Bupivacaine Hydrochloride And Epinephrine

Bupivacaine Hydrochloride And Epinephrine Manufacturers

• General Injectables & Vaccines, Inc
  

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  Bupivacaine Hydrochloride And Epinephrine | General Injectables & Vaccines, Inc

  

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  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 Bupivacaine Hydrochloride 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 intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Bupivacaine Hydrochloride is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).
  In recommended doses, Bupivacaine Hydrochloride 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 Bupivacaine Hydrochloride 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 Bupivacaine Hydrochloride 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, Bupivacaine Hydrochloride is not
  recommended for pediatric patients younger than 12 years. Bupivacaine Hydrochloride is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block). Use in Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 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 ampuls 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 Bupivacaine Hydrochloride (0.5% bupivacaine with 1:200,000 epinephrine in a 3 mL ampul) 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.) Unused portions of solution not containing preservatives, i.e., those supplied in single-dose ampuls and single-dose vials, should be discarded following initial use. This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.

  Table 1.

  Recommended Concentrations and Doses of Bupivacaine Hydrochloride Type of
  Each Dose
  Motor Block
  Conc.
  (mL)
  (mg)
  Block(1)
  Local infiltration
  0.25%(4)
  
  up to max.
  
  up to max.
  
  -
  Epidural
  
  
  0.75%(2,4)
  0.5%(4)
  0.25%(4) 10-20
  10-20
  10-20 75-150
  50-100
  25-50 complete
  moderate to complete
  partial to moderate
  Caudal
  
  0.5%(4)
  0.25%(4)
  15-30
  15-30
  75-150
  37.5-75
  moderate to complete
  moderate
  Peripheral nerves
  
  0.5%(4)
  0.25%(4)
  5 to max.
  5 to max.
  25 to max.
  12.5 to max.
  moderate to complete
  moderate to complete
  Retrobulbar(3)
  0.75%
  2-4
  15-30
  complete
  Sympathetic
  0.25%
  20-50
  50-125
  -
  Epidural(3)
  0.5%
  2-3
  10-15
  -
  Test Dose
  w/ epi
  
  (10-15 micrograms epinephrine)
  
  (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.
  (2)For single-dose use, not for intermittent epidural technique. Not for obstetrical anesthesia.
  (3)See PRECAUTIONS.
  (4)Solutions with or without epinephrine.
  

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• Hospira, Inc.
  

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  Bupivacaine Hydrochloride And Epinephrine | Hospira, Inc.

  

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  As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.

  The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time (see CLINICAL PHARMACOLOGY). The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of 0.5% BUPIVACAINE HCl with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, BUPIVACAINE HCl in dentistry is not recommended for children younger than 12 years.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Cardinal Health
  

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  Bupivacaine Hydrochloride And Epinephrine | Cardinal Health

  

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  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 Bupivacaine Hydrochloride 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 intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Bupivacaine Hydrochloride is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  In recommended doses, Bupivacaine Hydrochloride 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 Bupivacaine Hydrochloride 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 Bupivacaine Hydrochloride 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, Bupivacaine Hydrochloride is not recommended for pediatric patients younger than 12 years. Bupivacaine Hydrochloride is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block).

  Use in Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 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 ampuls 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 Bupivacaine Hydrochloride (0.5% bupivacaine with 1:200,000 epinephrine in a 3 mL ampul) 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.)

  Unused portions of solution not containing preservatives, i.e., those supplied in single-dose ampuls and single-dose vials, should be discarded following initial use.

  This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.
   

  Table 1. Recommended Concentrations and Doses of Bupivacaine Hydrochloride

  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

  10-20

  75-150

  complete

  0.5%4

   

  10-20

   

  50-100

   

  moderate

  to complete

  0.25%4

   

  10-20

   

  25-50

   

  partial

  to moderate

  Caudal

  0.5%4

   

  15-30

   

  75-150

   

  moderate

  to complete

  0.25%4

  15-30

  37.5-75

  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

  2-4

  15-30

  complete

  Sympathetic

  0.25%

  20-50

  50-125

  ─

  Epidural3

  Test Dose

  0.5%

  w/epi

   

  2-3

   

   

  10-15

  (10-15 micrograms

  epinephrine)

  ─

  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.

  2   For single-dose use, not for intermittent epidural technique. Not for obstetrical anesthesia.

  3   See PRECAUTIONS.

  4   Solutions with or without epinephrine.

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