Bupivacaine-ZN solution for injection 5 mg/ml ampoule 5 ml No. 10

Bupivacaine injection solution for:

Composition

Active ingredient: bupivacaine;

1 ml of bupivacaine hydrochloride in terms of 100% substance 5 mg;

Excipients: sodium chloride, diluted hydrochloric acid or sodium hydroxide, water for injections.

Contraindication

Hypersensitivity to amide-type local anesthetics or to other components of the drug.

Bupivacaine should not be used for intravenous regional anesthesia (Bier block).

Bupivacaine should not be used for epidural anesthesia in patients with severe hypotension, for example, in the case of cardiogenic or hypovolemic shock.

Epidural anesthesia, regardless of the local anesthetic used, has its own contraindications, which include: diseases of the nervous system in the active stage, 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; tuberculosis of the spine; purulent skin infection at or near the site of the lumbar puncture; blood clotting disorders or current treatment with anticoagulants.

Method of application

Bupivacaine should be administered by or under the supervision of a physician experienced in regional anesthesia. Small doses should be used to achieve adequate anesthesia.

It is important to take special care to prevent accidental intravascular injection. It is recommended to perform an aspiration test before and during the administration of the total dose. For epidural administration of high doses, a test dose of 3-5 ml of bupivacaine with adrenaline should be administered, since accidental intravascular injection may cause, for example, a short-term increase in heart rate, and accidental intrathecal injection may cause spinal block. Verbal contact with the patient should be maintained for 5 minutes after the test dose and the heart rate should be checked periodically. In addition, aspiration should be performed before the total dose, which should be administered slowly, at a rate of 25-50 mg/min, in stages, while maintaining constant verbal contact with the patient. If symptoms of intoxication occur, the drug should be discontinued immediately.

Application features

Pregnant women

Bupivacaine should not be used in early pregnancy unless the benefits are considered to outweigh the risks.

Children

It is not used in children for the indicated indications.

Drivers

Depending on the dose and method of administration, bupivacaine may have a temporary effect on movement and coordination.

Overdose

Systemic toxic reactions are mainly found in the central nervous system and the cardiovascular system. Such reactions can be caused by high blood concentrations of local anesthetics due to accidental intravascular administration, overdose, or particularly rapid absorption with extensive blood circulation.

Side effects

Adverse effects caused by the drug itself may be difficult to distinguish from the physiological effects of nerve blockade (e.g., decreased blood pressure, bradycardia) and from those caused directly by the needle puncture (e.g., nerve damage).

Interaction

Caution should be exercised when using bupivacaine with drugs structurally similar to local anesthetics, such as class IC antiarrhythmics, as their toxic effects are additive.

Specific interaction studies between local anesthetics and class III antiarrhythmics (e.g. amiodarone) have not been performed, but caution is advised in this case.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Shelf life - 3 years.