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Brief Summary (for full Prescribing Information and Patient Information, refer to Package Insert) (chloroprocaine hydrochloride) injection for intrathecal use INDICATIONS AND USAGE 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 • CLOROTEKAL® is contraindicated in patients with a known hypersensi - tivity to the active substance, medicinal products of the PABA (para-amino- benzoic acid) ester group, other ester-type local anesthetics or to any of the excipients [see Risk of Hypersensitivity Reactions] *HQHUDODQGVSHFL¿FFRQWUDLQGLFDWLRQVWRVSLQDODQHVWKHVLDUHJDUGOHVVRI the local anesthetic used, should be taken into account (e.g., decompensat - HGFDUGLDFLQVXI¿FLHQF\K\SRYROHPLFVKRFNFRDJXORSDWK\ • 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 PRECAUTIONS Risks with Neuraxial Administration Local 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 resusci - tative 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 Reactions Hypotension 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. Cardio - vascular 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 and response of treatment. Central Nervous System Reactions Neurological 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 FRQVLGHUWKHULVNEHQH¿WUDWLRSULRUWRWUHDWPHQW 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 Reactions CLOROTEKAL® 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 VHQVLWLYLW\KDVQRWEHHQGH¿QLWHO\HVWDEOLVKHG[see Adverse Reactions]. Risk of Chondrolysis in Patients Receiving Intraarticular Injections Intra-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 DQGZLWKRXWHSLQHSKULQHIRUSHULRGVRIWRKRXUV7KHUHLVLQVXI¿FLHQW information to determine whether shorter infusion periods are not associated ZLWKWKHVH¿QGLQJV7KHWLPHRIRQVHWRIV\PSWRPVVXFKDVMRLQWSDLQ 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 chon - drolysis. Patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Conditions Requiring Special Attention Some 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 >VHH8VHLQ6SHFL¿F Populations] • Elderly patients and patients in poor general condition >VHH8VHLQ6SHFL¿F Populations] 3DWLHQWVZLWKJHQHWLFGH¿FLHQF\RISODVPDFKROLQHVWHUDVH[see Adverse Reactions] • Patients taking anticoagulants or with congenital or acquired bleeding disorder • Patients with severe anemia Because ester-type local anesthetics are hydrolyzed by plasma cholines - terase produced by the liver, use CLOROTEKAL® cautiously in patients with advanced hepatic disease >VHH8VHLQ6SHFL¿F3RSXODWLRQV@. 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 REACTIONS The 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 Experience Because 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 QRWUHÀHFWWKHUDWHVREVHUYHGLQSUDFWLFH 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%) follow - ing CLOROTEKAL® administration were anesthetic complication, nausea, headache and hyperglycemia. DRUG INTERACTIONS Concurrent 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 Pregnancy Risk Summary The limited available data with chloroprocaine use in pregnant women are LQVXI¿FLHQWWRLQIRUPDGUXJDVVRFLDWHGULVNRIDGYHUVHGHYHORSPHQWDORXW - comes. 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 popula - tion, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Labor or delivery Local 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 parturi- HQW¶VUHÀH[XUJHWREHDUGRZQRUE\LQWHUIHULQJZLWKPRWRUIXQFWLRQ7KHXVH of obstetrical anesthesia may increase the need for forceps assistance. The use of some local anesthetic drug products during labor and delivery PD\EHIROORZHGE\GLPLQLVKHGPXVFOHVWUHQJWKDQGWRQHIRUWKH¿UVWGD\ or two of life. Maternal hypotension has resulted from regional anesthesia. Local anes - thetics produce vasodilation by blocking sympathetic nerves. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Lactation Risk Summary There are no data on the presence of chloroprocaine in human milk, the effects on the breastfed infant, or the effects on milk production. 7KHGHYHORSPHQWDODQGKHDOWKEHQH¿WVRIEUHDVWIHHGLQJVKRXOGEH 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 Use Safety and effectiveness in pediatric patient have not been established. Geriatric Use Patients over 65 years, particularly those with hypertension, may be at in - creased risk of developing hypotension while undergoing spinal anesthesia with CLOROTEKAL®. &OLQLFDOVWXGLHVRI&/2527(.$/GLGQRWLQFOXGHVXI¿FLHQWQXPEHUVRI subjects 65 and over to determine whether they respond differently from \RXQJHUVXEMHFWV2WKHUUHSRUWHGFOLQLFDOH[SHULHQFHKDVQRWLGHQWL¿HG differences in responses between the elderly and younger patients. In general an elderly patient will have greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions]. Hepatic and Renal Impairment Since ester-type local anesthetics are hydrolyzed by plasma cholines - terase produced by the liver, the risk of toxic reactions might be greater in patients with advanced hepatic disease. This drug and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions might be greater in patients with impaired renal function. OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use or to underventilation sec - ondary to upward extension of spinal anesthesia. Hypotension is commonly encountered during the conduct of spinal anesthesia due to relaxation of sympathetic tone, and sometimes, contributory mechanical obstruction of venous return [see Warning and Precautions and Adverse Reactions]. In the case of accidental intravenous administration, the toxic effect occurs within 1 minute. In mice, the intravenous LD50 of chloroprocaine HCl is 97 mg/kg and the subcutaneous LD50 of chloroprocaine HCl is 950 mg/kg. Management of Local Anesthetic Emergencies:WKH¿UVWFRQVLGHUDWLRQ is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of con - VFLRXVQHVVDIWHUHDFKORFDODQHVWKHWLFLQMHFWLRQ$WWKH¿UVWVLJQRIFKDQJH administration of CLOROTEKAL® must be stopped and oxygen should be administered [see Warning and Precautions]. 7KH¿UVWVWHSLQWKHPDQDJHPHQWRIFRQYXOVLRQVDVZHOODVXQGHUYHQ- tilation 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 RIFLUFXODWRU\GHSUHVVLRQPD\UHTXLUHDGPLQLVWUDWLRQRILQWUDYHQRXVÀXLGV and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force). If not treated immedi - ately, 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, DIWHULQLWLDODGPLQLVWUDWLRQRIR[\JHQE\PDVNLIGLI¿FXOW\LVHQFRXQWHUHGLQ the maintenance of a patient's airway or if prolonged ventilatory support (assisted or controlled) is indicated. DESCRIPTION CLOROTEKAL® 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 only Clorotekal is a registered trademark of Sintetica S.A. Manufactured for: B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Made in Switzerland LD-577-1 03/2018