Nesacaine label

Nesacaine

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Side Effects & Adverse Reactions

LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND
MANAGEMENT OF DOSE RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM
THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN,
OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL
RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also
ADVERSE REACTIONS and PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE RELATED TOXICITY,
UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT
OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH. NESACAINE (chloroprocaine HCl Injection, USP) contains
methylparaben and should not be used for lumbar or caudal epidural anesthesia because safety of this antimicrobial preservative has
not been established with regard to intrathecal injection, either intentional or unintentional. NESACAINE-MPF Injection contains no
preservative; discard unused injection remaining in vial after initial use.
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have
been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have
involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intraarticular
infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to
determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain,
stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective
treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and
some required arthroplasty or shoulder replacement.
Vasopressors should not be used in the presence of ergot-type oxytocic drugs, since a severe persistent hypertension may occur.
To avoid intravascular injection, aspiration should be performed before the anesthetic solution is injected. The needle must be
repositioned until no blood return can be elicited. However, the absence of blood in the syringe does not guarantee that intravascular
injection has been avoided.
Mixtures of local anesthetics are sometimes employed to compensate for the slower onset of one drug and the shorter duration of
action of the second drug. Experiments in primates suggest that toxicity is probably additive when mixtures of local anesthetics
are employed, but some experiments in rodents suggest synergism. Caution regarding toxic equivalence should be exercised when
mixtures of local anesthetics are employed.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local
anesthesia by infiltration and peripheral nerve block. They are not to be used for lumbar or caudal epidural anesthesia.
Nesacaine-MPF 2% and 3% Injections, in single dose vials without preservative and without EDTA, are indicated for the production
of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks.
Nesacaine and Nesacaine-MPF Injections are not to be used for subarachnoid administration.

History

There is currently no drug history available for this drug.

Other Information

NESACAINE – chloroprocaine hydrochloride injection, solution
NESACAINE MPF – chloroprocaine hydrochloride injection, solution
APP Pharmaceuticals, LLC
For Infiltration and Nerve Block
DESCRIPTION
Nesacaine and Nesacaine-MPF Injections are sterile non pyrogenic local anesthetics. The active ingredient in Nesacaine and
Nesacaine-MPF Injections is chloroprocaine HCl (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride),
which is represented by the following structural formula:

Formula1.jpg

Table 1: Composition of Available Injections

Product Indentification Chloroprocaine HCl Sodium Chloride Disodium EDTA dihydrate Methylparaben
Nesacaine 1% 10 6.7 0.111 1
Nesacaine 2% 20 4.7 0.111 1
Nesacaine-MPF 2% 20 4.7 – –
Nesacaine-MPF 3% 30 3.3 – –

The solutions are adjusted to pH 2.7–4.0 by means of sodium hydroxide and/or hydrochloric acid. Filled under nitrogen.

Nesacaine and Nesacaine-MPF Injections should not be resterilized by autoclaving.

Nesacaine Manufacturers

  • General Injectables & Vaccines, Inc
    Nesacaine | General Injectables & Vaccines, Inc
    No Recall

    Nesacaine | General Injectables & Vaccines, Inc

    Nesacaine | General Injectables & Vaccines, Inc

    Chloroprocaine may be administered as a single injection or continuously through an indwelling catheter. As with all local
    anesthetics, the dose administered varies with the anesthetic procedure, the vascularity of the tissues, the depth of anesthesia and
    degree of muscle relaxation required, the duration of anesthesia desired, and the physical condition of the patient. The smallest
    dose and concentration required to produce the desired result should be used. Dosage should be reduced for children, elderly and

    debilitated patients and patients with cardiac and/or liver disease. The maximum single recommended doses of chloroprocaine in
    adults are: without epinephrine, 11 mg/kg, not to exceed a maximum total dose of 800 mg; with epinephrine (1:200,000), 14 mg/kg,
    not to exceed a maximum total dose of 1000 mg. 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. Nesacaine is not approved for this use (see WARNINGS and DOSAGE AND
    ADMINISTRATION).
    Caudal and Lumbar Epidural Block: In order to guard against adverse experiences sometimes noted following unintended
    penetration of the subarachnoid space, the following procedure modifications are recommended:
    1. Use an adequate test dose (3 mL of Nesacaine-MPF 3% Injection or 5 mL of Nesacaine-MPF 2% Injection) prior to induction
    of complete block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural
    catheter. Allow adequate time for onset of anesthesia following administration of each test dose.
    2. Avoid the rapid injection of a large volume of local anesthetic injection through the catheter. Consider fractional doses, when
    feasible.
    3. In the event of the known injection of a large volume of local anesthetic injection into the subarachnoid space, after suitable
    resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of
    cerebrospinal fluid (such as 10 mL) through the epidural catheter.
    As a guide for some routine procedures, suggested doses are given below:
    1. Infiltration and Peripheral Nerve Block: NESACAINE or NESACAINE-MPF (chloroprocaine HCl Injection, USP)

    Anesthetic Procedure
    Solution Concentration%
    Volume (mL)
    Total Dose (mg)
    Mandibular
    2
    2-3
    40-60
    Infraorbital
    2
    0.5-1
    10-20
    Brachial plexus
    2
    30-40
    600-800
    Digital (without epinephrine)
    1
    3-4
    30-40
    Pudendal
    2
    10 each side
    400
    Paracervical (see also PRECAUTIONS)
    1
    3 per each of 4sites
    up to 120
    2. Caudal and Lumbar Epidural Block: NESACAINE-MPF INJECTION.
    For caudal anesthesia, the initial dose is 15 to 25 mL of a 2% or 3% solution. Repeated doses may be given at 40 to 60 minute
    intervals.
    For lumbar epidural anesthesia, 2 to 2.5 mL per segment of a 2% or 3% solution can be used. The usual total volume of
    Nesacaine-MPF Injection is from 15 to 25 mL. Repeated doses 2 to 6 mL less than the original dose may be given at 40 to 50 minute
    intervals.
    The above dosages are recommended as a guide for use in the average adult. Maximum dosages of all local anesthetics must be
    individualized after evaluating the size and physical condition of the patient and the rate of systemic absorption from a particular
    injection site.
    Pediatric Dosage: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and
    weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is
    determined by the child’s age and weight and should not exceed 11 mg/kg (5 mg/lb). For example, in a child of 5 years weighing
    50 lbs (23 kg), the dose of chloroprocaine HCl without epinephrine would be 250 mg. Concentrations of 0.5–1% are suggested for
    infiltration and 1–1.5% for nerve block. In order to guard against systemic toxicity, the lowest effective concentration and lowest
    effective dose should be used at all times. Some of the lower concentrations for use in infants and smaller children are not available
    in prepackaged containers; it will be necessary to dilute available concentrations with the amount of 0.9% sodium chloride injection
    necessary to obtain the required final concentration of chloroprocaine injection.
    Preparation of Epinephrine Injections—To prepare a 1:200,000 epinephrine-chloroprocaine HCl injection, add 0.1 mL of a 1 to
    1000 Epinephrine Injection USP to 20 mL of Nesacaine-MPF Injection.
    Chloroprocaine is incompatible with caustic alkalis and their carbonates, soaps, silver salts, iodine and iodides.
    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever
    injection and container permit. As with other anesthetics having a free aromatic amino group, Nesacaine and Nesacaine-MPF
    Injections are slightly photosensitive and may become discolored after prolonged exposure to light. It is recommended that these vials
    be stored in the original outer containers, protected from direct sunlight. Discolored injection should not be administered. If exposed
    to low temperatures, Nesacaine and Nesacaine-MPF Injections may deposit crystals of chloroprocaine HCl which will redissolve with
    shaking when returned to room temperature. The product should not be used if it contains undissolved (eg, particulate) material.
  • General Injectables & Vaccines, Inc
    Nesacaine | General Injectables & Vaccines, Inc
    No Recall

    Nesacaine | General Injectables & Vaccines, Inc

    Nesacaine | General Injectables & Vaccines, Inc

    Chloroprocaine may be administered as a single injection or continuously through an indwelling catheter. As with all local anesthetics, the dose administered varies with the anesthetic procedure, the vascularity of the tissues, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be used. Dosage should be reduced for children, elderly and debilitated patients and patients with cardiac and/or liver disease. The maximum single recommended doses of chloroprocaine in adults are: without epinephrine, 11 mg/kg, not to exceed a maximum total dose of 800 mg; with epinephrine (1:200,000), 14 mg/kg, not to exceed a maximum total dose of 1000 mg. 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. Nesacaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

    Caudal and Lumbar Epidural Block: In order to guard against adverse experiences sometimes noted following unintended penetration of the subarachnoid space, the following procedure modifications are recommended:

    1. Use an adequate test dose (3 mL of Nesacaine-MPF 3% Injection or 5 mL of Nesacaine-MPF 2% Injection) prior to induction of complete block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. Allow adequate time for onset of anesthesia following administration of each test dose.

    2. Avoid the rapid injection of a large volume of local anesthetic injection through the catheter. Consider fractional doses, when feasible.

    3. In the event of the known injection of a large volume of local anesthetic injection into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

    As a guide for some routine procedures, suggested doses are given below:

    1. Infiltration and Peripheral Nerve Block: NESACAINE or NESACAINE-MPF (chloroprocaine HCL Injection, USP)

    2. Caudal and Lumbar Epidural Block: NESACAINE-MPF INJECTION.

    For caudal anesthesia, the inital dose is 15 to 25 mL of a 2% or 3% solution. Repeated doses may be given at 40 to 60 minute intervals.

    For lumbar epidural anesthesia, 2 to 2.5 mL per segment of a 2% of 3% solution can be used. The usual total volume of Nesacaine-MPF Injection is from 15 to 25 mL. Repeated doses 2 to 6 mL less than the original dose may be given at 40 to 50 minute intervals.

    The above dosages are recommended as a guide for use in the average adult. Maximum dosages of all local anesthetics must be individualized after evaluating the size and physical condition of the patient and the rate of systemic absorption from a particular injection site.

    Pediatric Dosage: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's age and weight and should not exceed 11 mg/kg (5 mg/lb). For example, in a child of 5 years weighing 50 lbs (23 kg), the dose of chloroprocaine HCL without epinephrine would be 250 mg. Concentrations of 0.5-1% are suggested for infiltration and 1-1.5% for nerve block. In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. Some of the lower concentrations for use in infants and smaller children are not available in prepackaged containers; it will be necessary to dilute available concentrations with the amount of 0.9% sodium chloride injection necessary to obtain the required final concentration of chloroprocaine injection.

    Preparation of Epinephrine Injections - To prepare a 1:200,000 epinephrine-chloroprocaine HCL injection, add 0.1 mL of a 1 to 1000 Epinephrine Injection USP to 20 mL of Nesacaine-MPF Injection.

    Chloroprocaine is incompatible with caustic alkalis and their carbonates, soaps, silver salts, iodine and iodides.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever injection and container permit. As with other anesthetics having a free aromatic amino group, Nesacaine and Nesacaine-MPF Injections are slightly photosensitive and may become discolored after prolonged exposure to light. It is recommended that these vials be stored in the original outer containers, protected from direct sunlight. Discolored injection should not be administered. If exposed to low temperatures, Nesacaine and Nesacaine-MPF Injections may deposit crystals of chloroprocaine HCL which will redissolve with shaking when returned to room temperature. The product should not be used if it contains undissolved (eg, particulate) material.

  • Fresenius Kabi Usa, Llc
    Nesacaine | Fresenius Kabi Usa, Llc
    No Recall

    Nesacaine | Fresenius Kabi Usa, Llc

    Nesacaine | Fresenius Kabi Usa, Llc

    Chloroprocaine may be administered as a single injection or continuously through an indwelling catheter.  As with all local anesthetics, the dose administered varies with the anesthetic procedure, the vascularity of the tissues, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, and the physical condition of the patient.  The smallest dose and concentration required to produce the desired result should be used.  Dosage should be reduced for children, elderly and debilitated patients and patients with cardiac and/or liver disease.  The maximum single recommended doses of chloroprocaine in adults are: without epinephrine, 11 mg/kg, not to exceed a maximum total dose of 800 mg; with epinephrine (1:200,000), 14 mg/kg, not to exceed a maximum total dose of 1000 mg.  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.  Nesacaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION). 

    Caudal and Lumbar Epidural Block: In order to guard against adverse experiences sometimes noted following unintended penetration of the subarachnoid space, the following procedure modifications are recommended: 

    Use an adequate test dose (3 mL of Nesacaine-MPF 3% Injection or 5 mL of Nesacaine-MPF 2% Injection) prior to induction of complete block.  This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.  Allow adequate time for onset of anesthesia following administration of each test dose. Avoid the rapid injection of a large volume of local anesthetic injection through the catheter.  Consider fractional doses, when feasible. In the event of the known injection of a large volume of local anesthetic injection into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

    As a guide for some routine procedures, suggested doses are given below:

    Infiltration and Peripheral Nerve Block: NESACAINE or NESACAINE-MPF (chloroprocaine HCl Injection, USP)

    Anesthetic

    Procedure

    Solution Concentration %

    Volume

    (mL)

    Total

    Dose

    (mg)

    Mandibular

    Infraorbital

    Brachial plexus

    Digital (without epinephrine)

    Pudendal

    Paracervical (see also PRECAUTIONS)

    2

    2

    2

    1

    2

    1

    2  to 3

    0.5 to 1

    30 to 40

    3 to 4

    10 each side

    3 per each

    of 4 sites

    40 to 60

    10 to 20

    600 to 800

    30 to 40

    400

    up to 120

     

             2. Caudal and Lumbar Epidural Block: NESACAINE-MPF INJECTION.

             For caudal anesthesia, the initial dose is 15 to 25 mL of a 2% or 3% solution.  Repeated doses may be given at 40 to 60 minute intervals.

             For lumbar epidural anesthesia, 2 to 2.5 mL per segment of a 2% or 3% solution can be used.  The usual total volume of Nesacaine-MPF Injection is from 15 to 25 mL.  Repeated doses 2 to 6 mL less than the original dose may be given at 40 to 50 minute intervals.

    The above dosages are recommended as a guide for use in the average adult.  Maximum dosages of all local anesthetics must be individualized after evaluating the size and physical condition of the patient and the rate of systemic absorption from a particular injection site.

    Pediatric Dosage: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight.  For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight and should not exceed 11 mg/kg (5 mg/lb).  For example, in a child of 5 years weighing 50 lbs (23 kg), the dose of chloroprocaine HCl without epinephrine would be 250 mg.  Concentrations of 0.5 to 1% are suggested for infiltration and 1 to 1.5% for nerve block.  In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times.  Some of the lower concentrations for use in infants and smaller children are not available in prepackaged containers; it will be necessary to dilute available concentrations with the amount of 0.9% sodium chloride injection necessary to obtain the required final concentration of chloroprocaine injection.

    Preparation of Epinephrine Injections—To prepare a 1:200,000 epinephrine-chloroprocaine HCl injection, add 0.1 mL of a 1 to 1000 Epinephrine Injection USP to 20 mL of Nesacaine-MPF Injection.

    Chloroprocaine is incompatible with caustic alkalis and their carbonates, soaps, silver salts, iodine and iodides.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever injection and container permit.  As with other anesthetics having a free aromatic amino group, Nesacaine and Nesacaine-MPF Injections are slightly photosensitive and may become discolored after prolonged exposure to light.  It is recommended that these vials be stored in the original outer containers, protected from direct sunlight.  Discolored injection should not be administered.  If exposed to low temperatures, Nesacaine and Nesacaine-MPF Injections may deposit crystals of chloroprocaine HCl which will redissolve with shaking when returned to room temperature.  The product should not be used if it contains undissolved (eg, particulate) material.