lipuro: For administering infusion of diluted Profast-Lipuro, burettes, drop counters, syringe pumps, or volumetric infusion pumps should always be used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted Profast-Lipuro.
The maximum dilution must not exceed 1 part of Profast-Lipuro with 4 parts of 5% w/v glucose solution or 0.9% w/v sodium chloride solution or 0.18 % w/v sodium chloride and 4% w/v glucose solution (minimum concentration Profast 2 mg/mL). The mixture should be prepared aseptically immediately prior to administration and must be used within 6 hrs of preparation.
Profast-Lipuro must not be mixed with other solutions for injection or infusion.
Co-administration of Profast-Lipuro together with 5% w/v glucose solution or 0.9% w/v sodium chloride solution or 0.18% w/v sodium chloride and 4% w/v glucose solution via a Y-connector close to the injection site is possible. In order to reduce pain on initial injection, Profast-Lipuro may be mixed with preservative-free lidocaine injection 1% (mix 20 parts of Profast-Lipuro with up to 1 part of lidocaine injection 1%).
Before giving the muscle relaxants atracurium or mivacurium subsequent to Profast-Lipuro through the same IV line, it is recommended that the line be rinsed prior to administration.
Duration of Use: Profast-Lipuro can be administered for a maximum period of 7 days.
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What is the most important information I should know about Profast?
Hypersensitivity to Profast and to any of the components of Profast.
Use in pregnancy & lactation: The migration of Profast to foetus was reported; Profast should not be used in pregnancy and lactation.
Profast crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia.
Excretion of Profast in milk was reported and safety to the neonates has not been established. The use of Profast in lactation is not recommended and if necessary, lactation should be discontinued.
Use in children: The safety and efficacy of Profast in children is not established; use in children <3 years is not recommended. Profast is not recommended for sedation in children, and for maintenance of anaesthesia in children <3 years.
Use Profast as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Profast is administered as an injection at your doctor's office, hospital, or clinic.
- Do not use Profast if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If you will be receiving Profast for a long period of time, your doctor may give you a zinc mineral supplement. Discuss any questions or concerns with your health care provider.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
- If you miss a dose of Profast, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Profast.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Induction of anesthesia in patients ≥3 years of age; maintenance of anesthesia in patients >2 months of age; in adults, for monitored anesthesia care sedation during procedures; in adults, for sedation in intubated, mechanically-ventilated ICU patients
Note: Consult local regulations and individual institutional policies and procedures.
Off Label Uses
Postoperative nausea and vomiting (PONV), rescue therapy
Data from a randomized, blinded study supports the use of Profast in the treatment of postoperative nausea and vomiting.
Based on the Neurocritical Care Society Guidelines for the Evaluation and Management of Status Epilepticus, the use of Profast is an effective and recommended treatment for refractory status epilepticus in adults.
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What other drugs will affect Profast?
Profast-Lipuro can be used in combination with other drugs for anaesthesia (premedications, volatile anaesthetics, analgesics, muscle relaxants, local anaesthetics). Until now, no severe interactions with these drugs have been reported. Some of these centrally-acting drugs may exhibit a circulatory and respiratory depressive effect thus, leading to increased effect when used together with Profast-Lipuro. Concomitant use of benzodiazepines, parasymphatolytic agents or inhalation anaesthetics has been reported to prolong the anaesthesia and to reduce the respiratory rate.
After additional premedication with opioids, there may be a higher incidence and longer duration of apnoea.
Bradycardia and cardiac arrest may occur after treatment with suxamethonium or neostigmin.
It should be taken into consideration that the concomitant use of Profast and drugs for premedication, inhalation agents, or analgesic agents may potentiate anaesthesia and cardiovascular side effects. Concomitant use of central nervous depressants eg, alcohol, general anaesthetics, narcotic analgesics will result in intensification of their sedative effects.
After administration of fentanyl, the blood level of Profast may be temporarily increased, with an increase in the rate of apnoea.
Leucoencephalopathy has been reported with administration of lipid emulsions eg, Profast in patients receiving cyclosporine.
When used in addition to regional anaesthesia, the dosage of Profast-Lipuro may need to be reduced.
With the exception of 5% w/v glucose solution, 0.9% w/v sodium chloride solution, or 0.18% w/v sodium chloride and 4% w/v glucose solution, and lidocaine injection 1%, Profast-Lipuro must not be mixed with other solutions for injection or infusion.
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What are the possible side effects of Profast?
During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose of Profast, the type of premedication and other concomitant medication. Occasionally occurring marked hypotension may require the use of IV fluids, if necessary vasoconstrictive drugs, and slower administration of Profast-Lipuro. Account should be taken with the possibility of a severe drop in blood pressure in patients with impaired coronary or cerebral perfusion or those with hypovolaemia.
During general anaesthesia bradycardia occurred, in some cases, with progressive severity (asystole). The IV administration of an anticholinergic drug prior to induction or during maintenance of anaesthesia should be considered.
During induction of anaesthesia, spontaneous movements and myocloni are likely to be observed.
During maintenance of anaesthesia, coughing occasionally occurs.
During the recovery period, nausea, vomiting, headache, shivering and sensations of cold have seldom been reported as well as euphoria and sexual disinhibition.
Rarely, epileptiform convulsions including opisthotonus may occur, in isolated cases delayed by hrs or days after termination of administration of Profast. In isolated cases, after administration to epileptic patients, convulsions have been observed.
There have been reports of rare cases of postoperative fever and discoloration of urine following prolonged administration of Profast-Lipuro as well as severe cases of hypersensitivity reactions (anaphylaxis), which may include Quincke's oedema, bronchospasm, erythema and hypotension.
Isolated cases of pulmonary oedema after administration of Profast has also been reported.
The local pain that may occur during the initial injection of Profast-Lipuro can be minimized by the co-administration of lidocaine and by injection/infusion into the larger veins of the forearm and antecubital fossa.
Thrombosis and phlebitis are rare.
After co-administration of lidocaine, the following undesirable effects may occur: Giddiness, vomiting, drowsiness, convulsions, bradycardia, cardiac arrhythmia and shock.
There are isolated reports of severe tissue reactions after accidental extravascular administration.
Note: Patients are advised to inform their doctor or pharmacist if they experience any adverse reaction not described previously.
Profast is 2,6-diisopropylphenol and has a molecular weight of 178.27.
Profast is very slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11.03. The octanol/water partition coefficient for Profast at physiological pH is 6761:1. The emulsion is isotonic and has a pH of 6-8.5. In addition to the active component, Profast, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5 mg/mL) and egg phosphatide (12 mg/mL); with sodium hydroxide to adjust pH (6-8.5) and sufficient amount of water for injection.