Chloroprocaine Hydrochloride 30 mg/mL
Chloroprocaine Hydrochloride · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
Chloroprocaine hydrochloride is a local anesthetic given by injection into the epidural space to numb areas of the body during surgical procedures or pain management. It works by blocking nerve signals in the region where it is administered.
Key Facts
- Brand Name
- Chloroprocaine Hydrochloride
- Generic Name
- Chloroprocaine Hydrochloride
- NDC Code (Product)
0143-9210- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 30 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL
- Marketing Status
- Application #
- ANDA040273
- Marketing Start
- 11/01/1998
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 Chloroprocaine hydrochloride injection 2% and 3%, in single dose vials, without methylparaben preservative, 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.
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. Chloroprocaine hydrochloride injection is not approved for this use. (See WARNINGS and DOSAGE AND ADMINISTRATI…
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. Chloroprocaine hydrochloride injection, methylparaben free, 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 postmarketing 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 pediatr…
Contraindications
CONTRAINDICATIONS Chloroprocaine hydrochloride is 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.
Drug Interactions
Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe, prolonged hypotension or hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. The para-aminobenzoic acid metabolite of chloroprocaine inhibits the action of sulfonamides. Therefore, chloroprocaine should not be used in any condition in which a sulfonamide drug is being employed.
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 Chloroprocaine Hydrochloride used for?
Chloroprocaine hydrochloride is a local anesthetic given by injection into the epidural space to numb areas of the body during surgical procedures or pain management. It works by blocking nerve signals in the region where it is administered.
Is Chloroprocaine Hydrochloride a controlled substance?
Chloroprocaine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Chloroprocaine Hydrochloride?
The generic name for Chloroprocaine Hydrochloride is Chloroprocaine Hydrochloride. There are 5 other brand versions of Chloroprocaine Hydrochloride.
What is the NDC code for Chloroprocaine Hydrochloride 30 mg/mL?
The NDC (National Drug Code) for Chloroprocaine Hydrochloride 30 mg/mL is 0143-9210, listed by Hikma Pharmaceuticals USA Inc..