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CHLOROPROCAINE HYDROCHLORIDE

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Overview

What is Clorotekal?

CLOROTEKAL is a sterile non pyrogenic local anesthetic.

The active ingredient in CLOROTEKAL is chloroprocaine hydrochloride (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride), an ester local anesthetic, which is represented by the following structural formula:

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. The pH of the solution is between 3.0 and 4.0. The osmolality of the solution is 270 – 300 mOsm/kg.



What does Clorotekal look like?



What are the available doses of Clorotekal?

5 mL Type I clear glass ampoule contains 50 mg of chloroprocaine hydrochloride (10 mg/mL) equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine. ( )

What should I talk to my health care provider before I take Clorotekal?

How should I use Clorotekal?

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.

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.


What interacts with Clorotekal?

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What are the warnings of Clorotekal?

Sorry No Records found


What are the precautions of Clorotekal?

Sorry No Records found


What are the side effects of Clorotekal?

Sorry No records found


What should I look out for while using Clorotekal?

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 ( ) ( )

General and specific contra-indications to spinal anesthesia regardless of the local anesthetic used, should be taken into account ( )

Intravenous regional anesthesia ( )

Serious problems with cardiac conduction ( )

Local infection at the site of proposed lumbar puncture ( )

Septicemia. ( )


What might happen if I take too much Clorotekal?

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 .

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.


How should I store and handle Clorotekal?

StorageStore at 20°C to 25°C (68°C to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).StorageStore at 20°C to 25°C (68°C to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).The CLOROTEKAL is supplied as a 50mg/5mL (10 mg/mL) equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine Type I glass ampules, stored in cartons containing 10 single-dose ampules (NDC 68055-699-10).The product is intended for intrathecal administration.Solution which are discolored or which contain particulate matter should not be administered.The CLOROTEKAL is supplied as a 50mg/5mL (10 mg/mL) equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine Type I glass ampules, stored in cartons containing 10 single-dose ampules (NDC 68055-699-10).The product is intended for intrathecal administration.Solution which are discolored or which contain particulate matter should not be administered.The CLOROTEKAL is supplied as a 50mg/5mL (10 mg/mL) equivalent to 44.05 mg/5 mL (8.81 mg/mL) chloroprocaine Type I glass ampules, stored in cartons containing 10 single-dose ampules (NDC 68055-699-10).The product is intended for intrathecal administration.Solution which are discolored or which contain particulate matter should not be administered.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Chloroprocaine, like other local anesthetics, blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

Non-Clinical Toxicology
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 ( ) ( )

General and specific contra-indications to spinal anesthesia regardless of the local anesthetic used, should be taken into account ( )

Intravenous regional anesthesia ( )

Serious problems with cardiac conduction ( )

Local infection at the site of proposed lumbar puncture ( )

Septicemia. ( )

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 resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies . 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

The following serious adverse reactions are described, or described in greater detail, in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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