Sensorcaine

Sensorcaine Manufacturers

• General Injectables & Vaccines, Inc
  

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  Sensorcaine | 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 Sensorcaine should be reduced for young, 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. Sensorcaine is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).).
  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 up to 400 mg have been
  reported. 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
  See 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

  
  
  Each Dose
  Each Dose
  
  Type of Block
  Conc.
  (mL)
  (mg)
  Motor Block (1)
  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
  Retrobulbar (3)
  0.75% (4)
  2 to 4
  15 to 30
  complete
  Sympathetic
  0.25%
  20 to 50
  50 to 125
  
  Epidural (3)
  0.5%
  2 to 3
  10 to 15
  
  Test Dose
  w/epi
  
  10 to 15 mcg epinephrine (see PRECAUTIONS)
  10 to 15 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.
  2 For single dose use, not for intermittent epidural technique. Not for obstetric anesthesia.
  3 See PRECAUTIONS.
  4 Solutions with or without epinephrine.
  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever
  the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a
  precipitate.
  

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• General Injectables & Vaccines, Inc
  

  ×

  Sensorcaine | General Injectables & Vaccines, Inc

  

  ---

  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 young, 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. Sensorcaine is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).).
  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 up to 400 mg have been
  reported. 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
  See 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

  
  
  Each Dose
  Each Dose
  
  Type of Block
  Conc
  (mL)
  (mg)
  Motor Block (1)
  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
  Retrobulbar (3)
  0.75% (4)
  2 to 4
  15 to 30
  complete
  Sympathetic
  0.25%
  20 to 50
  50 to 125
     _
  Epidural (3)
  0.5%
  2 to 3
  10 to 15
     _
  Test Dose
  w/epi
  
  10 to 15 mcg epinephrine (see PRECAUTIONS)
  10 to 15 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.
  2 For single dose use, not for intermittent epidural technique. Not for obstetric anesthesia.
  3 See PRECAUTIONS.
  4 Solutions with or without epinephrine.
  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever
  the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a
  precipitate.
  HOW SUPPLIED
  SOLUTIONS OF SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) SHOULD NOT BE USED FOR THE PRODUCTION
  OF SPINAL ANESTHESIA (SUBARACHNOID BLOCK) BECAUSE OF INSUFFICIENT DATA TO SUPPORT SUCH USE.
  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 25.
  460817
  63323-468-17
  0.25%
  10 mL Single Dose Vials packaged in trays of 25.
  460217
  63323-462-17
  0.5%
  10 mL Single Dose Vials packaged in trays of 25.
  460237
  63323-462-37
  0.5%
  30 mL Single Dose Vials packaged in trays of 25.
  460231
  63323-462-31
  0.5%
  30 mL Single Dose Vials packaged in 5.
  461037
  63323-460-37
  0.75%
  30 mL Single Dose Vials packaged in trays of 25.
  Without Epinephrine:
  Product No.
  NDC No.
  Strength
  Size
  460417
  63323-464-17
  0.25%
  10 mL Single Dose Vials packaged in trays of 25.
  460433*
  63323-464-33
  0.25%
  30 mL ampules packaged in 5.
  460437
  63323-464-37
  0.25%
  30 mL Single Dose Vials packaged in trays of 25.
  460431
  63323-464-31
  0.25%
  30 mL Single Dose Vials packaged in 5.
  460617
  63323-466-17
  0.5%
  10 mL Single Dose Vials packaged in trays of 25.
  460637
  63323-466-37
  0.5%
  30 mL Single Dose Vials packaged in trays of 25.
  460631
  63323-466-31
  0.5%
  30 mL Single Dose Vials packaged in 5.
  460633*
  63323-466-33
  0.5%
  30 mL ampules packaged in 5.
  470217
  63323-472-17
  0.75%
  10 mL Single Dose Vials packaged in trays of 25.
  470237
  63323-472-37
  0.75%
  30 mL Single Dose Vials packaged in trays of 25.
  470233*
  63323-472-33
  0.75%
  30 mL ampules packaged in 5.
  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 Vials packaged in trays of 25.
  460357
  63323-463-57
  0.5%
  50 mL Multiple Dose Vials packaged in trays of 25
  Without Epinephrine:
  Product No.
  NDC No.
  Strength
  Size
  460557
  63323-465-57
  0.25%
  50 mL Multiple Dose Vials packaged in trays of 25.
  460757
  63323-467-57
  0.5%
  50 mL Multiple Dose Vials packaged in trays of 25.
  * Products manufactured for APP Pharmaceuticals, LLC.
  Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.), should not be
  used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema. When chemical
  disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is
  recommended that chemical disinfection be accomplished by wiping the ampule or vial stopper thoroughly with cotton or gauze that
  has been moistened with the recommended alcohol just prior to use.
  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.
  All trademarks are the property of APP Pharmaceuticals, LLC.
  
  APP
  APP Pharmaceuticals, LLC
  Schaumburg, IL 60173
  
  451106D/Revised: September 2010
  
  

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