Nesacaine

Dosage Forms & Strengths

injectable solution

• 1%
• 2%
• 3%

Caudal & Lumbar Epidural Block

Use chloroprocaine without preservatives

Caudal/epidural block: 2%-3% (preservative-free) total dose 300-750 mg q40-60min

Lumbar/sacral region: 40-75 mg for each segment to be anesthetized

Infiltration & Peripheral Nerve Block

Infiltration/peripheral nerve block: 1%-2%

Mandibular (2% solution): 40-60 mg (2-3 mL)

Infraorbital (2% solution): 10-20 mg (0.5-1 mL)

Brachial plexus (2% solution): 600-800 mg (30-40 mL)

Digital: 1% without epinephrine; 3-4 mL (30-40 mg total dose)

Pudendal (2% solution): 10 mL (400 mg total dose)

Paracervical (1% solution): 30 mg (3 mL) per site

Single doses should not exceed 800 mg; single dose with epinephrine should not exceed 1000 mg

Cervical/thoracic region: 30-60 mg for each segment to be anesthetized

Dosage Forms & Strengths

injectable solution

• 1%
• 2%
• 3%

Infiltration

< 3 years

• Safety and efficacy not established

> 3 years

• 0.5 - 1% concentration recommended; not to exceed 11 mg/kg

Nerve Block

< 3 years

• Safety and efficacy not established

> 3 years

• 1 - 1.5% concentration recommended; not to exceed 11 mg/kg

Frequency Not Defined

Common

• Anxiety
• Dizziness
• Restlessness
• Tremor
• Tinnitus
• Blurred vision

Rare (serious)

• Bradyarrhythmia
• Cardiac arrest
• Hypotension
• Excitation
• Depression
• Seizure
• Anaphylaxis
• Respiratory arrest

NESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:

NESACAINE-MPF (chloroprocaine HCl Injection, USP) without preservatives and without EDTA is supplied as follows:

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 2010

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.

For all uses of this medicine:

• Tell all of your health care providers that you take Nesacaine. This includes your doctors, nurses, pharmacists, and dentists.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Nesacaine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Epidural:

• This medicine may cause short-term loss of feeling and motor activity in the lower half of your body. Do not try to get out of bed or do other tasks or actions until feeling and motor activity have returned to normal.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of this medicine:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very upset stomach or throwing up.
• Sneezing.
• Sweating a lot.
• Fever.
• Very nervous and excitable.
• Feeling sleepy.
• Restlessness.
• Anxiety.
• Shakiness.
• Dizziness or passing out.
• Ringing in ears.
• Low mood (depression).
• Blurred eyesight.
• Change in balance.
• Seizures.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Chest pain or pressure.
• Very bad irritation where the shot was given.
• Change in color of skin to blue-black.

Epidural:

• Not able to control bladder.
• Not able to control bowels.
• Change in sex ability.
• Backache.

Nesacaine - chloroprocaine hydrochloride injection, solution
Nesacaine MPF - chloroprocaine hydrochloride injection, solution
APP Pharmaceuticals, LLC
For Infiltration and Nerve Block
DESCRIPTION
Nesacaine and Nesacaine-MPF Injections are sterile non pyrogenic local anesthetics. The active ingredient in Nesacaine and
Nesacaine-MPF Injections is chloroprocaine HCl (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride),
which is represented by the following structural formula:

Table 1: Composition of Available Injections

The solutions are adjusted to pH 2.7–4.0 by means of sodium hydroxide and/or hydrochloric acid. Filled under nitrogen.
Nesacaine and Nesacaine-MPF Injections should not be resterilized by autoclaving.

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.

HOW SUPPLIED
Nesacaine (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:

Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Nesacaine-MPF (chloroprocaine HCl Injection, USP) without preservatives and without EDTA is supplied as follows:

All trademarks are the property of APP Pharmaceuticals, LLC.

APP
Fresenius Kabi, LLC

Lake Zurich, IL 60047

451109E/Revised: December 2013