Bupivacaine ampoules 5mg/ml 4ml №5

Composition

1 ml: Active ingredient: bupivacaine hydrochloride monohydrate - 5.0 mg;

Local anesthetic agent

Mechanism of action

Bupivacaine is a long-acting amide-type local anesthetic. Reversibly blocks the conduction of pulses along the nerve fiber, disrupting the transport of sodium ions through sodium channels. May have a similar effect in the brain and myocardium. The most characteristic feature of bupivacaine is its duration of action, which does not greatly depend on the addition of epinephrine to it. Bupivacaine is the drug of choice for continuous epidural anesthesia. In low concentrations, it has less effect on motor fibers and has a shorter duration of action, which is advisable for short-term relief of pain, for example, during childbirth or after surgery. The relative density of the drug solution is 1004 at 20 ° C (equivalent to 1000 at 37 ° C, gravity has little effect on its distribution in the subarachnoid space. With a subarachnoid injection a small dose is administered, which leads to a relatively low concentration and short duration of the blockade. With subarachnoid the introduction of bupivacaine, which does not contain dextrose, anesthesia is less predictable, but longer than with the introduction of the solution of bupivacaine containing dextrose.

Indications and usage

Surgical anesthesia in adults and children over 12 years. Acute pain in adults and children over 1 year. Infiltration anesthesia, when long-term anesthetic effect is required, for example, in case of postoperative pain. Conductive anesthesia with a long-lasting effect or epidural anesthesia in cases in which the addition of epinephrine is contraindicated and significant muscle relaxation is undesirable. Anesthesia in obstetrics. With intrathecal administration. Spinal anesthesia during surgical operations on the lower extremities, including operations on the hip joint, lasting 3-4 hours and not requiring a pronounced motor block.

Contraindications

Hypersensitivity to any of the components of the drug or to other local anesthetics amide type.Severe arterial hypotension (cardiogenic or hypovolemic shock). Children age: up to 12 years with surgical anesthesia, up to 1 year: with all indications for use, with the exception of intrathecal anesthesia, in which the drug is allowed to enter from birth. Intravenous regional anesthesia (Bieru blockade) (accidental entry of bupivacaine into the bloodstream may cause the development of acute systemic toxic reactions). Paracervical blockade in obstetrics. Conditions that are contraindications to epidural or intrathecal anesthesia: diseases of the central nervous system (CNS) (for example, meningitis, tumors, polio, intracranial hemorrhage); purulent infections of the skin at or near the lumbar puncture site; spinal stenosis, active diseases (for example, spondylitis, tumors, tuberculosis) or injuries (for example, a fracture) of the spine; sepsis, subacute combined degeneration of the spinal cord due to pernicious anemia and tumors of the brain and spinal cord; cardiogenic or hypovolemic shock; coagulation disorder or active anticoagulant therapy.

Dosage and administration

Bupivacaine can only be used by physicians with local anesthetic experience or under their supervision. To achieve the required degree of anesthesia, you need to enter the lowest possible dose. Under no circumstances should accidental intravascular administration of the drug be allowed. Before and during the introduction of the drug is recommended to carry out an aspiration test. The drug must be administered slowly, at a rate of 25-50 mg / min or fractionally, maintaining continuous verbal contact with the patient and controlling the heart rate. During epidural administration, a dose of 3-5 ml of bupivacaine with epinephrine is pre-administered. In the case of accidental intravascular administration, a short-term increase in the heart rate occurs, and in case of accidental intrathecal administration, a spinal block arises. In the event of toxic signs, administration is immediately discontinued. Below are indicative doses that need to be adjusted depending on the depth of anesthesia and the patient's condition.Infiltration anesthesia: 5-60 ml of the drug at a concentration of 2.5 mg / ml (12.5-150 mg of bupivacaine) or 5-30 ml of the drug at a concentration of 5 mg / ml (25-150 mg of bupivacaine). Diagnostic and therapeutic blockade: 1-40 ml of the drug at a concentration of 2.5 mg / ml (2.5-100 mg of bupivacaine), for example, the trigeminal nerve blockade 1-5 ml of the drug (2.5-12.5 mg of bupivacaine ) and the cervical-thoracic node of the sympathetic trunk 10-20 ml of the drug (25-50 mg of bupivacaine). Intercostal blockade: 2-3 ml of the drug at a concentration of 5 mg / ml (10-15 mg of bupivacaine) per nerve, not exceeding the total number - 10 nerves. Large blockade (for example, epidural block, blockade of the sacral or brachial plexus): 15-30 ml of the drug at a concentration of 5 mg / ml (75-150 mg of bupivacaine). Anesthesia in obstetrics (for example, epidural and caudal anesthesia during vaginal delivery): 6-10 ml of the drug at a concentration of 2.5 mg / ml (15-25 mg of bupivacaine) or 6-10 ml of the drug at a concentration of 5 mg / ml (30- 50mg bupivacaine). Every 2-3 hours repeated administration of the drug in the initial dose is allowed. Epidural anesthesia for caesarean section: 15-30 ml of the drug at a concentration of 5 mg / ml (75-150 mg of bupivacaine). Epidural analgesia in the form of intermittent bolus administration: initially, 20 ml of the drug is administered at a concentration of 2.5 mg / ml (50 mg of bupivacaine), then every 4-6 h, depending on the number of damaged segments and the patient's age, 6-16 ml of the drug at a concentration 2.5 mg / ml (15-40 mg of bupivacaine). Epidural analgesia in the form of a continuous infusion (for example, postoperative pain): If during the previous hour the drug was not injected bolus. Do not exceed the maximum recommended daily dose (see below). During the course of surgery, additional administration of the drug is possible. With simultaneous use of narcotic analgesics, the dose of bupivacaine should be reduced. With long-term administration of the drug in a patient, it is necessary to regularly monitor blood pressure, heart rate and other signs of potential toxicity. If toxic effects occur, the drug should be stopped immediately. The maximum recommended dose. The maximum recommended single dose, calculated at the rate of 2 mg / kg body weight, is 150 mg for adults for four hours. This is equivalent to 60 ml of the drug at a concentration of 2.5 mg / ml (150 mg of bupivacaine) and 30 ml of the drug at a concentration of 5 mg / ml (150 mg of bupivacaine). The maximum recommended daily dose is 400 mg.However, when calculating the total daily dose, it is necessary to take into account the patient’s age, physique and other significant conditions. Children aged 1-12 years. Regional anesthesia should be performed by a doctor who has experience in working with children and is familiar with the appropriate injection technique. The dose in children is calculated on the basis of 2 mg per kg of body weight. In order to prevent the drug from entering the bloodstream, an aspiration test should be carried out before and during the administration of the main dose. The drug should be administered slowly, dividing the total dose into several injections, especially with lumbar and thoracic epidural anesthesia, continuously monitoring the performance of vital organs. Peritonsillar infiltration anesthesia in children from 2 years: at a dose of 7.5 mg and 12.5 mg per tonsil at a bupivacaine concentration of 2.5 mg / ml. The ileal-inguinal / ileal-hypogastric nerve blockade in children from 1 year: 0.1-0.5 ml / kg with a bupivacaine concentration of 2.5 mg / ml, which is equivalent to 0.25-1.25 mg / kg of body weight. For children aged 5 years and older, the drug may be administered at a concentration of bupivacaine 5 mg / ml, which is equivalent to 1.25-2 mg / kg. Penis blockade: 0.2-0.5 ml / kg with a bupivacaine concentration of 5 mg / ml, which is equivalent to 1.0-2.5 mg / kg. Data on epidural anesthesia in children (bolus or continuous administration) is limited. Method of preparation If it is necessary to obtain a solution with a concentration of 2.5 mg / ml, it is possible to dilute the preparation with a concentration of 5 mg / ml only with compatible solvents, such as a solution of sodium chloride 0.9% for injections, since after dilution the properties of the preparation may change. which can lead to precipitation. Breeding should be carried out only by qualified personnel with mandatory visual inspection before use. It is possible to use only transparent solutions without visible particles. A solution of the drug is intended for single use only. For intrathecal administration, bupivacaine can only be used by doctors who have experience with or under the supervision of local anesthesia. To achieve the required degree of anesthesia, you need to enter the lowest possible dose. The doses listed below are adults. Dose selection is carried out individually. Elderly patients and patients in late pregnancy dose should be reduced.The recommended injection site is at L3 level. There is no clinical experience with doses exceeding 20 mg. Intravenous access must be provided prior to the administration of the drug. The introduction is carried out only after confirmation of the ingress into the subarachnoid space (outflow from the needle of the transparent cerebrospinal fluid or aspiration). If the attempt is unsuccessful, only one additional attempt should be made at a different level and to a lesser extent. One of the reasons for the lack of effect can be a poor distribution of the drug in the subarachnoid space, which can be corrected by changing the position of the patient. Children with body weight less than 40 kg. Bupivacaine, injection, 5 mg / ml, is allowed in children. The main difference between adults and children is that in newborns and infants the volume of cerebrospinal fluid is larger, which requires a relatively high dose per kilogram of body weight compared to adults to achieve the same degree of blockade. Regional anesthesia should be performed by a doctor who has experience in working with children and is familiar with the appropriate injection technique. Doses in children listed in the table are indicative. Variability is possible. In determining the methods of anesthesia and taking into account the individual characteristics of patients, the generally accepted guidelines for anesthesia should be used. The minimum dose needed to achieve sufficient anesthesia should be administered.

Solution for injection 5 mg / ml. On 4 ml in ampoules of colorless neutral glass type I with a color ring of a break or with a color point and a notch or without a ring of a break, a color point and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or an alphanumeric coding with or without additional color rings, a two-dimensional bar code, alphanumeric coding can be additionally applied to the ampoules. On 5 ampoules in a blister strip packaging from a film of polyvinyl chloride and aluminum foil lacquered or polymer film, or without foil and without film. Or 5 ampoules are placed in a pre-made form (tray) of cardboard with cells for laying ampoules. 1 or 2 blister packs or cardboard trays along with instructions for use and scarifier or ampuln knife, or without scarifier and ampuln knife are placed in a carton (pack).

Prescription.