Nesacaine 10 mg/mL
CHLOROPROCAINE HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Nesacaine is a injection, solution containing chloroprocaine hydrochloride at 10 mg/mL, taken infiltration. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Nesacaine
- Generic Name
- CHLOROPROCAINE HYDROCHLORIDE
- NDC Code (Product)
63323-475- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INFILTRATION, PERINEURAL
- Marketing Status
- Application #
- NDA009435
- Marketing Start
- 10/14/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & 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 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 Epidur…
Warnings
WARNINGS 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 u…
Contraindications
CONTRAINDICATIONS Nesacaine and Nesacaine-MPF Injections are contraindicated in patients hypersensitive (allergic) to drugs of the PABA ester group. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the following conditions: existing neurological disease, spinal deformities, septicemia, and severe hypertension.
Adverse Reactions
ADVERSE REACTIONS Systemic: The most commonly encountered acute adverse experiences that demand immediate countermeasures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and may result from rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) may result in underventilation or apnea (“Total Spinal”). Factors influencing plasma protein binding, such as acidosis, systemic diseases that alter protein production, or competition of other drugs for protein binding sites, may diminish individual tolerance. Plasma cholinesterase deficiency may also account for diminished tolerance to ester-type local anesthetics. Central Nervous System Reactions: These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision or tremors may occur, possi…
Frequently Asked Questions
What is Nesacaine used for?
Nesacaine contains CHLOROPROCAINE HYDROCHLORIDE. It is a injection, solution taken infiltration. Consult your doctor for specific uses.
Is Nesacaine a controlled substance?
Nesacaine is not classified as a controlled substance by the DEA.
What is the generic name for Nesacaine?
The generic name for Nesacaine is CHLOROPROCAINE HYDROCHLORIDE. There are 6 other brand versions of CHLOROPROCAINE HYDROCHLORIDE.
What is the NDC code for Nesacaine 10 mg/mL?
The NDC (National Drug Code) for Nesacaine 10 mg/mL is 63323-475, listed by Fresenius Kabi USA, LLC.