CLOROTEKAL Solution for injection Ref.[28062] Active ingredients: Chloroprocaine

2.1 Important Dosage and Administration Information

CLOROTEKAL must only be administered by clinicians with the necessary knowledge and experience in the intrathecal anesthesia administration. The equipment, drugs, and personnel capable of dealing with an emergency, e.g. maintaining the patency of the airways and administering oxygen, must be immediately available, because in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anesthetics, even in the absence of individual hypersensitivity in the patient’s case history.

• Visually inspect parental drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.
• CLOROTEKAL is intended for single-use only. Discard any unused portion in an appropriate manner.
• CLOROTEKAL must be drawn up with a filter needle. Use CLOROTEKAL immediately after first opening. Protect from light. Do not freeze, heat, or autoclave [see How Supplied/Storage and Handling (16)].
• In the absence of safety studies and compatibility studies, this product must not be mixed or diluted with other products. In addition, this product should not be substituted with a different chloroprocaine product.
• The safety of CLOROTEKAL administration via continuous spinal catheters has not been established and administration by this route is not recommended.

2.2 Administration

Not for epidural administration.

Monitor vital signs during dural puncture and provide oxygen via face mask or nasal cannula. Slowly inject the entire dose, while monitoring the patient’s vital signs.

In general, the following points should be taken into consideration:

• A free flow of cerebrospinal fluid during the performance of spinal anesthesia is indicative of entry into the subarachnoid space.
• To avoid intravascular injection, aspiration should be performed before the anesthetic solution is injected. The needle must be repositioned until no blood return can be elicited. However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
• Do not puncture the skin if there are signs of infection or inflammation.
• The patient should have IV fluids running via an indwelling catheter to assure functioning intravenous access.

2.3 Recommended Dosing

The extent and degree of spinal anesthesia depend upon several factors including dosage, specific gravity of the anesthetic solution, volume of solution used, force of injection, level of puncture, and position of the patient during and immediately after injection.

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.

Doses above 50 mg have not been adequately tested for efficacy and safety.

Acute 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 (5.1) and Adverse Reactions (6)].

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 (5.1)].

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.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).