Spinal anesthesia for surgical procedures (urological procedures and procedures on the lower extremities lasting from 2 to 3 hours or for abdominal operations lasting 45 to 60 minutes).
Composition:
1 ml contains 5 mg of bupivacaine hydrochloride.
Action:
Local anesthetic drug from the group of amides. After administration into the subarachnoid space, the onset of action is rapid and the duration of action is long - depending on the dose of the drug used. T0,5 is 2.7 h. Bupivacaine is metabolised mainly in the liver (the main metabolite is pipecolylxylidine). Bupivacaine and its metabolites are mainly excreted via the kidneys; only 6% of the dose is excreted in the urine unchanged.
Contraindications:
Hypersensitivity to the components of the preparation or other local anesthetics with amide structure. General contraindications for subarachnoid anesthesia, regardless of the type of anesthetic used: acute diseases o.u.n. (meningitis, tumors, inflammation of the gray matter of the spinal cord, intracranial bleeding); narrowing of the spinal cord, active diseases (inflammation of the spine, tuberculosis of the spine, tumors) or recent spinal injuries; sepsis; subacute spinal cord degeneration in the course of pernicious anemia; purulent skin infection at the site of the intended administration; cardiogenic or hypovolemic shock; coagulation disorders or current anticoagulant therapy.
Precautions:
The drug can only be used by a physician experienced in performing subarachnoid anesthesia, in the case of acute toxic symptoms in the conditions of the possibility of conducting oxygen therapy and resuscitation, in centers employing trained personnel. Vaginal administration should be strictly avoided. Particularly cautiously use in patients with poor general condition, elderly, in advanced pregnancy, with IIST atrioventricular block. or III., advanced liver disease, severe renal failure. Patients taking Class III antiarrhythmics should be carefully monitored (ECG) during anesthesia. In elderly or more advanced patients, there is a greater risk of high or complete spinal anesthesia (lower doses are recommended). Caution in patients with hypovolaemia (risk of deepening hypotension); with neurological disorders (MS, hemiplegia, transverse paralysis, neuromuscular disorders).
Pregnancy and lactation:
The preparation can be used in early pregnancy only in cases where, in the doctor's opinion, the benefit for the mother outweighs the potential risk to the fetus. If bupivacaine is used in women with advanced pregnancy, the dose should be reduced. Bupivacaine is excreted in breast milk in a quantity not affecting the condition of the child being fed.
Side effects:
Side effects after spinal anesthesia may be a result of local anesthetic, a physiological response to nerve blockade (hypotension, bradycardia, urination disorders), direct damage due to puncture (eg hematoma), indirect puncture damage (e.g., meningitis) cerebrospinal fluid, epidural abscess) or cerebrospinal fluid leak after needle puncture (e.g., post-operative headache). During the use of the preparation may occur: very common (≥1 / 10) - hypotension, bradycardia, nausea; common (≥1 / 100, <1/10) - post-operative headaches, vomiting, urination disorders, incontinence; uncommon (≥1 / 1000, <1/100) - paresthesia, paresis, dyseosthesia, muscle weakness, backache; rarely (<1/1000) - cardiac arrest, allergic reactions, anaphylactic shock, unintentional total spinal anesthesia, paraplegia and other paralysis, neuropathy, arachnoiditis, respiratory disorders.
Dosage:
Adults and children over 12 years.A subarachnoid anesthesia for surgical procedures in the lower limbs and hip joint as well as in the abdominal cavity (also for Caesarean section)The recommended dose is 2-4 ml of the preparation (10-20 mg). Volume of more than 4 ml (20 mg) is not recommended. The anesthetic effect occurs 5-8 minutes after administration of the product and lasts for 2-3 hours in the lower limbs and hip joint and 45-60 minutes in the abdominal cavity.A subarachnoid anesthesia for urological proceduresThe recommended dose is 1.5-3 ml of the preparation (7.5-15 mg). The anesthetic effect appears 5-8 minutes after administration of the product and lasts for 2-3 hours. Regardless of the type of local anesthetic given - the range of segments under anesthesia is individual for a given patient and difficult to predict before anesthesia. The doses given above refer to adult patients with a standard physique. In elderly patients and women in advanced pregnancy, the dose should be reduced.Newborns, infants and children weighing up to 40 kg:recommended dose for children of m.c. <5 kg is 0.40-0.50 mg / kg, for children of m.c. 5-15 kg is 0.30-0.40 mg / kg m.c., for children of m.c. 15-40 kg is 0.25-0.30 mg / kg m.c.