Chloroprocaine

Mechanism-of-action class: Sodium Channel Interactions.

• 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.

• 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.contraindicated

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 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 chloroprocaine hydrochloride injection 3% or 5 mL of chloroprocaine hydrochloride injection 2%) prior to induction of complete block.

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 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.

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, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered.

Pregnancy Teratogenic Effects, Pregnancy Category C Animal reproduction studies have not been conducted with chloroprocaine. It is also not known whether chloroprocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Chloroprocaine should be given to a pregnant woman only if clearly needed. This does not preclude the use of chloroprocaine at term for the production of obstetrical anesthesia.

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS , WARNINGS and PRECAUTIONS ). In mice, the intravenous LD50 of chloroprocaine HCl is 97 mg/kg and the subcutaneous LD50 of chloroprocaine HCl is 950 mg/kg. Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.

• Mar 11, 1955NDANDA009435Fresenius Kabi Usa
• Sep 9, 1998ANDAANDA040273Hikma
• Sep 27, 2022NDANDA216227Harrow Eye

1. 1Eye Pain1019%
2. 2Drug Ineffective713%
3. 3Off Label Use713%
4. 4Product Temperature Excursion Issue713%
5. 5Hypotension35.6%
6. 6Product Label Confusion35.6%
7. 7Anaesthetic Complication23.7%
8. 8Areflexia23.7%
9. 9Arthralgia23.7%
10. 10Back Pain23.7%
11. 11Bradycardia23.7%
12. 12Corneal Abrasion23.7%
13. 13Drug Dose Omission23.7%
14. 14Dyspnoea23.7%
15. 15Eye Irritation23.7%

The 10 most recently updated of 51 ClinicalTrials.gov registrations naming Chloroprocaine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
  Recruiting · Phase 4 · Interventional · 128 enrolled · Duke University
  NCT07348614updated 2026-06-03
• Local Anesthetic Clinical Trial
  Enrolling by invitation · Phase 4 · Interventional · 400 enrolled · Baylor Research Institute
  NCT07601750updated 2026-05-22
• Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections
  Enrolling by invitation · Phase 4 · Interventional · 236 enrolled · Harrow Inc
  NCT07456826updated 2026-04-07
• The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
  Completed · Phase 2 · Interventional · 164 enrolled · Sintetica SA
  NCT03918798updated 2026-03-23
• Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
  Completed · Phase 3 · Interventional · 74 enrolled · Sintetica SA
  NCT05926258updated 2026-03-09
• Targeted Nerve Injection to the Knee (Nerve to Vastus Medialis): Comparing Two Adductor Canal Block Approaches
  Not yet recruiting · Phase 4 · Interventional · 25 enrolled · Duke University
  NCT07444827updated 2026-03-03
• Comparing Spinal Anesthesia With 1% Chloroprocaine Versus 1% Mepivacaine in Patients Undergoing Outpatient Primary Total Knee Arthroplasty
  Not yet recruiting · Phase 4 · Interventional · 170 enrolled · Nova Scotia Health Authority
  NCT07239999updated 2026-02-06
• The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine
  Completed · Phase 4 · Interventional · 100 enrolled · Harrow Inc
  NCT05934253updated 2025-09-16
• Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section
  Recruiting · Interventional · 60 enrolled · Aretaieion University Hospital
  NCT06376058updated 2025-07-22
• Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES
  Enrolling by invitation · Interventional · 20 enrolled · University of Kansas Medical Center
  NCT05688943updated 2025-06-05

Frequently asked questions

How does Chloroprocaine work?

Mechanism-of-action class: Sodium Channel Interactions.

What is Chloroprocaine used for?

According to FDA labeling, Chloroprocaine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Chloroprocaine?

Chloroprocaine is classified as Esters of aminobenzoic acid, Local anesthetics, Ester Local Anesthetic, Sodium Channel Interactions, Decreased Organized Electrical Activity, Local Anesthesia.

What are the brand names for Chloroprocaine?

Chloroprocaine is marketed under brand names including Clorotekal, Iheezo, Nesacaine.

What are the contraindications for Chloroprocaine?

Chloroprocaine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.