B. Braun’s Clorotekal® (chloroprocaine hydrochloride) Now Available
BETHLEHEM, PA – September 17, 2018 — B. Braun Medical Inc. launched its first FDA-approved local anesthetic for spinal anesthesia, Clorotekal® (chloroprocaine hydrochloride*). It is now available in 50 mg/ 5mL glass ampules.
“Clorotekal is a preservative free spinal anesthetic that is designed for rapid onset and short duration of action,” said Tom Sutton, Vice President, Medical Device and Pharmaceutical Systems at B. Braun. “Our mission is to reimagine regional anesthesia by adding products to our robust anesthesia therapy portfolio that continue to address post-operative pain.”
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.
IMPORTANT SAFETY INFORMATION
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.
The onset of action with chloroprocaine is rapid (usually 6 to 12 minutes), and the duration of anesthesia, depending upon the amount used and the route of administration.
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.
*Clorotekal is a registered trademark of Sintetica S.A. and is manufactured for B. Braun Medical Inc.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes
B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit the B. Braun USA website.