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Drug overview for CLOROTEKAL (chloroprocaine hcl/pf):
Generic name: chloroprocaine HCl/PF
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Anesthetics
Chloroprocaine hydrochloride is a short-acting local anesthetic of the ester type.
Chloroprocaine hydrochloride is used for infiltration anesthesia, and for peripheral, sympathetic, and epidural (including caudal) block anesthesia. Chloroprocaine hydrochloride solutions containing a preservative should not be used for caudal or epidural anesthesia. The drug is not used for spinal anesthesia. Chloroprocaine hydrochloride is not effective as a topical anesthetic.
Generic name: chloroprocaine HCl/PF
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Anesthetics
Chloroprocaine hydrochloride is a short-acting local anesthetic of the ester type.
Chloroprocaine hydrochloride is used for infiltration anesthesia, and for peripheral, sympathetic, and epidural (including caudal) block anesthesia. Chloroprocaine hydrochloride solutions containing a preservative should not be used for caudal or epidural anesthesia. The drug is not used for spinal anesthesia. Chloroprocaine hydrochloride is not effective as a topical anesthetic.
DRUG IMAGES
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The following indications for CLOROTEKAL (chloroprocaine hcl/pf) have been approved by the FDA:
Indications:
Spinal anesthesia
Professional Synonyms:
Intrathecal block
Local anesthetic intrathecal block
Subarachnoid block
Indications:
Spinal anesthesia
Professional Synonyms:
Intrathecal block
Local anesthetic intrathecal block
Subarachnoid block
The following dosing information is available for CLOROTEKAL (chloroprocaine hcl/pf):
Chloroprocaine hydrochloride may be administered by infiltration and by epidural (including caudal) block or by peripheral or sympathetic nerve block. Local anesthetics, including chloroprocaine hydrochloride, have been administered by continuous intra-articular infusion+ (e.g., for control of postoperative pain); however, such use has been associated with chondrolysis.(See Cautions: Musculoskeletal Effects in the Local Anesthetics, Parenteral, General Statement 72:00.) Chloroprocaine hydrochloride solutions containing preservatives should not be used for epidural or caudal block.
Partially used bottles of solutions which do not contain preservatives should be discarded.
Aspiration for blood should be performed prior to injection of chloroprocaine hydrochloride to avoid intravascular administration; however, a negative aspiration does not ensure protection against inadvertent intravascular injection.
Local anesthetics should only be administered by clinicians who are experienced in the diagnosis and management of dose-related toxicities and other acute emergencies associated with these agents. Resuscitative equipment, oxygen, drugs, and personnel required for treatment of adverse reactions should be immediately available when chloroprocaine is administered. For specific procedures and techniques of administration, specialized references should be consulted.
Dosage of chloroprocaine hydrochloride varies with the anesthetic procedure, the degree of anesthesia required, and individual patient response. The usual dosages should generally be reduced in young, geriatric, or debilitated patients and in patients with cardiac and/or hepatic disease. The smallest dose and lowest concentration required to produce the desired effect should be used.
Single adult doses of chloroprocaine hydrochloride (without epinephrine) should not exceed 800 mg. When administered with epinephrine (1:200,000), chloroprocaine hydrochloride doses should not exceed 1 g. The maximum dose in pediatric patients varies depending on age and weight.
In children older than 3 years of age who have normal lean body mass and normal body development, a maximum dose of 11 mg/kg is recommended. Chloroprocaine hydrochloride concentrations of 0.5-1% for infiltration and 1-1.5%
for nerve block are suggested in pediatric patients. It may be necessary to dilute commercially available concentrations with 0.9% sodium chloride injection to obtain the desired lower concentrations for use in infants and smaller children.
A 1:200,000 epinephrine/chloroprocaine hydrochloride solution may be prepared by adding 0.1 mL of 1:1000 epinephrine hydrochloride injection to 20 mL of a 2 or 3% chloroprocaine hydrochloride solution that does not contain a preservative. Solutions containing epinephrine should not be used for interdigital block.
Solutions of 2 or 3% chloroprocaine hydrochloride with or without epinephrine and containing no preservatives are used for epidural or caudal anesthesia. To prevent intravascular or subarachnoid injection of a large epidural dose of anesthetic solution, a test dose (approximately 3 mL of a 3% solution or 5 mL of a 2% solution) should be injected prior to administering the total dose. When clinical conditions permit, use of a test dose solution that contains epinephrine should be considered to detect inadvertent intravascular injection.
When a continuous block technique is used, a portion of each supplemental dose should be administered as a test dose to ensure that the catheter has not been displaced. At least 5 minutes should elapse after each test dose before proceeding further. Injection of a large, single dose through a catheter should be avoided; instead, the drug should be administered in fractional doses.
If a large volume of the drug is inadvertently injected into the subarachnoid space, consideration should be given to withdrawing a moderate volume (e.g., 10 mL) of cerebrospinal fluid through the catheter after appropriate resuscitation and if the catheter is in place to attempt recovery of the drug. For epidural anesthesia in the lumbar region, 2-2.5 mL of a 2 or 3% solution (40-75 mg) may be given for each segment.
The usual total volume is 15-25 mL (300-750 mg). Repeat doses which are 2-6 mL less than the initial dose may be given at 40- to 50-minute intervals. For caudal anesthesia, the initial dose is 15-25 mL of a 2 or 3% solution (300-750 mg) of chloroprocaine hydrochloride.
Repeat doses may be given at 40- to 60-minute intervals.
For infiltration or nerve block anesthesia, 1 or 2% chloroprocaine hydrochloride solutions may be employed. The following doses of chloroprocaine hydrochloride have been suggested for various nerve blocks in the average adult: mandibular nerve block, 2-3 mL of a 2% solution (40-60 mg); infraorbital nerve block, 0.5-1 mL of a 2% solution (10-20 mg); brachial plexus block, 30-40 mL of a 2% solution (600-800 mg); and interdigital block, 3-4 mL of a 1% solution without epinephrine (30-40 mg). In obstetrical anesthesia, the following doses have been suggested for nerve blocks: pudendal block, 10 mL of a 2% solution (200 mg) for each side; and for paracervical block, 3 mL of a 1% solution (30 mg) per each of 4 sites.
Partially used bottles of solutions which do not contain preservatives should be discarded.
Aspiration for blood should be performed prior to injection of chloroprocaine hydrochloride to avoid intravascular administration; however, a negative aspiration does not ensure protection against inadvertent intravascular injection.
Local anesthetics should only be administered by clinicians who are experienced in the diagnosis and management of dose-related toxicities and other acute emergencies associated with these agents. Resuscitative equipment, oxygen, drugs, and personnel required for treatment of adverse reactions should be immediately available when chloroprocaine is administered. For specific procedures and techniques of administration, specialized references should be consulted.
Dosage of chloroprocaine hydrochloride varies with the anesthetic procedure, the degree of anesthesia required, and individual patient response. The usual dosages should generally be reduced in young, geriatric, or debilitated patients and in patients with cardiac and/or hepatic disease. The smallest dose and lowest concentration required to produce the desired effect should be used.
Single adult doses of chloroprocaine hydrochloride (without epinephrine) should not exceed 800 mg. When administered with epinephrine (1:200,000), chloroprocaine hydrochloride doses should not exceed 1 g. The maximum dose in pediatric patients varies depending on age and weight.
In children older than 3 years of age who have normal lean body mass and normal body development, a maximum dose of 11 mg/kg is recommended. Chloroprocaine hydrochloride concentrations of 0.5-1% for infiltration and 1-1.5%
for nerve block are suggested in pediatric patients. It may be necessary to dilute commercially available concentrations with 0.9% sodium chloride injection to obtain the desired lower concentrations for use in infants and smaller children.
A 1:200,000 epinephrine/chloroprocaine hydrochloride solution may be prepared by adding 0.1 mL of 1:1000 epinephrine hydrochloride injection to 20 mL of a 2 or 3% chloroprocaine hydrochloride solution that does not contain a preservative. Solutions containing epinephrine should not be used for interdigital block.
Solutions of 2 or 3% chloroprocaine hydrochloride with or without epinephrine and containing no preservatives are used for epidural or caudal anesthesia. To prevent intravascular or subarachnoid injection of a large epidural dose of anesthetic solution, a test dose (approximately 3 mL of a 3% solution or 5 mL of a 2% solution) should be injected prior to administering the total dose. When clinical conditions permit, use of a test dose solution that contains epinephrine should be considered to detect inadvertent intravascular injection.
When a continuous block technique is used, a portion of each supplemental dose should be administered as a test dose to ensure that the catheter has not been displaced. At least 5 minutes should elapse after each test dose before proceeding further. Injection of a large, single dose through a catheter should be avoided; instead, the drug should be administered in fractional doses.
If a large volume of the drug is inadvertently injected into the subarachnoid space, consideration should be given to withdrawing a moderate volume (e.g., 10 mL) of cerebrospinal fluid through the catheter after appropriate resuscitation and if the catheter is in place to attempt recovery of the drug. For epidural anesthesia in the lumbar region, 2-2.5 mL of a 2 or 3% solution (40-75 mg) may be given for each segment.
The usual total volume is 15-25 mL (300-750 mg). Repeat doses which are 2-6 mL less than the initial dose may be given at 40- to 50-minute intervals. For caudal anesthesia, the initial dose is 15-25 mL of a 2 or 3% solution (300-750 mg) of chloroprocaine hydrochloride.
Repeat doses may be given at 40- to 60-minute intervals.
For infiltration or nerve block anesthesia, 1 or 2% chloroprocaine hydrochloride solutions may be employed. The following doses of chloroprocaine hydrochloride have been suggested for various nerve blocks in the average adult: mandibular nerve block, 2-3 mL of a 2% solution (40-60 mg); infraorbital nerve block, 0.5-1 mL of a 2% solution (10-20 mg); brachial plexus block, 30-40 mL of a 2% solution (600-800 mg); and interdigital block, 3-4 mL of a 1% solution without epinephrine (30-40 mg). In obstetrical anesthesia, the following doses have been suggested for nerve blocks: pudendal block, 10 mL of a 2% solution (200 mg) for each side; and for paracervical block, 3 mL of a 1% solution (30 mg) per each of 4 sites.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for CLOROTEKAL (chloroprocaine hcl/pf):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Long-acting Bupivacaine/Local Anesthetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1) PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) |
BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF |
There are 0 moderate interactions.
The following contraindication information is available for CLOROTEKAL (chloroprocaine hcl/pf):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Methemoglobinemia |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Atrial fibrillation |
| Bradycardia |
| Butyrylcholinesterase deficiency |
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
| Myasthenia gravis |
| Structural disorder of heart |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for CLOROTEKAL (chloroprocaine hcl/pf):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 18 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hypotension |
| Rare/Very Rare |
|---|
|
Anaphylaxis Bradycardia Cardiac arrhythmia Chondrolysis of articular cartilage CNS toxicity Hemiparesis Hypertension Methemoglobinemia Myocardial dysfunction Respiratory depression Seizure disorder Status asthmaticus Tachycardia Unconsciousness Urticaria Vasodilation of blood vessels Ventricular arrhythmias |
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Chills Headache disorder |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Apprehension Blurred vision Diplopia Dizziness Drowsy Dysgeusia Edema Euphoria Hypoesthesia Injection site sequelae Miosis Muscle fasciculation Nausea Nervousness Oral hypoesthesia Sensation of cold Sensation of warmth Skin rash Symptoms of anxiety Tinnitus Tremor Visual changes Vomiting |
The following precautions are available for CLOROTEKAL (chloroprocaine hcl/pf):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CLOROTEKAL (chloroprocaine hcl/pf):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CLOROTEKAL (chloroprocaine hcl/pf)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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