Sensorcaine 0.5% (Bupivacaine HCl) 5mg/mL 50mL multi dose vial | Sensorcaine

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of localanesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS, WARNINGS, andPRECAUTIONS).Management of Local Anesthetic EmergenciesThe first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vitalsigns and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should beadministered.The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoidinjection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effectiveassisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressureby mask.This may prevent convulsions if they have not already occurred.If necessary, use drugs to control the convulsions. A 50 to 100 mg bolus I.V. injection of succinylcholine will paralyze the patientwithout depressing the central nervous or cardiovascular systems and facilitate ventilation. A bolus I.V. dose of 5 to 10 mg ofdiazepam or 50 to 100 mg of thiopental will permit ventilation and counteract central nervous system stimulation, but these drugs alsodepress the central nervous system, respiratory and cardiac function, add to postictal depression, and may result in apnea. Intravenousbarbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediatelyafter the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment ofcirculatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinicalsituation (such as ephedrine or epinephrine to enhance myocardial contractile force).Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration ofoxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted orcontrolled) is indicated.Recent clinical data from patients experiencing local anesthetic-induced convulsions demonstrated rapid development of hypoxia,hypercarbia, and acidosis with bupivacaine within a minute of the onset of convulsions. These observations suggest that oxygen

The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of thetissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the durationof anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required toproduce the desired result should be administered. Dosages of Sensorcaine should be reduced for young, elderly and/or debilitatedpatients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should beavoided and fractional (incremental) doses should be used when feasible.For specific techniques and procedures, refer to standard textbooks.There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics followingarthroscopic and other surgical procedures. Sensorcaine is not approved for this use (see WARNINGS and DOSAGE ANDADMINISTRATION).).In recommended doses, Sensorcaine (bupivacaine HCl) produces complete sensory block, but the effect on motor function differsamong the three concentrations.0.25%—when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operationsin which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset ofaction may be slower than with the 0.5% or 0.75% solutions.0.5%—provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in whichcomplete muscle relaxation is essential.0.75%—produces complete motor block. Most useful for epidural block in abdominal operations requiring complete musclerelaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia.The duration of anesthesia with Sensorcaine is such that for most indications, a single dose is sufficient.Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as theusual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Sensorcaine up to225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualizationof each case.These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses up to 400 mg have beenreported. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may beprolonged by the addition of epinephrine.The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. Thesedosages should be reduced for elderly or debilitated patients. Until further experience is gained Sensorcaine is not recommended forpediatric patients younger than 12 years. Sensorcaine is contraindicated for obstetrical paracervical blocks, and is not recommendedfor intravenous regional anesthesia (Bier Block).Use in Epidural AnesthesiaDuring epidural administration of Sensorcaine, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Inobstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution notexceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containingepinephrine if not contraindicated. Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; themultiple dose vials contain a preservative and therefore should not be used for these procedures.Test Dose for Caudal and Lumbar Epidural BlocksSee PRECAUTIONS.Unused portions of solutions in single dose containers should be discarded, since this product form contains no preservatives.TABLE 1. DOSAGE RECOMMENDATIONS —SENSORCAINE (bupivacaine HCl) INJECTIONS

HOW SUPPLIEDSOLUTIONS OF SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) SHOULD NOT BE USED FOR THE PRODUCTIONOF SPINAL ANESTHESIA (SUBARACHNOID BLOCK) BECAUSE OF INSUFFICIENT DATA TO SUPPORT SUCH USE.Sensorcaine-MPF (methylparaben free) is available in the following forms:With Epinephrine:

Manufacturer

General Injectables & Vaccines, Inc

Active Ingredients

Source

• U.S. National Library of Medicine
• DailyMed
• Last Updated: 18 May 2013