B. Braun Medical Inc. will introduce its first FDA-approved local
anesthetic for spinal anesthesia -- Clorotekal® (chloroprocaine
hydrochloride) -- at the American Society of Regional Anesthesia
(ASRA) and Acute Pain Medicine’s 43rd annual conference from April
19-21 in New York City. B. Braun also will showcase, Xperius®
Ultrasound System and the Ultra 360® family of nerve block needles.
“B. Braun continues to reimagine regional anesthesia by adding
products to our robust regional anesthesia therapy portfolio that
address post-operative pain and help reduce the use of opioids,”
said Tom Sutton, Vice President, Medical Device and Pharmaceutical
Systems at B. Braun.
Clorotekal (chloroprocaine hydrochloride) is indicated for
intrathecal injection in adults for the production of subarachroid
block (spinal anesthesia). Indicated procedures include those
suitable for Clorotekal’s short duration of action. Clorotekal will
be available in 50mg/5ml glass ampules in the third quarter. Please
see prescribing information attached.
Sintetica SA, will offer an educational presentation at ASRA on
Saturday, April 21st titled “Fast Track Spinal Anesthesia: A New
Kid in Town.” The presentation will be made by Professor Narinder
Rawal, M.D., PhD., Timo Palas, M.D., Benjamin Fox, M.D., and Arthur
Atchabahian, M.D. It will be held from noon to 1 p.m. in the
Broadway Ballroom North at the Marriott Marquis. B. Braun will
provide lunch during the presentation. Pre-registration is not
required.
In booth #201 at ASRA, B. Braun will also feature its various
regional anesthesia solutions, including:
- Xperius Point-of-Care Ultrasound System:
Xperius is designed to be mobile and fit seamlessly into the care
area. Its anatomical imaging complements B. Braun’s regional block
needle portfolio, and its image quality promotes confident needle
targeting and positioning. Xperius’ fully articulating arm allows
for easy adjustment of the ultrasound monitor position and the
angle of the screen for ergonomic use and screen view. Xperius is
the first product resulting from a strategic alliance between B.
Braun Melsungen AG and Royal Philips1 (NYSE: PHG, AEX: PHIA).
- Ultra 360 Nerve Block Needles: Ultra 360
needles feature B. Braun’s echogenic 360º X-pattern. The ‘X’ is a
unique shape, which when combined with a clear coating, reflects
more ultrasound waves back to the probe than previous designs.2 The
needles are designed to provide visibility without compromising
puncture characteristics.
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 ostomy and
wound care, dialysis, nutrition, pharmacy admixture and
compounding. 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 www.BBraunUSA.com.
1 Philips is the manufacturer of the Xperius ultrasound system.
B. Braun Medical Inc. is the distributor of the Xperius ultrasound
system.2 Internal testing: ETRs JMLY-8ADPRZ, NPAK-9VRK2K
Important Safety InformationBrief Summary (for
full Prescribing Information and Patient Information, refer to
Package Insert)
CLOROTEKAL® (chloroprocaine
hydrochloride) injection for intrathecal
INDICATIONS AND USAGECLOROTEKAL® (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•
CLOROTEKAL® is contraindicated in patients with a 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 [see Risk of
Hypersensitivity Reactions]• 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• Septicemia
WARNINGS AND PRECAUTIONSRisks with Neuraxial
AdministrationLocal anesthetics should only be
administered 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 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 [see Adverse Reaction and
Overdosage]. 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.The clinician should take the appropriate measures to avoid
an intravascular injection. In addition, it is essential for the
clinician to know how to recognize and treat undesirable effects,
systemic toxicity and other complications. If signs of acute
systemic toxicity or total spinal block are observed, the injection
of the local anesthetic must be stopped immediately [see
Overdosage].
Cardiovascular System ReactionsHypotension and
bradycardia are well known side effects of all local anesthetics
[see Adverse Reaction and Overdosage].A serious, undesirable effect
of spinal anesthesia is high or total spinal block, with consequent
cardiovascular and respiratory depression. Cardiovascular
depression is induced by an extended block of the sympathetic
nervous system, which may induce severe hypotension and bradycardia
to the point of cardiac arrest. Respiratory depression is induced
by the block of the respiratory musculature and the diaphragm.
Careful and constant monitoring of cardiovascular and respiratory
(adequacy of ventilation) vital signs and the patient’s state of
consciousness should be accomplished after CLOROTEKAL®
injection.Patients over 65 years, particularly those with
hypertension, may be at increased risk for experiencing the
hypotensive effects of CLOROTEKAL®. Blood pressure should,
therefore, be carefully monitored after CLOROTEKAL® injection.
Hypotension may be controlled by vasoconstrictors in dosages
depending on the severity of hypotension response of treatment.
Central Nervous System ReactionsNeurological
damage may occur after spinal anesthesia, manifesting as
paresthesia, loss of sensitivity, motor weakness, paralysis, cauda
equina syndrome. Occasionally these symptoms persist and can be
permanent. Carefully evaluate patients with underlying
neuromuscular disorders and consider the risk-benefit ratio prior
to treatment.Carefully and constantly monitor cardiovascular and
respiratory (adequacy of ventilation) vital signs and the patient’s
state of consciousness after local anesthetic injection.
Restlessness, headache, anxiety, incoherent speech problems,
lightheadedness, paresthesia, numbness and tingling of the mouth
and lips, hearing problems, tinnitus, dizziness, blurred vision,
convulsions, loss of consciousness tremors, depression, or
drowsiness may be early warning signs of central nervous system
toxicity [see Adverse Reactions and Overdosage].
Risk of Hypersensitivity ReactionsCLOROTEKAL®
is contraindicated in patients hypersensitive to drugs of the PABA
ester group. Allergic type reactions may occur as a result of
sensitivity to the local anesthetic or to other formulation
ingredients. 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, anaphylaxis 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 [see
Adverse Reactions].
Risk of Chondrolysis in Patients Receiving
Intraarticular InjectionsIntra-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.
Conditions Requiring Special AttentionSome
patients require special attention in order to reduce the risk of
serious undesirable effects, even when locoregional anesthesia
constitutes the optimum choice for the surgical
intervention:• Patients with total or partial heart block,
since local anesthetics can suppress myocardial conduction•
Patients with high grade cardiac decompensation• Patients
with advanced liver or kidney damage [see Use in Specific
Populations]• Elderly patients and patients in poor general
condition [see Use in Specific Populations]• Patients with
genetic deficiency of plasma cholinesterase [see Adverse
Reactions]• Patients taking anticoagulants or with congenital
or acquired bleeding disorder• Patients with severe
anemiaBecause ester-type local anesthetics are hydrolyzed by plasma
cholinesterase produced by the liver, use CLOROTEKAL® cautiously in
patients with advanced hepatic disease [see Use in Specific
Populations].Local anesthetics should also be used with caution in
patients with impaired cardiovascular function since they may be
less able to compensate for functional changes associated with the
prolongation of A-V conduction produced by these drugs.ADVERSE
REACTIONSThe following serious adverse reactions are described, or
described in greater detail, in other sections:•
Cardiovascular System Reactions [see Warnings and
Precautions]• Central Nervous System Reactions [see Warnings
and Precautions]• Hypersensitivity Reactions [see Warnings
and Precautions]
Clinical Trials ExperienceBecause clinical
studies are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical studies of another drug
and may not reflect the rates observed in practice.During clinical
investigations, a total of 111 patients undergoing various surgical
procedures received CLOROTEKAL®. Patients were administered a dose
ranging from 30 to 50 mg of CLOROTEKAL®.Taking into consideration
data for 50 mg dose only, the most common adverse reaction in these
studies, (incidence greater than or equal to 10%) following
CLOROTEKAL® administration was procedural pain.The common adverse
reactions (incidence greater than or equal to 2% to less than 10%)
following CLOROTEKAL® administration were injection site pain and
hypotension.The less common/rare adverse reactions (incidence less
than 2%) following CLOROTEKAL® administration were anesthetic
complication, nausea, headache and hyperglycemia.
DRUG INTERACTIONSConcurrent administration of
vasopressor drugs (for the treatment of hypotension related to
obstetric blocks) and ergot-type oxytocic drugs may cause severe,
persistent hypertension or cerebrovascular accidents.The
para-aminobenzoic acid metabolite of chloroprocaine inhibits the
action of sulfonamides. Therefore, avoid use in any condition in
which a sulfonamide drug is being employed.No studies have been
performed on interactions between chloroprocaine and class III
antiarrhythmics (e.g., amiodarone). Carefully monitor these
patients for cardiovascular effects.The combination of various
local anesthetics may result in additive effects affecting the
cardiovascular system and the central nervous system. Monitor these
patients for signs and symptoms of local anesthetic toxicity.USE IN
SPECIFIC POPULATIONS
PregnancyRisk SummaryThe limited available data
with chloroprocaine use in pregnant women are insufficient to
inform a drug associated risk of adverse developmental outcomes.
There are no animal reproduction studies for chloroprocaine. There
are risks to the mother and the fetus associated with use of
chloroprocaine during labor and delivery (see Clinical
Considerations).The estimated background risk of major birth
defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or
other adverse outcomes. In the U.S. general population, the
estimated background risk of major birth defects and miscarriage in
clinically recognized pregnancies is 2 to 4% and 15 to 20%,
respectively.Clinical ConsiderationsLabor or deliveryLocal
anesthetics rapidly cross the placenta, and when used for epidural,
paracervical, pudendal or caudal block anesthesia, can cause
varying degrees of maternal, fetal and neonatal toxicity. The
incidence and degree of toxicity depend upon the procedure
performed, the type and amount of drug used, and the technique of
drug administration. Adverse reactions in the parturient, fetus and
neonate involve alterations of the central nervous system,
peripheral vascular tone and cardiac function.Spinal anesthesia may
alter the forces of parturition through changes in uterine
contractility or maternal expulsive efforts. Spinal anesthesia has
also been reported to prolong the second stage of labor by removing
the parturient’s reflex urge to bear down or by interfering with
motor function. The use of obstetrical anesthesia may increase the
need for forceps assistance.The use of some local anesthetic drug
products during labor and delivery may be followed by diminished
muscle strength and tone for the first day or two of life.Maternal
hypotension has resulted from regional anesthesia. Local
anesthetics produce vasodilation by blocking sympathetic nerves.
The fetal heart rate also should be monitored continuously, and
electronic fetal monitoring is highly advisable.
LactationRisk SummaryThere are no data on the
presence of chloroprocaine in human milk, the effects on the
breastfed infant, or the effects on milk production.The
developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for CLOROTEKAL®
and any potential adverse effects on the breastfed infant from
CLOROTEKAL® or from the underlying maternal condition.
Pediatric UseSafety and effectiveness in
pediatric patient have not been established.
Geriatric UsePatients over 65 years,
particularly those with hypertension, may be at increased risk of
developing hypotension while undergoing spinal anesthesia with
CLOROTEKAL®.Clinical studies of CLOROTEKAL® did not include
sufficient numbers of subjects 65 and over to determine whether
they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses
between the elderly and younger patients. In general an elderly
patient will have greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or other drug therapy
[see Warnings and Precautions].
Hepatic and Renal ImpairmentSince ester-type
local anesthetics are hydrolyzed by plasma cholinesterase produced
by the liver, the risk of toxic reactions might be greater in
patients with advanced hepatic disease.This drug and its
metabolites are known to be substantially excreted by the kidney,
and the risk of toxic reactions might be greater in patients with
impaired renal function.
OVERDOSAGEAcute emergencies from local anesthetics are generally
related to high plasma levels encountered during therapeutic use or
to underventilation secondary to upward extension of spinal
anesthesia. Hypotension is commonly encountered during the conduct
of spinal anesthesia due to relaxation of sympathetic tone, and
sometimes, contributory mechanical obstruction of venous return
[see Warning and Precautions and Adverse Reactions].In the case of
accidental intravenous administration, the toxic effect occurs
within 1 minute. In mice, the intravenous LD50 of chloroprocaine
HCl is 97 mg/kg and the subcutaneous LD50 of chloroprocaine HCl is
950 mg/kg.Management of Local Anesthetic Emergencies: the first
consideration is prevention, best accomplished by careful and
constant monitoring of cardiovascular and respiratory vital signs
and the patient’s state of consciousness after each local
anesthetic injection. At the first sign of change, administration
of CLOROTEKAL® must be stopped and oxygen should be administered
[see Warning and Precautions].The first step in the management of
convulsions, as well as underventilation or apnea, consists of
immediate attention to the maintenance of a patient airway and
assisted or controlled ventilation with oxygen and a delivery
system capable of permitting immediate positive airway pressure by
mask. Immediately after the institution of these ventilatory
measures, the adequacy of the circulation should be evaluated,
keeping in mind that drugs used to treat convulsions sometimes
depress the circulation when administered intravenously. Should
convulsions persist despite adequate respiratory support, and if
the status of the circulation permits, small increments of an
ultra-short acting barbiturate or a benzodiazepine may be
administered intravenously; the clinician should be familiar, prior
to the use of anesthetics, with appropriate anticonvulsant drugs.
Supportive treatment of circulatory depression may require
administration of intravenous fluids and, when appropriate, a
vasopressor dictated by the clinical situation (such as ephedrine
to enhance myocardial contractile force). If not treated
immediately, both convulsions and cardiovascular depression can
result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac
arrest. Recovery has been reported after prolonged resuscitative
efforts. Endotracheal intubation, employing drugs and techniques
familiar to the clinician, may be indicated, after initial
administration of oxygen by mask, if difficulty is encountered in
the maintenance of a patient’s airway or if prolonged ventilatory
support (assisted or controlled) is indicated.
DESCRIPTIONCLOROTEKAL® is a sterile non pyrogenic local
anesthetic.1 mL of solution for injection contains 10 mg of
chloroprocaine hydrochloride, equivalent to 44.05 mg/5 mL (8.81
mg/mL) chloroprocaine. It also contains the following inactive
ingredients: hydrochloric acid 1N (for pH adjustment), sodium
chloride, water for injection.
Rx onlyClorotekal is a registered trademark of Sintetica
S.A.
Manufactured for:B. Braun Medical
Inc.Bethlehem, PA 18018-3524 USA1-800-227-2862
Made in Switzerland
Koninklijke Philips NV (EU:PHIA)
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