Clorotekal Dosage

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.

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.

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.