Chloroprocaine

Chloroprocaine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Chloroprocaine is a local anesthetic that is FDA approved for the {{{indicationType}}} of local anesthesia. Common adverse reactions include neurologic: dizziness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Dosage varies with anesthetic procedure, vascularity of tissues, depth of anesthesia, degree of muscle relaxation required, duration of anesthesia, and physical condition of patient
• Local anesthesia: maximum single doses (without epinephrine), 11 mg/kg, not to exceed 800 mg.
• Local anesthesia: maximum single doses (with epinephrine 1:200,000), 14 mg/kg, not to exceed 1000 mg.
• Local anesthesia: (brachial plexus) 30 to 40 mL (600 to 800 mg) as a 2% solution [1]
• Local anesthesia: (caudal epidural) 15 to 25 mL of 2% or 3% methylparaben-free (MPF) solution, repeated every 40-60 min.
• Local anesthesia: (digital, without epinephrine) 3 to 4 mL (30 to 40 mg) as a 1% solution (without epinephrine).
• Local anesthesia: (infraorbital) 0.5 to 1 mL (10 to 20 mg) as a 2% solution.
• Local anesthesia: (lumbar epidural) 2 to 2.5 mL per segment of 2% or 3% methylparaben-free (MPF) solution; usual total volume 15 to 25 mL; repeat doses of 2 to 6 mL less than original dose may be given at 40 to 50 min intervals.
• Local anesthesia: (mandibular) 2 to 3 mL (40 to 60 mg) as a 2% solution.
• Local anesthesia: (paracervical) 3 mL per each of 4 sites as a 1% solution, total dose up to 120 mg.
• Local anesthesia: (pudendal) 10 mL on each side as a 2% solution, total dose 400 mg.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Chloroprocaine in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Chloroprocaine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Dosage must be individualized based on age and weight of patient.
• Local anesthesia: (infiltration) older than 3 years of age, 0.5% to 1% solution; max 11 mg/kg .
• Local anesthesia: (nerve blocks) older than 3 years of age, 1% to 1.5% solution; max 11 mg/kg .

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Chloroprocaine in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Chloroprocaine in pediatric patients.

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.

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 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.

Adverse Reactions

Clinical Trials Experience

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. In a survey of studies of epidural anesthesia, overt toxicity progressing to convulsions occurred in approximately 0.1 percent of local anesthetic administrations.

Cardiovascular System Reactions: High doses, or unintended intravascular injection, may lead to high plasma levels and related depression of the myocardium, hypotension, bradycardia, ventricular arrhythmias, and, possibly, cardiac arrest.

Allergic: Allergic type reactions are rare and may occur as a result of sensitivity to the local anesthetic or to other formulation ingredients, such as the antimicrobial preservative methylparaben, contained in multiple dose vials. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid type symptomatology (including severe hypotension). Cross sensitivity among members of the ester-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitely established.

Neurologic: In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur (see PRECAUTIONS). Subsequent adverse observations may depend partially on the amount of drug administered intrathecally. These observations may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Arachnoiditis, persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances (see DOSAGE AND ADMINISTRATION discussion of Caudal and Lumbar Epidural Block). Backache and headache have also been noted following lumbar epidural or caudal block.

Postmarketing Experience

There is limited information regarding Chloroprocaine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Chloroprocaine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Chloroprocaine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chloroprocaine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chloroprocaine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Chloroprocaine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Chloroprocaine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Chloroprocaine in geriatric settings.

Gender

There is no FDA guidance on the use of Chloroprocaine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chloroprocaine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chloroprocaine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chloroprocaine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chloroprocaine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chloroprocaine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Chloroprocaine Administration in the drug label.

Monitoring

There is limited information regarding Chloroprocaine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Chloroprocaine and IV administrations.

Overdosage

There is limited information regarding Chloroprocaine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Chloroprocaine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Chloroprocaine Mechanism of Action in the drug label.

Structure

There is limited information regarding Chloroprocaine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Chloroprocaine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Chloroprocaine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Chloroprocaine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Chloroprocaine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Chloroprocaine How Supplied in the drug label.

Storage

There is limited information regarding Chloroprocaine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Chloroprocaine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Chloroprocaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Chloroprocaine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Chloroprocaine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.