Diprivan
Diprivan: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Diprivan
ATX code: N01AX10
Active ingredient: propofol (propofol)
Producer: CORDEN PHARMA (Italy)
Description and photo update: 2019-26-08
Prices in pharmacies: from 658 rubles.
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Diprivan is a drug for non-inhalation general anesthesia and sedation.
Release form and composition
The drug is produced in the form of an emulsion for intravenous administration: an almost white or white homogeneous substance, practically without foreign inclusions, slight separation is possible during prolonged standing (20 ml each in glass transparent ampoules, 5 ampoules in plastic retainers, 1 retainer in a cardboard box; 50 ml in a glass syringe with a Luer lock and a polypropylene plunger, 1 syringe in blister packs, 1 package in a cardboard box; each box also contains instructions for using Diprivan).
1 ml of emulsion contains:
- Active ingredient: propofol - 10 mg;
- Auxiliary components: disodium salt of ethylenediaminetetraacetic acid (EDTA), soybean oil, glycerol, egg yolk phospholipids, sodium hydroxide, water for injection.
Pharmacological properties
Pharmacodynamics
The active ingredient in Diprivan is propofol (2,6-diisopropylphenol), a short-acting general anesthesia agent characterized by a rapid onset of action - approximately 30 seconds.
The mechanism of action of propofol, like other general anesthetics, is not fully known.
Usually, when using Diprivan to induce and maintain anesthesia, there is a decrease in mean arterial pressure (BP) and small changes in heart rate (HR). Hemodynamic parameters are generally relatively stable during maintenance of anesthesia, and the incidence of adverse hemodynamic changes is low. In addition, respiratory depression is possible after administration of the drug. However, any of the described effects are similar to those that occur with the intravenous administration of any other anesthetic and are easily controlled in a clinical setting.
Diprivan reduces intracranial pressure (ICP), decreases cerebral metabolism and cerebral blood flow. The decrease in ICP is more pronounced in patients with initially increased ICP.
Recovery from anesthesia, as a rule, occurs quickly, the patient retains a clear consciousness. In rare cases, headaches, postoperative nausea and vomiting are possible, but the frequency of their occurrence is lower than with the use of inhalation anesthesia, which is probably due to the antiemetic effect of propofol.
There is no suppression of the synthesis of adrenal cortex hormones when Diprivan is used in standard concentrations achieved in a clinical setting.
Pharmacokinetics
The decline in propofol concentration after the bolus dose and after the end of the infusion is described using an open three-phase model. In the first phase, rapid distribution occurs (half-period is 2–4 minutes). The second phase is characterized by rapid elimination (half-period is 30-60 minutes). The third (final) phase is characterized by the redistribution of propofol from weakly perfused tissue into the blood.
The drug is rapidly distributed and quickly excreted from the body. Its total ground clearance is 1.5–2 l / min. It is metabolized mainly in the liver with the formation of conjugates and the corresponding propofol quinol, which are excreted in the urine.
When Diprivan is administered to maintain anesthesia, the concentration of propofol in the blood asymptotically reaches an equilibrium value corresponding to the rate of administration.
Within the recommended infusion rates, the pharmacokinetics of the drug is linear.
Indications for use
Diprivan is used as a short-acting analgesic drug for intravenous administration during induction of anesthesia and to maintain general anesthesia.
Diprivan is used to achieve and maintain a sedative effect in the presence of the following indications:
- Artificial ventilation of the lungs (to suppress consciousness during intensive care in adult patients);
- Diagnostics and surgical interventions (for procedures in patients who are awake).
Contraindications
- Age up to 3 years;
- History of allergic reaction to Diprivan;
- Hypersensitivity to drug components.
The use of Diprivan is contraindicated in order to provide a sedative effect for intensive care in children of all age groups with croup or epiglottitis.
The drug should be used with caution in patients with respiratory, cardiac, hepatic or renal pathologies, as well as in hypovolemia and in debilitated patients.
Diprivan penetrates the placental barrier, its use can cause neonatal depression. Therefore, it cannot be used for anesthesia in obstetrics and during pregnancy, except for termination of pregnancy (abortion) in the first trimester.
The safety of using Diprivan during lactation (breastfeeding) has not been established.
Diprivan, instructions for use: method and dosage
As a rule, additional use of analgesic drugs / substances is required simultaneously with Diprivan.
There was no pharmacological incompatibility when using propofol in combination with epidural and spinal anesthesia, muscle relaxants, premedication agents, inhalation analgesics and anesthetics. If general anesthesia is used as an adjunct to existing regional anesthesia techniques, a reduction in the propofol dose may be required.
Use of the drug in adult patients:
- Induction of general anesthesia: induction of anesthesia is performed by infusion or slow bolus injections; regardless of the premedication, the introduction of Diprivan should be titrated (infusion or bolus injections of ~ 40 mg / 10 sec - for an adult patient in a satisfactory condition) depending on the patient's response until clinical signs of anesthesia appear. The average dose of propofol for most adults under the age of 55 is 1.5-2.5 mg / kg. It is possible to reduce the required total dose by introducing the drug more slowly, at a rate of 20-50 mg / min. For patients over 55 years of age, a lower dose is generally needed; patients of III and IV classes on the scale of the American Association of Anesthesiologists (ASA) should be administered at a lower rate (~ 20 mg / 10 sec);
- General Anesthesia Maintenance: Performed by continuous infusion or repeated bolus injections to maintain the required depth of anesthesia. With constant infusion, the rate of administration varies significantly and depends on the individual characteristics of the patients (as a rule, the introduction at a rate of 4-12 mg / kg / h guarantees the maintenance of an adequate condition). In the case of the technique of repeated bolus injections, the introduction of increasing doses is used, depending on the clinical need, from 25 to 50 mg;
- Providing sedation during intensive care: in order to achieve a sedative effect in ventilated adults receiving intensive care, Diprivan is recommended to be applied by means of a constant infusion, adjusting the rate depending on the required depth of sedation (normally the rate is within 0.3-4.0 mg / kg / h should provide a satisfactory effect);
- Providing a sedative effect while maintaining consciousness in patients during diagnostic and surgical procedures: the infusion rate and dose are selected individually and depends on the patient's clinical response. The standard dose to achieve a sedative effect is 0.5-1.0 mg / kg in 1-5 minutes, in order to maintain sedation, the rate is adjusted in accordance with the required depth of sedation (for most patients, the infusion rate varies within 1.5-4, 5 mg / kg / h). If it is necessary to quickly increase the depth of sedation, a bolus administration of 10-20 mg of propofol can be used as an addition to the infusion. For patients of III and IV classes on the ASA scale, a dose reduction and rate of administration may be required.
It is not recommended to use the ICC "Diprifyusor" system in adult patients in order to provide a sedative effect for intensive therapy and sedation while maintaining consciousness.
Use in elderly patients:
- Introductory anesthesia - lower doses of propofol are used, the dose is reduced in accordance with the patient's age and physical status; the reduced dose is administered at a slower than usual rate and titrated depending on the patient's response;
- Maintain Anesthesia or Provide Sedation - The “target concentration” or infusion rate must be reduced.
Elderly patients of III and IV classes on the ASA scale may require further reductions in the rate of administration of the drug and its dose.
To avoid depression of the respiratory and cardiovascular systems, elderly patients are not recommended a quick single or repeated bolus administration.
Application of Diprivan in childhood:
- Induction of general anesthesia: Slow administration of propofol to children is recommended until clinical signs of anesthesia appear. The dose is adjusted according to the weight and / or age of the child (for most patients over 8 years of age, the likely dose is 2.5 mg / kg; children under 8 years of age may need a higher dose). Reducing the dose of the drug is recommended for children of classes III and IV on the ASA scale;
- Maintaining general anesthesia: achieved by administering Diprivan through repeated bolus injections or continuous infusion in doses necessary to maintain the required depth of anesthesia. The rate of administration differs significantly from patient to patient (satisfactory anesthesia is usually achieved with an infusion rate in the range of 9-15 mg / kg / h);
- Providing conscious sedation in diagnostic and surgical procedures: in children, it is not recommended to use propofol for conscious sedation, since its effectiveness and safety with this use have not yet been confirmed;
- Providing sedation during intensive care: it is not recommended to use Diprivan for sedation in children, since its effectiveness and safety with this use has not yet been confirmed. In the case of unlicensed use, serious adverse side effects (including fatalities) were noted; it was not possible to establish a causal relationship of such effects with the use of Diprivan. Most often, adverse events were observed in children with respiratory tract infections when doses of the drug were administered in excess of the recommended doses for adults.
For any indications in childhood it is not recommended to inject Diprivan using the "Diprivusor" ICC system.
Suspension Diprivan may be administered undiluted using plastic syringes and glass infusion vials, or ready-made filled glass syringes. When using the drug in undiluted form in order to maintain general anesthesia, infusomats or perfusers should be used to control the rate of administration.
Diprivan is also used diluted with only 5% dextrose solution for intravenous administration, in glass vials or PVC bags. The dilution should not exceed a ratio of 1: 5 (2 mg propofol / ml), the solution should be prepared immediately before use in accordance with the rules of asepsis. The mixture is stable for 6 hours.
It is possible to inject a diluted Diprivan solution using various regulated infusion systems, but it must be borne in mind that the use of only such devices will not completely avoid the risk of uncontrolled accidental administration of the drug in large volumes. The infusion line should always include drip counters, burettes or dosing pumps. When choosing the maximum volume for diluted propofol in the burette, one must bear in mind the risk of uncontrolled administration.
You can enter the emulsion through a tee with a valve near the injection site, simultaneously with the introduction of an intravenous solution: 0.9% sodium chloride solution, 5% dextrose solution or 4% dextrose solution with 0.18% sodium chloride solution. The ready-to-use glass syringe has less plunger resistance than a disposable plastic syringe and is therefore easier to move. While injecting Diprivan manually using a ready-to-use glass syringe, the infusion system must not be left open between the syringe and the patient in the absence of supervision by medical personnel.
Adequate compatibility must be ensured when using a glass luer lock and polypropylene plunger syringe and syringe pump. The design of the pump, in particular, should prevent siphoning and provide for a blockage alarm at a pressure not exceeding 1000 mmHg. When a programmable pump or an equivalent pump is used, it is assumed that different syringes can be used; in the case of a ready-to-use glass syringe, only the "BD" 50/60 ml PLASTIPAK mode can be set. Propofol can be pre-mixed with alfentanil (500 mcg / ml) for injection, in a volume ratio of 20: 1-50: 1. Mixtures should be prepared using sterile equipment, and applied within 6 hours of preparation.
To reduce pain from the induction dose, immediately before administration, Diprivan can be mixed in a plastic syringe with 0.5% or 1% lignocaine solution for injection in a ratio of 20: 1.
Side effects
Usually, induction of anesthesia proceeds smoothly, with minimal signs of arousal. The most common adverse reactions (eg, hypotension) are pharmacologically predictable and are characteristic of any general anesthetic.
Cases reported in connection with intensive care and anesthesia (may also be due to the patient's condition or procedures):
- General reactions, reactions at the injection site: very often - pain at the injection site during induction 1;
- General: often - withdrawal syndrome in children 4;
- Cardiovascular system (CVS): often - hypotension 2, bradycardia 3, blood flow in children 4; infrequently - phlebitis and thrombosis; very rarely - pulmonary edema;
- Gastrointestinal tract (GIT): often - vomiting and nausea during recovery from anesthesia; rarely - pancreatitis;
- Central nervous system (CNS): often - headache on awakening; rarely - epileptiform movements, including opisthotonus and convulsions during induction, during anesthesia and upon awakening; very rarely - unconsciousness after surgery;
- Respiratory system: often - temporary apnea during induction of anesthesia;
- Musculoskeletal effects, connective tissue: rarely - rhabdomyolysis 5;
- Procedural complications: rarely - postoperative fever;
- Kidneys and urinary system: very rarely - discoloration of urine as a result of prolonged use;
- Immune system: very rarely - anaphylaxis (angioedema, bronchospasm, erythema, hypotension);
- Reproductive System: Very rare - sexual disinhibition.
Notes:
1 - it is possible to reduce pain at the injection site by introducing a suspension into the veins of the elbow and forearm, which are large in size; also, pain can be reduced by co-administration of Diprivan with 1% lignocaine solution.
2 - in case of hypotension, it may be necessary to inject fluid intravenously and reduce the rate of administration of Diprivan.
3 - serious cases of slowing of cardiac activity (bradycardia) are rare, with the exception of isolated reports of the progression of bradycardia to asystole.
4 - withdrawal syndrome (including rush of blood) in children occurs only when the drug is abruptly discontinued during intensive care.
5 - there are reports of very rare cases of rhabdomyolysis, when Diprivan was used in doses of more than 4 mg / kg / h in intensive care for sedation.
Overdose
In case of an overdose, it is possible to suppress the activity of the CVS and respiration. In case of respiratory depression, it is necessary to carry out artificial ventilation of the lungs with oxygen. In case of suppression of cardiovascular activity, the patient's head should be lowered; in severe cases, the introduction of pressor and plasma substituting agents is not excluded.
special instructions
Only personnel with special training in the field of anesthesia, and medical personnel trained in assisting patients during intensive care in appropriate situations, are allowed to enter Diprivan.
Patients must be monitored continuously. The room in which the drug is administered must be equipped with a system for artificial ventilation of the lungs, equipment for maintaining free airway, oxygen enrichment, as well as other resuscitation devices that are constantly ready for use.
A specialist performing a surgical or diagnostic procedure should not administer Diprivan.
In the process of using Diprivan anesthesia for diagnostic or surgical procedures in order to provide a sedative effect with preserved consciousness, constant monitoring of the patient is required to timely detect early signs of insufficient blood oxygen saturation, airway obstruction and hypotension.
When using Diprivan in order to provide a sedative effect during surgery, as in the case of using other sedatives, patients have a possibility of involuntary movements that can be dangerous for the site of surgery during procedures requiring immobilization.
Observing the patient to ensure his complete recovery from general anesthesia is required for an adequate period of time. In extremely rare cases, as a result of the use of Diprivan, there may be a lack of consciousness in the postoperative period, which may be accompanied by an increase in muscle tone. Loss of consciousness sometimes occurs after a period of wakefulness, the likelihood of spontaneous awakening is not excluded (proper monitoring of the patient who is unconscious should be established).
Diprivan has a weak vagolytic effect, its use is associated with manifestations of bradycardia (sometimes of a serious nature) and asystole. In this regard, before the induction of anesthesia, or during the maintenance of anesthesia (especially in the case of a likely predominance of vagal tone), as well as when used in combination with other drugs that can cause bradycardia, intravenous administration of an anticholinergic drug is advisable.
There is a risk of seizures when an anesthetic is given to a patient with epilepsy.
Patients with disorders of lipid metabolism and the presence of conditions that require the use of lipid emulsions with caution should be given increased attention. Blood lipid monitoring is recommended when prescribing the drug to patients at particular risk of fat accumulation. If, as a result of observations, insufficient excretion of lipids from the body is detected, it is necessary to adjust the dose. In the case of simultaneous intravenous administration of another lipid agent, its dose must be reduced taking into account the amount of lipid administered as part of Diprivan (1.0 ml contains about 0.1 g of fat).
As an induction of anesthesia (induction) in newborns, according to unregistered indications, propofol can lead to depression of the cardiovascular and respiratory systems when using the standard dosage regimen recommended for children.
There are no data on the use of Diprivan to provide sedation during intensive care in premature newborns. Clinical studies of the use of the suspension to provide sedation during intensive care in children with croup or epiglottitis have not been conducted.
While providing a sedative effect during intensive therapy, seriously ill patients receiving propofol, in very rare cases, were observed: metabolic acidosis, rhabdomyolysis, hyperkalemia, heart failure, in some episodes with fatal outcome. Most likely this was due to insufficient oxygen supply to tissues. A causal relationship has not been established between the use of Diprivan and these cases.
All sedative and therapeutic drugs used in intensive care (including Diprivan) must be titrated to maintain optimal hemodynamic parameters and optimal oxygen supply to body tissues.
EDTA, which is a part of the preparation, forms chelate complexes with metal ions, including zinc ions. In this regard, it is necessary to consider the possibility of additional zinc administration in the case of prolonged use of Diprivan, especially in patients with a predisposition to zinc deficiency, for example, with diarrhea, burns and / or sepsis.
Diprivan does not contain antimicrobial preservatives, therefore the suspension can be a favorable environment for the growth of microorganisms, including pathogenic ones. When filling a sterile syringe or infusion line with the drug, it is important to follow the rules of asepsis, draw up the suspension immediately after opening the ampoule, then immediately begin the administration. Aseptic conditions should be ensured during the entire infusion process in relation to the equipment for administration, and directly for Diprivan. Any infusion solutions added to the infusion line should be injected as close to the cannula as possible. Do not enter the suspension through a microbiological filter.
The syringe with Diprivan is disposable, intended for use in one patient. In accordance with the rules established, including for other lipid emulsions, the maximum duration of continuous infusion is 12 hours. The container with the emulsion and the infusion line are replaced after a 12 hour period or at the end of the infusion.
Before use, the container with the emulsion should be shaken, and the contents remaining after using it in any quantity should be destroyed.
Influence on the ability to drive vehicles and complex mechanisms
It is important to inform patients that for some time after general anesthesia with Diprivan, a deterioration in skills is likely, the implementation of which requires an increased concentration of attention and speed of psychomotor reactions, such as driving a car or working with complex mechanisms.
Application during pregnancy and lactation
Propofol penetrates the placental barrier, therefore, Diprivan is contraindicated for use during pregnancy and in obstetrics. However, the drug can be used in the first trimester of pregnancy to terminate it.
The safety of Diprivan for breastfed babies in the case of anesthesia in a nursing mother has not been established.
Pediatric use
For the induction and maintenance of anesthesia, Diprivan is approved for use from the age of 3.
It is forbidden to administer the drug to children of all age groups to provide a sedative effect during intensive care, surgical and diagnostic procedures, since the safety of propofol has not been proven. Although the connection with the use of Diprivan has not been established, serious side effects, including fatal ones, have been observed with unlicensed uses of the drug. Most often they occurred in children with respiratory tract infections, to whom the drug was administered in doses exceeding the recommended doses for adult patients.
Under no indications, Diprivan should not be administered to children using the Diprifyuzor ICC system.
With impaired renal function
In case of impaired renal function, Diprivan should be used with caution.
For violations of liver function
If hepatic function is impaired, Diprivan should be used with caution.
Use in the elderly
Elderly patients for induction of anesthesia require the introduction of lower doses of Diprivan.
Drug interactions
Before use, Diprivan should not be mixed with other infusion or injection solutions, except for 5% dextrose solution in PVC bags or glass vials for infusion, alfentanil or lignocaine for injection in plastic syringes.
Before the administration of muscle relaxants mivacurium and atracurium using the same infusion line as for Diprivan, it should be thoroughly rinsed beforehand.
Analogs
Diprivan's analogs are: Recofol, Proviv, Propofol Fresenius, Propofol-Medargo.
Terms and conditions of storage
Keep out of the reach of children at 2-25 ° C, do not freeze.
Shelf life: ampoules - 3 years, syringes - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Diprivan
Reviews about Diprivan are mostly positive. Patients who at different times were under anesthesia using propofol and other anesthetics compare their well-being and highlight the clear advantages of Diprivan - a quick recovery from anesthesia and the absence of side effects such as headaches, confusion, postoperative nausea and vomiting.
Price for Diprivan in pharmacies
Diprivan's price for 5 ampoules of 20 ml is about 1580-1603 rubles.
Diprivan: prices in online pharmacies
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Drug name Price Pharmacy |
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Diprivan 10 mg / ml emulsion for intravenous administration 20 ml 5 pcs. 658 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
