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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.
Chloroprocaine Hydrochloride 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 intra-articular 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.
Chloroprocaine Hydrochloride Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Chloroprocaine Hydrochloride Injection in single-dose containers without preservative and without EDTA, is indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks.
Chloroprocaine Hydrochloride Injection is not to be used for subarachnoid administration.
History
There is currently no drug history available for this drug.
Other Information
Chloroprocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic, isobaric solution. Each milliliter of 2% solution contains 20 mg of chloroprocaine hydrochloride; 4 mg sodium chloride; with 1.8 mg sodium metabisulfite added in water for injection. Each milliliter of 3% solution contains 30 mg of chloroprocaine hydrochloride; 2.1 mg sodium chloride; with 1.8 mg sodium metabisulfite added in water for injection. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It contains no bacteriostat, antimicrobial agent or added buffer. Discard unused portion.
It is intended for production of local anesthesia by nerve block, infiltration, caudal or other epidural blocks.
Chloroprocaine Hydrochloride Injection has a pH of 3.1 (2.7 to 4.0).
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
Chloroprocaine Hydrochloride Injection is identified chemically as 2-(diethylamino) ethyl 4‑amino-2 chlorobenzoate monohydrochloride. Its molecular Formula is: C13H19ClN2O2•HCl and the molecular weight is 307.22. It has the following structural formula:
Sources
Chloroprocaine Hydrochloride Manufacturers
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Hospira, Inc.
Chloroprocaine Hydrochloride | Hospira, 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. Chloroprocaine 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 3% or 5 mL of 2% Chloroprocaine Hydrochloride 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: Chloroprocaine Hydrochloride Injection
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
1
3 per each
of 4 sites
up to 120
(see also PRECAUTIONS)
2. Caudal and Lumbar Epidural Block: 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 Chloroprocaine Hydrochloride 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 pre-packaged 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 0.15 mL of 1 to 1000 Epinephrine Injection to 30 mL of Chloroprocaine Hydrochloride 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, Chloroprocaine Hydrochloride Injection is slightly photosensitive and may become discolored after prolonged exposure to light. It is recommended that this product be stored in the original outer containers, protected from direct sunlight. Discolored injection should not be administered. If exposed to low temperatures, Chloroprocaine Hydrochloride Injection 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 (e.g., particulate) material.
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