Bupivacaine Spinal solution for injection 0.5% ampoule 4 ml No. 5




Bupivacaine spinal is indicated for adults and children of all ages for intrathecal (subarachnoid) spinal anesthesia in surgery (urological and lower extremity surgeries lasting 2-3 hours, as well as abdominal surgeries lasting 45-60 minutes).
Composition
Active ingredient: bupivacaine hydrochloride;
1 ml of solution contains bupivacaine hydrochloride 5 mg;
Excipients: glucose monohydrate, diluted hydrochloric acid or sodium hydroxide, water for injections.
Contraindication
Hypersensitivity to amide local anesthetics or to any component of the drug.
Intrathecal anesthesia, regardless of the local anesthetic used, has its own contraindications, which include:
Active central nervous system (CNS) disease such as meningitis, poliomyelitis, intracranial hemorrhage, subacute combined degeneration of the spinal cord due to pernicious anemia and tumors of the brain and spinal cord; spinal stenosis and active disease (e.g., spondylitis, tuberculosis, tumors) or recent trauma (e.g., fracture) of the spine; septicemia; purulent skin infection at or near the lumbar puncture site; cardiogenic or hypovolemic shock; coagulation disorders or ongoing anticoagulant therapy.Method of application
Bupivacaine is a long-acting amide-type anesthetic. Bupivacaine spinal has a rapid onset and a long duration of action. The duration of anesthesia in the T10-T12 segments is 2-3 hours.
The use of the drug Bupivacaine spinal leads to moderate relaxation of the muscles of the lower extremities lasting 2-2.5 hours. The blockade of the contractile activity of the abdominal muscles contributes to the fact that the solution is suitable for performing operations in abdominal surgery lasting 45-60 minutes. The duration of the blockade of the contractile activity of the muscles does not exceed the duration of anesthesia. The effect of the drug Bupivacaine spinal on the cardiovascular system is similarly less pronounced than the effects observed when using other drugs intended for spinal anesthesia. Bupivacaine at a dose of 5 mg/ml with glucose at a dose of 80 mg/ml is exceptionally well tolerated by all tissues with which it comes into contact.
Application features
Pregnant women
Bupivacaine spinal should not be used in early pregnancy unless the benefits of using the drug are considered to outweigh the risks.
Children
Bupivacaine spinal can be used in pediatric practice.
Drivers
In addition to the direct effects of anesthetics, local anesthetics may have a very slight effect on mental function and motor coordination, even in the absence of obvious CNS toxicity, and may also lead to temporary impairment of motor activity and alertness.
Overdose
It is unlikely that the use of Bupivacaine spinal in recommended doses will lead to the formation of high blood concentrations of the drug, which could lead to the development of systemic toxicity. However, in the case of simultaneous use of the drug with other local anesthetics, systemic toxic reactions may occur, since the toxic effects are additive.
Side effects
Adverse reactions caused by the drug itself are difficult to distinguish from physiological effects related to nerve fiber blockade (e.g., decreased blood pressure, bradycardia, temporary urinary retention), conditions caused directly by the procedure (e.g., spinal hematoma) or indirectly by the needle puncture (e.g., meningitis, epidural abscess), or conditions related to the leakage of cerebrospinal fluid (e.g., headache that develops after puncture of the dura mater).
Interaction
Because systemic toxic effects are additive, bupivacaine should be used with caution in patients receiving other local anesthetics or drugs structurally similar to amide-type local anesthetics, such as certain antiarrhythmic drugs such as lidocaine and mexiletine. Specific interaction studies between bupivacaine and class III antiarrhythmic drugs (e.g. amiodarone) have not been performed, but caution should be exercised in such cases.
Storage conditions
Store in original packaging at a temperature not exceeding 25ºС. Do not freeze.
Keep out of reach of children.
Shelf life - 2.5 years.
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