July 30, 2016
Recommended Topic Related To:

Sensorcaine

"Through June of this year, the cholesterol-lowering drug rosuvastatin (Crestor, AstraZeneca) was the most prescribed branded drug in the United States, and the arthritis drug adalimumab (Humira, Abbott Laboratories) was the best-sel"...

A A A

Sensorcaine




Indications
Dosage
How Supplied

DOSAGE AND ADMINISTRATION

The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of Sensorcaine should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided 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 intraarticular infusions of local anesthetics following arthroscopic and other surgical procedures. Sensorcaine is not approved for this use (see WARNINGS).

In recommended doses, Sensorcaine (bupivacaine HCl) produces complete sensory block, but the effect on motor function differs among the three concentrations.

0.25% - when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action 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 which complete muscle relaxation is essential.

0.75% - produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, 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 the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Sensorcaine up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case.

These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses have been up to 400 mg. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may be prolonged 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. These dosages should be reduced for elderly or debilitated patients. Until further experience is gained, Sensorcaine is not recommended for pediatric patients younger than 12 years. Sensorcaine is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block).

Use In Epidural Anesthesia

During epidural administration of Sensorcaine, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservative and therefore should not be used for these procedures.

Test Dose For Caudal And Lumbar Epidural Blocks

The Test Dose of Sensorcaine (0.5% bupivacaine with 1:200,000 epinephrine in a 3 mL ampule) is recommended for use as a test dose when clinical conditions permit prior to caudal and lumbar epidural blocks. This may serve as a warning of unintended intravascular or subarachnoid injection (see PRECAUTIONS). The pulse rate and other signs should be monitored carefully immediately following each test dose administration to detect possible intravascular injection, and adequate time for onset of spinal block should be allotted to detect possible intrathecal injection. An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or cardiovascular effects from the epinephrine (see WARNINGS and OVERDOSAGE).

TABLE 1: Recommended Concentrations and Doses of SENSORCAINE (bupivacaine HCl) INJECTIONS

Type of Block Conc. Each Dose Motor Block1
(mL) (mg)
Local Infiltration 0.25%4 up to max. up to max.
Epidural 0.75%2,4 10 to 20 75 to 150 complete
0.5%4 10 to 20 50 to 100 moderate to complete
0.25%4 10 to 20 25 to 50 partial to moderate
Caudal 0.5%4 15 to 30 75 to 150 moderate to complete
0.25%4 15 to 30 37.5 to 75 moderate
Peripheral Nerves 0.5%4 5 to max. 25 to max. moderate to complete
0.25%4 5 to max. 12.5 to max. moderate to complete
Retrobulbar3 0.75%4 2 to 4 15 to 30 complete
Sympathetic 0.25% 20 t0 50 50 to 125
Dental3 0.5% 1.8 to 3.6 9 to 18
  w/epi per site per site
Epidural3 0.5% 2 to 3 10 to 15
Test Dose w/epi 10 to15 mcg epinephrine (see PRECAUTIONS)
1 With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with 0.25% may also produce complete motor block for intra-abdominal surgery.
2For single dose use, not for intermittent epidural technique. Not for obstetric anesthesia.
3 See PRECAUTIONS.
4 Solutions with or without epinephrine.

HOW SUPPLIED

These solutions are not for spinal anesthesia.

Sensorcaine-MPF (methylparaben free) is available in the following forms:

With Epinephrine

Product No. NDC No. Strength Size
460837 63323-468-37 0.25% 30 mL Single Dose Vials packaged in trays of twenty-five
460817 63323-468-17 0.25% 10 mL Single Dose Vials packaged in trays of twenty-five
460217 63323-462-17 0.5% 10 mL Single Dose Vials packaged in trays of twenty-five
460237 63323-462-37 0.5% 30 mL Single Dose Vials packaged in trays of twenty-five
460231 63323-462-31 0.5% 30 mL Single Dose Vials packaged in fives.
461037 63323-460-37 0.75% 30 mL Single Dose Vials packaged in trays of twenty-five

Without Epinephrine

Product No. NDC No. Strength Size
460417 63323-464-17 0.25% 10 mL Single Dose Vials packaged in trays of twenty-five
460437 63323-464-37 0.25% 30 mL Single Dose Vials packaged in trays of twenty-five
460431 63323-464-31 0.25% 30 mL Single Dose Vials packaged in fives.
460617 63323-466-17 0.5% 10 mL Single Dose Vials packaged in trays of twenty-five
460637 63323-466-37 0.5% 30 mL Single Dose Vials packaged in trays of twenty-five
460631 63323-466-31 0.5% 30 mL Single Dose Vials packaged in fives.
470217 63323-472-17 0.75% 10 mL Single Dose Vials packaged in trays of twenty-five
470237 63323-472-37 0.75% 30 mL Single Dose Vials packaged in trays of twenty-five

Sensorcaine (preserved with methylparaben) is available in the following forms:

With Epinephrine

Product No. NDC No. Strength Size
460157 63323-461-57 0.25% 50 mL Multiple Dose Vial spackaged in trays of twenty-five.
460357 63323-463-57 0.5% 50 mL Multiple Dose Vials packaged in trays of twenty-five.

Without Epinephrine

Product No. NDC No. Strength Size
460557 63323-465-57 0.25% 50 mL Multiple Dose Vials packaged in trays of twenty-five
460757 63323-467-57 0.5% 50 mL Multiple Dose Vials packaged in trays of twenty-five

Solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Solutions containing epinephrine should be protected from light.

Manufactured for: &PP Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Revised: August 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/7/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Related Drugs
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations