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The Only FDA-Approved Chloroprocaine Hydrochloride Indicated for Spinal Anesthesia

Indications: Clorotekal®* (chloroprocaine hydrochloride) is indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for CLOROTEKAL’s short duration of action.

Contraindications: Known hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anesthetics or to any of the excipients. General and specific contraindications to spinal anesthesia regardless of the local anesthetic used should be taken into account (e.g., decompensated cardiac insufficiency, hypovolemic shock, coagulopathy). Intravenous regional anesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area). Serious problems with cardiac conduction. Local infection at the site of proposed lumbar puncture and Septicemia.

*Clorotekal is a registered trademark of Sintetica S.A. and is manufactured for B. Braun Medical Inc. 

A Closer Look at Clorotekal

PRESERVATIVE-FREE: Clorotekal is formulated without sodium bisulfate or methylparaben.

RAPID ONSET: Clorotekal has a rapid onset of action, usually 6 to 12 minutes.

SHORT DURATION: Clorotekal provides adequate spinal anesthesia for short-duration outpatient procedures.

ISOBARIC SOLUTION: Range of relative density 1.0070 - 1.0080 g/g

1. Mathevet, P., Dargent, D., Roy, M., & Beau, G. (1994). A Randomized Prospective Study Comparing Three Techniques of Conization: Cold Knife, Laser, and LEEP. Gynecologic Oncology, 54(2), 175-179.
2. Peng, Y., Cheng, Y., Wang, G., Wang, S., Jia, C., Yang, B., . . . Geng, D. (2008). Clinical application of a new device for minimally invasive circumcision. Asian Journal of Andrology, 10(3), 447-454.
3. Yadeau, J. T., Fields, K. G., Kahn, R. L., Lasala, V. R., Ellis, S. J., Levine, D. S., . . . Roberts, M. M. (2018). Readiness for Discharge After Foot and Ankle Surgery Using Peripheral Nerve Blocks. Anesthesia & Analgesia, doi:10.1213/ane.0000000000003456
4. Zendejas, B., Cook, D. A., Hernández-Irizarry, R., Huebner, M., & Farley, D. R. (2012). Mastery Learning Simulation-Based Curriculum for Laparoscopic TEP Inguinal Hernia Repair. Journal of Surgical Education, 69(2), 208-214.

Clinical Studies of 1% Chloroprocaine

Study Design:

  • Study 1 was a phase 2 single-center, prospective, randomized, observer-blinded study.
  • Evaluated the efficacy and the tolerability of 1% chloroprocaine in three doses 30, 40, and 50 mg after spinal injection.
  • In 45 adult patients undergoing short duration (<40 minutes) lower limb surgery.

Efficacy Results:

  • Neither rescue anesthesia nor rescue analgesia was required for subjects randomized to chloroprocaine 50 mg.
  • Three subjects in the 30 mg dose group and three subjects in the 40 mg dose group required intraoperative rescue medications.
  • Doses above 50 mg have not been adequately tested for efficacy and safety.
*Spinal anesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomized, observer-blinded study in adult patients.

Study Design:

  • Study 2 was a phase 3, multicenter, prospective, randomized, observer-blinded study.
  • Evaluated the safety and efficacy of 50 mg of chloroprocaine 10 mg/mL in intrathecal anesthesia versus 10 mg of bupivacaine 0.5%.
  • In 130 adult patients undergoing short duration (<40 minutes) low abdominal surgery (gynecological or urological) and lower limb surgery.
  • Each patient received a single dose of anesthetic: 50 mg of chloroprocaine or 10 mg of bupivacaine.

Efficacy Results:

  • Efficacy was determined by the proportion of patients who were able to complete the surgical procedure without the need for rescue intravenous analgesic or sedation drugs.
  • Efficacy results proved that 6 of 66 subjects (9%) in the chloroprocaine group required rescue compared to 6 of 64 (9%) in the bupivacaine group.
*Prospective, observer-blinded, randomized clinical study to investigate and compare the efficacy of intrathecal plain solutions containing Chloroprocaine 1% (50 mg) versus Bupivacaine 0.5% (10mg)

Specifications

Product Details

Product Size:

50mg/5mL

NDC#

0264-7055-10

Clorotekal Contact

B. Braun Medical Inc. Medical Affairs Specialists

If you are a healthcare professional requiring medical information on Clorotekal, please contact:
You are encouraged to report negative side effects of prescribed drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

CLOROTEKAL® (chloroprocaine hydrochloride) is a prescription drug indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for Clorotekal’s short duration of action.

CONTRAINDICATIONS

Known hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anesthetics or to any of the excipients. General and specific contraindications to spinal anesthesia regardless of the local anesthetic used should be taken into account (e.g., decompensated cardiac insufficiency, hypovolemic shock, coagulopathy). Intravenous regional anesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area). Serious problems with cardiac conduction. Local infection at the site of proposed lumbar puncture and Septicemia.

DOSAGE AND ADMINISTRATION

CLOROTEKAL is intended for single-dose administration only. To obtain an effective block to the T 10 level with one single administration in an adult of average height and weight (approximately 70 kg), the recommended dose is 50 mg (5 mL).

WARNINGS AND PRECAUTIONS

Risks with Neuraxial Administration: Local anesthetics should only be administered after insuring 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. Cardiovascular System Reactions: hypotension and bradycardia. Central Nervous System Reactions: paresthesia, loss of sensitivity, motor weakness, paralysis, cauda equina syndrome and permanent neurological injury. Allergic Reactions: in patients with a known hypersensitivity to the active substance or to other formulation ingredients. Chondrolysis: in intra-articular infusions in arthroscopic and other surgical procedures.

ADVERSE REACTIONS

Adverse reactions reported with an incidence greater than or equal to 2 % following CLOROTEKAL administration are procedural pain, injection site pain and hypotension. To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Vasopressor and Ergot-Type Oxytocic Drugs: May cause severe, persistent hypertension or cerebrovascular accidents. Avoid concurrent administration.

• Sulfonamide Drugs: Avoid use in any condition in which a sulfonamide drug is being employed.

• Antiarrhythmics: No studies have been performed on interactions between chloroprocaine and class III antiarrhythmics (e.g. amiodarone).

• Local Anesthetics: Avoid combination of various local anesthetics.