Cetacaine Topical Anesthetic (Cetylite)

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ACTIVE INGREDIENTS

Benzocaine....................................................14.0%

Butyl Aminobenzoate.......................................2.0%

Tetracaine Hydrochloride.................................2.0%

CONTAINS

Benzalkonium Chloride....................................0.5%

Cetyl Dimethyl Ethyl Ammonium Bromide....0.005%

In bland, water-soluble base.

ACTION

The onset of Cetacaine produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCl and bridged by the intermediate action of Butamben.

It is believed that all of these agents act by reversibly blocking nerve conduction. Speed and duration of action is determined by the ability of the agent to be absorbed by the mucous membrane and nerve sheath and then to diffuse out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert metabolites which are excreted in the urine.

INDICATIONS

Cetacaine is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Spray is indicated for use to control pain or gagging. Cetacaine in all forms is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible.

DOSAGE AND ADMINISTRATION

Cetacaine Spray should be applied for approximately one second or less for normal anesthesia. Only a limited quantity of Cetacaine is required for anesthesia. Spray in excess of two seconds is contraindicated. Average expulsion rate of residue from spray, at normal temperatures, is 200 mg per second.

Tissue need not be dried prior to application of Cetacaine. Cetacaine should be applied directly to the site where pain control is required. Cetacaine Liquid may be applied with a cotton applicator or directly to tissue. The cotton applicator should not be held in position for extended periods of time, since local reactions to benzoate topical anesthetics are related to the length of time of application.

ADVERSE REACTIONS

Hypersensitivity Reactions:    Unpredictable adverse reactions (ie, hypersensitivity, including anaphylaxis) are extremely rare.

Localized allergic reactions may occur after prolonged or repeated use of any aminobenzoate anesthetic. The most common adverse reaction caused by local anesthetics is contact dermatitis charaterized by erythema and pruritus that may progress to vesiculation and oozing. This occurs most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations of allergy develop during use, the drug should be discontinued. To minimize the possibility of a serious allergic reaction, Cetacaine preparations should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact.

PRECAUTION

On rare occasions, methemoglobinemia has been reported in connection with the use of benzocaine-containing products. Care should be used not to exceed a two second spray. If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated).

USE IN PREGNANCY

Safe use of Cetacaine has not been established with respect to possible adverse effects upon fetal development. Therefore, Cetacaine should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Cetacaine is used.

Appropriate pediatric dosage has not been established for this product.

CONTRAINDICATIONS

Cetacaine is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Cetacaine should not be applied to large areas of denuded or inflamed tissue. Cetacaine should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient. Dosage should be reduced in the debilitated elderly, acutely ill, and very young patients.

Individual dosage of tetracaine hydrochloride in excess of 20 mg is contraindicated. Cetacaine should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine.

Jetco® Cannula for Cetacaine Spray

• The supplied 4" stainless steel Jetco® cannula (J-4) for Cetacaine Spray is especially designed for accessibility and application of Cetacaine, at the required site of pain control.
• The Jetco cannula is also available in 6", (J-6) and 8" curved configuration, (J-8).
• Replacement Jetco cannulas are available.
• The Jetco cannula is inserted firmly into the protruding plastic stem on each bottle of Cetacaine Spray.
• The Jetco cannula may be removed and reinserted as many times as required for cleansing or sterilization, and is autoclavable.

PACKAGING AVAILABLE

Cetacaine Spray 56 g. including propellant.*

Cetacaine Liquid 56 g.

Cetacaine Hospital Gel 29 g. Tube.

*WARNING

Contains CFC-114 and CFC-11, substances which harm public health and environment by destroying ozone in the upper atmosphere.

Rx Only.

CETYLITE

INDUSTRIES, INC.

9051 River Road

Pennsauken, NJ 08110-3293

1-800-257-7740

www.cetylite.com

Made in U.S.A.Rev.     9/03.1

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