Category General Anesthetics \ Intravenous Anesthetics

Alias propofol, propofol, diprivan, diprivan, propofol, propofol, propofol, propofol.

Propofol, propofol, diprivan

Dipr Ivan TM PFS 10 mg/ml

Propofol injection instructions

Drug name

Generic name: propofol injection

Trade name: diprivan TM PFS/DIPRIVAN

English name: propofol injection

Chinese pinyin: pork tongue leaves with ice cream powder

The main component of this product and its chemical name are called: 2,6-propofol.

Its structural formula is:

Molecular formula: C 12H 18O.

Molecular weight: 178.27

Character; Role; letter

This product is a white "oil-in-water" isotonic water-soluble intravenous emulsion. Each milliliter contains propofol 10mg, which is pre-loaded in the syringe.

Pharmacology and toxicology

Propofol (2,6 6- Dippropofol) is a general anesthetic with quick onset (about 30 seconds) and short action time.

Anesthesia recovered quickly. Like all general anesthetics, people know little about the mechanism of propofol.

In a word, when diprivan was given to induce and maintain anesthesia, arterial blood pressure decreased slightly and heart rate changed slightly. However, in the maintenance stage, hemodynamic parameters usually remain relatively stable, and there are few drastic fluctuations in hemodynamic parameters.

Although ventilation inhibition may occur after administration of diprivan, its effect is similar to that of other intravenous anesthetics, and it is easy to be solved clinically.

Diprivan can reduce cerebral blood flow, intracranial pressure and cerebral metabolism. For patients with increased intracranial pressure, reducing intracranial pressure has a greater effect.

Anesthesia resuscitation is usually faster, and the mind is clear, and the incidence of headache and postoperative nausea and vomiting is low.

In short, compared with inhalation anesthesia, the incidence of nausea and vomiting after propofol anesthesia is lower. There is evidence that this may be related to the anti-vomiting effect of propofol. At the clinical concentration, norepinephrine has no inhibitory effect on the synthesis of adrenocortical hormone.

Pharmacokinetics:

The decrease of propofol concentration after shock dose or infusion termination can be described by a three-chamber open model. The distribution in one room (prime minister) is characterized by rapid distribution (half-life is 2-4 minutes) and rapid elimination (half-life is 30-60 minutes), and the redistribution of propofol in poorly perfused tissues is characterized by slow terminal phase.

Propofol is widely distributed in the body and cleared quickly (the overall clearance rate is 1.5 ~ 2 liters/min). Inactive propofol and corresponding quinone-alcohol conjugate are formed mainly through liver metabolism and excreted from urine.

When propofol is anesthetized with diprivan, the plasma concentration gradually approaches the steady-state value of the known administration rate. When the infusion rate of diprivan is within the recommended range, its pharmacokinetics is linear.

Indications:

Diprivan is a short-acting intravenous anesthetic, which is suitable for inducing and maintaining general anesthesia.

Diprivan can be used to enhance the sedation of adult patients receiving mechanical ventilation.

Diprivan can also be used for conscious sedation during surgery and diagnosis.

Usage and dosage:

Please refer to the operating instructions of diprivanol infusion system (TCI) controlled by "Diprifusor”target, including the software of" Diprifusor”TCI system, as shown in Part E. This usage is limited to the induction and maintenance of anesthesia in adults. "Diprifusor”TCI system is not recommended for intensive care of patients or conscious sedation or children.

Using diprivan usually requires the addition of painkillers.

Deprivan has been used as an auxiliary drug for spinal cord and epidural anesthesia, combined with commonly used preoperative drugs, neuromuscular blockers, inhalation anesthetics and analgesics, and has not yet encountered drug compatibility contraindications. Deprivan, as an auxiliary regional anesthesia technique for general anesthesia, requires a low dose.

I. Adults

General anesthesia induction

Diprivan propofol can induce anesthesia by slow intravenous injection or drip. For patients who have been given or not before operation, it is suggested to inject diprivane (40mg per 10 second for normal adults) gradually, and observe the patient's reaction until the clinical signs show that anesthesia takes effect. Most adult patients less than 55 years old need about 1.5 ~ 2.5 mg/kg of diprivan, and a smaller administration rate (20 ~ 50 mg/min) can reduce the total dose required. Beyond this age, the demand will generally decrease. For ASA3 and 4 patients, the administration rate should be slower (about 20mg per 10 second).

General anesthesia maintenance

Diprivan can maintain the required depth of anesthesia by continuous infusion or repeated single injection.

Continuous infusion

The required drug delivery rate is obviously different between patients, and usually the rate range of 4 ~ 12 mg/kg per hour can maintain satisfactory anesthetic effect.

Repeated single injection

If the technique of repeated single administration is adopted, the dosage of each administration can be 25 mg to 50 mg according to clinical needs.

Strengthen sedation during guardianship

For intensive care patients, it is not recommended to use "Diprifusor”TCI system to infuse diprivan.

When used as a sedative for intensive care patients receiving artificial ventilation, it is recommended to continue infusion of propofol. The infusion rate should be adjusted according to the required sedation depth. Usually, the infusion rate is 0.3-4.0 mg/kg per hour, and satisfactory sedative effect should be obtained.

Conscience and calmness during operation and diagnosis.

Diprifusor“TCI "system is not recommended for conscious sedation.

When it is used for conscious sedation during surgery and diagnosis, it should be given individually and gradually according to the patient's clinical response.

Most patients need 0.5 ~ 1 mg/kg. Initial anesthesia takes about 1 ~ 5 minutes.

While maintaining sedation, intravenous drip of diprivane is needed to maintain the required level of sedation. Most patients need 1.5 ~ 4.5 mg/kg per hour. In addition to drip, if you need to deepen the depth of sedation, you can inject 10 ~ 20 mg once. For ASA3 and 4 patients, the speed and dosage of administration should be reduced as appropriate.

B, elderly patients

Diprivan propofol should be given gradually to observe the patient's reaction. For patients over 55 years old, the dosage of diprivan required for anesthesia induction and conscious sedation for surgery and diagnosis may be low.

C, children

For children, it is not recommended to use "Diprosone" TCI system to infuse Diprosone.

General anesthesia induction

Diprivan is not recommended for children under 3 years old.

When used for anesthesia induction in children, it is suggested to give diprivan slowly until the clinical signs show that anesthesia takes effect, and adjust the dose according to age and/or weight. Most patients over 8 years old need about 2.5mg/kg of diprivane for anesthesia induction. Below this age, the required dose may be greater. Children with ASA3 and 4 levels are advised to use a lower dose.

General anesthesia maintenance

Diprivan is not recommended for children under 3 years old.

Diprivan can maintain the required depth of anesthesia by infusion or repeated single injection. The required administration rate is obviously different between patients. Usually, the administration rate of 9 ~ 15 mg/kg per hour can achieve satisfactory anesthetic effect.

Strengthen sedation during guardianship

Diprivan is not recommended as a sedative for children because its safety and effectiveness have not been proved.

Serious adverse reactions (including death) of unregistered indications have been reported, but the direct correlation with diprivan has not been determined. These reports usually occur in children with respiratory tract infections, and the dosage given exceeds the recommended dosage for adults.

Conscience and calmness during operation and diagnosis.

In view of the unclear safety and effectiveness, it is not recommended for sedation in children.

D, administration method

In plastic syringes or glass infusion bottles or pre-loaded syringes, undiluted diprivane can be used for infusion. When using undiluted diprivan to maintain anesthesia, it is suggested to use micropump or quantitative infusion pump to control infusion speed.

Diprivan can also be used after dilution, but it can only be diluted with 5% glucose intravenous injection and stored in PVC infusion bags or infusion glass bottles. The dilution shall not exceed 5 times (2mg propofol/ml). Diluents should be prepared under aseptic conditions and before administration. The diluent is stable within 6 hours.

There are various infusion control techniques that can use diluted diprivan, but the danger of accidentally inputting excessive diprivan diluent cannot be avoided by using a single drug delivery device. Infusion equipment must include burette, droplet counter or infusion pump with capacity scale. Uncontrolled infusion risk must be considered when determining the dilution multiple in the burette.

Diprivan can also be added into 5% glucose infusion, 0.9% sodium chloride infusion or 4% glucose and sodium chloride injection (containing 0. 18% sodium chloride) for intravenous infusion through the Y-shaped tee near the injection site.

Because the friction resistance of glass prefilled syringe is less than that of disposable plastic syringe, it is more convenient to use. Therefore, if diprivan prefilled syringe is pushed manually, the catheter connecting syringe and patient must not be opened without protection.

When the injection pump is used to automatically inject prefilled syringes, its adaptability should be ensured. In particular, the pump should be designed to prevent siphon, and there should be blockage alarm when the pressure is greater than 1000mmHg. If you use a programmable injection pump or an injection pump suitable for different syringes, you should choose "B-D" 50/60 ml "Plastipak" to inject diprivan.

Diprivan and alfentanil injection (500mg/ml) can also be mixed in the volume ratio of 20: 1 to 50: 1. The mixture should be prepared under aseptic conditions and used within 6 hours after preparation.

In order to relieve the pain at the initial stage of injection, when it is used for anesthesia induction, diprivan and 0.5% or 65,438+0% lidocaine injection can be mixed in a plastic syringe at a ratio not exceeding 20: 65,438+0, and immediately prepared before injection.

Dilution of propofol and its combined application with other drugs

(See "Other Precautions" section)

A bill is prepared by combining the addition of drugs and diluents.

Mix 5% glucose intravenous injection before use. 1 serving of diprivan can be mixed with no more than 4 portions of 5% glucose solution and packed in PVC infusion bags or infusion glass bottles. If it is necessary to mix in PVC bag, a certain amount of injection should be taken out from the infusion bag, and then the same amount of diprivan should be added.

The mixed solution was prepared before administration under aseptic conditions, and the solution was stable within 6 hours. 0.5% or 1% lidocaine hydrochloride injection (without preservatives) 20 parts of diprivan and 0.5% or 1% lidocaine hydrochloride injection not more than1part are prepared by mixing immediately before administration under aseptic conditions, and are only used for inducing anesthesia.

Combined administration through "Y" tube

The combined administration of 5% glucose intravenous injection is close to the injection site through the Y-shaped connecting tube.

0.9% sodium chloride intravenous injection

Ditto ditto

4% glucose and sodium chloride (containing 0. 18% sodium chloride) injection is the same as above.

Target-controlled infusion of E.DIPRIFUSOR”TCI system.

It is necessary to limit the use of DIPRIFUSOR TCI system in the induction and maintenance of general anesthesia in adults. It is not recommended to strengthen the sedation or conscious sedation of intensive care patients or children.

Diprivan can be administered through target-controlled infusion system to realize anesthesia induction and maintenance in adult patients. The system allows anesthesiologists to set and adjust the target concentration of propofol in blood to achieve and control the required induction speed and anesthesia depth. Diprivanol is only applicable to "Diprivasor" TCI system. The system only works with electronic identification tags on propofol prefilled syringes that have been identified by diprivan. "DIPRIFUSOR”TCI system automatically adjusts the intravenous injection speed according to the identified diprivanol concentration. Users must be familiar with the user menu of injection pump, use TCI system to give diprivan and use the identification system correctly. All these materials are included in the training manual of DIPRIFUSOR of Jielikang Company.

The following is a guide to propofol target concentration. According to the individual differences of pharmacokinetics and pharmacodynamics between patients, the target concentration of propofol should be gradually increased according to the patient's response to achieve the required depth of anesthesia.

For adult patients under 55 years old, the target concentration of propofol during anesthesia induction is generally 4 ~ 8 mg/ml. It is suggested that the initial target concentration of patients who have been given drugs before operation is 4mg/ml, and that of patients who have not been given drugs before operation is 6mg/ml. The induction time at this target concentration is generally 60 ~ 120 seconds. High target concentration can accelerate anesthesia induction, but it may be accompanied by more significant hemodynamic and respiratory inhibition.

Patients over 55 years old, ASA3 and 4 require a lower initial target concentration. Then, the target concentration was increased by 0.5 ~ 1 .0 mg/ml every1min to achieve gradual anesthesia induction.

Generally, adjuvant analgesics are needed, and the target concentration needed to maintain anesthesia can vary with the dosage of adjuvant drugs. Generally speaking, the target concentration of propofol for diprivan is 3 ~ 6 mg/ml, which can maintain satisfactory anesthetic effect.

Propofol concentration during pre-awakening is generally 1.0 ~ 2.0 mg/ml, which may change with the dosage of analgesic during maintenance.

counteraction

systematic

Anesthesia induction is usually smooth and there is little excitement. During anesthesia induction, hypotension and transient apnea may occur depending on the dosage, preoperative medication and other drugs used.

Occasionally, during intravenous infusion and maintenance anesthesia, a lower administration rate of diprivane is needed to correct hypotension.

During resuscitation, only a few patients experienced nausea, vomiting and headache.

In intensive care patients, rhabdomyolysis is rarely reported when the dose of diprivane exceeds 4mg/kg per hour.

During the induction, maintenance and resuscitation of anesthesia, epileptic movements, such as convulsions and hunchback, occasionally occur.

Allergic reactions, including angioedema, bronchospasm, erythema and hypotension, will occur after taking diprivan, but this situation is rare.

There are also reports of pulmonary edema. There are reports of postoperative fever.

Like other anesthetics, sexual excitement may occur.

After taking diprivan for a long time, there are occasional reports of urine discoloration.

location

Local pain can occur during the induction period of diprivan anesthesia, which can be relieved by combining lidocaine (see usage and dosage) or using thick veins of forearm and anterior cubital fossa. Thrombosis and phlebitis are rare. Unexpected clinical extravasation and animal experiments show that the tissue reaction of diprivan is very small. Intra-arterial injection in animals will not cause local tissue reaction.

Contraindications

Patients who are known to be allergic to diprivan are prohibited.

Matters needing attention

Diprivan should be managed by a trained anesthesiologist or ICU doctor. Respiratory tract should be kept clear during medication, and resuscitation equipment such as artificial ventilation and oxygen supply should be provided. Surgeons or diagnostic surgeons should not use propofol.

Early signs of hypotension, airway obstruction and hypoxia should be closely observed when diprivan is used for conscious sedation in surgery and diagnosis.

After general anesthesia, the patient must be fully awake before he can leave the hospital. Unconsciousness for a period of time after diprivan anesthesia is rare, sometimes accompanied by increased muscle tension. Before this happens, sometimes it takes a while to recover, and sometimes it doesn't. Although patients can wake up on their own, comatose patients still need care.

For patients with heart, respiratory tract, kidney or liver damage or patients with decreased circulating blood volume and weakness, Diprospan should be used with the same caution as other intravenous anesthetics.

Diprivane lacks the activity of relieving vagus nerve, and is related to reports of bradycardia (occasionally severe) and cardiac arrest. Intravenous anticholinergic drugs should be considered before anesthesia induction or during anesthesia maintenance, especially when vagus nerve tension seems to be dominant or when diprivan is combined with other drugs that may cause bradycardia.

Epilepsy patients may be in danger of convulsion when using diprivane.

Diprivan should be used cautiously in patients with fat metabolism disorder and other situations where fat emulsion must be used cautiously.

It is suggested that the blood lipid level should be monitored when propofol is used in patients with special risk of fat overload. If monitoring shows that fat is improperly removed from the body, the dosage of diprivan should be adjusted accordingly. If the patient is receiving intravenous fat emulsion at the same time, the dosage should be reduced, because the amount of fat infused by diprivan preparation should be considered, that is, 1.0 ml of diprivan contains about 0. 1 g of fat.

Other preventive measures

Diprivan contains no antibacterial preservatives and supports the growth of microorganisms. When pumping primacaine, it must be strictly disinfected and used immediately after opening ampoules or vials. Diprivan and infusion devices must be kept sterile during the whole infusion period. Any medicine or liquid added from the infusion line of diprivan must be added close to the venous catheter, and diprivan should not be administered through the microbial filter.

Diprivan and any syringe containing Diprivan should be used once. According to the established guidelines for other fat emulsions, a single infusion of diprivan should not exceed 65,438+02 hours. At the end of infusion or when the infusion time reaches 65,438+02 hours, in either case, the reservoir and infusion line of diprivan must be discarded or replaced.

Precautions for use/handling

Shake it well before use, and discard it no matter how much trichlorfon remains after use.

Diprivan infusion devices must be kept sterile (see other precautions).

Influence on the ability to drive or operate machines

Patients should be informed that at some point after general anesthesia, skills such as driving and operating machines may be affected.

Medication for pregnant and lactating women

be pregnant

Propofol should not be used during pregnancy, but it is always used when the pregnancy is terminated in the first three months of pregnancy.

maternity department

Diprivan can penetrate placenta, which may be related to neonatal depression. This drug should not be used for obstetric anesthesia.

Nursing with breast milk

Breastfeeding mothers have not confirmed the safety of diprivane for newborns.

Please refer to the usage and dosage section for children's medication.

Please refer to the usage and dosage section for medication for elderly patients.

drug interaction

Diprivan has been used in spinal cord and epidural anesthesia, together with commonly used preoperative drugs, neuromuscular blockers, inhalation anesthetics and analgesics, without any pharmacological compatibility contraindications. When local anesthesia must be supplemented by general anesthesia, the dosage of diprivan can be reduced.

Incompatibility (of drugs)

Diprosone should not be mixed with any injection before use, but it can be mixed with 5% glucose solution in PVC infusion bag or glass infusion bottle, lidocaine and alfentanil injection in plastic syringe.

Neuromuscular blockers, atracurium and mepiquat cannot be administered through the same intravenous infusion route as diprivan before they turn red.

excessive

Accidental overdose may lead to cardiac and respiratory depression. Artificial ventilation should use oxygen to deal with respiratory depression. For the treatment of cardiovascular depression, it is necessary to lower the patient's head. If the inhibition is serious, plasma compatibilizer and booster should be used.

Specification: 50ml: 500mg

Validity: 2 years

The preserved premarin should be stored at 2 ~ 25℃ and cannot be frozen.

Registration number of imported drugs. :BX20000025