"The US Food and Drug Administration (FDA) today approved a drug for children and adults with hemophilia B called albutrepenonacog alfa (Idelvion, CSL Behring), which combines albumin with factor IX to reduce injection frequency."...
Nesacaine (chloroprocaine) 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 (chloroprocaine) -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 (chloroprocaine) and Nesacaine (chloroprocaine) -MPF Injections are not to be used for subarachnoid administration.
DOSAGE AND ADMINISTRATION
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 intraarticular infusions of local anesthetics following arthroscopic and other surgical procedures. Nesacaine is not approved for this use (see WARNINGS)
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 (chloroprocaine) -MPF 3% Injection or 5 mL of Nesacaine (chloroprocaine) -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:
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 on each||400|
|Paracervical (see also PRECAUTIONS)||1||side 3 per each of 4 sites||up to 120|
2. Caudal and Lumbar Epidural Block: NESACAINE (chloroprocaine) -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 (chloroprocaine) -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 (chloroprocaine) and Nesacaine (chloroprocaine) -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 (chloroprocaine) 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.
NESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:
|Product No.||NDC No.||Strength||Vial size|
|470530||63323-475-30||1% (10 mg/mL)||30 mL multiple dose vial packaged individually.|
|470630||63323-476-30||2% (20 mg/mL)||30 mL multiple dose vial packaged individually.|
NESACAINE-MPF (chloroprocaine HCl Injection, USP) without preservatives and without EDTA is supplied as follows:
|Product No.||NDC No.||Strength||Vial size|
|470720||63323-477-20||2% (20 mg/mL)||20 mL single dose vial packaged individually.|
|470820||63323-478-20||3% (30 mg/mL)||20 mL single dose vial packaged individually.|
Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Manufactured for: APP Pharmaceuticals, LLC Schaumburg, ILS0173. Revised: February 2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/9/2010
Additional Nesacaine Information
- Nesacaine Drug Interactions Center: chloroprocaine inj
- Nesacaine Side Effects Center
- Nesacaine FDA Approved Prescribing Information including Dosage
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.
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