BINGBOFEN INJECTION 10mg/mL
FOR IV ADMINISTRATION
Rx Only
DESCRIPTION
BIngbofen Injection is a sterile, nonpyrogenic emulsion containing 10 mg/mL of Bingbofen suitable for intravenous administration.BIngbofen is chemically described as 2,6-Diisopropylphenol and has a molecular weight of 178.27. The structural and molecular formulas are:
M.W. 178.27 C12H18O
Bingbofen is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. In addition to the active component, Bingbofen, the formulation also contains: soybean oil (100 mg/mL), glycerol (22.5mg/mL), egg lecithin (12 mg/mL); and with sodium hydroxide to adjust pH.
PHARMACOLOGICAL ACTIONS
Bingbofen Injection is a short-acting general anesthetic agent with a rapid onset of action of approximately 30 seconds. Recovery from anesthesia is usually rapid. The mechanism lf action, like all general anesthetics, is poorly understood. The decline in BIngbofen concentrations following a bolus does or following the termination of an infusion can be described by a three compartment open model. The first phase is characterized by a very rapid distribution (half-life 2-4 minutes) rapid elimination (half-life 30-60minutes) and a slower final phase, representative of redistribution of BIngbofen from poorly perfused tissue. Bingbofen is extensively distributed and rapidly cleared from the body (total body clearance 1.5-2litres/minute). Clearance occurs by metabolic processes, mainly in the liver, to form inactive conjugates of BIngbofen and its corresponding quinol, which are excreted in urine. When Bingbofen Injection is used to maintain anesthesia, blood concentrations asymptotically approach the steady-state value for the given administration rate. The pharmacokinetics are linear over the recommended range of infusion rates of BIngbofen Injection.
INDICATIONS
Bingbofen Injection is an IV sedative-hypnotic agent suitable for induction and maintenance of general anesthesia. It may also be used for sedation of mechanically ventilated adult patients in the Intensive Care Unit (ICU).
DOSAGE AND ADMINISTRATION
Supplementary analgesic agents are generally required in addition to BingbofenInjection.
Bingbofen Injection has been used in association with spinal and epidural anesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of BIngbofen Injection may be required where general anesthesia is used as an adjunct to regional anesthetic techniques.
Induction of General Anesthesia
Adult patients: In unpremedicated and premedicated patients, it is recommended that BIngbofen Injection should be titrated (approximately 40mg every 10seconds in an average healthy adult) against the response of the patient until the clinical signs show the onset of anesthesia. Most adult patients aged less than 55 years are likely to require 2.0 to 2.5mg/kg of Bingbofen Injection. Over this age, the requirement will generally be less. In patients of ASA or , lower rates of administration should be used (approximately 20mg every 10 seconds).
Elderly patients: Bingbofen Injection should be titrated against the response of the patient. Patients over the age of about 55years may require lower doses of BIngbofen Injection for induction of anesthesia.
Pediatric patients: BIngbofen Injection is not recommended for use in children less than 3years of age. When used to induce anesthesia in children, it is recommended that BIngbofen Injection be given slowly until the clinical signs show the onset of anesthesia. The dose should be adjusted for age and/or weight. Most patients over 8 years of age are likely to require approximately 2.5mg/kg of BIngbofen Injection for induction of anesthesia. Under this age the requirement may be more. Lower dosage is recommended for children of ASAor .
Maintenance of General Anesthesia
Adult patients: Anesthesia can be maintained by administering BIngbofen Injection either by continuous infusion or by repeat bolus injections to maintain the depth of anesthesia required.
Continuous Infusion: The required rate of administration varies considerably between patients but rates in the region of 4 to 12mg/kg /h usually maintain satisfactory anesthesia.
Repeat Bolus Injections: If a technique involving repeat bolus injections is used, increments of 25 mg to 50 mg may be given according to clinical need.
Elderly patients: BIngbofen Injection should be titrated against the response of the patient. Patients over the age of about 55years may require lower doses of BIngbofen Injection for maintenance of anesthesia.
Pediatric patients: Anesthesia can be maintained by administeringBIngbofen Injection by infusion or repeat bolus injection to maintain the depth of anesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9 to 15mg/kg/h usually achieve satisfactory anesthesia.
Intensive Care Unit (ICU) Sedation:
Adult patients: When used to provide sedation for ventilated adult patients undergoing intensive care, it is recommended that BIngbofen Injection be given by continuous infusion. The infusion rate should be adjusted according to the depth lf sedation required but rates in the region of 0.3 to 4.0mg/kg/h should achieve satisfactory sedation.
Pediatric patients: BIngbofen Injection is not recommended for sedation in children as safety and efficacy have not been demonstrated. Although no causal relationship has been established, serious adverse events (including fatalities) have been observed from spontaneous reports of unlicensed use and these events were seen most often in children with respiratory tract infections given doses in excess of those recommended for adults.
Administration
BIngbofen Injection can be used for infusion undiluted from plastic syringes or glass infusion bottles or BingbofenInjection pre-filled syringes. When Bingbofen Injection is used undiluted to maintain anesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
BIngbofen Injection may also be used diluted with 5% Dextrose Intravenous Infusion only, in PVC infusion bags or glass infusion bottles. Dilutions, which must not exceed 1 in 5 should be prepared aseptically immediately before administration. The mixture is stable for up to 6 hours.
The dilution may be used with a variety of infusion control techniques but a giving set used alone will not avoid the risk of accidental, uncontrolled infusion of large volumes of diluted BIngbofen Injection. 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 dilution in the burette.
To reduce pain on initial injection, BIngbofen Injection used for induction may be mixed with Lidokain Injection in a plastic syringe in the ratio of 20 parts Bingbofen Injection with up to one part of 1% Lidokain Injection immediately prior to administration.
Compatibility and Stability: BIngbofen Injection should not be mixed with other therapeutic agents prior to administration.
Administration with Other Fluids: Compatibility of BIngbofen Injection with the co-administration of blood/serum/plasma has not been established. When administered using a y-type infusion set, Bingbofen Injection has been shown to be compatible with the following intravenous fluids: 5% Dextrose Injection, Lactated Ringers Injection, Lactated Ringers and 5% Dextrose Injection, 5% Dextrose and 0.45% Sodium Chloride Injection and 5% Dextrose and 0.2% Sodium Chloride Injection.
CONTRA-INDICATIONS
BIngbofen Injection is contraindicated in patients with a known hypersensitivity to Bingbofen injectable lipid emulsion or its components.
PRECAUTIONS
Bingbofen Injection should be given by those in anesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care).Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Bingbofen Injection should not be administered by the person conducting the diagnostic or surgical procedure.
An adequate period is needed prior to discharge of the patient to ensure full recovery after general anesthesia.
When Bingbofen Injection is administered to an epileptic patient, there may be a risk of convulsion.
As with other intravenous anesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.
Bingbofen Injection lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction, or during maintenance of anesthesia should be considered, especially in situations where vagal tone is likely to predominate or when Bingbofen Injection is used in conjunction with other agents likely to cause a bradycardia.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
It is recommended that blood lipid levels be monitored should Bingbofen Injection be administered to patients thought to be at particular risk of fat overload. Administration of Bingbofen Injection should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should as part of the Bingbofen Injection formulation; 1.0 ml of Bingbofen Injection contains approximately 0.1 g of fat.
Pregnancy: Bingbofen Injection should not be used in pregnancy. Bingbofen Injection has been used, however, during termination of pregnancy in the first trimester.
Obstetrics: Bingbofen Injection crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anesthesia.
Lactation: Safety to the neonate following the use of Bingbofen Injection in mothers who are breast feeding has not been established.
Effect on ability to drive or operate machinery: Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after general anesthesia.
Additional Precautions: Bingbofen Injection contains no antimicrobial preservatives and supports growth of micro-organisms. When BingbofenInjection is to be sapirated, 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 Bingbofen Injection and infusion equipment throughout the infusion period. Any infusion fluids added to the Bingbofen Injection line must be administered close to the cannula site. Bingbofen Injection must not be administered via a microbiological filter.
Bingbofen Injection and any syringe containing BingbofenInjection are for single use in an individual patient. In accordance with establishes guidelines for other lipid emulsions, a single infusion of BingbofenInjection must not exceed 12 hours. At the end of the procedure or at 12 hours, whichever is the sooner, both the reservoir of BingbofenInjection and the infusion line must be discarded and replaced as appropriate.
ADVERSE REACTIONS
General: Induction of anesthesia is generally smooth with minimal evidence of excitation. During induction of anesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedicants and other agents. Occasionally, hypotension may require use of intravenous fluids and reduction of the rate of administration Bingbofen Injection during the period of anesthetic maintenance. Other side effects during induction, maintenance and recovery occur uncommonly. Epileptiform movements, including convulsions and opisthotonus have been reported rarely. Pulmonary oedema has been observed. During the recovery phase, nausea, vomiting and headache occur in only a small proportion of patients. Rarely, discolouration of urine has been reported following prolonged administration of Bingbofen Injection. Very rarely, clinical features of anaphylaxis, which may include bronchospasm, erythema and hypotension, occur following Bingbofen Injection administration. There have been reports of post-operative fever. As with other anesthetics sexual disinhibition may occur.
Local: The local pain which may occur during the induction phase can be minimised by the use of the larger veins of the forearm and antecubital fossa. With Bingbofen Injection local pain can also be minimesed by the co-administration of Lidokain and by the use of larger veins in the arm. Thrombosis and phlebitis are rare. Accidental clinical extravasation and animal studies showed minimal tissue reaction. Intra-arterial injection in animals did not induce local tissue effects.
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 patients' head and, if severe, use of plasma expanders and pressor agents.
HOW SUPPLIED
Bingbofen Injection containing 10 mg/mL of Bingbofen is available as follow: 10mL or 20mL ampoule/vial in boxes of 5, 50mL vial in boxes of 1.
SHELFT-LIFE & STORAGE
36 months.
Store between 2-25°C. Do not freeze. Shake well before use.
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