Expiration date: 02/2025

Composition

Active substance: bupivacaine hydrochloride monohydrate for injection 5.28 mg.

Excipients: dextrose monohydrate, 2M sodium hydroxide for injection to adjust to pH 4.0-6.0 water for injection.

Packaging

5 pieces

pharmachologic effect

Marcaine SPINAL HEAVY - local anesthetic of the amide type. When intrathecal effect occurs rapidly, and its duration varies from medium to long term. The duration of effect is dose-dependent.

The solution of the drug hyperactivity and to distribute the force of gravity influences in the subarachnoid space. A small volume of distribution in the intrathecal space leads to a lower average density and a decrease in duration of effect of the drug compared with isobaric solution. Solutions containing dextrose not give less predictable level blockade. Relative density at 20 ° C was 1,026 (corresponding to 1,021 at 37 ° C). The pH of the solution is 4.0-6.0.

Bupivacaine reversibly inhibits the conduction of impulses along nerve fibers by blocking the passage of sodium ions through the cell membrane.

testimony

Intrathecal anesthesia (subarachnoid, spinal) in surgical and obstetric interventions:

On the lower parts of the abdomen (including caesarean section).

On the lower extremities (including the hip joint).

When urologic surgery lasting 1.5-3 hours.

Contraindications

Hypersensitivity to any component of the drug or to other local anesthetics of amide type.

Pregnancy and breast-feeding

Pregnancy was used in a large number of pregnant women and women of childbearing age. The effects of the drug on reproductive function or increased frequency of malformations was noted. Patients in the later stages of pregnancy is recommended to use smaller doses of the drug.

Lactation: passes into breast milk in quantities that pose no danger to the child.

Dosing and Administration

During the epidural anesthesia is necessary to conduct a test dose of 3-5 ml. During the test dose for 5 min is necessary to maintain verbal contact with the patient and determine the heart rate regularly. Aspirate should be carried out before the introduction of the main dose, which should be administered slowly, 25-50 mg / min under constant review. When the minimum toxic effects of further administration was stopped. When used in adults enter 5.1 ml (2.5-12.5 mg) for stellate ganglion blockade to block the trigeminal nerve - 10-20 ml (25-50 mg) for continuous epidural - 20 ml (50 mg) was first then 6-16 ml (15-40 mg) every 4-6 hours, for interkostalnoy blockade - 2-3 ml (10-15 mg) per one nerve (total 10 nerves), for large closures (sacral, brachial, and others. ) - 15 30 ml (75-150 mg). For anesthesia in obstetrics using the following initial doses (can be repeated every 2-3 hours) for epidural and caudal anesthesia (with vaginal delivery and vacuum extraction) - 6-10 ml (15-25 mg) for epidural blockade with caesarean section - 15-30 ml (75-150 mg) for bilateral pudendal blockade - 5-10 ml (12.5-25 mg). The maximum recommended dose for a period of 4 hours - 2 mg / kg (150 mg). The maximum recommended dose - 400 mg / day. The total dose should be calculated taking into account the patient's physical status. The concentration of the solution used depends on the type of anesthesia: infiltration - 0.25%, conductor - 0.25-0.5%, retrobulbar - 0.75%, the sympathetic blockade - 0.25%, lumbar epidural anesthesia - 0.25-0.75%, caudal - 0.25-0.5%, conductor - 0.5 % (with the addition rate of epinephrine 1: 200,000).

Side effects

Very common: hypotension, bradycardia, nausea.

Frequent: postdural puncture headache, vomiting, urinary retention, urinary incontinence.

Less Frequent: paresthesia, paresis, dysaesthesia, muscle weakness, pain in the lumbar region.

Rare: cardiac arrest, a total spinal block, paraplegia, paralysis, neuropathy, arachnoiditis, respiratory depression, allergic reactions. In the most severe cases - anaphylactic shock.

Storage conditions

Store at 2-25 ° C. Do not freeze.

Shelf life

3 years